IACM-Bulletin of 29 August 2010

Source: [International Association for Cannabinoid Medicines (IACM)

 >http://www.cannabis-med.org]

29 August 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.

(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.

(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)

USA/The Netherlands: 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:

(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])

Contact:

[International Association for Cannabinoid Medicines (IACM)

 >http://www.cannabis-med.org]
Am Mildenweg 6

 D-59602 Ruethen

 Germany

 Phone: +49 (0)2952-9708571

 Fax: +49 (0)2952-902651

 Email: info@cannabis-med.org

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