IACM-Bulletin of January 30, 2011

Germany — Applications for personal cultivation of cannabis for medicinal purposes cannot generally be dismissed, the Cologne Administrative Court has ruled

In a ruling of 21 January, the Administrative Court of Cologne has decided in part in favour of a patient suffering from multiple sclerosis, who had applied for an approval for personal cultivation of cannabis for medicinal purposes. The dismissal of 10 August 2010 by the Federal Institute for Pharmaceuticals and Medical Products (BfArM), which is controlled by the Federal Health Ministry, was unlawful, the court said. Now the Institute has to re-examine the application. The notification of 10 August 2010 was mainly substantiated on the basis of security concerns with regard to cultivation in the home, the use of a non-standardized substance and the alleged damage to the international reputation of Germany by allowing personal cultivation of cannabis. In addition, the BfArM argued that the applicant can buy cannabis in a pharmacy. Michael Fischer from Mannheim has required cannabis for many years, and was acquitted in a criminal procedure in 2003 for violation of the narcotics law, since it was ruled that he acted in a state of emergency.

He was previously granted an exemption by the BfArM to use cannabis from the pharmacy, which is imported from the Netherlands. About 40 patients in Germany currently have similar permission. However, in view of his high cannabis requirement, Mr. Fischer cannot afford its cost. The Administrative Court ruled that no imperative reasons against an approval exist. The measures of security the plaintiff intends to install would be sufficient. The year-long personal cultivation would serve as proof that the plaintiff would not damage himself by treatment with this cannabis. The violation of the International Drug Conventions associated with the approval would not require revocation of his permission to cultivate, either. Even in case of a violation of the Conventions the BfArM would have administrative discretion, since the interests of the plaintiff must be taken into account adequately. The German Association for Cannabis as Medicine (ACM), which finances the test case welcomed the ruling.

The dismissal of 10 August was based on a directive from the Federal Health Ministry. Notes in the records of Mr. Fischer at the BfArM state that permission for personal cultivation of cannabis in his case was "without alternative," but the Institute had to follow the directive. Now the Ministry has not only sustained a judicial defeat, but also must address critical questions from members of the German Bundestag on this issue.

More at:

- http://www.pharmazeutische-zeitung.de/index.php

- http://www.justiz.nrw.de/Presse/presse_weitere/PresseOVG/21_01_2011/index.php

- http://www.123recht.net/article.asp?a=84464&ccheck=1

(Sources: Press release by the Administrative Court of Cologne of 21 January 2011, dpa of 21 January 2011)

News in brief

Science — Mechanisms of action

According to scientists of the University of Coimbra, Portugal, many cannabinoids inhibit the uptake of adenosine and dopamine from synapses. A synapse is a junction that permits a nerve cell to pass a signal to another cell. The inhibition of the uptake of these two substances by cannabinoids was independent from cannabinoid receptors. According to the investigators these effects "should be an additional mechanism to consider when interpreting synaptic effects of cannabinoids." (Source: Pandolfo P, et al. Eur J Pharmacol 2011 Jan 22. [in press])

Science — Spinal cord injury

According to animal research at the University of Kiel, Germany, the number of cannabinoid-1 receptors changes after spinal cord injury, increasing in some areas of the brain and decreasing in others. (Source: Knerlich-Lukoschus F, et al. J Neurotrauma 2011 Jan 25. [in press])

Science — Posttraumatic stress disorder

According to researchers of National Centers for Posttraumatic Stress Disorder in the USA, who followed 432 military veterans with a diagnosis of posttraumatic stress disorder, those with a poorer treatment outcome had a higher risk for later cannabis use (at 4 months after discharge from a centre). They noted that "these effects were specific to cannabis and were not found for the other substances examined." (Source: Bonn-Miller MO, et al. Psychol Addict Behav 2011 Jan 24. [in press])

Science — Alzheimer's disease

According to research at the Louisiana State University in New Orleans, USA, the endocannabinoid 2-arachidonoylglycerol protects nerve cells against the damage by beta-amyloid. Beta-amyloid is increasingly produced in Alzheimer's disease. Researchers noted that their "results suggest that elevation of endogenous 2-AG by inhibiting its hydrolysis has potential as a novel efficacious therapeutic approach for preventing, ameliorating or treating Alzheimer's disease." (Source: Chen X, et al. Neuroscience 2011 Jan 19. [in press])

Science — Alzheimer's disease

According to Italian researchers the endocannabinoid palmitoylethanolamide exhibits anti-inflammatory properties able to counteract amyloid-beta-induced toxic effects on astrozytes, and "suggest novel treatment for neuroinflammatory/neurodegenerative processes." (Source: Scuderi C, et al. J Cell Mol Med 2011 Jan 21. [in press])

Science — Sepsis

According to Spanish researchers the natural cannabinoid cannabidiol (CBD) prevented from negative consequences of sepsis in a mouse model. It prevented dilation of small arteries and veins. (Source: Ruiz-Valdepenas L, et al. J Neuroinflammation 2011;8(1):5.)

Science — THC administration

Scientists at the University of Kentucky, USA, investigated nasal administration of THC preparations in animals. Mean bioavailability values were 13.3 and 15.4 per cent for a THC nasal solution and a gel formulation. (Source: Al-Ghananeem AM, et al. Drug Dev Ind Pharm 2011 Jan 18. [in press])

Science — Interaction

Scientists of the University of Guelph, Canada, demonstrated that the cannabinoid cannabigerol (CBG) inhibited the effects of cannabidiol (CBD) against nausea and vomiting in animals (rats and shrews). They concluded that "interactions between moderate doses of CBG and CBD may oppose one another at the 5-HT(1A) receptor in the regulation of nausea and vomiting." (Source: Rock EM, et al. Psychopharmacology (Berl) 2011 Jan 18. [in press])

Science — Appetite

Researchers at the University of Sao Paulo, Brazil, demonstrated that cannabidiol (CBD) inhibited the increased appetite induced by CB1 receptor agonists. They suggest "that its role as a possible food intake regulator should be further investigated." (Source: Scopinho AA, et al. Pharmacol Biochem Behav 2011 Jan 14. [in press])

Science — Cancer

Scientists at the Complutense University of Madrid, Spain, investigated reasons why glioma cells may be resistant to the anti-tumoural action of cannabinoids. They observed that a certain mechanism, the stimulation of the so-called midkine/ALK axis renders glioma cells resistant to cannabinoid action and suggest that "selective targeting of the Mdk/ALK axis could help to improve the efficacy of THC treatment in tumors." (Source: Lorene M, et al. Cell Death Differ 2011 Jan 14. [in press]).