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01/01/05

Open Letter of Concern for the Health and Safety of Canada's Medicinal Cannabis Community

In August of 2003, in response to a court order by Ontario Justice Lederman addressing a lawsuit initiated by medicinal cannabis users and suppliers, (1) Health Canada began the distribution of cannabis products being cultivated by Prairie Plant Systems to a small percentage of the nation's federally licensed users. From the outset of the 5-year, $5.7 million cultivation contract awarded to PPS in 2001, medical users and patient-advocacy organizations have raised concerns with Health Canada over the safety and quality of the federal supply of cannabis.

Canadians for Safe Access, Canada's largest medicinal cannabis patients rights organization, has brought to light many of these patient concerns through communication and consultation with the Office of Cannabis Medical Access (OCMA), former Ministers of Health McLellan and Pettigrew, Deputy Minister of Health Ian Green, and Minister of Public Health Caroline Bennett. We have had the support of many private researchers and elected officials in our ongoing attempts to improve the federal program, including MP Libby Davies and Senator Pierre Claude Nolin, who have recently worked with Canadians for Safe Access in order to initiate an Auditor General investigation into the OCMA.

With Health Canada's recent announcement that it will soon initiate both a pilot program for the distribution of cannabis through B.C. pharmacies, (2) as well as a major open label examination into the safety of cannabis as a medicine, (3) Canadians for Safe Access believes that it is imperative that the many questions surrounding the safety and quality of the PPS cannabis finally be addressed and answered. Two significant concerns that deserve Health Canada's attention are:

  1. The considerable health and ethical problems that may result from subjecting some of Canada's sickest citizens to a potentially unsafe, low quality cannabis product.

  2. The implementation of large scale studies into the safety of cannabis as a medicine based on the use of a sub-standard product, which will produce very poor results of questionable scientific relevance.

If the following legitimate concerns over the PPS cannabis are not adequately addressed by Health Canada and PPS, both the pharmacy-based distribution pilot program and the large-scale, multi-center $1.8 million Marijuana Open Label Safety Initiative (MOLSI) may simply confirm what CSA and medical users have been suggesting since Health Canada began to distribute this product, which is that the poor quality PPS cannabis may be unsafe to use as a medicine.

This overview will examine and explain the four main areas of concern in regards to the safety and efficacy of the Prairie Plant Systems/Health Canada cannabis product:

  1. Quality and Potency
  2. Heavy Metals
  3. Biological Contamination
  4. Gamma Irradiation

Quality and Potency

Shortly after Health Canada began the distribution of the PPS cannabis to licensed users in August of 2003, CSA obtained a sample of the product for the purpose of testing. Upon initial physical examination, it became apparent that claims by PPS and Health Canada that the PPS cannabis was 10%THC seemed overly optimistic. The product was of very fine grind with visible stalk and stems peppered throughout and very little detectable trichome development. (4) When put under flame, it produced a dark smoke with an unpleasant taste and odor. The cannabis burned very poorly and left a thick black residual ash, immediately suggesting inadequate nutrient flushing. This was later confirmed by an examination of tests conducted by Norwest labs for PPS, which show unusually high levels of phosphorous, calcium, and magnesium ­ all of which are "flowering" fertilizers used at the end of growth cycle, and are typically to blame for the poor combustion and acrid taste of inferior quality black-market cannabis.

Early users of the PPS product were equally unimpressed, with many calling the government cannabis unsmokable, including longtime exemptee Jim Wakeford who told the Globe and Mail that it was "totally unsuitable for human consumption". (5) Through an Access to Information Act request, CSA learned that out of the initial 93 people who ordered the cannabis between September 2003 and the end of March 2004, nearly 30% physically returned it to Health Canada. (6) Needless to say, if 30% of AIDS patients suddenly returned their anti-viral drugs, or 30% of MS patients returned their anti-spasmotics, we would consider this a major health scandal; and yet when these same AIDS and MS patients go so far as to return this poor quality product to the government, Canadians only learn about this incredibly high rate of return through Information Act requests by patient-advocacy groups. Such a lack of accountability and of transparency in this important area of public health is absolutely unacceptable.

The lack of strain selection has also been a major cause for concern and complaint by both medical users and medicinal cannabis activists. Compassion clubs, which currently distribute medicinal cannabis to over 7000 critically and chronically ill Canadians, have long ago realized that certain strains of cannabis have a more significant effect in reducing the symptoms of some conditions than others, and therefore Health Canada's decision to only allow PPS to make a single strain available severely undermines the overall applicability and effectiveness of the entire federal distribution program.

CSA's first independent cannabinoid tests were conducted in early September of 2003, and the results showed the PPS product to have just over 3%THC, rather than the 10% THC claimed by both Health Canada and PPS. (7) A series of follow-up tests further confirmed this data, including definitive tests conducted by the Quebec Institute of Public Health Toxicology lab that compared a sample of VICS organic cannabis with the contents of an unopened package of the PPS product. In 2 separate tests conducted by this highly experienced laboratory, the PPS cannabis measured just over 5%THC, while VICS cannabis came in at 19%THC, prompting the Chemist Michel Lefebvre to suggest that the PPS cannabis was "presumably leaves", and that the VICS cannabis was "flowers or buds". (8) Since these tests were conducted, PPS has obtained permission from Health Canada to send out a stronger, 12%THC product. Although this second batch of cannabis is still ground far too fine and contains a large amount of visible stem and stalk, cannabinoid tests commissioned by CSA suggest that this product does indeed contain 12%THC. A strain/symptom survey protocol recently completed by the VICS suggests that although low-THC cannabis (<15%THC) may be effective in increasing appetite and to reducing nausea in conditions such as AIDS or cancer, the mitigation of severe chronic pain and the reduction of spasticity from MS and other dystonic movement disorders appears to be more significant with cannabis of over 15%THC. An upcoming VICS double-blind clinical protocol comparing the analgesic effect of different strengths of cannabis may better address the significance of strength and dosage in the reduction of chronic pain.

Heavy Metals

The PPS production facility is located at the bottom of an abandoned zinc and copper mine in Flin Flon, Manitoba. As a result of over 80 years of mining and smelting, a number of official Conservation Canada, Natural Resources Canada and Environment Canada reports suggest that Flin Flon and the surrounding region is one of the most environmentally contaminated areas in North America. (9) According to MiningWatch Canada's 2001 report titled Financial Options for the Remediation of Mine Sites: a preliminary study, the severity of the contamination may actually be too great to remedy in the foreseeable future:

"The sheer size of the contaminated area in Flin Flon makes it impossible to remediate. In particular, there is a large volume of tailings that blow in the wind, and the metal content (copper, cadmium and lead) makes it difficult for vegetation to establish. Community concerns have historically not been adequately addressed, and much information, including that collected by Health Canada (e. g., toxic metal levels in blueberries) has not been made available to the residents of Flin Flon..."

(10)

As a result of significant concerns over the massive heavy metal contamination of air, water and soil in Flin Flon, CSA commissioned a heavy metal analysis of the PPS cannabis by an EPA and CAEAL certified lab in September of 2003. The results of these tests showed that the PPS cannabis was high in both lead and arsenic. (11) Through a subsequent Access to Information Act Request, CSA also received a copy of every heavy metal test conducted by PPS and Health Canada up to and including March 9th, 2004. Although these tests showed lower concentrations of lead and arsenic than CSA's initial tests had detected, examination by independent researchers suggested that elevated levels of manganese and phosphorous in the PPS cannabis may be of some health concern, particularly when they are inhaled into the lungs rather than ingested through the gut.

Health Canada's reaction to these test results has been totally unsatisfactory. When informed by CSA that its independent tests showed high levels of heavy metals in the PPS cannabis, Health Canada spokesperson Jirina Vlk stated that Health Canada's own tests showed that heavy metal concentrations in the PPS cannabis were similar to those found in Canadian tobacco, and well within allowable limits. When pressed as to what these "allowable limits" might be, she admitted that there are currently no legal limits to heavy metal content in either cannabis or tobacco in Canada.(12) This disingenuous response is of little reassurance to the critically and chronically ill Canadians who depend on cannabis for their health and well-being.

Biological Impurities

The aforementioned biological and heavy metal test results obtained from Health Canada by CSA were commissioned by PPS and performed by Winnipeg's Norwest labs between July 24th 2003 and March 9th, 2004. These tests show an alarmingly high level of biological impurities prior to gamma irradiation. Of particular concern was the high level of aerobic bacteria, which came in at 125,000 CFUs (colony forming units per gram) in tests dated July 24th of 2003. By comparison, biological testing commissioned by the Vancouver Island Compassion Society (VICS) on its own organic cannabis have come in at 120 CFUs.(13) In other words, prior to gamma irradiation the PPS cannabis has had up to 1000 times more potentially pathogenic bacteria than the completely organic VICS cannabis. This suggests that despite government assurances to the contrary, there are major problems in the handling, drying and/or processing of this cannabis product.

In addition, the Norwest lab tests show dangerously high levels of molds, including penicillium (10,000 CFUs) and aspergillus (3000 CFUs). Penicillium has been associated with many types of pulmonary and urinary tract infections, with immunosuppressed hosts showing a particular vulnerability to this type of infection. (14) High levels of aspergillus are of great concern as well, since many aspergillus antigens are fungal allergens and may initiate allergic bronchopulmonary aspergillosis. (15) As with penecillium, immunosuppression is one of the major factors predisposing individuals to the development of opportunistic infections due to exposure to aspergillus - which are referred to as aspergillosis ­ therefore HIV/AIDS, Hepatitis-C, and cancer sufferers may be particularly vulnerable to this type of opportunistic infection.

Although most (but not all) of the penecillium and aspergillus mold found on the PPS cannabis can be destroyed by gamma irradiation, they both produce mycotoxins that cannot be. Penecillium produces a carcinogenic, nephrotoxic mycotoxin called ochratoxin A,(16)and certain common types of aspergillus produce a group of dangerous mycotoxins called aflatoxins. Because of their demonstrated carcinogenic properties and acute toxicological effect, aflatoxins are perhaps the best known and most commonly studied of all mycotoxins. Produced by Aspergillus flavus and parasiticus, evidence of acute and sometimes terminal aflatoxicosis in humans has been reported from all over the world. In addition, in 1988, the IARC placed aflatoxin B1 on the list of human carcinogens. This is supported by a number of epidemiological studies done in Asia and Africa that have demonstrated a positive association between dietary aflatoxins and liver necrosis, cirrhosis, and carcinoma of the liver.(17) As was stated earlier, gamma irradiation may destroy most aspergillus and penicillium mold, but except in extremely high doses it doesn't destroy aflatoxins ­ in fact, some studies suggest that low level gamma irradiation may actually increase the production of aflatoxins. (18)

PPS and Health Canada have never identified the root cause of this high level of contamination, nor have they acknowledge or sought to address the significant concerns over the potentially deleterious effects it may have on the end-users of the PPS product.

Gamma Irradiation

Gamma irradiation is a controversial decontamination technique that has never been studied for safety in smoked or inhaled products anywhere in the world. Although it effectively destroys most bacteria, it does not destroy viruses or mycotoxins, and is often used to cover up biological contamination resulting from poor production, processing or handling practices. One of the bi-products of gamma irradiation is the production of Unique Radiolytic Products (URPs), which are a new class of chemicals resulting from irradiations that are not otherwise found in nature. Of significance in the gamma irradiation of whole plant cannabis is the potential production of cyclobutanones, which are toxic, carcinogenic chemicals that form when fats are subjected to gamma irradiation,(19) and which have been directly linked to the development of colon cancer in rats (Raul et al, 2002).(20) In addition, gamma irradiation has been shown to destroy terpenes like myrcene and linalool (fan et al, 2002),(21) which have known therapeutic properties and are found in high concentrations in some strains of whole-plant cannabis.(22) Terpenes may also play a significant role in the synergistic effect and bioavailability of THC and other cannabinoids.(24)

A conversation with Dr. Richard Viau, Director of Health Canada's Drug Analysis Services on December 8th of this year suggests that government is only now investigating the potential dangers of gamma irradiation and cyclobutanones, despite a CSA press release addressing this problem dating back to September 15th of 2003.(24) Since there is quite simply no international research that can assure end-users of the PPS product of the long-term safety of gamma irradiation on humans - particularly on smoked or inhaled product - it seems logical that the "precautionary principle" (whereas the safety of research subjects and consumers is placed before any unproven scientific assumption of harmlessness) should be applied in this important health matter, and that the distribution of gamma irradiated cannabis by Health Canada should cease immediately.

Conclusion

In conclusion, Canadians for Safe Access urges Health Canada, the Office of Cannabis Medical Access and Prairie Plant Systems to:

1) Impose an immediate moratorium on the distribution or use of the cannabis produced by Prairie Plant Systems in clinical research or otherwise until all of the above concerns have been fully addressed and adequately remedied.

2) Acknowledge and explain the high levels of heavy metals and biological impurities detected through PPS' own testing, as well as independent tests conducted by CSA.

3) Remedy the poor cultivation, handling, or storage practices have resulted in such high levels of biological impurities and heavy metals.

4) Immediately terminate the use of gamma irradiation on the federal supply of cannabis in light of the total absence of studies supporting its safety in inhaled products.

5) Properly address patient concerns relating to the lack of strain selection and poor quality of the PPS product.

Over the last 2 years, Canadians for Safe Access has worked towards the goal of ensuring that all Canadians needing a safe source of medicinal cannabis can access it without undue harm or hindrance. This has included supporting the good work of Canada's unregulated network of compassion clubs and societies, as well as addressing concerns with Health Canada's Office of Cannabis Medical Access and Marijuana Medical Access Regulations. This letter - like the many other CSA-funded tests, press releases and consultations that have preceded it - is written in the spirit of public service, and is an attempt to address the current defects plaguing our federal medicinal cannabis program.

For some patients the therapeutic use of cannabis is an educated choice; for many it is the only treatment option remaining. Either way, Canada's critically and chronically ill should not be treated as test subjects in Health Canada's federal cannabis production and distribution program. The legitimate concerns outlined in this letter reflect months of research and hundreds of patient complaints; they deserve the attention of Health Canada, Health Minister Dosanjh, the press and the Canadian public, just as the end-users of this program deserve the safest, strongest medicine available right now.


Notes

  1. Queen v. Hitzig: http://johnconroy.com/lederman.pdf [PDF]
  2. From the Vancouver Province, 17th Dec., 2004. Available at: http://www.mapinc.org/newscsa/v04/n1801/a06.html
  3. Health Canada website: http://www.cihr-irsc.gc.ca/e/4625.html
  4. See CSA website for pictures: http://safeaccess.ca/research/HCvsVICSpics.htm
  5. Globe and Mail Newspaper, Toronto. September 16th, 2003. Available at: http://www.mapinc.org/newscsa/v03/n1396/a08.html
  6. ATI request available at: http://safeaccess.ca/pr/mmarfoi.pdf
  7. Results available at the CSA website: http://safeaccess.ca/research/VICS_HCcannabinoid_test.pdf
  8. Test results available at: http://safeaccess.ca/pr/quelabresults.htm
  9. CSA website: http://safeaccess.ca/research/flinflon.htm
  10. MiningWatch website http://www.miningwatch.ca/documents/financial_options_paper.pdf
  11. CSA website: http://safeaccess.ca/research/flinflon/
  12. View Magazine. 23rd October, 2003. Available at: http://www.mapinc.org/newscsa/v03/n1666/a03.html
  13. CSA website: http://safeaccess.ca/research/flinflon/aflatoxins.htm
  14. http://www.doctorfungus.org/thefungi/Penicillium.htm
  15. Germaud P. & Tuchai, E. 1995. Allergic bronchiopulminary aspergillosis treated with itraconazole. Chest. 107: 883.
  16. Pitt, J.I. 2000. Toxigenic fungi: which are important? Med. Mycol. 38: 17-22.
  17. CSA website: http://safeaccess.ca/research/flinflon/aflatoxins.htm
  18. Priyadarshini E. & Tulpule P.G. 1979. Effect of Graded Doses of Gamma-Irradiation on aflatoxin production by aspergillus parasiticus in wheat. Fd. cosmet. Toxicol., Vol. 17, 1979, 505-507.
  19. CSA website: http://safeaccess.ca/research/flinflon/
  20. CSA website: http://safeaccess.ca/research/flinflon/Radiolytic_Compounds.pdf
  21. CSA website: http://safeaccess.ca/research/flinflon/Fan_Cilantro_Irradiation%20.pdf
  22. McPartland & Mediavilla 2002.
  23. Russo E & McPartland J. 2001. Cannabis and cannabis extracts: greater than the sum of their parts? From E. Russošs Cannabis Therapeutics in HIV/AIDS. Haworth Integrative Healing Press.
  24. CSA website: http://safeaccess.ca/pr/csapr7.htm


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