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IACM-Bulletin of 05 June 2011

Germany: Sativex expected to be available in pharmacies in July for the treatment of spasticity in multiple sclerosis

According to a press release by the Spanish company Almirall and the British company GW Pharmaceuticals the cannabis extract Sativex has been granted regulatory approval by the German authorities for the treatment of spasticity due to multiple sclerosis in patients who have not responded adequately to other anti-spasticity medication. Sativex, which contains about equal amounts of THC (dronabinol) and CBD (cannabidiol) is expected to be launched in July 2011.

Approval in Germany follows successful completion in March 2011 of the EURopean Mutual Recognition Procedure with all six countries involved recommending approval (Germany, Denmark, Sweden, Italy, Czech Republic and Austria). In addition to Germany, launch is also expected before the end of 2011 in Denmark and Sweden. Launches in Italy, Czech Republic and Austria are expected in 2012. A further submission for approval is expected to be made later in 2011 with a view to expanding the approval of Sativex to additional EURopean countries. Sativex is already available for the treatment of spasticity in MS in the UK and Spain. Sativex has been developed by GW Pharmaceuticals and Almirall holds the marketing rights to this medicine in EURope (except the United Kingdom).

More at:

(Source: Press release by GW Pharmaceuticals and Almirall of 26 May 2011)

Holland: Government bans foreigners from coffee shops

The Dutch government said on 27 May it would start banning tourists from buying cannabis from coffee shops and impose restrictions on Dutch customers by the end of the year. The Netherlands is well known for having one of EURope's most liberal soft drug policies that has made its cannabis shops a popular tourist attraction, particularly in Amsterdam. Backed by the right-wing extremist party of Geert Wilders, the coalition government that came into power last year announced plans to curb drug tourism as part of a nationwide programme to promote health and fight crime.

Under the new rules, only Dutch residents will be able to sign up as members of cannabis shops. Dutch customers will have to sign up for at least a year's membership and each shop would be expected to have only up to 1,500 members, a justice ministry spokesman said. The policy will roll out in the southern provinces of Limburg, Noord Brabant and Zeeland by the end of the year and the rest of the country next year.

More at:

(Source: Reuters of 30 May 2011)

World: Global Commission on Drug Policy calls for the legalization of cannabis

A high-level international commission declared the global "war on drugs" a failure and urged nations to consider legalizing cannabis and other drugs to undermine organized crime and protect their citizens' health. The Global Commission on Drug Policy called for a new approach to reducing drug abuse to replace the current strategy of strictly criminalizing drugs and incarcerating drug users while battling criminal cartels that control the drug trade. "The global war on drugs has failed, with devastating consequences for individuals and societies around the world," said the report issued by the commission on 2 June.

The study urges "experimentation by governments with models of legal regulation of drugs," adding: "This recommendation applies especially to cannabis, but we also encourage other experiments in decriminalization and legal regulation." The 19-member panel includes Cesar Gaviria (former Colombian President), Giorgos Papandreou (current Greek Prime Minister), Kofi Annan (former U.N. Secretary-General), George Shultz (former US Foreign Minister), Ernesto Zedillo (former Mexican President), Ruth Dreifuss (former Swiss President), Fernando Henrique Cardoso (former Brazilian President), Mario Vargas Llosa (writer, Peru), Thorvald Stoltenberg (former UN High Commissioner for Refugees, Norway) and Javier Solana (former EURopean Union High Representative for the Common Foreign and Security Policy, Spain). The commission's report adds that money spent by governments on futile efforts to reduce the supply of drugs and on jailing people on drug-related offenses could be better spent on different ways to reduce drug demand and the harm caused by drug abuse.

The full report is available here

(Source: Reuters of 2 June 2011)

News in brief

USA: California
According to a press release by California NORML patients who are allowed to use cannabis for medicinal purposes number 750,000 to 1,125,000 in California, or about 2-2.5 per cent of the population. Just a tiny fraction of these patients is enlisted in the state's voluntary identification card program, which issued 12,659 cards in 2009-2010. Therefore, California patient numbers must be estimated from other sources. Among the most salient are medical cannabis registries in Colorado and Montana, which include 2.5 per cent and 3.0 per cent of the population, respectively. According to government data, the total number of users in the state, including non-medical ones, amounts to 6.7 per cent of the population within the past month, or 11.3 per cent within the past year, slightly higher than the national average in cannabis use (6.0% monthly and 10.4% yearly). (Source: Press Release by California NORML of 30 May 2011)

USA: Federal government
Justice Minister Eric Holder promised on 2 June to clarify the Justice Department's position on state medical cannabis laws after federal prosecutors recently warned they might prosecute everyone from licensed growers to regulators. "We're going to bring clarity so that people understand what this policy means and how this policy will be implemented," Holder said. Holder didn't go into detail about plans for clarification. But he said the department was wary of medical cannabis dispensaries being seen as a form of de facto cannabis legalization. On 27 May the attorney general from Arizona, Tom Horne, had sued the U.S. Justice Department on behalf of the state and Governor Jan Brewer asking a federal judge to rule on whether compliance with the Arizona law on medicinal cannabis provides protection from federal prosecution or not. (Sources: Associated Press of 27 May and 2 June 2011)

Science: Variants of the CB1 receptor
A group of scientists from the USA and Spain investigated whether certain variants of the gene which encodes the CB1 receptor are associated with type 2 diabetes and coronary heart disease. They studied 2,411 participants of the Framingham Study (mean age 60 years). No associations between certain gene variants of the cannabinoid receptor and these diseases were found. (Source: de Miguel-Yanes JM, et al. Obesity (Silver Spring). 2011 Jun 2. [in press])

Science: Pain
According to animal research at the University of Minnesota in Minneapolis, USA, with a selective CB1 receptor agonist (arachidonylcyclopropylamide) and a selective CB2 receptor agonist (AM1241) effects at both receptors reduce tumour pain synergistically. They concluded that "the peripheral cannabinoid receptors are a promising target for the management of cancer pain and mixed cannabinoid receptor agonists may have a therapeutic advantage over selective agonists." (Source: Khasabova IA, et al. Behav Pharmacol. 2011 May 21. [in press])

Science: Inflammation
According to research at the University of Catania, Italy, endocannabinoids inhibit the release of nerve growth factor from mast cells. Nerve growth factor induces angiogenesis (formation of blood vessels). Researchers concluded that "cannabinoids could be considered for antiangiogenic treatment in disorders characterized by prominent inflammation." (Source: Cantarella G, et al. Biochem Pharmacol. 2011 May 12. [in press])

Science: Anxiety
According to research at the University of Georgia in Athens, USA, blockade of the enzyme that degrades the endocannabinoid 2-arachidonoylglycerol (2-AG) produces anxiolytic effects in rats. (Source: Sciolino NR, et al. Pharmacol Res. 2011 May 11. [in press])

Science: Psychosis
Scientists of the University of Utrecht, The Netherlands, investigated the relationship between cannabidiol (CBD) content in cannabis and subclinical psychiatric experiences in 1877 cannabis users. There was a negative relationship between positive symptoms (delusions, hallucinations, etc.) and CBD content, but not with negative symptoms (blunted emotion, inability to experience pleasure, lack of motivation). Researchers concluded that "although the observed effects are subtle, using high cannabidiol content cannabis was associated with significantly lower degrees of psychotic symptoms providing further support for the antipsychotic potential of cannabidiol." (Source: Schubart CD, et al. Schizophr Res. 2011 May 16. [in press])

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