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IACM-Bulletin of 27 November 2005

UK: Sativex available for individual patients as an unlicensed medicine

On 15 November GW Pharmaceuticals announced that its cannabis extract Sativex may be imported from Canada for individual patients in the UK as an unlicensed medicine. This development is in response to enquiries from a number of UK doctors and individual patients who have been in contact with the Home Office to request access to Sativex.

In accordance with the Medicines Act, a medicine which has yet to be licensed in the UK may be prescribed and supplied in response to an unsolicited request to fulfill the special needs of an individual patient under a physician’s direct personal responsibility. Sativex has been available on prescription in Canada since late June. The Home Office will develop a licensing regime for Sativex. GW expects to discuss the implementation practicalities with the Home Office over the coming weeks.

Irrespective of these plans the company is still planning to submit an application for Marketing Authorisation to the responsible authorities during 2006. Only after such an approval there will be a more easy access to Sativex in the UK.

(Source: Press release of GW Pharmaceuticals of 15 November 2005)

Holland: Office for Medicinal Cannabis optimistic that medical cannabis programme will continue

In reaction to an article by the Austrian newspaper "Der Standard" of 3 November, which was cited in the last IACM-Bulletin Dr. Marco van de Velde, head of the Office for Medicinal Cannabis of the Dutch Health Ministry, refuted the report that the government intends to stop the programme on medicinal cannabis.

"Recently a commission evaluated the Dutch policy on the provision of medicinal cannabis," Dr. van de Velde wrote. "The commission gave a positive opinion and advised the Minister to continue the program and to focus on research and development. The Minister subscribed to this proposal and will discuss this issue in the House of Commons coming month."

"Der Standard" reported that the medical cannabis programme under which cannabis is delivered by pharmacies for medical purposes will be stopped at the end of 2005. The same article also reported that the conservative government intends to restrict the access to coffee shops to citizens of the Netherlands. According to the Austrian newspaper the Dutch embassy in Austria informed the Austrian government, which will take over the presidency of the EURopean Union in January 2006. Michael Simoner, the journalist who wrote the article, was the only journalist who was allowed to participate in this informal meeting of representatives of the Dutch and Austrian government. In a personal communication he confirmed the statements made by the Dutch representatives.

(Sources: Personal communication by Marco van de Velde of 24 November 2005, personal communication by Michael Simoner of 25 November 2005, Der Standard of 3 November 2005)

News in brief

USA: San Francisco
The city of San Francisco adopted regulations on medical marijuana clubs after allegations of abuse at several of the city's 35 facilities. The proposed rules require cannabis dispensary operators to apply for permits that include criminal and employment background checks. Club owners would have to pay $6,610 for a permit along with $3,100 for a business license. The regulations also would govern where and how the clubs could do business, prohibiting them from opening in industrial or residential areas. The zoning guidelines would prevent dispensaries from operating within 500 feet of schools or within 1,000 feet if cannabis-smoking is allowed on the premises. (Source: Associated Press of 15 November 2005)

Science: Clinical study in multiple sclerosis
Results of the 12 months study on cannabis and THC in multiple sclerosis by Dr. John Zajicek and colleagues has now been published as a journal article in the Journal of Neurology, Neurosurgery and Psychiatry. So far, only a short conference report was available in the journal Multiple Sclerosis. The study found that long-term treatment of spasticity due to MS by THC reduced as measured by the Ashworth Scale. The whole plant cannabis extract did not change this objective measure of spasticity compared to placebo. The abstract is available in the clinical study database on the IACM website. (Source: Zajicek JP, et al. J Neurol Neurosurg Psychiatry 2005;76(12):1664-9.)

USA: California
On 23 November a 40-year-old Oakland woman who lost her medical cannabis case before the U.S. Supreme Court in June asked a lower federal court, the 9th U.S. Circuit Court of Appeals, to revive her request to be able to use cannabis without threat or fear of prosecution. In the renewed challenge, Angel Raich, who uses cannabis against chronic pain and nausea now argues that she has the constitutionally guaranteed right to use cannabis because it is the only medication that allows her to avoid intolerable pain and death. She claims that her personal liberty outweighs federal laws outlawing cannabis. (Source: Associated Press of 23. November 2005)

USA: Irvin Rosenfeld
Irvin Rosenfeld, who has been using medical cannabis for more than 20 years is not allowed to participate in the 2006 North American Challenge Cup for the disabled, because he is using a drug that is on the doping list. The US Anti-Doping Agency denied his request for an exemption. Rosenfeld is one of only six people alive who still get cannabis cigarettes from the federal government under a program called Compassionate Care Investigational New Drug, which was stopped in the early 1990s for the admission of new patients. (Source: Providence Phoenix of 25 November 2005)

Science: Pain
Combined administration of THC and one of the two opioids fentanyl and buprenorphine, all given as skin patches, proved to be more efficacious than the cannabinoid and the opiods alone in an animal study. THC in the applied dose produced no reduction of pain. However, THC enhanced fentanyl's potency by 3.7-fold at 2-h, and 5.8-fold at 4-h. Buprenophine's potency was increased 8.2-fold at 2-h and 7.2-fold at 4-h when co-administered with THC. Researchers concluded that "the enhancement of transdermal opioids by THC could lead to the design of an effective combination analgesic patch." (Source: Cichewicz DL, et al. EUR J Pharmacol 2005 Nov 7; [electronic publication ahead of print])

Science: Obesity
The CB1 receptor antagonist rimonabant inhibited the proliferation of fat cells (adipocytes) in a dose-dependent manner in a cell study with fat cells of mice. (Source: Gary-Bobo M, et al. Mol Pharmacol 2005 Nov 9; [electronic publication ahead of print])

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