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Major Studies of Drugs and Drug Policy | ||||
Canadian Senate Special Committee on Illegal Drugs | ||||
Volume 2 - Policies and Practices In Canada |
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Chapter 13 - Regulating Therapeutic Use of CannabisResearch 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:
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:
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
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. [1][43] Health Canada, Therapeutics
Products Programme, Research Plan for
Marijuana for Medicinal Purposes : A Status Report, 9 June 1999. [2][44] Gillian Lynch, Director General,
Drug Strategy and Controlled Substances Programme, Health Canada, Proceedings
of the Special Committee on Illegal Drugs, Senate of Canada, First Session,
Thirty-Seventh Parliament, 2001-2002, Issue No. 22, pp. 47-48. [3][45] Proceedings of the Special
Committee on Illegal Drugs, Senate of Canada, First Session, Thirty-seventh
Parliament, 2001, Issue no. 10, p. 10 :38-10 :39. [4][46] Dann Nichols, Assistant Deputy
Minister, Healthy Environments and Consumer Safety Branch, Health Canada,
Proceedings of the Special Committee on Illegal Drugs, Senate of Canada, First
Session, Thirty‑Seventh Parliament, 2001-2002, Issue No. 22, page 46. |