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A clinical trial recently launched in Canada is the first of its kind to collect real-world data on the use of validated medical cannabis products.

The Medical Cannabis Real-World Evidence clinical trial allows patients to choose medical cannabis products that have been tested and have information on what is in the product, including the milligrams of THC and cannabidiol and other phytocannabinoids being consumed.

Quote from Clarke on cannabis

Patients in the clinical trial are able to access a variety of medical cannabis products, including dried flower, oil extracts, edibles and topical preparations through an online platform that was developed by Shoppers Drug Mart, a Canadian retail pharmacy chain.

The goals of the study are to collect evidence on the efficacy of the medical cannabis products and to provide physicians with real-world data to help guide them when prescribing these products.

Healio Primary Care spoke with Hance Clarke, MD, PhD, director of pain services at Toronto General Hospital, to learn more about the trial and how the findings will improve physicians’ understanding of medical cannabis products.

Q: What prompted you to conduct this study?

A: In Canada, since it first became accessible in 1999-2001, I had patients in the early 2000s who would say they were using cannabis for neuropathic pain or sleep, and all that I could say was, “great, nice to know, but there’s not much that I can do for you.” That landscape changed in 2013 when in Canada, a new regulation came into being that put the country into the forefront of cannabis. In 2018, that changed again, and it’s now become a legalized recreational product for Canada. Much of the world appears to be following suit.

There’s a lot that befell over the past 7 years since cannabis has had a legal framework — one that involves the physician’s wheelhouse. The problem is that early in that switch in 2013, many patients who would come to see me were already consumers of cannabis and they wanted to get access to products that were not recreationally legal yet. Their only protection was to come to a doctor who would be willing to authorize it. We don’t prescribe it, we give them medical authorization forms. Fast forward 6 years later, in the media, cannabis is somehow the utopia of society: it will heal and fix all things.

We know that there isn’t a single drug in the universe that at best helps more than one in three people who take it for a chronic condition. Part of the frustration is that we can certainly see that cannabis has been helpful for our patients — I see it and authorize it. But some of my patients were using a product and finding an effect, but then they’d go back to purchase another product and it’s completely ineffective, or it is not the same product but has the same label.

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One of the biggest issues in terms of physicians feeling confident in using these types of medications is understanding what their patient is taking and relying on the fact that it at least has been standardized or validated. Hats off to Ken Weisbrod and his team at the Shoppers Drug Mart for putting this together in the Canadian ecosystem, along with the input of everyone.

There’s a block chain technology, a company called TruTrace Technologies in California, that has created an architecture, and of the approximately 180 licensed producers in Canada, 12 of the producers have been brave enough to step up and say, “We want to test our products and put it in this platform.” That way, if a physician chooses this product, they will know the top five cannabinoids that are in this product, as well as all of the other analyses that have been done by the lab. If their patient sees a benefit with this product, they know that this is the same product they can access and can expect the same results from the product the next time they purchase it.

Believe it or not, this industry has been around now for 7 years and is worth billions of dollars, and we’re just getting to this stage of actually having validity and reliability in terms of what patients are taking. I honestly think that the trial will move this industry forward towards helping us sort out, at least, the strong signals in what is helpful to patients so that we can figure out what’s next for patients. For example, identifying the cannabinoids that we should focus on for randomized control trials and specific disease-modifying conditions like osteoarthritis, Parkinson’s and other conditions that do not have a lot of evidence. That is the starting place. We need to know exactly what people are taking and be sure of the molecules causing the symptom improvements before we start to then put it into a randomized control trial.

Q: What was the most interesting finding so far in the clinical trial?

A: We just launched the platform, which any physician in Canada who has an interest in cannabis can access. There’s a really small physician population — less than 5% of doctors — who are even willing to authorize this. It’s been this niche marketplace where a specific cannabis doctor, per se, would be prescribing it. We’re hoping to provide at least some semblance of reassurance to those who are considering it, and many doctors who have tried typical treatment courses are considering it for their patients. When dealing with cannabis and cannabinoid medicines, it’s very tricky because if a doctor doesn’t engage with their patient, that patient can get it recreationally. But the recreational market enables a variance of anywhere from 10% to 22% of their products based on what has been labeled. Which patient with a complex chronic medical condition looking for symptom relief would tolerate a 22% variability from one dose to the next? We certainly wouldn’t even tolerate a 0.5% variability in some pharmacological products, so why is it any different for cannabis products being used for the treatment of a medical condition?

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Q: How could the results of this trial impact recommendations and guidance on medical cannabis?

A: First, we’ll have a national repository of comparative real-world data. We’re starting with 2,000 patients, but that repository can certainly grow. We can then mine the data to, for example, determine how many patients were using the medication for their osteoarthritis. We know there is a huge population of patients currently using it, but what are the constituents that are actually helping this population, and what are the ones that aren’t? Once we can do that, we can start to move that information into animal testing models and potentially create novel therapeutics in some of these areas based on what the cannabinoids are doing physiologically.

If I were a patient and cannabis is something that I want to use as a therapy for my condition, I would absolutely want to know that the product I’m going to use will be available 3 months from now. I would want to know its’ composition, and I’d want to know that there’s been some regulatory framework so that I know I get the same product every time I order it. That does not exist currently in the marketplace, so I think that’s an important message that has to get out to the public, from a safety standpoint. Cannabis is currently not a reimbursed medicine and patients pay for these products, and so they should know what they’re getting themselves into.

Q: Can physicians in the United States utilize this research? How do trends in medical cannabis use in Canada compare to trends the United States?

A: The trends are very similar — I do know that the FDA has had some interest in what we are doing and what we have designed. Everyone will be able to benefit from the knowledge gained. One of the things where Canada has certainly separated itself from the rest of the world is that we have created this big industry, but we have also created a culture of research and the ability to look at this on a national level, whereas the U.S. is still pretty siloed in terms of federal legislation and state legislation. Not only are we leading from an industry perspective, we now have the opportunity to guide some of the scientific discoveries that can then be spun off into the preclinical world in the U.S. or in the U.K., where they’re now having discussions about how to do this, and do this even better than Canada, because we’ve done some things well and some things very poorly.

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Q: What are the potential benefits of using medical cannabis instead of other pain medications like opioids?

A: I treat pain. I see my chronic pain patients who are beholden to the opioid crisis and on high-dose opioids, and the reluctance of physicians to push opioid dosing into the hundreds of milligrams per day in the future is going to benefit the population as a whole. But there are millions of North Americans who are currently on high-dose opioids. Could cannabis be helpful in this scenario? Absolutely. But how can we start to put together dosing algorithms and use them as alternatives until we have a true foundation and an understanding of the products, and then integrate them into treatment recommendations? Right now, the chronic pain patient is just at the mercy of anything that is coming out, and cannabis became the next new molecule. It’s certainly helpful for some, but not for everybody. Our hope is that we get to the place where we understand what parts of the plant are helpful and integrate that information to help patients wean off their opioids. We’re just not there yet, and this will hopefully help us move closer to that goal and help patients regain their lives.

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