Chapter 13 - Regulating Therapeutic Use of Cannabis

Research plan

 

Health Canada’s Office of Cannabis Medical Access is responsible for the administration of the MMAR. It also co-ordinates other initiatives related to cannabis, including research on the safety and effectiveness of marijuana used for therapeutic purposes and the establishment of a reliable Canadian source of research-grade marijuana.

As stated previously, Health Canada released a report in June 1999 announcing a research plan for the therapeutic use of marijuana. The document[1][43] laid out a five-year research plan for evaluating the risks and benefits of the use of marijuana for medical purposes. The plan included the following elements:  

vv     a research agenda composed of projects to address the issues of safety and efficacy of smoked marijuana and cannabinoids;

vv     mechanisms for medical access to marijuana outside the projects (for example section 56 exemptions discussed previously in this chapter); and

v     the development of a Canadian source of research-grade marijuana.

Scientific research

As part of the government’s strategy to address the issue of medical marijuana, Health Canada decided to sponsor research activities to evaluate the safety and efficacy of smoked marijuana and of cannabinoids. Health Canada was concerned that the evidence of the therapeutic value of smoked marijuana was heavily anecdotal and that the scientific studies supporting the safety and efficacy of marijuana for therapeutic claims were inconclusive. Health Canada was also concerned about the health risks associated with the use of marijuana, especially in smoked form.  

The strategy has been developed with advice from the Therapeutic Products Programme’s (TPP) Expert Advisory Committee on New Active Substances, an external body of scientific and medical experts who provided advice to the TPP.

Currently, there is a partnership program between Health Canada and the Canadian Institutes of Health Research (CIHR), a granting agency. This is to ensure scientific validity of the studies. The Health Canada/CIHR Medical Marijuana Research Program (MMRP) has been established as a five-year research plan with estimated funding of up to $7.5 million. The initial focus is on the smoked form of marijuana, although future initiatives are also to focus on non-smoked marijuana and cannabinoids.

We are aware of at least two studies that have been planned:

vv     In July 2001, Health Canada and the CIHR announced a contribution of $235,000 to fund a pilot study at McGill, with about 32 patients, aimed at evaluating the effects of smoked marijuana for chronic neuropathic pain.

vv     In June 2001, Health Canada announced funding of $840,000 to support a research project by the Community Research Initiative of Toronto (CRIT) on the efficacy of smoked marijuana in the treatment of wasting syndrome in those living with HIV/AIDS. At the time, it was entering the second phase of a three-part research project on smoked marijuana – The acute effects of smoked cannabis on appetite in persons living with HIV/AIDs (PHAs): A randomized, double-blind, placebo-controlled, crossover pilot study.   

 

It should be noted, however, that neither of these projects is currently under way because they do not have access to marijuana.

In addition to pilot projects, Health Canada has announced that research-grade marijuana will be provided to eligible individuals who agree to provide health information for monitoring and research purposes. Health Canada will collect and analyse this information for research purposes. Once again, Health Canada has yet to provide marijuana to authorized users.

Health Canada has indicated that the knowledge gained from the overall research program will be used, in part, to amend the MMAR if necessary. For example, category 2 symptoms may need to be adjusted or the daily dosage may need to be more precisely determined. Health Canada also indicated that if no benefits were shown, the continued need of the MMAR would be in doubt.

Clearly, research on the therapeutic aspects of marijuana is essential. While Health Canada should be applauded for establishing a research plan, what is less commendable is the pace at which the research is progressing. As stated, the authorized pilot projects have yet to commence their research because Canada must rely on an American source for research-grade marijuana. This means that American institutions, in particular the National Institute on Drug Abuse, are entitled to review Canadian research protocols to determine whether or not they will deliver their marijuana products to Canadian researchers.

 

Our first source or our first attempt at sourcing the marijuana for research purposes was through NIDA, the National Institute on Drug Abuse in the States. They have seed and dried product. We are still negotiating with them to get some dry product.

 

In order to use their product, we have to have the protocols that the product will be used for approved by both the health department there and NIDA themselves. Once they have approved the actual scientific protocol, then it has to go to the DEA to see if they will allow the export. [2][44]

 

While further research is essential, it does not suggest that therapeutic use is not justified in specified circumstances. The ongoing research should focus on confirming  its justification and on identifying new medical conditions or symptoms for which cannabis has therapeutic value. Research to determine the value of cannabis as a medicine per se should also be a priority, as should finding alternative delivery systems that are as effective as smoked cannabis.

Before leaving the issue of research, mention should be made of the considerable expertise and knowledge currently residing in the Compassion Clubs, which have become established outside of the legal system. This source of valuable information and expertise has not been acknowledged under Health Canada’s current research plan. We feel strongly that the information they have must be gathered and analysed for research purposes. The validity of ongoing research using what some consider to be low-quality, low-potency cannabis imported from the National Institute on Drug Abuse or similar type of product that may be produced in Canada must also be called into question. Hilary Black, founder and co-director of the B.C. Compassion Club Society, stated the following.

 

We created a research proposal with a team of research scientists from Vancouver. However, we were turned down because we refuse to facilitate a study using a placebo or low-quality, low-potency cannabis imported from the US National Institute on Drug Abuse. Any study attempting to prove the efficacy of cannabis as a medicine using such a low-potency herb, or unknown strains such as those currently being grown in Canada by Plant Prairie Systems, is destined to fail. There is no need to import cannabis for research, considering the high quality and huge quantity of cannabis being produced in Canada. The information we could gather is being requested by doctors, patients, pharmaceutical companies, Plant Prairie Systems and Health Canada, yet we are not financially empowered to facilitate this research. [3][45]

Research-grade marijuana

As was previously stated, another priority in Health Canada’s research plan was the development of a Canadian source of research-grade marijuana. A request for proposal (RFP) was released on 5 May 2000 through Public Works and Government Services Canada. The purpose of the RFP was to establish a Canadian source of quality, standardized, affordable, research-grade marijuana for scientific research. Originally, the marijuana was to be made available only to qualified, approved scientists for research. A number of proposals were received by the closing date of 28 June 2000. The evaluation criteria included: financial status, qualifications of personnel, security requirements respecting personnel, etc. No experience in growing marijuana was required, although there was a requirement for experience in growing plant material for human consumption.   

In December 2000, a contract was awarded to Prairie Plant Systems Inc. of Saskatoon (PPS) to provide Health Canada with a reliable source of affordable, quality, standardized marijuana for medical and research purposes. Health Canada also announced that until the domestic supply was established, it would submit requests to the U.S. National Institute of Drug Abuse to obtain research-grade marijuana for clinical trials being conducted in Canada on behalf of researchers.

PPS met the contract requirements for security and was given authorization to begin growing marijuana. The site chosen for the cultivation of research-grade marijuana in Canada was an abandoned mine in Flin Flon, Manitoba. While to some this appears comical, Health Canada justifies this decision because of the security this location provides and the opportunity to control the temperature, the humidity and the growing conditions.

The first product was expected to be delivered to Health Canada by early 2002. Under the terms of the five-year, $5.7 million contract that Prairie Plant Systems Inc. signed with Health Canada, the company would

  

vv     Set up and operate a marijuana growing, processing, fabrication and storage establishment;

vv     Conduct laboratory testing and quality control of marijuana throughout the product life cycle;

vv     Fabricate, package, label and store marijuana material;

vv     Distribute marijuana product to recipients authorized by Health Canada; and

vv     Conform to the requirements of the CDSA including stringent security and physical measures.

 

Health Canada also announced that this product would, in addition to use for research purposes, be made available to authorized Canadians using it for medical purposes who agree to provide information to Health Canada for monitoring and research purposes.

This spring, Health Canada revealed that the first crop could not be used for research purposes because of the varying quality. While they had hoped to obtain seeds from the National Institute on Drug Abuse, the seeds that were used were obtained from police seizures in Canada. This led to a collection of marijuana with different strains and characteristics. Health Canada states the importance of research-grade marijuana as follows:  

 

Going back to the comments we made earlier on why Health Canada is involved in the study of medical marijuana, it is to determine whether to develop the scientific evidence that is required to determine whether there is a benefit. In order to develop that scientific evidence, one must have a base product that meets research standards. It was not a question of whether Prairie Plant Systems did in fact grow marijuana; it was a question of whether the product they developed was consistent, research‑grade standard such that it could be used in legitimate scientific research. [4][46]

 

While we are sympathetic to this argument, there would appear to be no justification for not supplying this product to those who have been authorized to do so under the CDSA, particularly since the safety of the product, in regard to pesticides, moulds, etc., should not be in question.