As the medical cannabis industry blossoms in Europe, there is an urgent need to consider the cross-over between the nascent cannabis business and the established pharmaceutical industry.
Growing public support for medical cannabis is pushing progressive legislation in an increasing number of countries. As Cannabis Europa Paris approaches on February 8th, we examine what knowledge the cannabis industry can take from the development of the pharmaceutical industry.
BREAKING THE BARRIERS
Developing medical cannabis products has unique difficulties incomparable to modern medical products. Firstly, there is the taboo around cannabis to consider and the legal restrictions within most countries, despite recent progress at the international level, such as the World Health Organisation’s recently announced recommendation that cannabis be moved to Schedule 1. These issues create barriers to research that has hindered progress for decades.
Secondly, the nature of the plant itself complicates matters, because it contains more active ingredients than most plants that have ever been studied before. Even the terpenes can be very active in enhancing bioavailability, so it’s not just CBD and THC that researchers need to worry about, but THCa, CBDa, CBG, THCV etc. There are more than 120 cannabinoids with potential therapeutic value, and anecdotally, patients have found that a product that contains a mix of these cannabinoids generally works better than pure CBD or THC.
Meanwhile, to receive medical registration for a product, it is usually required to characterise every element of the product that is above a certain percentage. Given that there are an effectively infinite number of combinations of different cannabinoids, it can seem almost impossible to pin down exactly what each of them does and how they interact with each other, which makes the traditional pharmaceutical method appear totally unfeasible.
DATA-BASED DEVELOPMENT
Dr Rosemary Mazanet, Chief Scientific Officer for US-based medical cannabis company Columbia Care said: “We make products now based on data that we get from small populations, knowing which cannabinoids are working better. We make a product and can change it overnight, whereas a pharmaceutical company would have to ‘Phase 1’ a combination product again. So, it would take another eight years and however-many dollars.”
Moreover, when it comes to randomised controlled trials, which are a core element of any pharmaceutical drug development, it can be tricky to conduct these for cannabis products. In countries where people have easy access to cannabis, those placed on the placebo can often find a way to take the active drug anyway.
Dr Mazanet said: “I think randomised trials are possible when they’re seeking approval and the drug is not available outside the study. But anyone who has done Phase 4 trials after some things are available will tell you it’s very hard, because people will do everything they can to get the drug.”
All this means that the traditional pharmaceutical model may not fit perfectly for developing medical cannabis products. That said, there are still key parts of that process that are useful and relevant. For example, it’s important to be clear what we are actually talking about, as ‘medical cannabis’ is an extraordinarily broad category of medicines.
“My problem is when people say ‘cannabis works’ or ‘cannabis doesn’t work’. Well, what do you mean by cannabis? How much of each cannabinoid are we talking about? Whilst it’s impossible to recreate the pharmaceutical experience, we can at least do a good job in saying what the product is.”
Dr Rosemary Mazanet, CSO Columbia Care and Cannabis Europa Speaker
Another important element is, of course, the emphasis on patient safety and on evidence of efficacy. Whilst randomised controlled trials face legitimate methodological issues, observational studies can be conducted using patients before treatment as their own control. Many companies also use big data capture: noting what people buy repetitively with their own money. If people are choosing to repeat-buy a product for their condition, that would indicate it is working for them.
Cannabis products, whilst uniquely difficult to pin down, must ultimately have the same goal as any pharmaceutical drug – to help treat medical conditions as efficiently as possible. This will inevitably require much trial-and-error, but it is crucial to maximise the information-gathering at this stage if regulators across the globe are to take cannabis products seriously as a medicine.
