PR: Recommendations for the Medicinal Marijuana Clinical Trials
Recommendations for the Medicinal Marijuana Clinical Trials
Letter to Health Minister Alan Rock
August 2, 2000
To Health Canada and the Honorable Alan Rock, Minister of Health:
The Canadian Cannabis Coalition is an umbrella organization encompassing diverse facets of the cannabis industry, including marijuana researchers, producers and distributors, concerned citizens and compassionate cannabis distribution centres nationwide. For the last three years, Canadian Compassion Clubs have been distributing medicinal marijuana to over 2000 people with illnesses ranging from HIV/AIDS, cancer, multiple sclerosis, fibromyalgia, glaucoma and epilepsy to muscular dystrophy, arthritis, chronic pain, bi-polar disorder, rheumatic illnesses, anxiety, opiate withdrawal, insomnia and alcoholism. This experience has given us extensive, unique and specialized knowledge of the factors affecting the soundness and safety of the clinical research trials that will be undertaken by Health Canada and on behalf of the Canadian public.
On Nov. 23, 1997, the Minister of Health, Alan Rock stated that a “product is approved as long as there is proof that it is safe for use and offers the medical value that its producer’s claim.” The medicinal value that we claim is directly related to the factors we will highlight in this communique.
The following information is the basis of a more thorough and detailed report that the CCC hopes will further inform research into medicinal marijuana. In the interim, we are passing on the following information to ensure that the clinical trials are designed to meet the objective of determining the safety and effectiveness of smoking marijuana for medicinal purposes. We are also including the latest information on harm reduction considerations that your study, in the name of safety, has the duty to incorporate.
We have compiled the following information in the best interest of the people living with illness whom this study will affect both directly as participants and indirectly as future recipients of medicinal marijuana. We hope to see this information incorporated into the design of the clinical trials. If our unique perspective is not taken into account in these studies, Health Canada cannot claim to have tested for the safety and effectiveness of marijuana use for medical purposes.
Testing for Harm Reduction and Benefits:
- It should be noted that the criteria for herbal medicines to be approved differ from those for synthetic drugs. The criteria for herbal medicine stipulate that they must demonstrate “a history of use in other countries or in aboriginal cultures”.
- There is a plethora of evidence attesting to the effectiveness and harmlessness of cannabis as well as to its use in traditional Indian and Chinese medicine. Marijuana is currently used in every part of the world, especially in India, Asia, and Africa.
- The tests currently being applied to marijuana are those intended for synthetic drugs. Cannabis should not have to pass these extensive and expensive tests for approval.
- Instead, these trials could be better used to test modern harm reduction strategies, such as potency levels and modes of ingestion, and to advance research on the benefits of medicinal marijuana. We hope this opportunity will be seized.
Strain Selection:
- The medicinal value of cannabis is directly related to strain selection.
- In general, cannabis sativa has stimulating effects while cannabis indica is a relaxant.
- Each strain of cannabis interacts differently with different medical conditions and different people. For example, cannabis sativa stimulates the appetite in people suffering from AIDS related Wasting Syndrome. Cannabis indica is very effective for relaxing brain centres and muscles associated with Epilepsy and Multiple Sclerosis.
- We recommend care be taken to ensure appropriate strains are selected and compared for medicinal benefits.
Potency:
- Cannabis can be safer if it is more potent. The main risk of cannabis use appears to be lung irritation from inhaling hot plant-matter. High potency marijuana means that less inhalation of hot plant matter is necessary for the same effect.
- Our experience with medicinal marijuana users demonstrates that more potent marijuana is generally more effective.
- Despite the fact that there is no known toxicity level for THC, the present contract calls for a 6-8% THC content for the marijuana to be used in the clinical trials. High potency cannabis contains at least 10% THC.
- We recommend that marijuana with higher levels of THC be used in these trials. “The most potent possible” could be a new safety standard for medical marijuana.
Mode of Ingestion/Delivery System:
- Food prepared with oil or butter, as well as teas and tinctures made from the cannabis plant allow the medicine to be absorbed through the digestive tract. Some medicinal users rely entirely on this mode of ingestion and find it is more effective for their particular symptoms than smoking.
- Water pipes can cool the temperature of inhaled plant matter and filter out potential carcinogen substances.
- Vaporizers eliminate the safety concerns related to smoke inhalation. Since marijuana is not combusted in vaporizers, no smoke is emitted. Vaporizers also seem to have a unique psychoactive effect.
- There is no proof that synthetic cannabis, “the patch”, nor suppositories are safer or more effective. Anecdotal evidence reveals the contrary.
- Modes of ingestion and delivery systems currently utilized and known to be safe and effective, as alternatives to smoking marijuana, are valuable areas of research for Health Canada to pursue.
Safe and Organic Supply:
- Studies have produced evidence that tobacco related cancers are the result of the chemical phosphate fertilizers used in the growing process (Kilthau, Gustave F., Cancer Risk in Relation to Radioactivity in Tobacco. Vol. 67, Radiologic Technology, 01-11-1196, p.p. 217). The US Department of Health and Human Services, Public Health Services named phosphate fertilizer as a carcinogenic substance in the National Toxicology Programís 9th Report on Carcinogens 2000. (http://ehis.niehs.nih.gov/roc/toc9.html).
- We have witnessed the negative impact of non-organic marijuana, as opposed to organic marijuana, on terminally and chronically ill people with lowered immune systems.
- We strongly recommend that the clinical research program include the use of organically grown cannabis. This would provide an opportunity for tests to be done on the radioactive and heavy metal content of both naturally and synthetically fertilized cannabis. Safety standards should be based on these results.
- We further recommend that the clinical trial participants and future recipients of medicinal marijuana be informed about the toxicity and radioactivity levels of their medicine. Exclusive Criteria for Selecting Cannabis Growers:
- The criteria for growers exclude small-scale growers. Long-time growers who may have criminal records are also excluded. Valuable experience and breeding is lost – and nothing is gained – as a result of these criteria. This is not in the best interest of the medicine recipients.
- We recommend that criteria for selecting cannabis growers for the trials allow for the inclusion of small-scale and experienced growers. Medicinal and Preventative Applications:
- The list of currently approved medicine includes stimulants, relaxants and anti-depressants. A pill taken for stress, depression, fatigue, loss of appetite, lack of sleep, motivation or focus is considered medicinal.
- Healthy people also use medicine preventatively, for example to reduce stress.
- For these clinical trials to be thorough, they should test all these legitimate medicinal and preventive applications of marijuana.
Quality of Life Measures
- The manner in which a personís quality of life is affected by a medicine or medical procedure is typically included in clinical trials.
- The great diversity of marijuana strains with identifiable effects, and the ability of users to self-titrate , enable each medicinal user to find a combination of psychological and physical relief suitable to their lives and medical needs.
- Our experience reveals that the quality of life of medical marijuana users is positively affected by the autonomy they maintain with this medicine and their ability to control its effects.
- Negative quality of life indicators for medicinal marijuana are associated with its lack of accessibility and affordability, cleanliness factors, and its illegal status as opposed to the effects of the plant itself.
- In order for Quality of Life Indicators to be researched effectively, clinical trial participants must have consistent access to a wide variety of strains and must maintain control of their use.
In Conclusion: Respecting our Economy, Culture and Dignity
We urge you to respect our knowledge of this plant. We hope that Health Canada and the Honorable Minister Alan Rock recognize that we are sharing our knowledge to improve the current state of the medical marijuana supply, for the safety and dignity of recipients of this medicine as well as for the integrity of Health Canadaís studies.
We do not wish to see medical marijuana controlled by a corporate pharmaceutical monopoly that would ultimately destroy our plant, our economy and our culture. Nor do we wish to see regulations that diminish the value and potential of this plant. We hope that you understand the ultimate health risks associated with such policies. The potential of this plant as a medicine lies primarily in its accessibility and affordability. These are two factors over which you have direct control and influence.
We strongly recommend that the information we have provided will be incorporated into the design of these and future clinical trials. We look forward to your response and invite you to contact us for further information, references, resources, and assistance.