Opinion: Legalization is changing the medical cannabis research landscape

Sep 4 2018, 4:52 pm

Written by Judith Stamps for Daily Hive. Judith is the author of Unthinking Modernity:  Innis, McLuhan and the Frankfurt School, numerous journal articles, essays and letters to the editor, and served as editor of the quarterly journal, Cannabis Digest.

Here’s a vicious circle, Canadian style.

In 2001, following a court order to create a medical cannabis program, Health Canada announced a five-year, $7.4 million research fund to be administered by the Office of Cannabis Medicine Access (OCMA). Cannabis medicine was not yet approved, thus, studies were needed.

Over the next three years, the OCMA provided grants for three such studies: two for chronic pain; one for improving appetite in HIV/AIDS patients. In 2003, with no clear explanation, the Office cancelled the ongoing HIV/AIDS trial. In 2004, with no public announcement, it suspended further funding. Then in 2006, the newly elected Harper Conservatives cut $4 million from the program, effectively ending it.

Health Canada’s position remains that cannabis is not an approved medicine. Why? There is no research.

See also

RCTs: The Language of Modern Medicine

It isn’t that cannabis has never been studied. Physicians have evaluated its medical effectiveness for millennia. Their method has been careful observation of patients.

In the 19th century, physicians in North America published over a hundred such observations in medical journals. In 1973, renowned activist, Dr. Tod Mikuriya, published, Marijuana: Medical Papers 1839-1972, providing a window onto unique years in cannabis history. Readers can find recent studies at PubMed, Project CBD, and Granny Storm Crow’s List.

But by Health Canada’s standards, this work is inadequate. At present, the only widely accepted facts come from randomized controlled trials (RCTs), conducted in three phases.

Phase one tests a drug on healthy subjects, providing a baseline: heart rate, blood pressure, electrocardiogram readings, and effects on mood and cognition.

Phase two tests the drug on a hundred or more subjects with the disease under investigation.

Phase three does the same with a group large enough to be statistically significant: 750 to 1,500 subjects. Key components of RCTs are randomized assignment, and the use of a control group. In phases two and three, subjects are divided at random into two groups: one is given the active drug, the other (the control group), a placebo.

Phyto-Pharma: The Road Ahead  

Clearly, we cannot rely on governments for such research and standard pharmaceutical companies focus only on synthesized molecules: ones that can be copyrighted.

Essential are research groups that study whole plant cannabis. Tetra Bio-Pharma (TBP), a private, publicly traded company, established in 2016, is the first such enterprise in Canada. Its co-founder and chief medical researcher is herbalist, Dr. Guy Chamberland.

TBP is set this fall to run a phase three trial with smoked cannabis for break-through pain in cancer patients. In this trial, 946 patients at five different sites will receive 280 mg compressed cannabis pellets, to be smoked in a pipe. Half will receive a placebo and all will have access to rescue tablets, should the pellets fail.

At the same time, TBP will conduct a phase two trial with vaped pellets, for patients with fibromyalgia. Active pellets will contain 9.5% THC, and 2.5% CBD, proportions achieved by blending three strains of cannabis; and standardized to no more than 3% variation.  The cannabis is provided by Canadian Licensed Producer, Aphria, and trials will be conducted by a third party: Montreal-based clinic, Santé Cannabis.

Who Will Benefit?

If TBP’s pellets prove successful, they will be given a Drug Identification Number and covered by health insurance plans. Patients and doctors who know little about cannabis, estimated to be 85%, will be more likely to try it.

Patients in hospital settings and long-term care facilities will have better access. Eventually, their doctors may choose it as a first line pain medication, an alternative to opioids, rather than an additive. Though many patients have done well treating themselves, growing their own, or finding suitable dispensaries, most will want a more conventional approach.

Patients will benefit, too from TBP’s precise, standardized dosing, and from a stable supply of a set blend. Weak points in cannabis supply today are uncertain levels of concentration and capricious changes in available strains. Weakest of all is unevenness of access: some Canadian cities have dispensaries with staff experienced in cannabis medicine, many have none.

For the majority of Canadians in need, TBP’s pain remedy will arrive none too soon.

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