IACM-Bulletin of August 19, 2007

Germany — MS patient receives a certificate of exemption for the medical use of cannabis by the Federal Health Ministry

By a letter of 9 August the Federal Institute for Pharmaceuticals and Medical Products (FPMP), an agency of the Federal Health Ministry, for the first time issued a certificate of exemption for the medical use of cannabis extract. The 51 year old patient from Baden-Wuerttemberg had applied for a certificate of exemption for the import of cannabis from the Netherlands. Instead, the agency suggested she use a cannabis extract, which would be made available by pharmaceutical companies at the end of August.

So far, the price of the extract to patients is unknown. The FPMP had said earlier, that it will cost only a fraction of pure dronabinol (THC). Additional patients have also applied for a certificate of exemption for the import of cannabis from the Netherlands or for cultivation for personal use, but insist on their applications so that legal proceedings are expected to take place before administrative courts on this issue. In a ruling of 19 May 2005 the Federal Administrative Court had decided, that the FPMP cannot generally dismiss all applications by patients for an approval of the medical use of cannabis. In the case of cannabis, cultivation for personal use should be considered. However, the FPMP stated that both cultivation of cannabis for personal use and import of cannabis from the Netherlands will not be approved.

On 9 July, a patient with Crohn's disease, whose application had been dismissed by the FPMP, was remanded for the import of cannabis. On 16 August a patient with hepatitis C was sentenced to one year in prison without probation for possession of cannabis. His application to the FPMP was also dismissed earlier this year. "It is shameful that a civilized country does not find options for these patients other than treating them as criminals and throwing them in jail," said Dr. Franjo Grotenhermen, Chairman of the German Association for Cannabis as Medicine.

(Source: Association for Cannabis as Medicine)

Canada — Health Ministry approves cannabis extract for the use in cancer pain

On 7 August GW Pharmaceuticals and Bayer announced that Health Canada has approved Sativex, a cannabis extract with equal concentrations of dronabinol (THC) and cannabidiol (CBD), which is sprayed into the mouth, as analgesic treatment in adult patients with advanced cancer, who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy.

In 2005, Health Canada approved Sativex for the treatment of neuropathic pain in adults with multiple sclerosis. Dr. Geoffrey Guy, GW’s Chairman, commented: "GW is delighted to receive Health Canada’s regulatory approval for Sativex in the relief of cancer pain. Sativex has been shown to provide important pain relief to the most high need patients with advanced cancer." The efficacy of Sativex has been demonstrated in a placebo controlled parallel group study in patients with cancer pain. The study showed that in patients with advanced cancer who were already taking the strongest available pain treatments, more than four of ten patients taking Sativex were able to achieve a further clinically important reduction in pain.

The 2007 Sativex Product Monograph is available at:

http://www.bayerhealth.com/display.cfm?Object_ID=272&Article_ID=197

(Source: Press release by GW Pharmaceuticals of 7 August 2007, www.gwpharm.com)

USA — The Health Department of New Mexico does not intend to grow and distribute cannabis

The Health Department of New Mexico said on 15 August that it will not comply with the portion of the new medical cannabis law that requires it to oversee production and distribution of the drug. "The Department of Health will not subject its employees to potential federal prosecution, and therefore will not distribute or produce medical marijuana," said Dr. Alfredo Vigil, who heads the agency.

The department will continue to certify patients as eligible to possess cannabis, protecting them from state prosecution, Vigil said. Thirty patients have been approved to participate in the program since the law took effect 1 July 2007. The state Department of Health and its employees could face federal prosecution if they implement that part of the law which deals with the state-licensed production and distribution of the drug, the attorney general of New Mexico wrote in a letter of 6 August. The law requires the department to issue rules by 1 October for licensing producers and developing a distribution system. That provision is unique in the laws of the 13 states that have legalized the medical use of cannabis.

(Sources: Associated Press of 10 August 2007, Albuquerque Tribune of 15 August 2007)

News in brief

Science — Cannabis use

According to statistical data on cities in California, Colorado, Washington State and Oregon, presented by researchers of the Texas A&M Health Science Center there was no influence of medical cannabis laws on the extent of illegal cannabis use. The scientists assume that the "use of the drug by those already sick might 'de-glamorise' it and thereby do little to encourage use among others." (Source: Gorman DM, et al. Int J Drug Policy 2007;18(3):160-7.)

USA — Raids in California

The raids in California of cannabis distribution centres for patients continue. Last month, the federal drug agency DEA (Drug Enforcement Administration) raided 10 dispensaries in Los Angeles, confiscated more than 240 kilograms cannabis and arrested five people. (Source: Reuters of 14 August 2007)

Science — Violence

According to the Centre for Addictions Research of British Columbia, Canada, the use of alcohol and cocaine played a significant role in explaining the occurrence of violence, while cannabis use was without significant influence. Groups of subjects in treatment for a primary problem with cocaine (n=300), cannabis (n=128), alcohol (n=110), other drugs (33), tobacco (n=249) or gambling (n=199) completed a self-administered questionnaire on this issue. (Source: Macdonald S, et al. Addict Behav, 13 July 2007; [Electronic publication ahead of print])

Switzerland — André Fuerst

Following the dismissal of an appeal before the Federal Court André Fuerst, the founder of "Hanf-Info", has to serve a jail sentence of 29 months. (Source: www.hanf-info.ch)

Science — Huntington's disease

In animal studies cannabidiol (CBD) protected against damage of the certain brain region (striatum) by a chemical. Researchers concluded that CBD provides neuroprotection against damage of striatum, which may be relevant for Huntington's disease, a disorder characterized by the loss of nerve cells of the striatum. (Source: Sagredo O, et al. Eur J Neurosci, 2 August 2007; [Electronic publication ahead of print])

Science — Toxicity to the heart

The use of doxorubicin, an effective anti-cancer drug, may damage the heart, which limits its clinical use. In research with mice it was demonstrated that two CB1 receptor antagonists protected against this damage. (Source: Mukhopadhyay P, et al. J Am Coll Cardiol 2007;50(6):528-36.)