IACM-Bulletin of August 29, 2010

Science — Production of THC by genetically modified bacteria

Scientists of the Technical University of Dortmund, Germany, have genetically manipulated bacteria in a manner that allows them to produce the main psychoactive compound of cannabis. This procedure for the production of THC (dronabinol) is thought to be less laborious and therefore cheaper in comparison to the currently used procedure in Germany, said Oliver Kayser of the university on 17 August.

To date, dronabinol has been produced from fibre hemp in Germany. Cannabidiol (CBD) is extracted from this hemp and converted into THC. Chemical extraction from THC-rich drug hemp is not allowed in Germany. The synthetic manufacture of dronabinol would also be costly in comparison to the new procedure. Kayser is anticipating production costs with the new procedure of only about 2,500 Euros per kilogram of THC. E. coli bacteria with isolated genes are responsible for the production of THC in the plant are used. Together with a pharmaceutical company, the University of Dortmund is planning the foundation of a company for THC production.

More at:

http://derstandard.at/1281829392202/Tetrahydrocannabinol-Bakterien-koennen-ohne-viel-Aufwand-Cannabis-Wirkstoff-produzieren

(Source: Standard of 17 August 2010)

Germany — Changes in the narcotics law to allow for the approval of Sativex intended

The government wants to allow pharmaceutical companies to apply for approval of cannabis-based medicines in Germany. In a commentary, the government writes: "Since in Europe (Great Britain) a medicinal drug with cannabis extract for the symptomatic treatment of spasticity in multiple sclerosis was approved, it is currently necessary to lift the general ban on cannabis for medicinal purposes for a forthcoming application for an approval of this medicine." As in other European countries, which have approved or want to approve Sativex the law change is restricted to cannabis-based medicines approved by the health authorities. The approval in Germany is expected in 2011 and is restricted to the treatment of spasticity in multiple sclerosis.

The government is following the recommendations of the expert committee for narcotics of 3 May, that is the reclassification of "Cannabis (marijuana, plants and parts of plants belonging to the species cannabis)" from Annex I to Annex II of the narcotics law, as long as they "are intended for the production of preparations for medicinal purposes." The committee also recommended adding the following item to Annex III of the narcotics law: "Cannabis extract (extract obtained from plants and parts of plants belonging to the species cannabis)" and only "in preparations approved as medicines." Annex I of the German narcotic law includes substances that cannot be prescribed and are not marketable, such as heroin, cocaine, LSD and cannabis. The inclusion of cannabis extract in Annex III of the narcotics law refers to the expected approval of Sativex.

Extended comment on the changes by the ACM in German:

http://www.cannabis-med.org/nis/data/file/stellungnahme_2010.pdf

(Source: Bill of a 25th ordinance for the change of the regulations for the German narcotics law)

Germany — Federal Institute for Drugs and Medical Devices rejects application for self-cultivation of cannabis for medicinal purposes

The Federal Institute for Drugs and Medical Devices (BfArM), which is controlled by the Federal Health Ministry, has enjoined a multiple sclerosis sufferer to self-cultivate cannabis. The notification of 10 August was mainly substantiated with security concerns with regard to cultivation in his home, increased danger for abuse, the use of a non-standardized substance and the damage to the international reputation of Germany. In addition, the BfArM argues that the applicant can buy cannabis in a pharmacy. Michael Fischer from Mannheim has needed cannabis for many years and was acquitted in a criminal procedure for violation of the narcotics law after he acted in a state of emergency.

He was already granted an exemption by the BfArM to use cannabis from the pharmacy, which is imported from the Netherlands. However, in view of his high cannabis needs, the drug from the pharmacy would cost about 1,500 Euros (about 1,900 US Dollars) therefore the only alternative for Mr. Fischer is self-cultivation. His application was not handled by the BfArM for several years despite the Federal Administrative Court ruling of 19 May 2005, which pointed out that in the case of an exemption for the medical use of cannabis, an approval for the self-cultivation would be considered. The court ruling also says: "The reference to a medical drug that is neither readily available nor affordable by normal citizens is no alternative to achieve the public interest in the use of cannabis to combat illness."

Only an application for failure to act before the Administrative Court of Cologne resulted in this decision by the BfArM. This decision apparently was based on a directive from the Federal Health Ministry, since notes in the records of Mr. Fischer at the BfArM say that "the grant of a permission for cannabis self-cultivation is therapeutically substantiated and due to the precarious situation is without alternative." Now, the Federal Health Ministry would have to decide, say the notes.

More in the ACM-Mitteilungen of 28 August 2010:

http://www.cannabis-med.org/german/acm-mitteilungen/ww_de_db_cannabis_artikel.php?id=66

(Sources: Notification by the BfArM of 10 August 2010, press release by Dr. Oliver Tolmein of 18 August 2010)

Holland/USA — The cannabis grower Bedrocan goes international and intends to get approval by US health authorities in the long run

Bedrocan International since recently based in Oakland, USA, is a subsidiary company of Bedrocan BV in the Netherlands. Since 2003 Bedrocan is producing high-quality standardized cannabis under the control of the Dutch Health Ministry for delivery in pharmacies. The company is also trying to get an approval to grow cannabis on behalf of the Israeli government. Michael Sautman, head of Bedrocan International is aiming to position the company in the rapidly expanding industry of medical cannabis in the USA and to help professionalise production. Sautman's vision is to use the American pharmaceutical drug-approval process to legalize medical cannabis nationwide.

The process to get approval by the US Food and Drug Administration (FDA) takes years and costs millions. There are many regulatory barriers to Bedrocan's plan. To do FDA-approved cannabis research, scientists must get the drug from a federally approved source. There is only one in the country - at the University of Mississippi - and getting government permission to use its product is tough. Scientists could also presumably cultivate their own research cannabis, but they need federal permission for that too, and so far such requests have been denied.

More at:

http://www.baycitizen.org/marijuana/story/dutch-company-enters-oakland-pot-scene/

(Source: Bay Citizen of 13 August 2010)

News in brief

Science — Motility of the stomach

According to research at the St George's University of London, UK, cannabinoids induce a reduction in pacemaker frequency of stomach motility. Researchers observed an increase on this motility after administration of a substance (apomorphine) that induces vomiting in animals. They noted that their research with the synthetic cannabinoid WIN 55,212-2 "reveals new insights into the mechanism regulating the decrease in motility induced by cannabinoids." (Source: Percie du Sert N, et al. Neurogastroenterol Motil. 2010 Aug 22. [in press])

Science — Aging

According to research at the University of Bonn, Germany, genetically modified mice without CB1 receptors present with an accelerated decrease of learning and memory. These aging-like changes were restricted to cognitive abilities and skin structure. No other organs presented with signs of accelerated aging. Researchers concluded "that the lack of CB1 receptor does not induce accelerated aging in general." (Source: Bilkei-Gorzo A, et al. Neurobiol Aging. 2010 Aug 17. [in press])

Science — Arthritic pain

According to research at the University of Nottingham, UK, the levels of the endocannabinoids anandamide (AEA) and 2-arachidonoyl glycerol (2-AG) were increased in the spinal cord of rats with experimental arthritis. Arthritis was induced by injections of a chemical into the joints. CB1 and CB2 receptors were involved in the control of pain in these animals. Researchers noted that the "novel control of spinal neuronal responses by spinal CB(2) receptors suggests that this receptor system may be an important target for the modulation of pain" in arthritis. (Source: Sagar DR, et al. Arthritis Rheum. 2010 Aug 18. [in press])

Science — Huntington disease

Researchers from Leuven, Belgium, compared the distribution of CB1 receptors in 20 patients suffering from Huntington disease and 14 healthy controls. They observed a profound decrease of CB1 availability throughout the grey matter of the brain in patients, even in early disease stages. They noted that "this is the first, to our knowledge, in vivo demonstration of disturbance of the endocannabinoid system in a human neurologic disease." (Source: Van Laere K, et al. J Nucl Med. 2010 Aug 18. [in press])

Science — Irritable bowel syndrome

Scientists at the Academic Medical Center Amsterdam, The Netherlands, investigated rectal sensitivity of 10 patients with irritable bowel syndrome and 12 healthy volunteers following placebo, and two different doses of THC (5 and 10 mg) in a double blind, cross-over design. THC did not alter rectal perception to distension compared to placebo in healthy subjects or patients. Researchers concluded their results "argue against (centrally acting) CB agonists as tool to decrease visceral hypersensitivity" in patients with irritable bowel syndrome. (Source: Klooker TK, et al. Neurogastroenterol Motil. 2010 Aug 16. [in press])

Science — Degradation of anandamide

According to research at Stony Brook University in New York, USA, cyclooxygenase-2 (COX-2) possesses the capacity to depredate anandamide (AEA). COX-2 is known to mediate inflammation and contributes to neurodegeneration. Anandamide is primarily degraded by fatty acid amide hydrolase (FAAH). Scientists noted that their "findings establish COX-2 as a mediator of regional AEA metabolism in mouse brain." (Source: Glaser S, et al. J Pharmacol Exp Ther. 2010 Aug 11. [in press])