Canada’s first medical marijuana clinical trial has been registered with Health Canada, a milestone that could be the first step toward legitimacy in the eyes of the medical community.
The trial will measure the effects of marijuana on patients with osteoarthritis of the knee versus other patients who receive a placebo.
For years, the Canadian medical establishment and Health Canada have not accepted marijuana as a legitimate form of medication, despite reports from patients who say it’s an effective alternative to opiates for pain relief, and research from other countries that backs up that finding.
But a Supreme Court ruling in 2000 gave Canadian patients access to medical marijuana, putting Health Canada in the awkward position of distributing a substance it officially does not condone.
In April, Health Canada transferred to doctors much of the responsibility for deciding which patients can access medical marijuana, a move that did not sit well with the Canadian Medical Association.
The lack of clinical trials on the efficacy and side effects of marijuana has been a major sticking point for many doctors. They’re used to prescribing pharmaceuticals whose dosages have been determined by clinical studies.The upcoming Health Canada-approved trial will focus on vaporized cannabis, helping to ease doctors’ objections over the use of dried marijuana, which they say encourages smoking.
Health Canada has licensed more than a dozen commercial medical pot producers across the country, and those companies have a vested interest in establishing marijuana as a credible medication among doctors.
The clinical trial was commissioned by Prairie Plant Systems, the first licensed medical pot producer to launch such research in Canada.
The study will “provide prescribing physicians with the clinical data they are looking for regarding dosing,” said Brent Zettl, president and CEO of Prairie Plant Systems.
The company said it chose to focus on arthritis patients for the first trial because they are the group who has used medical marijuana the most.
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The trial will study several varieties of medical marijuana that have varying degrees of the plant’s two most active cannabinoids: THC (which produces the high feeling) and CBD (which can mitigate pain). It will also study the safety of vaporized cannabis.
The Arthritis Society has voiced its support of the trials.
“Clinical research is the necessary first step to get us to where we want to go: more treatment options available for the arthritis community,” said its chief mission officer Joanne Simons.
Prairie Plant Systems is finalizing the agreements for the two main trial sites and says patient recruitment will begin in the coming weeks.
It will follow the type of trial that doctors are familiar with for other pharmaceuticals: controlled, randomized and double-blind.
Medical marijuana has not undergone clinical trials for several reasons, including its stigma as an illegal street drug, as well a lack of industry money to fund the multiple and expensive stages of testing. Cannabis can’t be patented like Viagra or Lipitor because it’s a plant, undercutting the financial reward for funding clinical trials.
Health Canada has doled out a handful of production licences and has received hundreds more applications from entrepreneurs looking to cash in on the new industry, which the government believes could be worth $1.3 billion and grow from 40,000 to 400,000 users in the next decade.
The licensed producers recognize that the support of the medical community holds the key to unlocking the millions in potential sales revenue from shipping their product to patients. They have formed an industry association — the Canadian Medical Cannabis Industry Association — that aims to provide better education for doctors and promote further study of the plant’s medical usage.