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IACM-Bulletin of December 1, 2013

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Czech Republic — Most patients do not have the financial means to buy cannabis from the pharmacies

The Czech Republic legalized the medical use of cannabis this year becoming effective on 1 April, but maintained strict restrictions on growing, selling and importing it. For most patients the solution is still growing the plant themselves. Some 20,000 patients who are estimated to be eligible for cannabis treatment have no chance to get it legally - although so far police have largely ignored renegade growers who technically would face prison. Patients and medical experts blame interference by the Health Ministry, which has long fiercely opposed legalizing the medical use of cannabis. "There's a very consistent effort from the Ministry of Health not to make the law really enforced," said Dr Tomas Zabransky, a U.N. and EU adviser on drug issues.

The ministry denies deliberately blocking access to medical cannabis, but few question that its policies have raised steep barriers for patients to access cannabis legally. The Health Ministry banned health insurance companies from covering the cost of medical cannabis, and set the maximum amount patients are allowed at 30 grams per month, an amount Zabransky says often falls woefully short of providing effective relief. The government also allowed imports of just four types of cannabis that can be obtained only from the Netherlands, where it is produced by the company Bedrocan, at a cost of about 10 US dollars (about 7.50 Euros) per gram - prohibitive for most patients in a nation where the average monthly salary is 1,300 US dollars (about 950 Euros) and the average pension is 500 US dollars (about 370 Euros).

Associated Press of 15 November 2013.

UK/USA — More than 100 children with epilepsy receive a new cannabis extract rich in CBD

The British company GW Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has allowed the conduction of clinical studies with Epidiolex, their cannabis extract that contains Cannabidiol (CBD) as its active ingredient, for use in treating children with Dravet syndrome, a rare and severe form of infantile-onset, genetic, drug-resistant epilepsy syndrome. The company hopes to start the trials in 2014.

In addition to GW’s clinical development program for Epidiolex in Dravet syndrome, GW has also made arrangements to enable independent U.S. paediatric epilepsy specialists to treat high need paediatric epilepsy cases with Epidiolex immediately. To date, a total of 125 children with epilepsy receive this medication.

Press release by GW Pharmaceuticals of 15 November 2013.

Science/Human — Oral THC has similar psychoactive effects to smoked cannabis

In pain patients oral THC (dronabinol) caused similar psychoactive effects to the intake of dronabinol by inhalation of cannabis. This is the result of a study at the Brigham and Women's Hospital and Harvard Medical School in Boston, USA. Scientists performed a randomized controlled trial of single dose placebo, 10 or 20 mg oral THC in 30 chronic non-cancer pain patients taking opioids and not using cannabis. Hourly, for 8 hours, subjects completed a standardised questionnaire, the Addiction Research Center Inventory (ARCI). Comparison sample was the ARCI ratings in a study with 20 subjects with no pain, monitored every 30 minutes after smoking a 2% THC (low) and a 3.5% (high strength) cannabis cigarette.

The 10 and 20 mg THC doses had significantly elevated scores on 4 of 5 subscales of the ARCI compared to placebo. ARCI peak effects at 2 hours were similar to peak effects of smoked cannabis at 30 minutes. Authors concluded that “in pain patients, oral dronabinol has similar psychoactive effects to smoking marijuana.” This result underscores the necessity to start a treatment with THC with low doses and then slowly increase according to unwanted and therapeutic effects.

Issa MA, Narang S, Jamison RN, Michna E, Edwards RR, Penetar DM, Wasan AD. The Subjective Psychoactive Effects of Oral Dronabinol Studied in a Randomized, Controlled Crossover Clinical Trial For Pain. Clin J Pain. 2013 Nov 25. [in press]

News in brief

Switzerland — Sativex will be available soon

GW Pharmaceuticals announced that the company received marketing authorization for their cannabis extract Sativex for the treatment of spasticity in multiple sclerosis. Sativex will be commercialized in Switzerland by GW’s European partner, Almirall.

Press release by GW Pharmaceuticals of 27 November 2013.

Australia — Government of New South Wales rejects proposal for medical use of cannabis

Last November the NSW government established a parliamentary inquiry into the use of cannabis for medical purposes. The committee recommended AIDS and terminally ill patients be allowed to possess and use up to 15 grams of dry cannabis. However the NSW government has rejected the proposal.

Rheumatology Update of 22 November 2013.

Science/Animal — CBDV may be beneficial in epilepsy

The natural cannabinoid CBDV (cannabidivarin) reduced the activity of epilepsy-related genes in a mouse model of epilepsy. Researchers wrote that their results “provide the first molecular confirmation of behaviourally observed effects of the non-psychoactive, anticonvulsant cannabinoid, CBDV, upon chemically-induced seizures and serve to underscore its suitability for clinical development.”

School of Chemistry, The University of Reading, UK.

Amada N, et al. PeerJ 2013;1:e214.

Science/Animal — CB2 receptors are involved in the perception of pain in arthritis

The systemic administration of the synthetic cannabinoid JWH133, which binds to the CB2 receptor, reduced pain from osteoarthritis (OA) in mice. There was a negative correlation between the number of CB2 receptors in the spinal cord and severity of joint damage. Authors wrote that these findings “suggest that targeting CB2 receptors may have therapeutic potential for treating OA pain.”

University of Nottingham, Uk.

Burston JJ, et al. PLoS One 2013;8(11):e80440.

Science/Animal — New oestrogen receptor modulators bind to CB2 receptors

Animal studies showed that the new selective oestrogen receptor modulators bazedoxifene and lasofoxifene block CB2 cannabinoid receptors. They are “inverse agonists” at the CB2 receptor. These medications are intended for use in osteoporosis. Authors wrote that these drugs “can potentially be repurposed for novel therapeutic indications for which CB2 is a target.”

Department of Pharmacology and Toxicology, University of Louisville School of Medicine, USA.

Kumar P, et al. Biochem Biophys Res Commun. 2013 Nov 22. [in press]

Science/Human — Compared with alcohol illegal drugs play a minor role in fatal traffic accidents

In 21% of 895 drivers killed in road accidents in Sweden between 2008 and 2011 alcohol was present. In 2.5% only illegal drugs (mainly THC and amphetamines) were detected. In another 1.8% illegal drugs were present together with alcohol. Authors wrote that “compared with alcohol, the prevalence of illicit and psychoactive prescription drugs was fairly low despite a dramatic increase in the number of drug-impaired drivers arrested by the police after a zero-tolerance law was introduced in 1999.”

Department of Forensic Genetics and Forensic Toxicology, National Board of Forensic Medicine, Linköping, Sweden.

Ahlner J, et al. Scand J Public Health. 2013 Nov 21. [in press]

Science/Human — Endocannabinoid levels are altered in patients with posttraumatic stress disorder

Borderline personality was associated with altered serum levels of the endocannabinoids anandamide and 2-arachidonoylglycerol (2-AG). Posttraumatic stress disorder was associated with alterations of the endocannabinoid oleoylethanolamide.

Central Institute of Mental Health, Heidelberg University, Mannheim, Germany.

Schaefer C, et al. Eur Arch Psychiatry Clin Neurosci. 2013 Nov 20. [in press]

Science/Animal — Palmitoylethanolamine improved arthritis

The administration of endocannabinoid palmitoylethanolamine improved arthritis, which was induced in mice. In addition, blood levels of pro-inflammatory substances were significantly reduced by a treatment with palmitoylethanolamine + luteolin. Luteolin is a flavonoid present in many plants such as celery, green pepper and olive oil. Authors wrote that the 2 substances together exert “an anti-inflammatory effect during chronic inflammation.”

Department of Clinical and Experimental Medicine and Pharmacology, School of Medicine, University of Messina, Italy.

Impellizzeri D, et al. Arthritis Res Ther 2013;15(6):R192.

Science/Cells — CBD inhibits signs of inflammation in tissue of the human bowel

The pro-inflammatory substance interleukin 17A is linked to inflammatory bowel disease such as Crohn’s disease. Cannabidiol (CBD), anandamide and hydrocortisone reduced the damage of the bowel mucosa caused by interleukin 17A.

Faculty of Health Sciences, The University of Adelaide, Australia.

Harvey BS, et al. Cytokine. 2013 Nov 13. [in press]