The Montreal study, now in Phase 2, will try to determine if cannabis can be used as a less-dangerous substitute for opiate-based painkillers
By the time she decided to try cannabis pills, Joanne Fiorito was in dire straits.
Fiorito could barely lift her feet when she walked and sometimes used an electric wheelchair to get around. Occasionally she’d wake up in the middle of the night, riddled with pain from her tensing muscles.
The 61 year old has lived with multiple sclerosis for most of her life and, despite her use of heavy doses of painkillers and muscle relaxants, the symptoms were only getting worse.
Last winter her neurologist suggested she take a chance and participate in a clinical trial on medical cannabis.
“I had nothing to lose,” Fiorito said. “(The cannabis) was like a miracle. Within three days my legs were less stiff, they didn’t feel as heavy.
“At physiotherapy, they time me for six minutes to see how far I can walk. In October I did 89 meters. This week, it was 251 meters. I’m not joking when I say it’s like a miracle.”
Fiorito is one of 70 Montreal-area patients participating in a clinical trial for medicinal cannabis capsules. The study, which entered its second phase last April, will try to determine if cannabis can be used as a less-dangerous substitute for opiate-based painkillers.
If it’s successful — and the capsules are approved by Health Canada’s Office of Controlled Substances — cannabis could be sold in pharmacies and covered by provincial health insurance.
The study is a partnership between Montreal’s Santé Cannabis clinic and the Ottawa-based Tetra Pharma Bio. It mainly focuses on people with chronic pain and cancer pain who have never tried medical cannabis before.
“This is about giving people like Joanne (Fiorito) a chance to access medicine that is quality-controlled and affordable,” said Erin Prosk, the co-founder of Santé Cannabis. “The medical cannabis system we have now is not enough. It’s a Band-Aid, it’s a temporary solution.”
Canada’s medical cannabis system has existed under its current form for only four years. Each of the roughly 250,000 patients with prescriptions can order weed online from one of 115 producers licensed by the federal government.
But unlike with the vast majority of medicines, cannabis isn’t covered by health insurance. In fact, patients have to pay sales tax on it.
Adding to patients’ financial burden, the Cannabis Act — which will legalize the sale of recreational pot starting Oct. 17 — actually adds a 10-per-cent excise tax for medical cannabis users.
“The Cannabis Act is causing collateral damage in our world,” said Prosk. “Some people think that with legalization, patients can just go to the store and buy cannabis. But the people who use medical cannabis need a specific pharmaceutical-grade product to treat specific symptoms.”
In the study, patients are either given a placebo or capsules that contain a high concentration of two cannabinoids; tetrahydrocannabinol (THC) — which has a psychoactive and pain-numbing affect — and cannabidiol (CBD) — which can be used as an anti-inflammatory, a muscle relaxant and to treat epilepsy.
Thus far, only one of the 70 patients recruited has reported experiencing severe side effects from the drug.
“Except for that one case, where the patient wasn’t able to tolerate it, everyone has been tolerating it quite well,” said Dr. Antonio Vigano, who is leading the trial. “I was surprised at how tolerable it was, at how safe it was. That’s the main concern, when you do these trials, is to make sure the product is safe.”
For the first phase of the study, patients were given a low dose of the CBD and THC pills so their bodies could adjust to the drug. Vigano says that, for some, it was enough to notice a different in pain management.
Gradually, the doctors increase patient doses until they reach a point where the medicine takes affect.
“Our theory was that starting low and increasing slowly is really important to increase that tolerability,” said Vigano, an associate professor of oncology at McGill University. “That’s what we’re seeing in practice. It’s encouraging.”
Prosk has been on the forefront of the fight to increase access to medical marijuana for years and says cannabis research is still in its infancy.
As her clinic’s study is underway, the University of British Columbia is leading a trial on the use of medicinal pot for people who struggle with post-traumatic stress disorder.
“Considering where we were four years ago — just getting the system to license cannabis producers off the ground — it’s unreal how far we’ve come,” said Prosk. “We’re global leaders in cannabis research and we’re getting interest from international companies. Countries like Germany and Australia are looking to Canada for leadership.
“There’s huge potential here and the right people are finally taking notice.”
Santé Cannabis and Tetra Pharma Bio still have reams of data to study and there are many more roadblocks on the way to having their product approved. But Prosk says the future looks promising.
For Fiorito, the clinical trial has been a lifesaver.
“I used to wake up in the night, screaming in pain,” she said. “I’m not waking up at night anymore. I’d say 80 per cent of the pain is gone.
“Last year, I felt like the wheelchair was pretty close to my ass if I may say so. I felt like, ‘Oh she’s really gaining on me, I’ll be stuck in that wheelchair for the rest of my life.’ Last week, my neurologist said he hadn’t seen me move like that in years. It’s a miracle.”
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