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Medical Cannabis

The Canadian Model

Last October, Canada became only the second country in the world (after Uruguay) to nationally legalize cannabis.

Canada’s transition to legal weed has not been without its bumps in the road. A large part of the country is dealing with cannabis shortages that some industry observers say may last for several years.

But despite those setbacks, Canada’s medical cannabis sector is doing just fine, especially when it comes to researching the medical benefits of cannabis and developing products designed to meet the public’s healthcare needs.

Dr. Mark Ware is chief medical officer at Canopy Growth, a major cannabis producer whose headquarters in Ontario are less than 50 miles from the St. Lawrence River and New York state.

Canopy Growth has been Wall Street’s poster child for what a successful legal cannabis company can be.

In 2014, Canopy Growth became the first publicly traded cannabis company in North America. This past August Constellation Brands, a major multinational alcoholic beverage company (they make Corona beer), invested an additional $4 billion into Canopy, the biggest such investment so far in the legal cannabis sector.

This past February the company reported better-than-expected quarterly results, due to a rapidly growing legal cannabis market — with revenue of $97.7 million Canadian ($73.6 million U.S.), or a year-over-year increase in revenue of 283 percent. Canopy Growth is one of the world’s largest legal cannabis companies, and it is rapidly diversifying into medicinal cannabis.

Dr. Ware came over to Canopy last year after 17 years as a professor of family medicine and anesthesia at McGill University in Montreal.

“I was working in pain management prior to becoming interested in the cannabinoids area,” he tells DOPE Magazine, “and recognizing the challenges that were present in pharmacological therapies for patients with severe chronic pain. At the same time, I was becoming aware of the fact that patients were claiming that using cannabis was helping them manage their symptoms.”

He also spent a decade as executive director of the Canadian Consortium for the Investigation of Cannabinoids and was vice-chair of Canada’s Task Force on Cannabis Legalization and Regulation.

Having federally-legal cannabis in Canada, he says, has created huge advantages when it comes to medical cannabis research.

“That gives us an opportunity to engage and to talk and get universities on board and get the academic community to take [cannabis] more seriously,” he observes. “Also, to allow the financial community to engage so investments can proceed, and markets are more open to investments into this space.”

Ware joined Canopy with a mission to build up the company’s research and development side. Like in the U.S., Canada had only limited cannabis research in the years leading up to legalization, and Canadian-based researchers have been scrambling to catch up on the science of cannabis.

“We basically hit the ground running; started building up the clinical trials and all the pieces necessary to essentially create a pharmaceutical program within Canopy Growth,” he says.

After decades of researching cannabis, Ware believes there are “three big pillars” where medicinal cannabis has already proven itself: with issues regarding pain, mood and sleep.

And those three ailments, he says, often interact with one another, since chronic pain can cause sleep problems and sleep problems can affect mood.

While there is great potential for medical cannabis to be used as a treatment for other conditions, Ware says researchers have to consider another “three pillars” — regarding quality, safety and efficacy.

“The first step is to make sure that you have products that are of sufficient quality to pass regulatory review and that are consistent, and that meet the standards expected by the physicians and patients when they use the prescription medicine,” he says.

“Then you start to explore your safety and efficacy equations. There’s plenty of conditions where there’s no research, and there is no data and study of patients reporting [cannabis use]. Picking the right indication, pursuing it with a view to establishing a signal of efficacy, is important.”

“Then, monitoring the safety of patients using this is a concern for many people. Cannabis is a powerful drug. It’s not without its risks, so one has to be careful in terms of patient selection and monitoring for side effects and so on, taking safety very seriously. If you couple those three things together, then you have the basis of a solid research program.”

One of the big challenges when researching cannabis, says Ware, is the fact that people have been using it for decades and that there is so much anecdotal evidence regarding the ailments pot is supposed to treat.

There’s also the fact that a large number of people, both in the general population and the medical community, still see cannabis as a recreational drug — while not necessarily recognizing the medical value of cannabinoids.

Cannabis research, Ware says, is taking place “in reverse” via a very unorthodox path, as compared to how other medications are discovered and tested.

“We’re really coming at this in a very different way from standard drug development,” he observes, “where typically a molecule is discovered in a lab, passed through its clinical trial inspections and becomes used in a new, widespread way.”

And it would be wrong, he adds, to dismiss any anecdotal evidence about the medical benefits of cannabis.

“I think to not include that experience in the consideration of how one moves forward with this would be to miss an incredible opportunity,” he says.

“People have been experimenting with cannabis for a long time. This led to the growth of potential effectiveness in some conditions and, of course, that’s a long list. It’s also given us important signals as to potential risks and harm. We can’t have one without the other. The anecdotes and the epidemiology of cannabis use can give rise to important signals in both safety and efficacy that have to be included in any discussion or consideration of where it goes as a therapy.”

Canada, along with Israel, is leading the way in terms of the research and development side of medical cannabis. And Ware believes that sharing that experience and information is important as legal, medical cannabis becomes an important international commodity.

“Just learning how we talk about this with a patient; how do we separate recreational and medical? How do we talk to doctors? How do we try to frame this in a way that understands the history, but also respects the future of what this can be?”

But that doesn’t mean, he adds, that the United States is falling behind when it comes to the research and development of cannabis and its medical potential.

“There’s phenomenal work happening in the U.S., in both the basic science in the cannabinoid field and some exploratory work, some new developments,” he says. “And there is the remarkable FDA-approved CBD [drug Epidiolex], the world’s first. This is not trivial. Not to underplay the role the U.S. plays in some of the innovation — some of the discovery that’s happening in the U.S. is also world-leading.”

For Ware, medical cannabis research is “really just trying to encourage and support a rational conversation about cannabis use as a therapy. I know Canada’s had a long time to think about it. We can share that with others.”

The Entrepreneur

Dahlia Mertens isn’t a trained scientist or doctor. But she’s a business owner who has over a decade of hands-on experience with cannabis and how it can help people.

A former massage therapist, Mertens once spent a season as a trimmer on a cannabis farm in northern California. While there, she discovered the health benefits of cannabis oil.

“When I came back home from California, I started doing my own experimentation in my kitchen: trying different oil recipes, looking online, doing research,” she tells DOPE, “and just playing around with recipes. Then I started using it on my clients. My massage oil — that was my first product.”

After much trial and error, Mertens developed a line of cannabis-infused topical products: Mary Jane’s Medicinals, established in 2009. And since then the Telluride, Colorado-based business has developed into a multi-million-dollar enterprise.

“So you don’t have to listen to me … you can try the products,” she laughs. “But you can listen to me, because I think after 10 years of doing this I have some authority on the subject.”

Mertens is a vocal advocate for the legalization of medical cannabis. In a recent opinion piece in GreenEntrepreneur.com, she argued against the long-held criticism that there’s no definitive proof that cannabis can safely and effectively treat a wide variety of ailments.

There are a lot of holes in that argument, she says.

“First, plenty of pharmaceutical drugs, that we broadly accept as legitimate medicine, received approval from the U.S. Food and Drug Administration without conclusive proof, or even convincing evidence, that they safely work,” she wrote. “And the safety and efficacy of those drugs aren’t even buttressed by a mountain of anecdotal evidence — unlike cannabis use, which has thousands of years of documentation.”

And that anecdotal evidence, she said, cannot and should not be dismissed.

“When tens of thousands of people report similar beneficial effects from medical marijuana products, chances are they’re onto something,” she added in the op-ed. “That body of anecdotal evidence has long since passed the point of critical mass — it’s no longer appropriate to shrug off anecdotal accounts as nothing more than unfounded hearsay.”

Mertens says she didn’t know about the body’s endocannabinoid system when she began making her products, and how cannabis can work with that endocannabinoid system — a series of neuroreceptors found throughout the body which help to maintain physical and mental health.

But she understands the science now. And she’s seen firsthand how cannabis can stimulate the body’s natural healing responses.

“That was the big surprise, kind of the ‘aha’ moment for me [when] treating with topicals,” she remembers.

Mertens’ topicals, meanwhile, are a hit with people suffering from a variety of ailments.

“Arthritis is a big one,” she notes. “A lot of people have reported back to us that they are off of their pain meds and just using the topicals.”

Patients with nerve damage and skin disorders have also gotten back to Mertens’ company with positive results after using their topicals. And she thinks topical cannabis products have helped to change many people’s minds about cannabis and remove the decades-long stigma surrounding marijuana.

“From the beginning of when I started this business till now, I have seen a big transition with people,” she says. “I’ve gotten a lot of very conservative people that would never consider smoking a joint open [up] to cannabis through these topicals. I feel like they’re an amazing ambassador, because they are a kind of a non-invasive approach to experience just the medicinal aspects of cannabis without any of the … ‘scary’ psychoactive effects that some people would be afraid of, or not want to experience.”

A lot of this education is taking place on the grassroots level, she says, because most doctors have been forced to stay away from information regarding cannabis as a medical treatment.

“The medical community hasn’t had the access, the education that they need,” Mertens adds. “Doctors are very, you know, analytical and scientifically based, so really much of what they do … relies upon the scientific process, and we haven’t had enough of that with cannabis. They can’t give it the credit.”

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