After 20 Years of Medical Cannabis, Gaps in Product Testing Leave Some Canadians Feeling Like Guinea Pigs

Article by CBC News

The Current After 20 years of medical cannabis, gaps in product testing leave some Canadians feeling like guinea pigs Social Sharing Facebook Twitter Pinterest Reddit LinkedIn Email Open letter calls on Health Canada to remove barriers to testing products CBC Radio · Posted: May 18, 2021 4:00 AM ET | Last Updated: 8 hours ago According to Health Canada, 321,539 Canadians had active medical cannabis authorizations at the end of last year. That includes the use of products designed to be inhaled, applied as topical creams, or eaten. (Victor Moussa/Shutterstock) 289 comments The Current19:41 Calls for more clinical trials on medical marijuana products Rebecca Zak hoped a prescription for medical cannabis would help with her insomnia, but the need to experiment with dosage levels left her feeling like "her own guinea pig."

Rebecca Zak hoped a prescription for medical cannabis would help with her insomnia, but the need to experiment with dosage levels left her feeling like “her own guinea pig.”

“I was lying there, just full body buzz in the middle of the night,” said Zak, from Dundas, Ont.

“I didn’t know, is this what I’m supposed to be looking for, is this working? So there was a lot of confusion for me,” she told The Current’s Matt Galloway.

Zak asked her doctor for the cannabis oil prescription. Her physician advised her to start with a small dose and increase incrementally. When the first prescription didn’t work, she tried a stronger product, but this brought some “uncomfortable side effects” — and still no end to her insomnia.

According to Health Canada, 321,539 Canadians had active medical cannabis authorizations in December 2020. Researchers suggest that number could be far higher because not all people who use the drug medicinally seek medical authorization.

Despite medical cannabis being legal in Canada for 20 years, cannabis researcher James MacKillop said not enough is known about the efficacy or safety of the many products available.

“There’s not a lot of guidance from either physicians or so-called cannabis professionals because there isn’t good evidence to base that on,” said MacKillop, director of the Michael G. DeGroote Centre for Medicinal Cannabis Research at McMaster University.

Without definitive research, MacKillop worries that “patients may be delaying or ultimately not accessing evidence-based treatments, if they’re using products that are ultimately not shown to be effective.”

Last month, he was one of more than 200 scientists and clinicians who signed an open letter asking Health Canada to remove barriers to that kind of research.

“There is an urgent need for randomized controlled trials (RCTs) evaluating the effectiveness and safety of the numerous medical cannabis products currently available to patients in Canada,” the letter said.

In Canada, cannabis products are made to safety standards akin to food or agricultural products, but not to the same standard as pharmaceuticals, which is the bar that products must meet to qualify for clinical trials.

“The same products that are approved for manufacture and sale by Health Canada don’t meet their standards for being studied in trials,” MacKillop said.

In a statement to The Current, Health Canada said it is drafting a response to the open letter, but that its “clinical trial regulations [are] in alignment with international standards” and “aimed at protecting the safety of clinical trial participants and the integrity of the data generated.”

As a patient, Zak thinks more research into the efficacy of medical cannabis could have saved her “time and money and discomfort.”

She’s since found alternative relief from her insomnia — reading in the bathtub.

Court approval created ‘grey area’

Canada began allowing marijuana for medicinal use in 2001 to alleviate suffering for people with terminal or chronic conditions.

But the nature of that approval is part of the “disconnect that’s really tripping up a lot of researchers nationwide,” MacKillop said.

“It wasn’t approved by Health Canada as a specific medication for a specific indication or condition. It was approved by the courts for people to have access to it,” he told Galloway.

“Now there are dozens of licensed producers who have products that people are using for many different conditions, not just the conditions that the legal cases were based on.”

MacKillop said that creates a “grey area” where licences for clinical trials are hard to secure from Health Canada, even if researchers have already secured funding for peer-reviewed trials.

Globally there are 218 ongoing registered clinical trials involving medical cannabis, including 18 underway in Canada, according to ClinicalTrials.gov, a U.S. government database.

MacKillop said there is “moderate” evidence cannabis can help with pain and some other conditions, such as multiple sclerosis.

But for conditions such as anxiety, depression, and PTSD, he said “the evidence ranges from non-existent to actually negative.”

Barriers hurt Canada’s industry, research

Cannabis producers are “fully aligned” with researchers calling for more trials, said George Smitherman, president and CEO of the Cannabis Council of Canada (C3), a national industry association.

He thinks that research would ultimately benefit consumers.

“I think this is really … driven by the desire to see medicinal cannabis more effectively oriented toward addressing people’s ailments,” he told The Current.

Smitherman, who previously served as a Liberal health minister in Ontario, said barriers to cannabis research are jeopardizing the potential benefits that Canada could reap from legalizing it before many other countries.

“We’re really setting ourselves back and missing out on tremendous opportunities to better inform good, appropriate use of cannabis,” he said.

Smitherman said his organization, which represents about half the cannabis being produced and sold in Canada, has been lobbying Health Canada for change for months. He said the regulator has responded with incremental changes.

We’re really setting ourselves back and missing out on tremendous opportunities to better inform good, appropriate use of cannabis– George Smitherman

In September, Health Canada published clarifications around the requirements for conducting clinical research with cannabis. In its statement to The Current, the regulator said it subsequently “heard from stakeholders that more flexibility is necessary to facilitate cannabis research in Canada,” and it’s working to update the clarification.

Smitherman said it will take more than “a few more words of clarification” to solve the problem.

“It’s really important to impress upon Health Canada that we want to see Canadian medical cannabis research reaffirmed as a priority for the government, and for Canada to have the ambition to re-establish itself as a global leader,” he said.

B.C. woman used cannabis in surgery recovery

Aly Benson has been using cannabis as a medical treatment for six years. She thinks her everyday life would be “very, very painful” without it.

The Abbotsford, B.C., resident initially started using CBD bath bombs to help with nerve damage related to a shoulder injury. When numbness limited her mobility, she says the baths reduced the inflammation.

“Not being able to walk actually turned into, ‘Hey, let’s go for a little bit of a 10-kilometre walk,'” said Benson, who works at a Toronto-based cannabis e-commerce company. She also volunteers with the patient advisory board of Medical Cannabis Canada, a non-profit patient advocacy organization.

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