1 -118 October 2007

To the Health Select Committee Submission from the National Organisation for the Reform of Marijuana Laws (NORML NZ Inc) in support of Petition 2005/0084 from Chris Fowlie, on behalf of NORML New Zealand Inc, and 2,991 others: We, the undersigned, request that parliament give urgent attention to changing the law to allow individuals to obtain, possess and use cannabis for treatment of serious medical conditions when this has been recommended or endorsed in writing by the individual’s registered medical practitioner. Contents 1 2 3 Executive Summary About NORML New Zealand Medicinal use of cannabis and cannabinoids - a review of the evidence 2 6 7

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3.1

A brief history of medicinal cannabis use

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3

3.2

A review of the evidence

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3.3

Safety and appropriate delivery of cannabinoid medicines

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3.4

Estimated number of NZ medicinal cannabis patients

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3.5

Case studies: examples of NZ medicinal cannabis patients

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4

Government-level commissions support change

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8

4.1

Medical support for change

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9

4.2

Public support for change

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5

The international experience

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5.1

Examples of medicinal cannabis dosage and plant numbers

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6 7

Commonly asked questions about medicinal cannabis References & further information

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7.2

Suggested websites

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7.3

Suppliers of medicinal cannabis products

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Appendices (attached):

16 Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ GreenCross_patient_testimonies.rtf NORML_Clinical_Applications_for_Cannabis_and_Cannabinoids.pdf NORML_Marinol_vs_Natural_Cannabis.pdf NORML_Cannabinoids_Cancer_Hope.pdf NORML_Cannabis_Mental_Health_Context.pdf Russo_Chronic_Cannabis_Use_in_the_IND_programme.pdf MedicinalCannabis-RationalGuidelinesforDosing.pdf MPP_Extracts_IOM_Assessing_The_Science_Base_1999.pdf GreenPartySurveyofDoctors.pdf Dutch Govt Specification sheet (Bedrocan-Bedrobinol).pdf

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1.

Executive Summary

This submission presents the case for allowing a compassionate policy of safe access to medicinal cannabis for registered patients. We have not attempted to collate all the evidence relating to medicinal cannabis, as that has been done elsewhere, and many such reports are widely available on the Internet. Instead, we have tried to provide an analysis of the most pertinent points that we believe should be considered by policymakers. Cannabis prohibition applies to everyone, including the sick and dying. Of all the negative consequences of prohibition, perhaps none is as terrible as the denial of effective relief to seriously ill people who could benefit from the therapeutic use of cannabis. Modern research suggests that cannabis is a valuable aid in the treatment of a wide range of clinical applications including: Ÿ pain relief -- particularly neuropathic pain and arthritis; Ÿ appetite stimulant, especially for patients suffering from cancer, HIV, AIDS wasting syndrome, anorexia or dementia; Ÿ anti-nausea - helping patients undergoing cancer chemotherapy or other debilitating treatments; Ÿ easing muscle spasms in neurological disorders such as multiple sclerosis or spinal cord injury; Ÿ neuroprotection and protection against some types of malignant tumours; Ÿ cannabis or its derivatives are also effective in treating a host of other conditions such as Glaucoma, Alzheimer's, Amyotrophic Lateral Sclerosis, Diabetes, Fibromyalgia, Gliomas, Gastro Intestinal Disorders, Hepatitis C, hypertension, Osteoporosis, Pruritis and Tourette's syndrome. Prohibition increases harms Conventional medicines are not effective for all patients. People suffering from any of the conditions mentioned above, for whom the conventional medical options have proven unsafe or ineffective, have two options: either continue suffering without effective treatment, or illegally obtain cannabis. More than 11,000 New Zealanders may already be doing so. The risks and harms to those who find relief through medicinal cannabis, are magnified by treating them as criminals: Ÿ unsafe and hazardous supply, including contamination with fungus, mould or chemicals; Ÿ uncertainty of supply - cannabis can be hard to find, or a bust means their medication is lost; Ÿ prohibition-related violence and theft, such as home invasions; Ÿ increased anxiety due to criminal status and fear of arrest; Ÿ increased financial costs due to having to buy medicine at illicit market prices; Ÿ significant risk of arrest, conviction and imprisonment; Ÿ being treated more harshly by the courts due to persistent growing; Ÿ being presumed a dealer for growing or possessing more than one ounce - even property seizure is a real possibility. Despite these risks a large number of patients choose to self-medicate with cannabis, for the simple reason that it is the most effective treatment for their condition.

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The need for law reform The New Zealand Health Select Committee has previously examined the use of cannabis. The report of the 2001-3 cannabis Inquiry concluded “cannabis has been shown to be effective in providing relief for some medical disorders ... the issue of medicinal use should be dealt with independently from the legislation regulating general use.” Under the current law, the decision as to whether a patient can use cannabis medicinally is made not by doctors but the Minister of Health, under advisement from the Police and Customs Service. The Minister of Health may consider: Ÿ an application from a medical practitioner for a license to run a clinical trial involving one or more of their patients Ÿ an application from a medical practitioner to directly import for their patient a medicine that has been approved by an overseas health authority, or unapproved raw cannabis plant for medicinal use. Medicinal cannabis use is controlled under the Medicines Act 1981, the Misuse of Drugs Act 1975 and the Misuse of Drugs Regulations 1977. The Minister’s powers of approval are currently delegated to the manager of Medsafe, the therapeutics arm of the Ministry of Health. However, as the Health Select Committee's 2003 cannabis inquiry report noted, "the National Drug Intelligence Bureau (NDIB), comprising staff from the New Zealand Police and New Zealand Customs Service, advises the Ministry of Health on applications for medicinal use of unapproved raw cannabis plant." Every patient who has had the courage to apply has been refused. Patients have consistently told us they have been unable to convince doctors to apply, not due to a lack of support, but a reluctance by doctors to "put their neck out" and risk losing their careers and livelihood. Many have told us their doctors lost interest once they discovered what the application process would involve. The current approach is futile, onerous, politicised, does not provide any actual assistance to patients, and should be changed. Natural cannabis is more effective When discussing the therapeutic use of cannabis and cannabinoids, opponents inevitably respond that patients should not smoke their medicine. A comprehensive review of the literature by Hollister (1998) noted that "whether smoked marijuana should become a therapeutic agent requires a cost-benefit analysis of the potential benefits versus the adverse effects of such use as we now know them." Smoked cannabis does pass the costbenefit analysis. The risks are small, especially for terminally ill patients, while the potential benefits are much greater. Cannabis has a remarkably low toxicity, and possibly an anticancer action. There is no known lethal dose. Many pharmaceutical medicines have severe negative side effects, which far outweigh the few, if any, negative side effects that these patients experience from medicinal cannabis. For example, 13,718 New Zealanders required hospitalisation for adverse reaction to conventional medications in 2001/2 (NZHIS, 2004). Any adverse effects from cannabis "are within the range of effects tolerated for other medications." (IOM, 1999) Legislation that allows only for pharmaceutically produced cannabis-based medicines such as Sativex would be ineffective. Cannabis is easy and cheap to grow when compared with the cost of pharmaceutical cannabis derivatives (Sativex is said to cost around $300 per week for the average patient). To this end, patients will continue to grow their own if it remains the cheapest and more accessible option. Furthermore, several clinical trials have shown whole herbal cannabis is more effective than single extracts like Sativex or

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synthetic alternatives such as Marinol. The advantages of inhaling herbal cannabis include: Ÿ Naturally-occurring cannabis contains about 60 unique compounds, whereas artificial derivatives contain one or two at most. Cannabis is an holistic medicine. Ÿ Patients prefer different strains for different conditions. For example, some strains contain higher amounts of THC (for effective pain relief), while other strains have larger amounts of CBD (for relieving muscle spasms, for example) Ÿ Inhalation means more accurate dose titration and quicker relief from symptoms. Swallowed cannabis can take up to three hours to reach full effect and is difficult to judge the dose; Ÿ Synthetic THC can be more psychoactive than natural cannabis, as the liver changes THC into a stronger metabolite; Ÿ Marinol and Sativex are more expensive than natural cannabis; Ÿ Patients ultimately prefer natural cannabis to extracts or synthetic alternatives. For more information, see the attached report, Marinol vs Natural Cannabis: Pros, Cons and Options for Patients. In any case, medicinal cannabis does not need to be smoked. Alcohol-based tinctures provide the speedy benefits and accurate dose titration of inhalation, and can readily be made to a standard strength. The harmful effects of smoking can also be avoided with the use of vapourisers, which do not burn the plant material, but heat it to the point where the active ingredients are released as steam. A recent study (Abrams 2007) at the University of California at San Francisco concluded vapourisation is "a safe an effective mode of delivery of THC." Another recent study, at the University of New York, found vapouriser users were 60 per cent less likely than smokers to report respiratory symptoms such as coughing, tightness or phlegm (Earlywine, 2007). The international experience The amassed body of evidence in favour of medical marijuana has led to important legislative and judiciary developments around the world. Several jurisdictions overseas have changed their laws, or are considering it, including 13 states in America, Canada, Spain, Portugal, the UK, the Netherlands, Germany, Switzerland and Italy. The Compassionate Use Act 1996 legalised medical marijuana in the State of California and 12 other states have done the same. In 2001 Canada legalised medical marijuana: Health Canada supplies herbal marijuana, or patients can grow their own. In the Netherlands, the Bureau of Medical Cannabis now supplies two varieties of medical grade marijuana through pharmacies. Medical cannabis trials using whole herb extract have been carried out in Britain since 2000, many using GW Pharmaceuticals’ sub-lingual spray, Sativex, and several countries have shown an interest in GWP’s products. Reported abuses overseas have been low or non-existent. In California, teenage marijuana use dropped following the regulation of medicinal cannabis. A recent study examined cannabis use in several US states that allow medicinal use and found no evidence that recreational use had increased. Researchers concluded that the passage of medical cannabis laws may "de-glamorise" the drug’s use and "thereby [does] little to encourage [its] use" among non-medical patients (Gorman, 2007). Our proposals for safe access

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New Zealand should base it's approach on the successful aspects of overseas examples. Patients already use medicinal cannabis, and will continue to do so whether it is officially allowed or not. Regulating medicinal cannabis will reduce the risks that are already associated with its use. Ÿ Patients should be able to grow and possess an adequate amount of cannabis for their own medicinal use. Ÿ Dosages and plant limits should be decided by the doctor and patient together. The various US state plant limits provide a useful guide. Ÿ If the patient is unable to grow their own supply, they should be able to nominate a caregiver or community organisation to grow the plants for them. Ÿ Patients and their nominated growers could be registered as a medicinal cannabis grower with the police or other appropriate authority, such as the Ministry of Health. Ÿ The Government itself could be a nominated grower and could use tertiary institutions or crown research institutes to grow a supply of standardised cannabis, which could be distributed to patients through pharmacies. Ÿ The Government could import standardised medicinal cannabis from the Netherlands Office of Medicinal Cannabis Ÿ Registered patients should be able to import cannabis seeds from overseas seed vendors, many of whom have bred strains for specific medical conditions. Ÿ Provision should be made for patients to access harm reduction equipment such as vaporisers and waterpipes. Ÿ Clinical trials of pharmaceutical grade cannabis-based products such as Sativex ought to be completed expeditiously in order to provide an alternative to patient-grown medicinal cannabis, so that those who do not wish to grow their own can still have safe access to medicinal cannabis. Recommendations The medicinal cannabis user should not be considered a criminal. Many very ill people have had to fight long court battles to defend themselves for the use of a medicine that has helped them. Most are convicted and some have been imprisoned. This situation obviously needs to change. There are sufficient clinical trials, case studies and anecdotal reports to justify a compassionate regime allowing medicinal use - and there is significant public support. A TV3/TNS poll in November 2006 found 63% of respondents supported legalising cannabis for medicinal use. Green MP Metiria Turei's Misuse of Drugs (Medicinal Cannabis) Amendment Bill deserves to be further considered by policymakers and the wider community, and so we ask the Health Select Committee to recommend to parliament that it support this Bill.

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2.

About NORML New Zealand Inc.

NORML New Zealand is a non-profit incorporated society founded in 1979 that campaigns to end to marijuana prohibition. We are committed to reducing harms relating to drugs. NORML believes that current measures ostensibly taken to reduce harms are in reality designed to reduce use, whether harmful, non-harmful or even beneficial. Such an approach is inherently unjust (being an attack on those who use drugs responsibly including medically) and risks inflicting greater harms on those punished than would be caused by the drugs themselves. NORML supports the right of all adults to use, possess and grow their own cannabis. We recognise that a commercial market for marijuana will always exist, and we therefore promote ways to best to control that market. Our aims are: Ÿ Ÿ Ÿ Ÿ Ÿ To reform New Zealand’s marijuana laws; To provide neutral, unbiased information about cannabis and its effects; To engage in political action appropriate to our aims; To inform people of their rights; To inform give advice and support to victims of prohibition.

NORML believes drug policy should: Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ have realistic goals; be regularly evaluated, be shown to be effective or be changed; take account of the different patterns and types of harms caused by specific drugs; separate arguments about the consequences of drug use from arguments about morals; be developed in the light of the costs of control as well as the benefits; ensure that the harms caused by the control regimes themselves do not outweigh the harms prevented by them; provide the greatest level of harm reduction for drug users, their families and their communities; minimise the number of drug users who experience problems resulting from their drug use; be evidence based, as well as having the support of the community.

NORML can be contacted at: Chris Fowlie (09) 302 5255 norml@norml.org.nz NORML New Zealand Inc. PO Box 3307, Auckland. Will de Cleene (021) 165 8073 wellington@norml.org.nz

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3.
3.1

Medical use of cannabis and cannabinoids
A brief history of medicinal use

Medicinal cannabis is not new. Historical references reach back at least 5000 years, as the physicians of the ancient world extolled its virtues in their most important medical texts. The Chinese Pen T’sao (3700BC), the Indian Athara Veda (1100BC) and the Persian Zend-Avesta (700BC) all name cannabis among their top five most prized medicinal herbs. 2000 years ago Dioscorides listed Cannabis Sativa in his Materia Medica, praising its numerous therapeutic properties (Conrad, 1997& Booth 2003). During the Ages of Reason and Enlightenment, cannabis was enthusiastically incorporated into Modern Medicine. Queen Victoria’s personal physician Sir John Russell Reynolds described “Indian hemp” as “one of the most valuable medicines we possess”. From 1840 to 1900, over 100 articles were published in scientific journals, enumerating the therapeutic powers of cannabis. By the early 20th century, cannabis was the third most common ingredient in patent medicines for sale in Western countries including New Zealand. In Aotearoa, Mother Mary (Susan) Aubert, founder of Our Sisters of Compassion, pioneered medical marijuana cultivation and application. In the late 1800s, with the help of traditional Maori knowledge, she successfully combined the curative powers of native plants and cannabis. The resulting remedies, packaged under the name “Rongoa” (Maori for medicine) were so effective, that eventually up to 4000 bottles a month were being sold throughout NZ and Australia (Yska, 1990). This bi-culturally inspired medical marijuana industry helped fund Aubert’s extraordinary life-work as a healer, teacher and philanthropist, for which she has been Beatified by the Vatican. Even before Mother Aubert’s time, NZ pharmacists imported cannabis in patent medicines or extracts and by the turn of the century, its use was almost universal among our doctors and herbalists. In 1928, specific licensing for medicinal cannabis was introduced here. But in 1954, the World Health Organisation relented to pressure from the US Federal Bureau of Narcotics (FBN) and stopped all trade in “Indian Hemp” for medicine. The American introduction of cannabis prohibition (shortly after alcohol prohibition had been repealed) was conducted with naked contempt for the medical profession. At the time, there were dozens of cannabis-based medicines, produced by reputable drug companies like Squibb, Merck, and Eli Lily, and used safely by many people. The American Medical Association (AMA) was one of the most vocal organisations to testify against cannabis prohibition, arguing that it would deprive patients of a past, present and future medicine (Booth, 2003). But Commissioner of the FBN, Harry J. Anslinger, rammed through the Marihuana Tax Act in 1937, which prohibited cannabis at a Federal level. Doctors who continued to prescribe cannabis began to be prosecuted routinely. Legitimate medicinal use was rapidly destroyed, while illicit recreational use flourished: a pattern that has followed cannabis prohibition around the world. Anslinger and his political allies applied their considerable international weight and eventually oversaw the ratification of the UN Single Convention on Narcotic Drugs in 1961, which effectively ended medicinal cannabis worldwide (Conrad 1997, & Booth, 2003).

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Scientific research continued, however, and in 1965 Israeli chemist Dr Raphael Mechoulam published his discovery of delta-9 tetrahydrocannabinol (THC), marijuana’s principle psychoactive chemical. It represented a new class of pharmaceutical compounds: the cannabinoids. In 1988 and 1992, the discoveries of the human cannabinoid receptor system and its endogenous correlate, anandamide, were made by Allyn Howlett, William Devane and Mechoulam. With a human endocannabinoid system identified, a world of medical possibilities opened up (Conrad, 1997).

3.2

A review of the evidence

Cannabis plants contain over 400 compounds and about sixty of these, called cannabinoids, are unique to the plant. Among the most psychoactive is delta-9tetrahydrocannabinol (THC), while cannabidiol (CBD) and cannabinol (CBN) are nonpsychoactive but possess distinct pharmacological effects. The discovery of an endogenous cannabinoid system has furthered our understanding of how cannabis works. Cannabinoid receptor sites are now known to exist in the nervous systems of all animals more advanced than hydra and mollusks. The receptors evolved with our species and are intricately involved in normal human physiology -- including the control of movement, pain, reproduction, memory, and appetite, among other biological functions. The human body's neurological, circulatory, endocrine, digestive, and musculoskeletal systems - and even cartilage tissue - have now all been shown to possess cannabinoid receptor sites. Although much is still unknown about cannabinoids in the body, a general scientific picture of endocannabinoid function is beginning to emerge. The anandamide system appears to be regulatory in nature, balancing biological activity between "up" and "down regulation" (Melemede, 2005). A simple example is the appetite vs. nausea duality: stimulation of the anandamide system with cannabinoids brings about hunger in patients suffering from excessive nausea. There are two main types of endocannabinoid receptor, CB1 and CB2, which act as docking sites for different cannabinoids in diverse areas of the nervous system (Smith, 2002). Together, these receptor types manage homeostasis (stable activity) in a wide range of biochemical functions, by engaging cannabinoids which can be produced within the body, plant-derived, or synthetic. This "homeostatic regulatory" model helps to explain how cannabis works in virtually all of its known medicinal applications. Adverse neurological activity is managed through the endocannabinoid system either naturally (with anandamide) or through medical intervention (with THC etc.). The body's endocannabinoid system can benefit from additional stimulation by plant-derived or synthetic cannabinoids. For example, cannabinoid receptors naturally increase in areas where nerve damage has occurred, protecting the brain from further damage through a variety of mechanisms. In the massive and sudden disturbance wrought by serious brain injury or stroke, rapid delivery of cannabinoids can slow or arrest this process completely (Caberlotto, 2003; Hampson, 1998; Panikashvili, 2001). The main therapeutic actions of cannabis may be summarised as: Ÿ Neuroprotective: Cannabinoids perform a multitude of regulatory, protective tasks throughout the nervous system, including for example, prevention of neural cell death from over-stimulation by excitatory neurochemicals, such as glutamate, which proliferates immediately after a stroke.

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Ÿ Analgesic: The endocannabinoid system runs parallel to the endorphine system in pain control, performing anti-nociceptic functions in both the central and peripheral nervous systems: cannabinoids and opiates have been shown to work in conjunction with increased effectiveness. Ÿ Antiemetic/Appetite-stimulant: Cannabinoids regulate the appetite/nausea function. Indeed, cannabinoids have been found in mice milk, where they initiate the hunger reflex (Fride, 2001). Cannabis can reverse appetite loss and nausea in a wide range of illnesses. Ÿ Immunological/Anti-inflammatory: The immune system is supported by cannabinoid activity in a variety of ways, most importantly perhaps, the induction of programmed death (apoptosis) in abnormal cells, which can slow, arrest or reverse cancer growth. Cannabinoids also modulate the basic anti/pro-inflammatory ("Th1 & Th2") chemistry of the immune system, usually as an anti-inflammatory, bringing relief for sufferers of arthritis and similar immunity disorders. Researchers at the University of Geneva have demonstrated how THC reduces inflammation that leads to hardening of arteries (Batkai, 2007). Cannabinoids also appear to exert an antibiotic action as part of their immunilogical function (Mechoulam, 2005). Ÿ Psychological: The subtle and complex actions of cannabinoids in the higher brain functions provide for a variety of therapeutic possibilities. The motivational and antidepressive effects of cannabis, described by numerous medicinal users, are likely related to the endocannabinoid system. Ÿ Relaxant: Active cannabinoids soften muscle contraction, expand air and blood vessels and reduce intraocular pressure. These activities are protective against spasticity, spasming, palpitations, asthma and glaucoma. A selection of common therapeutic uses for cannabis: Ÿ HIV & AIDS. Cannabis can reduce the nausea, vomiting, and loss of appetite caused by the ailment itself and by various medications. Ÿ Glaucoma. Cannabis can reduce intraocular pressure, alleviating the pain and slowing — and sometimes stopping — damage to the eyes. Only recently have scientists discovered cannabinoid receptors anandamide, 2-AG and PEA in the cornea, ciliary body and retina of human eyeball tissues. As the ciliary body regulates intraocular eye pressure, this may explain how cannabis helps alleviate glaucoma. Ÿ Multiple Sclerosis. Cannabis can limit the muscle pain and spasticity caused by the disease, as well as relieving tremor and unsteadiness of gait. Ÿ Epilepsy. Cannabis can prevent epileptic seizures in some patients. David Prince, Professor of Neurology and Neurological Sciences at Stanford University School of Medicine found that cannabinoids can help protect against the sensory overload of epilepsy by a process of retrograde signalling of the pyrimidial and inhibitory interneurons. Ÿ Chronic Pain. Cannabis can alleviate the chronic, often debilitating pain caused by a myriad of disorders and injuries.

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Ÿ Cancer. Cannabis stimulates the appetite and alleviates nausea and vomiting, which are common side effects of chemotherapy treatment. Cannabinoids also trigger the body's natural antitumoral activities. Research in this area has demonstrated potential for the treatment of several cancer types, including glioma brain tumours and breast cancer. Manuel Guzman and colleagues at the Complutense University in Spain found that cannabis extracts shrank brain tumours by inhibiting the process of angiogenesis. Cannabinoids reduced blood vessel production by increasing levels of ceramide, which controls cell death. Recent research has also found cannabinoids to have therapeutic applications for the following illnesses: prion diseases, Alzheimer's, amyotropic lateral sclerosis, diabetes, fibromyalgia, gastro-intestinal disorders, hepatitis C, hypertension, osteoporosis, pruritis, post-traumatic stress disorder, strokes, Tourette's syndrome, dystonia, rheumatoid arthritis, sleep apnea. Many patients also report that cannabis is useful for treating or moderating: postoperative trauma, migraines, menstrual cramps, labour pains, alcohol and opiate addiction, depression and other debilitating mood disorders. A comprehensive examination of the latest research is contained in the attached report, Clinical Applications for Cannabis and Cannabinoids, by Paul Armentano (NORML_Clinical_Applications_for_Cannabis_and_Cannabinoids.pdf).

3.3

Safety and appropriate delivery of cannabinoid medicines

General Pharmacological Safety Recent years have seen a renewed interest in the medicinal properties of cannabis, not only because of it's effectiveness as a medicine, but also because of its remarkably low toxicity. Overdoses in humans have not been recorded, a degree of safety that is very rare among modern medicines, including most pharmaceuticals. The Health Select Committee said in its 2003 cannabis inquiry report that the Christchurch Health and Development Study had found that "for the majority of occasional recreational cannabis users there is no evidence to suggest that usage has harmful effects." The inquiry report noted that those people who do experience harm "tend to come from already socially disadvantaged groups and have pre-existing problems. For the majority of occasional cannabis users, there is a low risk of cannabis-related harm." US Drug Enforcement Administration Administrative Law Judge, Francis Young, said in 1988: "Marijuana is the safest therapeutically active substance known to man... The evidence clearly shows that marijuana is capable of relieving the distress of great numbers of very ill people, and doing so with safety under medical supervision. . .it would be unreasonable, arbitrary and capricious for the DEA to continue to stand between those sufferers and the benefits of this substance." Professor Lester Grinspoon, M.D., Associate Professor of Psychiatry, Harvard Medical School agreed, adding “Marijuana is one of the least toxic substances in the whole pharmacopoeia”, while Oxford University's Professor Leslie Iverson, in his book The Science of Marijuana, noted: "By any standards, THC must be considered a very safe drug both acutely and on long-term exposure."

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The Missoula Chronic Clinical Cannabis Use Study (Russo, 2002) examined the long-term effects of using medicinal cannabis and found significant benefits and very few adverse effects: "Results demonstrate clinical effectiveness in these patients in treating glaucoma, chronic musculoskeletal pain, spasm and nausea, and spasticity of multiple sclerosis. All 4 patients are stable with respect to their chronic conditions, and are taking many fewer standard pharmaceuticals than previously. Mild changes in pulmonary function were observed in 2 patients, while no functionally significant attributable sequelae were noted in any other physiological system examined in the study, which included: MRI scans of the brain, pulmonary function tests, chest Xray, neuropsychological tests, hormone and immunological assays, electroencephalography, P300 testing, history, and neurological clinical examination. These results would support the provision of clinical cannabis to a greater number of patients in need. We believe that cannabis can be a safe and effective medicine with various suggested improvements in the existing Compassionate IND program" Mental Health The 1998 Health Select Committee of Inquiry into the Mental Health Effects of Cannabis stated in its conclusions that, "Based on the evidence we have heard in the course of this inquiry, the negative mental health impact of cannabis appears to have been overstated... [and] occasional cannabis use represents few risks to the mental health of most adult users." However, NORML recognises there are concerns surrounding cannabis use and mental health, which need to be taken into account. Regulation of medical marijuana through the public health system provides the best possible protection for patients. In the current environment of total prohibition, patients either suffer, or seek cannabis illegally, without the support of health professionals. Any mental health problems that medicinal cannabis users may experience could go unreported, undetected and untreated. They may also be exacerbated by anxiety brought by criminalisation and fluctuations in quality and supply of the medicine. The best policy to mitigate any mental health concerns regarding medicinal cannabis is to bring it under the auspices of the legal health system, with its use prescribed and monitored by doctors and health professionals. Driving Concerns about driving should not affect the provision of cannabis as a medicine. Legislation to address the question of automobile operation while impaired by medicinal or other drugs is currently being considered by Parliament. Medicinal cannabis should be treated like any other medicine: if the patient is impaired, driving should be prohibited. Medicinal cannabis products could come with warnings advising patients not to drive or operate heavy machinery for several hours following use. Lung-delivery Concerns Inhalation of cannabis provides optimal dose delivery for most conditions due to its rapid action and easy titration. However this usually requires smoking, which raises separate health issues. This can be overcome by the use of vapourisers, which allow lung delivery without smoking (see below). However, it should be noted that especially for those

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suffering from terminal illnesses, the cumulative damage caused by smoking is of minor concern. It would seem pernicious to deprive them of relief in deference to anti-smoking sentiment. Smoking & Lung Cancer Because cannabis smoke contains similar carcinogens to tobacco smoke, it has long been suspected that the cannabis smoking population of the developed world would begin to suffer from increased lung cancer incidents. However a substantial recent epidemiological study has failed to support this prediction. The 2005 study of over 2,000 individuals found no increase in lung cancer risk for marijuana smokers. The research was lead by pulmonary scientist Donald Tashkin of the University of California, Los Angeles, who had previously conducted laboratory research that predicted a carcinogenic effect from cannabis smoking. But looking at residents of Los Angeles County, he found that even those who smoked more than 20,000 joints in their life did not have an increased risk of lung cancer. The researchers compared 1,212 lung and upper-airway cancer patients with 1,040 healthy controls to create the statistical analysis. After controlling for tobacco, alcohol and other drug use as well as matching patients and controls by age, gender and neighbourhood; marijuana smoking could not be linked to the cancers. In fact, in some data groups, cannabis-only smokers fared better than non-smokers. Tashkin conceded that the results suggest cannabis smoking could even be protective against lung cancer and speculated that this may be due to the known anti-tumoural actions of various cannabinoids. Tashkin and his colleagues presented their findings in May 2006, at a meeting of the American Thoracic Society in San Diego (Tashkin, 2006). Vapourisation Although fears that cannabis smoking leads to lung cancer are probably unfounded, there are other respiratory problems associated with smoking which are clearly best avoided by medicinal cannabis users not suffering from terminal illness. However, a safe and effective mode of lung-delivery is available for these patients. This alternative form of inhalation is called vapourisation which involves heating cannabis until the resins evaporate, but without burning the solid plant matter. The cannabinoids are inhaled as a vapour, not smoke. This way, doses can be delivered through the lungs without the inhalation of the various toxins associated with the combustion of plant matter. A recent study (Abrams et al, 2007) at the University of California examined the effectiveness of vapourisers and found peak plasma concentrations and bioavailability of THC were similar to smoking. Unlike smoking, vaporisation did not increase the amount of carbon monoxide in the lungs. Researchers concluded vapourisation of cannabis is "a safe an effective mode of delivery of THC." The abstract states: "Although cannabis may have potential therapeutic value, inhalation of a combustion product is an undesirable delivery system. The aim of the study was to investigate vaporization using the Volcano device as an alternative means of delivery of inhaled Cannabis sativa. Eighteen healthy inpatient subjects enrolled to compare the delivery of cannabinoids by vaporization to marijuana smoked in a standard cigarette. One strength (1.7, 3.4, or 6.8% tetrahydrocannabinol (THC)) and delivery system was randomly assigned for each of the 6 study days. Plasma concentrations of delta-9-THC, expired carbon monoxide (CO), physiologic and neuropsychologic effects were the main outcome measures. Peak plasma concentrations and 6-h area under the plasma concentration–time curve of THC were similar. CO levels were reduced with vaporization. No adverse events

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occurred. Vaporization of cannabis is a safe and effective mode of delivery of THC. Further trials of clinical effectiveness of cannabis could utilize vaporization as a smokeless delivery system." Another recent study, by Mitch Earlywine and Sara Barnwell at the University of New York, found vapouriser users were 60 per cent less likely than smokers to report respiratory symptoms such as coughing or phlegm. The abstract states: "Cannabis smoking can create respiratory problems. Vaporizers heat cannabis to release active cannabinoids, but remain cool enough to avoid the smoke and toxins associated with combustion. Vaporized cannabis should create fewer respiratory symptoms than smoked cannabis. We examined self-reported respiratory symptoms in participants who ranged in cigarette and cannabis use. Data from a large Internet sample revealed that the use of a vaporizer predicted fewer respiratory symptoms even when age, sex, cigarette smoking, and amount of cannabis used were taken into account. Age, sex, cigarettes, and amount of cannabis also had significant effects. The number of cigarettes smoked and amount of cannabis used interacted to create worse respiratory problems. A significant interaction revealed that the impact of a vaporizer was larger as the amount of cannabis used increased. These data suggest that the safety of cannabis can increase with the use of a vaporizer. Regular users of joints, blunts, pipes, and water pipes might decrease respiratory symptoms by switching to a vaporizer." Vapouriser technology is improving all the time, both in terms of effective dose delivery and ease of use. A number of vapouriser models are currently available, with their popularity as a safer alternative to smoking steadily increasing among medicinal and recreational users alike. It would be a small step for the Ministry of Health to approve and supply a standard vapouriser model for prescribed medicinal marijuana use.

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3.4

Estimated number of NZ medicinal cannabis patients

Around 11,400 New Zealanders could already be using medicinal cannabis illegally although the actual number could be much higher. We have extrapolated this figure from Australian research, which estimated about 18,900 people in New South Wales in any year might benefit from the medical use of cannabis or cannabinoids (Hall et al, 2000). However, their analysis covered only certain conditions, and did not include patients suffering chronic or acute pain, for example. There is ample data from clinical trials and anecdotal reports to suggest that cannabis may be beneficial for many more conditions, so the true number of patients who use medicinal cannabis could be much higher. Tens of thousands of New Zealanders suffer from the conditions that modern research has shown cannabis to be beneficial for. This is a partial list of some of these conditions. Even if only ten per cent of patients with these conditions found cannabis to be more beneficial that conventional medications, that represents a remarkable opportunity to improve patient well-being and quality of life. Ÿ AIDS and HIV: 2474 New Zealanders were diagnosed with HIV from 1985 to 2005. Ÿ Alzheimer's: the most common form of dementia, affecting approximately 17,000 to 21,000 New Zealanders. Ÿ Arthritis: one in every six people over the age of 15 years - or, one in every three people over the age of 45 years. Ÿ Asthma: one in four NZ children and one in six adults has asthma Ÿ Cancer affects 1 in 3 New Zealanders. Ÿ Epilepsy: One in fifty people have epilepsy at some point in their life. Epilepsy is a common neurological disorder that affects 1% to 2% of the population. Ÿ Fibromyalgia: has a female to male ratio of 7–9 to 1, affects 0.5–5% of the population (prevalence increases with age), and an incidence of 0.58% yearly in pain-free women. Ÿ Glaucoma: Approximately 2 % of the population over the age of 40 are affected, while 10% over the age of 70 have glaucoma. Ÿ Multiple Sclerosis: about one New Zealander in every thousand has MS. Thus, there are approximately 4000 people in New Zealand diagnosed with MS. Ÿ Osteoporosis: It’s estimated that over 30% of New Zealand women over the age of 50 have osteoporosis. Ÿ Parkinson's Disease: It affects about one in 500 people; approximately one percent of people over 60 have Parkinson's. Ÿ Stroke: In New Zealand in the year 2003, there are probably about 32,000 people who have suffered a stroke at some time in the past. Ÿ Tourette's Syndrome: strikes roughly 1 in 1000 children, usually between the ages of 6 and 9, but can occur as late as 21 years of age. (Sources: www.moh.govt.nz/aids; www.alzheimers.org.nz/faqs.php#faq02; www.arthritis.org.nz; www.asthmanz.co.nz; www.cancernz.org.nz; www.epilepsy.org.nz/main.cfm?id=34; www.nzma.org.nz/journal/1161174/439/content.pdf; www.glaucoma.org.nz; www.msnz.org.nz/aboutms/whogetsms.asp; www.msd-newzealand.com; www.parkinsons.org.nz/aboutpd.asp; www.stroke.org.nz/stroke_statistics.htm; www.tourette-syndrome.com/tourette-syndrome-faq.htm)

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3.5

Case studies of New Zealand medicinal cannabis patients

A significant proportion of our members use cannabis for medicinal reasons. Some of them have allowed us to present a survey, below, of their medicinal use and the effect of the current law. We have also attached in the Appendix several letters from members of the Green Cross medicinal cannabis patient's support group. While some patients have indicated they are prepared to appear before the committee to share their experiences, many are concerned about their status as "criminals" in the eyes of the law and will only appear if they can be assured of a private and confidential hearing, and that their details will not be passed on to the police. PATIENT A DISCLOSURE: Name disclosure permitted (if asked for) MEDICAL USAGE: Chronic back pain - moderates pain USAGE PATTERN: Daily / Moderate (less than 2 joints ) MEDICAL PRACTITIONER: Doctor is fully aware of and supports patient’s medical usage. Would prescribe if legally allowed to. PREFERRED SUPPLY OPTION: Home cultivation NEGATIVE EFFECTS OF CURRENT LAW: Criminalisation, uncertain supply of medicine PATIENT B DISCLOSURE: Name disclosure permitted for private hearing only MEDICAL USAGE: Depression/ Anxiety: Induces sense of well-being and improves motivation: Asthma: Dilates airways, eases breathing USAGE PATTERN: Daily / Moderate MEDICAL PRACTITIONER: Doctor is aware of and supports patient’s medical usage. Would prescribe if legally allowed to. PREFERRED SUPPLY OPTION: Home cultivation NEGATIVE EFFECTS OF CURRENT LAW: Criminalisation, uncertain supply of medicine PATIENT C DISCLOSURE: Name disclosure permitted for private hearing only / Prepared to appear MEDICAL USAGE: Pain relief: Moderates back pain; Opiate addiction: Alternative to methadone, moderates withdrawal symptoms; Hep. C: Increases motivation against energy-sapping qualities of the disease. USAGE PATTERN: Daily / Medium-heavy (5-6 joints) MEDICAL PRACTITIONER: Both doctor and methadone clinic have full knowledge and maintain a neutral stance toward patient’s usage. PREFERRED SUPPLY OPTION: Home cultivation NEGATIVE EFFECTS OF CURRENT LAW: Criminalisation, uncertain supply of medicine PATIENT D DISCLOSURE: Name disclosure permitted for private hearing only (potentially prepared to appear) MEDICAL USAGE: Post operative trauma (major abdominal surgery): Moderates pain; induces sense of well-being; superior to morphine; Arthritis: Moderates pain; reduces inflammation; Respiratory complaints: Dilates airways; reduces inflammation USAGE PATTERN: Daily / Medium (approx. 2 joints) MEDICAL PRACTITIONER: Doctor knows but maintains a neutral stance PREFERRED SUPPLY OPTION: Home cultivation NEGATIVE EFFECTS OF CURRENT LAW: Patient has been arrested and charged with cultivation for supply. Crown is threatening to seize her property under the Proceeds of Crime Act.

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PATIENT E DISCLOSURE: Name disclosure permitted for private hearing only (Does not wish to appear) MEDICAL USAGE: Chronic post operative trauma (triple heart bypass): Controls heart palpitations; moderates pain; induces sense of well-being USAGE PATTERN: Daily / Moderate MEDICAL PRACTITIONER: Has not found a sympathetic doctor (with enough knowledge of cannabis medicines) PREFERRED SUPPLY OPTION: Home cultivation NEGATIVE EFFECTS OF CURRENT LAW: Criminalisation, uncertain supply of medicine PATIENT F DISCLOSURE: Anonymous MEDICAL USAGE: Chronic body pain: Moderates pain USAGE PATTERN: Daily / Moderate MEDICAL PRACTITIONER: Doctor has full knowledge and would prescribe if allowed PREFERRED SUPPLY OPTION: Home cultivation NEGATIVE EFFECTS OF CURRENT LAW: Criminalisation, uncertain supply of medicine PATIENT G DISCLOSURE: anonymous MEDICAL USAGE: Depression: Induces sense of well-being; increases motivation USAGE PATTERN: Occasional / Smoked or eaten MEDICAL PRACTITIONER: Doctor cautiously supportive: would potentially prescribe if allowed PREFERRED SUPPLY OPTION: Home Cultivation NEGATIVE EFFECTS OF CURRENT LAW: Criminalisation, uncertain supply of medicine PATIENT H DISCLOSURE: Anonymous MEDICAL USAGE: Chronic pain: Moderates pain USAGE PATTERN: Daily / Moderate MEDICAL PRACTITIONER: Doctor has full knowledge and supports usage. Would potentially prescribe if allowed PREFERRED SUPPLY OPTION: Home cultivation NEGATIVE EFFECTS OF CURRENT LAW: Criminalisation, uncertain supply of medicine PATIENT I DISCLOSURE: Anonymous MEDICAL USAGE: A.D.H.D.: Increases attention span and concentration; Asthma: Dilates airways, eases breath USAGE PATTERN: Daily / Moderate (Vapourises refined resin (hashish) MEDICAL PRACTITIONER: Doctor has full knowledge and would prescribe if allowed PREFERRED SUPPLY OPTION: Home cultivation NEGATIVE EFFECTS OF CURRENT LAW: Criminalisation, uncertain supply of medicine

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4.

Government-level commissions support change

Virtually every government-appointed commission to investigate marijuana's medical potential has issued favourable findings. The New Zealand Health Select Committee's 2003 cannabis inquiry report said: "Cannabis has been shown to be effective in providing relief for some medical disorders, and this option is consistent with the United Nations drug conventions ... It has been claimed that one of the alleged costs of cannabis prohibition is that it prevents patients with life-threatening and chronic illnesses, such as AIDS and cancer, from using cannabis for therapeutic purposes. There is evidence that cannabinoids may be useful as anti-nausea agents, as appetite stimulants in patients with AIDS-related wasting, as antispasmodic agents in neurological disorders such as multiple sclerosis, and as analgesics for pain that is unrelieved by existing analgesics... Professor Paul Smith from the University of Otago referred to the large volume of research that demonstrates that THC and other cannabinoids have many therapeutic effects in the treatment of human disease. In addition to the therapeutic advantages noted above, Professor Smith added the reduction of nausea and vomiting and the prevention of wasting by appetite stimulation in diseases such as cancer and AIDS; the reduction of intraocular pressure in glaucoma; the reduction of spasticity in multiple sclerosis; potent analgesic effects; and, increasingly, evidence that some cannabinoids may protect against brain damage following stroke... A standardised cannabis cigarette or other cannabis plant product might theoretically be able to be approved for prescription for research or study, if it is manufactured to the standards required under the Medicines Act... We recommend to the Government that it pursue the possibility of supporting the prescription of clinically tested cannabis products for medicinal purposes." Britain's House of Lord's Science and Technology Committee found in 1998 that the available evidence supported the legal use of medical cannabis. M.P.s determined: "The government should allow doctors to prescribe cannabis for medical use. ... Cannabis can be effective in some patients to relieve symptoms of multiple sclerosis, and against certain forms of pain. ... This evidence is enough to justify a change in the law." The Committee reaffirmed their support in a March 2001 follow-up report criticising Parliament for failing to legalise the drug. The Committee expressed concern that the existing approach to the licensing of cannabis-based medicines "place the requirements of safety and the needs of patients in an unacceptable balance. ... Patients with severe conditions such as multiple sclerosis are being denied the right to make informed choices about their medication. There is always some risk in taking any medication ... but these concerns should not prevent them from having access to what promises to be the only effective medication available to them." U.S. investigators reached a similar conclusion in 1999. After conducting a nearly two-year review of the medical literature, investigators at the National Academy of Sciences, Institute of Medicine affirmed: "Scientific data indicate the potential therapeutic value of cannabinoid drugs ... for pain relief, control of nausea and vomiting, and appetite

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stimulation. ... Except for the harms associated with smoking, the adverse effects of marijuana use are within the range tolerated for other medications." Nevertheless, the authors noted cannabis inhalation "would be advantageous" in the treatment of some diseases, and that marijuana's short- term medical benefits outweigh any smoking-related harms for some patients. More than 60 U.S. and international health organisations currently support granting patients immediate legal access to medicinal marijuana under a physician's supervision including the American Public Health Association, Australian Medical Association (NSW), Health Canada, Canadian AIDS Society, British Medical Association, the US Institute of Medicine, the US Presbyterian Church and the Federation of American Scientists (see www.norml.org/index.cfm?Group_ID=3388 for a more complete listing.). Several others, including the American Cancer Society, the American Medical Association and the New Zealand Medical Association support the facilitation of wide-scale, clinical research trials so that physicians may better assess cannabis' medical potential.

4.1

Medical support for allowing compassionate use

A survey of 500 New Zealand doctors by the Green Party in 2003 revealed that, although there is a general lack of knowledge among doctors about medicinal cannabis, the more knowledge a doctor holds, the more likely they are to support the use of medicinal cannabis. Ÿ One in five doctors had patients already using cannabis medicinally; Ÿ 47 per cent had patients who had discussed the option of using cannabis; Ÿ 32 per cent would consider prescribing legal medicinal cannabis products. Medical organisations that have called for immediate access to medicinal cannabis include: Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ AIDS Action Council American Academy of Family Physicians American Medical Student Association American Nurses Association American Preventive Medicine Association American Public Health Association American Society of Addiction Medicine Australian Medical Association Body Positive - New Zealand California Medical Association Green Cross Patients Support Group - New Zealand Lymphoma Foundation of America New England Journal of Medicine US Institute of Medicine

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4.2

Public support for allowing medicinal cannabis

NZ Opinion Polls A poll by TV3/TNS in November 2006 found 63% of respondents supported legalising medicinal cannabis. According to a UMR Insight poll of 750 people published in The Dominion in August 2000, sixty per cent of New Zealanders favour significant law reform. Forty-one per cent wanted to stop criminalising cannabis users, plus an additional nineteen per cent want cannabis completely legalised. This was described by the Dominion as evidence that "taking a hard line on cannabis is not a vote winner". A One News/Colmar Brunton poll in April 2000 also found support for decriminalising cannabis had grown since their last poll. Of those surveyed 55% approved law changes, while 40% were opposed. A TV3/CM Research poll in 1996 found that 88% favoured introducing instant fines for small-scale cannabis use, 65% favoured "decriminalisation" and 35% supported "legalisation". US Opinion Polls The votes in US state ballots have shown the American public clearly distinguishes between the medical use and the recreational use of marijuana. Opinion polls have consistently shows a majority support legalising medical use for seriously ill patients (see www.norml.org/index.cfm?Group_ID=3392 for a complete listing of polls). For example: 72 percent of respondents agreed with the statement, "Adults should be allowed to legally use marijuana for medical purposes if a physician recommends it." (AARP, November 2004, Sample Size: 1,706) 80 percent of respondents supported allowing adults to "legally use marijuana for medical purposes." (Time Magazine/CNN Poll, October 2002. Sample Size: 1,007)

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5. The international experience
International treaties do not prevent the medical use or research of any controlled drugs. The UN Single Convention on Narcotic Drugs (1961) states: "the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes". Articles 1, 2, 4, 9, 12, 19, and 49 contain provisions relating to "medical and scientific" use of controlled substances. In almost all cases, parties are permitted to allow the dispensation and use of controlled substances under a prescription, subject to recordkeeping requirements and other restrictions. Signatories may also, if they choose, opt out of any of the provisions of the treaty. In recent years a number of jurisdictions around the world have moved to allow the legal use of medicinal cannabis by various means: USA: Medicinal cannabis was manufactured in the United States from 1860 to 1937, by all the major pharmaceutical companies such as Eli Lilly and Merck. Since 1996, voters in thirteen US states -- including Alaska, Arizona, California, Colorado, Hawaii, Maine, Nevada, Oregon and Washington -- have passed initiatives exempting patients who use marijuana under a physician's supervision from state criminal penalties. Patients may grow their own cannabis or nominate someone to do it for them. Eight of these require patients to be listed on a confidential state registry, the others do not (see www.norml.org/index.cfm?Group_ID=3391 for a summary of state medical marijuana laws). Available evidence indicates that these laws are functioning as voters intended, and that reported abuses are minimal. Marinol or synthetic THC is approved by the FDA and available on prescription throughout the US. The US federal government also supplies standardised marijuana cigarettes to patients registered under the Compassionate Investigational New Drug Programme (IND). Marijuana is grown under license at the University of Mississippi. The active ingredients are removed, then sprayed back onto the plant so that every part contains an equal amount of active ingredient. It is then rolled into cigarettes so that each one delivers a standard dose. Such an approach could be considered for implementation here - although we note widespread patient dissatisfaction with the quality of this product. Canada legalised the possession and cultivation of medical marijuana in 2001 and licensed the cannabis-derived medicine Sativex in 2005, which is now available there by prescription through pharmacies. Canadian patients have four options: they may choose to grow their own, nominate another person to do it for them, be sent government-grown cannabis, or be prescribed Sativex (currently available for neuropathic pain, cancer pain, and "off label" prescriptions). Health Canada has put together a comprehensive collection of resources to help guide doctors and patients. UK: GW Pharmaceuticals is licensed by the UK Home Office to grow and produce wholecannabis medicinal extracts. Their first product is called Sativex, an oromucosal spray derived from whole cannabis. GWP have identified several more potential extracts and uses (see www.gwpharm.com/research_pipeline.asp). Although Sativex is not yet approved in the UK, the Home Office has allowed doctors since 2005 to use it to treat patients on a case-by-case basis. GW has licensed Sativex to Bayer Healthcare for the UK, Canadian, Australian and New Zealand markets, to Almirall Prodesfarma for the remainder of Europe, and Japan's Otsuka Pharmaceuticals for the US market.

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Spain: Doctors are allowed to prescribe Sativex. In any case, prosecutions for growing or possession cannabis are rare, given the decriminalised status of cannabis there. The Netherlands: Adults can legally grow up to five plants at home, and possess cannabis for their own use. The Office of Medicinal Cannabis (OMC, part of the Ministry of Health, Welfare and Sport) distributes three varieties of standardised medical-grade cannabis through pharmacies. Bedrocan, Bedrobinol and Bidiol have been bred to provide a standard amount of active ingredients and are guaranteed free of fungus, mould and impurities. Significantly, the OMC may export their standardised medicinal cannabis to other countries. The Minister for Health, Welfare and Sport told the Dutch Parliament on 31 October 2006 the Canadian, German and Italian governments had expressed interest in purchasing Dutch medicinal cannabis to supply their own patients. The OMC website (www.cannabisoffice.nl/eng/index.html) states: The Office of Medicinal Cannabis is the organisation of the Dutch Government which is responsible for the production of cannabis for medical and scientific purposes. The Office delivers medicinal cannabis of high quality. The office has the monopoly of the trade in cannabis. Due to an international treaty the Netherlands are obliged to organize its Office this way. The OMC has also the monopoly on the import and export of cannabis and cannabis resin and the OMC decides about the exemptions of possession of cannabis and cannabis resin. The OMC supplies the following products and services: Ÿ Cannabis for medicinal purposes: Ÿ In the Netherlands exclusively to pharmacies, pharmacy-holding GP's, hospitals and veterinarians Ÿ The OMC is willing to deliver also outside the Netherlands in case the authorities of that particular country agree on that. Ÿ Cannabis for scientific research. Ÿ Import and export of cannabis and cannabis resin. Ÿ Opium Act exemptions for cannabis and cannabis resin. Germany: The Federal Institute for Pharmaceuticals and Medical Products (BfArM), an institution of the Federal Health Ministry, wrote to several patients in June 2007 and agreed in principle with their right to use cannabis for medicinal purposes. The applicants were advised to use a cannabis extract manufactured by a pharmacy chosen by the patient. Italy: The Minister of Health Livia Turco decreed on 28 April 2007 that THC and the THCderivative nabilone will be allowed for medical use. The decree took immediate effect and did not need to be considered by parliament. Switzerland: Following a recommendation from their Health Committee, the Swiss National Parliament adopted on 20 November 2007 a resolution to relax prohibition of the medical use of natural cannabis products. The decision allows the Health Ministry to issue exemptions for the medical use of cannabis and the approval of cannabis-based medicines. Israel: The Israel Defence Force, in conjunction with Dr Raphael Mechoulam of

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Jerusalem's Hebrew University, has used cannabis to treat soldiers for Post-Traumatic Stress Disorder. New South Wales: The report of the Working Party on the Use of Cannabis for Medical Purposes recommended that because the development of safer means of delivering the therapeutic effects of cannabis than by smoking would take some time, immediate action was necessary on compassionate grounds to relieve the suffering of seriously ill people. A two year trial was proposed, whereby approved people with certain medical conditions would be exempted from criminal prosecution for possessing, growing and using cannabis for medical purposes. On 20 May 2003 the NSW Premier, Bob Carr, announced that a bill would be introduced ‘at the earliest opportunity’ to provide for a four year trial of the medical use of cannabis. He told the NSW parliament that: "Medical evidence supports the proposition that, although harmful in other respects, marijuana can relieve suffering in a number of cases. We have an obligation to minimise human pain and distress wherever we can. Under the proposal approved by Cabinet, patients will be able to access cannabis through a new Office of Medicinal Cannabis to be established within the New South Wales Department of Health. Eligibility will, of necessity, be tightly defined. Patients will be required to demonstrate that conventional treatment will not relieve their suffering." Premier Carr stated that the NSW Government would work with medical, pharmaceutical and research institutions to examine options for the source of cannabis for registered medicinal users. The main possibilities outlined by the Premier included: Ÿ Decriminalising the growing of cannabis plants or the possession of personal use quantities by eligible patients. Ÿ Government regulating the supply and providing it to patients. The Government could buy the cannabis from an overseas jurisdiction such as Canada, or grow it under ‘very carefully supervised conditions’ in New South Wales. Ÿ Obtaining Commonwealth Government approval to import the cannabis spray being developed in the United Kingdom in cooperation with the British Government, if and when it becomes available. In media interviews, the Premier clarified that the four year ‘trial’ was not intended to be a clinical trial, as there was already sufficient clinical evidence from overseas: ‘It’s been proven in the other jurisdictions [Canada, the UK and the USA]. It would repeat their experience if we were to say timidly this is only going to be a trial conducted by doctors.’ (Lateline, ABC TV, 20 May 2003, available at http://www.abc.net.au/lateline/content/2003/s859641.htm)

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5.1

Examples of cannabis dosages and plant numbers

Dosage Dosages are best decided by health professionals in consultation with their patients. Patients have widely varying needs. Some patients report they need only a few specks as their symptoms require. Others may need to medicate almost all the time, particularly those with chronic pain or other severe symptoms. Individual dosages may change with time or severity of symptoms. Patients often report it can be difficult to accurately judge the correct dose of swallowed medicinal cannabis products such as Marinol, as it can require up to two hours to take effect. Accurate dose titration and immediate relief of symptoms is possible with inhaled cannabis, or drops of tinctures, which take almost immediate effect. The US Food and Drug Administration (FDA) has issued a dosing guideline for Dronabinol (synthetic THC, or Marinol) of 30-90mg per day. Researchers applied these guidelines to herbal cannabis and calculated how much would need to be smoked in order to achieve the FDA’s recommended daily dosage. For average cannabis that is 10% THC, 1.8 grams per day would be required for a dose of 30mg THC, or 5.5 grams for a dose of 90mg THC. For cannabis that is very potent, such as 20% THC, 0.9 grams would be required to achieve a dose of 30mg THC, or 2.8 grams for a dose of 90mg THC. That adds up an estimated range of 339 to 2000 grams per year, which the researchers say is consistent with amounts reported in surveys of patients in California and Washington (Carter, et al, 2004). The US Federal government's Compassionate Use Investigational New Drug Program has supplied a handful of patients with federally-grown medical marijuana for almost 3 decades. All of those patients have received 300 pre-rolled joints per month, every month, since entering the program. Patients suffering from chronic pain receive 50% more than the others, or 450 joints per month. The weight of those joints is about 0.9 grams each, not including the paper. The US government has therefore established a medical marijuana dose range of between one half and three quarters of a pound per patient per month. (Russo et al, 2002) Plant numbers Setting plant limits based on arbitrary amounts therefore risks denying effective treatment to those most in need, and/or criminalising those patients who happen to require more medication than others. If there must be a limit set in law, it would be better to limit the growing area rather than the number of plants. This is because plant yield is more closely related to the available area than to plant numbers. Plants require light to grow and the available light (sunlight or indoor growing lamps) is a fixed quantity. Putting more plants into the same area will result in smaller plants, and the total yield will be approximately the same. US State medical marijuana programs include various plant limits (available at www.norml.org/index.cfm?Group_ID=3391), several of which regulate growing areas rather than plant numbers: Alaska: Patients (or their primary caregivers) may legally possess no more than one ounce of usable marijuana, and may cultivate no more than six marijuana plants, of which no more than three may be mature. California: Proposition 215 did not set any limits regarding the amount of marijuana

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patients may possess and/or cultivate. Senate Bill 420, which took effect on January 1, 2004, imposes statewide guidelines outlining how much medicinal marijuana patients may grow and possess. Under the guidelines, qualified patients and/or their primary caregivers may possess no more than eight ounces of dried marijuana and/or six mature (or 12 immature) marijuana plants. However, S.B. 420 allows patients to possess larger amounts of marijuana when such quantities are recommended by a physician. The legislation also allows counties and municipalities to approve and/or maintain local ordinances permitting patients to possess larger quantities of medicinal cannabis than allowed under the new state guidelines. Sonoma County guidelines allow up to 3 lbs for possession; and a maximum 100 square feet cultivation area with 25 plants or fewer. Del Norte County allows up to 99 plants and 1 pound (454 grams) in possession. Berkeley allows up to 10 plants and 2.5 pounds (1135 grams) in possession. Humboldt County guidelines allow patients 100 square feet garden and 3 lbs with no plant number limit. Mendocino County allows 25 plants in no more than 100 sq ft garden, plus up to 2 lbs. processed marijuana per patient. Oakland (San Francisco) allows indoor growers to have up to 72 plants in maximum 32 sq. ft growing area. Outdoor growers can have 20 plants, no area limit. The weight limit is 3 lbs dried marijuana per patient. San Diego City Council guidelines allow up to 1lb of marijuana, and 24 plants in 64 square feet indoors. Colorado: Patients (or their primary caregivers) may legally possess no more than two ounces of usable marijuana, and may cultivate no more than six marijuana plants. Hawaii: Patients (or their primary caregivers) may legally possess no more than one ounce of usable marijuana, and may cultivate no more than seven marijuana plants, of which no more than three may be mature. Maine: Patients (or their primary caregivers) may legally possess no more than one and one-quarter ounces of usable marijuana, and may cultivate no more than six marijuana plants, of which no more than three may be mature. Montana: Patients (or their primary caregivers) may possess no more than six marijuana plants. Nevada: Patients (or their primary caregivers) may legally possess no more than one ounce of usable marijuana, and may cultivate no more than seven marijuana plants, of which no more than three may be mature. New Mexico: The law mandates the state Department of Health to issue rules governing the use and distribution of medical cannabis to state-authorised patients, including defining the amount of cannabis that is necessary to constitute an "adequate supply" for qualified patients, and the creation of state-licensed "cannabis production facilities".

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Oregon: Patients (or their primary caregivers) may legally possess no more than six mature cannabis plants, 18 immature seedlings, and 24 ounces of usable cannabis. Rhode Island: Patients (or their primary caregivers) may legally possess 2.5 ounces of cannabis and/or 12 plants, and their cannabis must be stored in an indoor facility. Vermont: Patients (or their primary caregiver) may legally possess no more than two ounces of usable marijuana, and may cultivate no more than three marijuana plants, of which no more than one may be mature. Washington: Patients (or their primary caregivers) may legally possess or cultivate no more than a 60-day supply of marijuana.

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6.

Commonly asked questions about medicinal cannabis

"Existing provisions are adequate. Why do we need this?" Existing provisions are not adequate. While the Misuse of Drugs Act and the Medicines Act both theoretically allow cannabis to be approved on a case-by-case basis, these provisions have proved to be too cumbersome, onerous and burdensome to be practical or useful. No application has ever been approved. However, it's important to note that the existing provisions can remain and either approach could be used to satisfy the needs of patients and doctors. "Politicians shouldn't decide what medicines are approved" Yes - and that's exactly our point. The current process requires the Minister of Health to make a decision that inevitably will be seen as political. We want to take the politics out of the equation, and let health professionals and patients decide what treatment is most appropriate. "Smoking any medicine is not right" For seriously ill or terminally ill people, smoking is usually the least of their concerns. Furthermore, medicinal cannabis does not need to be smoked. In fact, smoke can be avoided entirely through the use of vapourisers, tinctures, and cannabis-based food or drinks (for more information about vapourisers, see section 3.3. However, inhalation provides an instant onset and easily titrated dose, unlike swallowed pills which take up to 2 hours to have any effect, and are hard to keep down for someone suffering nausea. It is also important to note that marijuana smoke is not the same as tobacco smoke. Several recent studies have shown a "protective" effect (due to the therapeutic action of cannabinoids) and actually found a lower rate of lung cancer among marijuana smokers than tobacco smokers or even non-smokers (Tashkin et al, 2006). "Allowing medicinal cannabis sends the wrong message that we condone the recreational use of cannabis" It is unlikely that allowing exemptions for medical uses of cannabis will be seen as condoning the non-medical use of cannabis. In the US, survey evidence shows majority support for medical uses of cannabis, yet there is strong support for the continued prohibition of non-medical cannabis. In fact, allowing the medical use of cannabis sends a powerful message about the appropriate context of medicines and drug taking in general. "Allowing medicinal cannabis could encourage more people to use cannabis" Such concerns, though popular among opponents of cannabis law reform, are based on rhetoric – not fact – and should not be used to stall progressive public policy. The enactment of US state laws legalising the medical use of cannabis has not been associated with an increase in recreational use, according to data published in the International Journal of Drug Policy. To the contrary, investigators speculated that the passage of medical cannabis laws may "de-glamorise" the drug’s use and "thereby [does] little to encourage [its] use among other" non-medical patients (Gorman 2007). "Medicinal cannabis could be diverted to the black market"

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Firstly, authorities would know the names and addresses of license holders. Furthermore, the size of the illicit cannabis market makes it unlikely that cannabis grown for medical purposes would be diverted. Following from Hall et al (2001), the number of people who would be permitted to use cannabis for medical purposes is less than 2.5% of those using cannabis for non-medical purposes, so it is unlikely to have any substantial impact. "International treaties prevent us from allowing medicinal cannabis" International treaties do not prohibit the medical use of controlled drugs. The UN Single Convention on Drugs (1961) states: "the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes". Articles 1, 2, 4, 9, 12, 19, and 49 contain provisions relating to "medical and scientific" use of controlled substances.

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7.

References & further information

Abrams, Vizoso, Shade et al. Vaporization as a Smokeless Cannabis Delivery System: A Pilot Study. Clinical Pharmacology and Therapeutics, 2007 Apr 11 (available at http://www.nature.com/clpt/journal/vaop/ncurrent/abs/6100200a.html) Batkai S, et al. Decreased age-related cardiac dysfunction, myocardial nitrative stress, inflammatory gene expression and apoptosis in mice lacking fatty acid amide hydrolase, Am J Physiol Heart Circ Physiol. 2007 April 13 Booth, Martin. Cannabis: a History, UK: Random House, 2003 Braude and Szara, ed. Pharmacology of Marihuana, NIDA Monograph. New York: Raven Press, 1976 Caberlotto L et al. Corticotropin-Releasing Hormone (CRH) mRNA Expression in Rat Central Amygdala in Cannabinoid Tolerance and Withdrawal: Evidence for an Allostatic Shift? Neuropsychopharmacology, 2003 Carter, G.T., Weydt, P., Kyashna-Tocha, M., Abrams, D. Medicinal cannabis: Rational guidelines for dosing. IDrugs 2004, 7:464-470 Cohen and Stillman, ed. The Therapeutic Potential of Marihuana. New York: Plenum, 1975 Conrad, Chris. Hemp for Health, Vermont: Healing Arts Press, 1997 Earlywine, Mitch & Barnwell, Sara. Decreased respiratory symptoms in cannabis users who vaporize. Harm Reduction Journal, 2007, 4:11 Fride E, Ginzburg Y, Breuer A, Bisogno T, Di Marzo V, Mechoulam R: "Critical role of the endogenous cannabinoid system in mouse pup suckling and growth." Eur J Pharmacol 2001, 419:207-214 Gorman DM and Huber J Charles Jr. Do Medical Cannabis Laws Encourage Cannabis Use? International Journal of Drug Policy, 2007 Vol. 18 no. 3, pp. 160-7 Green Party of Aotearoa/New Zealand. Medicinal cannabis survey of registers doctors. October 2003 (available at www.greens.org.nz/campaigns/cannabis/SurveyofDoctors.pdf) Green Party of Aotearoa/New Zealand. Major public support for medicinal cannabis law change. 11 July 2006 (www.greens.org.nz/searchdocs/PR9983.html) Grinspoon & Bakalar. Marihuana, the Forbidden Medicine, 2nd edition, Yale University Press, 1997 Grotenhermen, F., Leson, G., et al. Developing limits for driving under cannabis, Addiction (OnlineEarly Articles), doi:10.1111/j.1360-0443.2007.02009.x Hall, W. et al. The health and psychological consequences of cannabis use: Monograph prepared for the National Task for on Cannabis. Canberra: Australian Government Publishing Service, 1994 Hall W, Degenhardt L and Currow D. Allowing the medical use of cannabis, Medical Journal of Australia 2001; 175: 39-40 (www.mja.com.au/public/issues/175_01_020701/hall/hall.html) Hall W, Degenhardt L. Estimated number of potential medical users of cannabis. Sydney: National Drug and Alcohol Research Centre, 2000 (www.med.unsw.edu.au/ndarc) Hampson, et al. Cannabidiol and delta-9-tetrahydrocannabinol are neuroprotective antioxidants. Proceedings of the National Academy of Sciences. 1998. 95:8268-8273 (available at

45 http://www.pnas.org/cgi/reprint/95/14/8268.pdf) Haney M, Gunderson EW, Rabkin J, Hart CL, Vosburg SK, Comer SD, and Foltin RW. Dronabinol and Marijuana in HIV-Positive Marijuana Smokers: Caloric Intake, Mood, and Sleep. J Acquir Immune Defic Syndr. 2007 Jun 21 Hollister, Leo. Health aspects of cannabis: revisited. International Journal of Neuropsychopharmacology (1998): 1, 71-80 House of Lords Select Committee on Science and Technology (United Kingdom). Cannabis: the scientific and medical evidence. London: The Stationery Office, 1998 Iversen, Prof Leslie. The Science of Marijuana, Oxford University Press, 2000 Kaiser Permanente. “Marijuana Use and Mortality", American Journal of Public Health, April 1997 Mechoulam, R., Plant cannabinoids: a neglected pharmacological treasure trove, British Journal of Pharmacology, 3 October 2005 146, 913–915 Melemede, Robert. Harm Reduction - the cannabis paradox. Harm Reduction Journal, 2005, 2:17 Mikuriya, Tod (Ed.) Marijuana: Medical Papers 1839-1972. Oakland: Medi-Comp Press, 1973 Murphy and Bartke, ed. Marijuana/Cannabinoids: Neurobiology and Neurophysiology. Boac Raton: CRC Press, 1992 New Zealand Health Information Service. Public hospital patient statistics, 14 September 2004. (available at www.nzhis.govt.nz/stats/hospstats.html) New Zealand Health Select Committee (Brian Neeson, chair). Report of the Inquiry into the mental health effects of cannabis, 1998 New Zealand Health Select Committee (Steve Chadwick, chair). Report of the Inquiry into the public health strategies related to cannabis use and the most appropriate legal status, 2003 New Zealand Press Association. Greens Back Cannabis Call With Doctor Survey, 3 October 2003 (www.mapinc.org/drugnews/v03/n1503/a12.html?228174) NORML US. State Medi-Pot Laws Not Associated With Increased Drug Use, Study Says; 15 Aug 2007 (www.norml.org/index.cfm?Group_ID=7334) Mechoulam, Raphael, ed. Cannabinoids as Therapeutic Agents. Boca Raton: CRC Press, 1986 NSW Inquiry into the Use of Cannabis for Medical Purposes. Report on Consultation on the Findings and Recommendations of the Working Party on the Use of Cannabis for Medical Purposes, Office of Drug Policy (The Cabinet Office), July 2001 NSW Parliamentary Library Research Service. Medical Cannabis Programs:A Review of Selected Jurisdictions (Briefing Paper No 10/04) August 2004 (available at http://www.parliament.nsw.gov.au/prod/parlment/publications.nsf/key/MedicalCannabisProgramsAR eviewofSelectedJurisdictions) NSW Working Party on the Use of Cannabis for Medical Purposes. Volume I: Executive summary; Volume II: Main report. Sydney: NSW Government, 2000 (available at www.druginfo.nsw.gov.au/druginfo/reports/medical_cannabis.html) Panikashvili, et al. An endogenous cannabinoid (2-AG) is neuroprotective after brain injury. Nature, 2001. 413: 527-531

46 Peterson, Dana: Cannabis: Information relating to the debate on law reform (Background paper No. 23). Parliamentary Library. Wellington: April 2000 (available at http://www.parliament.nz/enNZ/PubRes/Research/Papers/2/d/d/2dd6a3cafbd4445aaca9ea078a4715ba.htm) Randall, Robert. Marijuana, Medicine and the Law. Washington DC: Galen Press, 1989 Russo, E, et al. Chronic Cannabis Use in the Compassionate Investigational New Drug Program: An Examination of Benefits and Adverse Effects of Legal Clinical Cannabis, Journal of Cannabis Therapeutics, Vol. 2(1) 2002 (available at www.cannabismd.org/reports/russo2.php) Smith, Paul. Cannabis on the Brain, Dunedin: Dunmore Press, 2002 Tashkin, Morgenstern, et al. “Marijuana use and cancers of the lung and upper aerodigestive tract: results of a case-control study”, Presentation at the ICRS Conference on Cannabinoids, 24-27 June 2005, Clearwater, USA, in Scientific American of 24 May 2006 US Drug Enforcement Administration. In the Matter of Marihuana Rescheduling Petition, Docket 8622, Opinion, Recommended Ruling, Findings of Fact, Conclusions of Law, and Decision of Administrative Law Judge. Washington, DC: September 6, 1988 US National Academy of Sciences Institute of Medicine. Marijuana and medicine: assessing the science base. Washington: National Academy Press, 1999 (available at http://www.iom.edu/?id=5608&redirect=0Excerpts) US National Academy of Sciences Institute of Medicine. Marijuana and Health. Washington, DC: National Academy Press, 1982 US National Academy of Sciences Institute of Medicine. Marijuana and Medicine: Assessing the Science Base. Washington: National Academy Press, 1999 US National Academy of Sciences Institutes of Health. Workshop on the Medical Utility of Marijuana: Report to the Director, 1997 Vinciguerra, Vincent; Moore, Terry; Brennan, Eileen. Inhalation Marijuana as an Antiemetic for Cancer Chemotherapy. New York State Journal of Medicine, October 1988; 88: 525 - 527 Yska, Redmer. New Zealand Green. Auckland: Bateman, 1990

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Suggested websites:
NORML's medicinal cannabis website: www.norml.org.nz/medical NZ medicinal cannabis patients support group: www.greencross.org.nz Patient testimonies: www.marijuanauses.com International Association for Cannabis as Medicine: www.cannabis-med.org Clinical studies involving cannabis: http://intraspec.ca/marijuana-clinical-studies.php International Cannabinoid Research Society: www.cannabinoidsociety.org Centre for Medicinal Cannabis Research at the University of California at San Fransisco: www.cmcr.ucsd.edu Netherlands Office of Medicinal Cannabis: www.cannabisoffice.nl/eng/index.html NSW report: The Use of Cannabis for Medical Purposes: www.druginfo.nsw.gov.au/druginfo/reports/medical_cannabis.html US Institute of Medicine: Marijuana and Medicine; Assessing the Science Base: www.nap.edu/html/marimed/ UK House of Lords Science and Technology report on medicinal cannabis: www.parliament.the-stationery-office.co.uk/pa/ld199798/ldselect/ldsctech/151/15101.htm

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Suppliers of medicinal cannabis, extracts or synthetic alternatives:
Sativex (GW Pharmaceuticals, UK): www.gwpharm.com/sativex.asp Health Canada fact sheet on Sativex: www.hc-sc.gc.ca/dhp-mps/prodpharma/noticesavis/conditions/sativex_factsheet_e.htm; information for doctors: http://www.hc-sc.gc.ca/dhpmps/marihuana/how-comment/medpract/infoprof/information_rev_e.html; information for patients: http://www.hc-sc.gc.ca/dhp-mps/marihuana/how-comment/applicantdemandeur/info_patient_e.html Netherlands Office of Medicinal Cannabis www.cannabisoffice.nl Maripharm (Netherlands): www.maripharm.nl Pharmos Corp (Israel): www.pharmoscorp.com Marinol (Unimed, USA): www.marinol.com Cannasat (Canada): www.cannasat.com Cannador (Institute for Clinical Research, Germany): www.ikf-berlin.de/projekte2_e.htm

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