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IACM-Bulletin of 01 November 2015

Australia: The government wants to allow the cultivation of cannabis in the country for sell in pharmacies

Australia is altering its drug laws to allow for the cultivation of cannabis for medicinal and scientific purposes, the government said on 17 October 2015. Draft amendments to the Narcotics Drugs Act are being finalised to allow for the controlled cultivation of cannabis, giving patients access to "a safe, legal and sustainable supply of locally produced products for the first time," Health Minister Sussan Ley said in a statement.

Australian manufacturers, researchers and patients currently have to access international supplies of legal medicinal cannabis, with cost, limited supply and export barriers making this challenging.
Allowing for the controlled cultivation of cannabis in Australia will provide the critical "missing piece" where laws already exist to licence the manufacture and supply of medicinal cannabis-based products, but local production of the crop remains forbidden, Ley said. The government plans to create a licensing scheme to ensure that the cultivation of cannabis meets Australia's international obligations and to manage the supply of the drug from farm to pharmacy.

Reuters of 17 October 2015

Science/Human: Mixed results in two clinical studies with a cannabis extract in cancer pain

On 27 October GW Pharmaceuticals and Otsuka Pharmaceutical reported results from the remaining two Phase 3 trials of their cannabis extract Sativex in the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. Consistent with the previously reported trial (trial 1), Sativex did not meet the primary endpoint in these trials. However, an analysis of patients across the two Phase 3 trials which involved only clinical sites in the U.S. showed a statistically significant improvement in pain for Sativex compared with placebo and improvements of sleep quality and other secondary efficacy endpoints. Trial 2 recruited a total of 397 patients at clinical sites in the U.S., Mexico and EURope. Patients received Sativex or placebo as adjunctive treatment to optimized opioid therapy and remained on stable doses of their background opioid therapy during the study. A third study (trial 3), which was conducted entirely outside the U.S. and which used a different clinical design, failed to show separation from placebo on the primary endpoint.

“While the results overall have been disappointing, and not necessarily wholly consistent with clinical experience, nonetheless they suggest that Sativex may have a useful role in the treatment of certain subgroups of patients with advanced cancer pain who have exhausted opioid treatments,” stated Dr Marie Fallon, Professor of Palliative Care, University of Edinburgh and a principal investigator in the Phase 3 program. “In particular, the U.S. patients enrolled in this program showed a useful therapeutic benefit whereas results in EURopean patients were generally not favorable. These U.S. patients were less frail, hence the Sativex intervention was subjected to less “noise,” providing clearer results and valuable guidance in determining the optimal target patient population for Sativex.”

Press release by GW Pharmaceuticals of 27 October 2015

Canada: Liberal Party, which wants to legalize cannabis, wins election

Canada's Liberal Party won the election on 19 October with 184 seats in parliament. They only needed 170 seats to form a majority in the 338-seat lower chamber. The Liberal platform included, among other things, marijuana legalization. "We will legalize, regulate, and restrict access to marijuana," their manifesto states.

“Canada’s current system of marijuana prohibition does not work. It does not prevent young people from using marijuana and too many Canadians end up with criminal records for possessing small amounts of the drug. Arresting and prosecuting these offenses is expensive for our criminal justice system. It traps too many Canadians in the criminal justice system for minor, non-violent offenses. At the same time, the proceeds from the illegal drug trade support organized crime and greater threats to public safety, like human trafficking and hard drugs. To ensure that we keep marijuana out of the hands of children, and the profits out of the hands of criminals, we will legalize, regulate, and restrict access to marijuana.”

Manifesto of the Liberal Party on marijuana

News in brief

Science/Human: The use of cannabis may reduce opioid consumption according to a case report
A 57-year-old man, who underwent liver transplantation and was taking high doses of hydromorphone for chronic abdominal pain before surgery, was able to reduce the opioid dose considerably within five months by the use of cannabis. Authors wrote that “concurrent benefits of initiating medical cannabis may include improvements in pain profile and functional status along with reductions in opioid-related side effects. This highlights the potential for medical cannabis as an adjunct medication for weaning patients from opioid use.”
Department of Anesthesia, University of Toronto, Canada.
Meng H, et al. Can J Anaesth. 2015 Oct 27. [in press]

Science: Participations for survey on cannabis and eating experiences required
The Institute of Psychology, Health and Society of the University of Liverpool is conducting an online survey on cannabis use and eating experiences. Participants must be over 18 and have used cannabis at least once in the last 6 months.
Link to the survey

UNO: Attempt to decriminalise drugs foiled
An attempt by officials of the United Nations to get countries to decriminalise the possession and use of all drugs has been foiled, the BBC revealed. A paper from the UN Office on Drugs and Crime (UNODC) has been withdrawn after pressure from at least one country. The document, which was leaked, recommends that UN members consider "decriminalising drug and possession for personal consumption". It argued "arrest and incarceration are disproportionate measures."
BBC of 19 October 2015

Science/Animal: How the endocannabinoid system may be involved in autism
Research in mice suggests that the activation of the CB1 receptor by the endocannabinoid anandamide, which involved the hormone oxytocin, controls the reward from social interaction. Authors wrote that “deficits in this signalling mechanism may contribute to social impairment in autism spectrum disorders and might offer an avenue to treat these conditions.”
Department of Anatomy and Neurobiology, University of California, Irvine, USA.
Wei D, et al. Proc Natl Acad Sci U S A. 2015 Oct 26. [in press]

Science/Cells: CBD may improve the function of the blood brain barrier
In a cell model of the blood brain barrier (BBB) CBD prevented the increase in permeability caused by deprivation of oxygen and glucose. This effect was mediated by PPAR-Gamma-receptor and the 5-HT1A-receptor. Authors concluded that “these data suggest that activity at the BBB could represent an as yet unrecognised mechanism of CBD-induced neuroprotection in ischaemic stroke.”
School of Medicine, University of Nottingham, Royal Derby Hospital, UK.
Hind WH, et al. Br J Pharmacol. 2015 Oct 24. [in press]

Science/Animal: A CBD cream improved symptoms in a mouse model of multiple sclerosis
Researchers investigate the efficacy of a new formulation of cannabidiol (CBD) as a topical treatment in an experimental model of autoimmune encephalomyelitis, a model for multiple sclerosis. Results showed that daily treatment with topical 1 % CBD-cream may exert neuroprotective effects, diminishing clinical disease score, by recovering of paralysis of hind limbs. CBD had significant effects on parameters of inflammation.
IRCCS Centro Neurolesi "Bonino-Pulejo", Messina, Italy.
Giacoppo S, et al. Daru 2015;23(1):48.

Science/Animal: The protective effects of silymarin on the liver involve cannabinoid receptors
Silymarin, a standardized extract of the milk thistle seeds (Silybum marianum), increased the number of CB2 receptors and decreased CB1-receptors. Researchers wrote that they “identified a new mechanism of the hepatoprotective effect of silymarin via modulation of cannabinoid receptors in fibrotic liver.”
Department of Biochemistry, Faculty of Pharmacy, Zagazig University, Egypt.
El Swefy S, et al. Naunyn Schmiedebergs Arch Pharmacol. 2015 Oct 16. [in press]

Science/Animal: THC and endocannabinoids act differently in an animal model of schizophrenia
Using a rat model of schizophrenia, researchers compared the effects on neuronal activity of systematic administration of THC with a substance (URB597), which inhibits the degradation of anandamide. They found different effects on the brain and concluded that such “information is important for understanding why marijuana and synthetic cannabinoid use may be contraindicated in schizophrenia patients while endocannabinoid enhancement may provide a novel therapeutic approach.”
Department of Pharmacology and Center for Biomedical Neuroscience, University of Texas Health Science Center San Antonio, USA.
Aguilar DD, et al. J Psychopharmacol. 2015 Oct 28. [in press]

Science/Human: No effect of a single low dose of THC on abdominal pain resulting from chronic pancreatitis in clinical study
In 24 patients suffering from abdominal pain as result of chronic pancreatitis (CP), who received one dose of 8 mg THC or 5 or 10 mg diazepam in a cross-over design no significant differences were found for pain intensity, alertness, mood, calmness or balance. Authors wrote that “a single dose of delta-9-THC was not efficacious in reducing chronic pain resulting from CP, but was well tolerated with only mild or moderate AEs [adverse effects].”
Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
de Vries M, et al. Br J Clin Pharmacol. 2015 Oct 27. [in press]

Science/Human: Nabilone did not reduce pain and nausea in patients treated for head and neck cancer
Fifty-six patients, who were treated for head and neck cancer received either nabilone or placebo during and after radiotherapy, experienced no benefit from the cannabinoid, which acts similar as THC. Nabilone had no effect on quality of life, pain, nausea, appetite, weight, mood and sleep. Authors concluded that “at the dosage used, nabilone was not potent enough to improve the patients' quality of life over placebo.”
Canada Faculty of Medicine, Laval University, Québec, Canada.
Côté M, et al. Ann Otol Rhinol Laryngol. 2015 Oct 25. [in press]

Science/Human: High doses of THC may be associated with relevant side effects
In a 5-week placebo-controlled study with 12 opioid-dependent patients, who remained on opioids, 40 mg of THC caused increased heart rate and anxiety, which made dose-reduction necessary. These effects were observed already following 20 mg of THC in one patient. This study underlines the necessity of individual dose finding for THC.
University of Kentucky College of Medicine, Center on Drug and Alcohol Research, Lexington, USA.
Jicha CJ, et al. Drug Alcohol Depend. 2015 Oct 9. [in press]

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