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IACM-Bulletin of 09 January 2016

Germany: The government presents a draft for a law, which would make cannabis flowers available on prescription by every doctor and force health insurances to reimburse cannabis-based medicines in certain cases

On 7 January the Federal Health Ministry presented a detailed draft for a law, which would set up a state cannabis agency to regulate the cultivation and distribution of cannabis to pharmacies. More patients would be given regulated access to the drug on prescription and paid for by their health insurance under measures outlined in the draft bill. Health organizations and associations, including the German ACM (Association for Cannabis as Medicine), were invited to comment on the draft until 5 February. Patients would get cannabis-based medicines (cannabis flowers, extracts, dronabinol, nabilone) reimbursed, if no other treatment works for them. On 1 October 2015 527 patients suffering from at least 60 different diseases, including chronic pain, inflammatory diseases, psychiatric conditions, neurological diseases, appetite loss and nausea have been legally authorised to obtain cannabis at their own expense, because other treatments are not effective enough.

So far, an exemption by the Federal Institute for Drugs and Medical Devices is necessary to get access to cannabis. In the future every physician will be able to prescribe cannabis flowers, which will be available from every pharmacy. The maximum amount to be prescribed will be 100g per month, but this amount can be exceeded in justified cases. According to the draft the cannabis agency will be installed at the Federal Institute for Drugs and Medical Devices. The agency will not only supervise the production and distribution of cannabis products, but also set the maximum price for cannabis in pharmacies. Patients, who want their costs to be reimbursed, have to participate in accompanying research, which is intended to run until the end of December 2018 to get a basis for further decisions on re-imbursement by health insurances from August 2019 on.

Anouncment by the Federal Health Ministry of Germany of 7 January 2016

Science/Human: Cannabidiol reduces seizure frequency in epilepsy of children and young adults according to open clinical study

Cannabidiol (CBD) might reduce seizure frequency and might have an adequate safety profile in children and young adults with highly treatment-resistant epilepsy. This is the result of an open study with 214 patients conducted between 15 January 2014 and 15 January 2015 in several centres across the USA (New York, Philadelphia, Boston, Chicago, San Francisco, Miami, Houston, Atlanta, Salt Lake City, Winston Salem, Columbus). Patients were given oral CBD at 2-5 mg/kg body weight per day, up-titrated until intolerance or to a maximum dose of 25 mg/kg or 50 mg/kg per day (dependent on study site). 162 (76%) patients who had at least 12 weeks of follow-up after the first dose of cannabidiol were included in the safety and tolerability analysis, and 137 (64%) patients were included in the efficacy analysis.

In the safety group, 20% patients had Dravet syndrome and 19% patients had Lennox-Gastaut syndrome. The remaining patients had intractable epilepsies of different causes and type. Adverse events were reported in 79% of the 162 patients within the safety group. Adverse events reported in more than 10% of patients were somnolence (25%), decreased appetite (19%), diarrhoea (19%), fatigue (13%), and convulsion (11%). Five (3%) patients discontinued treatment because of an adverse event. Serious adverse events were reported in 30% patients, including one death-a sudden unexpected death in epilepsy regarded as unrelated to the intake of CBD. 12% patients had severe adverse events possibly related to cannabidiol use, the most common of which was status epilepticus (6%). The median monthly frequency of motor seizures was 30.0 before the start of the study and 15.8 over the 12 week treatment period. The median reduction in monthly motor seizures was 36.5%.

Devinsky O, Marsh E, Friedman D, Thiele E, Laux L, Sullivan J, Miller I, Flamini R, Wilfong A, Filloux F, Wong M, Tilton N, Bruno P, Bluvstein J, Hedlund J, Kamens R, Maclean J, Nangia S, Singhal NS, Wilson CA, Patel A, Cilio MR. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol. 2015 Dec 23. [in press]

Science/Human: Pre-treatment with CBD did not influence effects of smoked cannabis

CBD (cannabidiol), which was administered to healthy subjects 90 minutes before smoking a cannabis cigarette, did not influence psychological effects and heart rate. Scientists of the New York State Psychiatric Institute and the Department of Psychiatry, Columbia University Medical Center, and other institutions published these results in the journal Neuropsychopharmacology. They conducted a double-blind, within-subject laboratory study, where 31 cannabis smokers received either 0, 200, 400 or 800 mg oral CBD and either cannabis with a THC concentration of 0.01% (inactive) or about 5.5% (5.3-5.8%) at 8 different occasions.

CBD, which alone produced no significant psychoactive or cardiovascular effects, did not significantly alter subjective ratings of “high” or heart rate. Cannabis self-administration, subjective effects, and cannabis ratings did not vary as a function of CBD dose relative to placebo capsules. Authors concluded that their “findings suggest that oral CBD does not reduce the reinforcing, physiological or positive subjective effects of smoked cannabis.”

Haney M, Malcolm RJ, Babalonis S, Nuzzo PA, Cooper ZD, Bedi G, Gray KM, McRae-Clark A, Lofwall MR, Sparenborg S, Walsh SL. Oral Cannabidiol does not Alter the Subjective, Reinforcing or Cardiovascular Effects of Smoked Cannabis. Neuropsychopharmacology. 2015 Dec 28. [in press]

News in brief

USA: Vermont governor wants to legalize cannabis
On 7 January Vermont Governor Peter Shumlin said he would seek to legalize cannabis through the legislative process, instead of through voter initiatives, for the first time in the United States.
Reuters of 7 January 2016

Science/Human: No effect of moderate cannabis use by adolescents on educational performance
In a long-term study with 2235 adolescents there was no association between cannabis use at the age of 15 and educational performance at the age of 16. Authors concluded that “modest cannabis use in teenagers may have less cognitive impact than epidemiological surveys of older cohorts have previously suggested.”
Clinical Psychopharmacology Unit, University College London, UK.
Mokrysz C, et al. J Psychopharmacol. 2016 Jan 6. [in press]

Science/Animal: CB2 receptor agonists may reduce the development of tolerance to morphine in cancer pain
In rats with neuropathic pain due to cancer the injection of a synthetic cannabinoid (AM1241), which binds to the CB2 receptor, into the spinal canal alleviated tolerance to morphine.
Cancer Hospital of Harbin Medical University, China.
Zhang M, et al. Anesth Analg. 2015 Dec 30. [in press]

Science/Animal: CBD exerts antidepressant-like effects in mice
In a mouse model of depression CBD exerted antidepressant-like effects. It increased the levels of two neurotransmitters, serotonin and glutamate, in a certain brain region (ventromedial prefrontal cortex).
Universidad de Cantabria, Santander, Spain.
Linge R, et al. Neuropharmacology 2015;103:16-26.

Science/Cells: Anandamide showed anti-cancer effects in human glioma cells
The endocannabinoid anandamide increased programmed cell death and other anti-cancer effects in human glioma cells. Authors concluded that anandamide “exhibits therapeutic potential in the management of human glioma,” which is a very aggressive brain cancer.
Department of Neurosurgery, Zhongnan Hospital of Wuhan University, China.
Ma C, et al. Mol Med Rep. 2015 Dec 28.
[in press]

Science/Animal: Cannabinoids reduce inflammation pain in sickle anaemia
Researchers showed that cannabinoids ameliorate mast cell activation, inflammation and neurogenic inflammation in sickle mice via both cannabinoid receptors 1 and 2. Thus, cannabinoids influence systemic and neural mechanisms, ameliorating the disease pathobiology and pain in mice with sickle cell anaemia.
University of Minnesota, USA.
Vincent L, et al. Haematologica. 2015 Dec 24. [in press]

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