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IACM-Bulletin of 23 January 2005

Science/UK: Cannabis extract reduces cancer pain in clinical study

The British firm GW Pharmaceuticals reported further positive clinical trial results with its cannabis-based medicine Sativex on 19 January and said a UK regulatory hearing on the drug was expected within six months. The company also announced it was looking at an eventual launch in the United States.

The trial was a multi centre placebo-controlled parallel group study including 177 patients. Participants had advanced cancer and were experiencing pain that was not responding adequately to other treatments. In addition to study medication, all patients remained on their analgesic medication during the trial. The study included two different study medications - Sativex (a cannabis extract containing THC and CBD) and a THC-rich extract.

Sativex achieved a statistically significant improvement in pain in comparison to placebo. Approximately 40 per cent of patients on Sativex showed a greater than 30 per cent improvement in their pain. The other active arm of this study, GW’s THC extract did not show a significant effect in pain. This trial therefore suggests that Sativex is the more effective product for use in cancer pain.

GW's under-the-tongue cannabis spray has won qualified approval in Canada for treatment of neuropathic pain in multiple sclerosis, but it is still awaiting a green light in Britain. UK approval is viewed as crucial, as it would open the door to the larger EURopean market. The registration of the medicine has proved more complicated and lengthy than expected. UK marketing approval was originally expected by the end of 2003.

(Sources: Reuters of 19 January 2005, press release of GW Pharmaceuticals of 19 January 2005)

USA: Dispute on driving licence of a medical marijuana user

A Department of Motor Vehicles employee was disciplined for ordering an extra driving evaluation for a medical marijuana user with a case before the U.S. Supreme Court, the agency said on 14 January.

After Diane Monson's lawyer complained she was being unfairly targeted for review without any driving violations, the DMV concluded that she did not need to appear for the re-examination hearing, spokesman Bill Branch said.

Monson who uses the drug to relieve back pain, received notice from the DMV last month ordering her to appear at a re-examination hearing or face losing her driving licence. The notice did not say why she was selected. Re-examination hearings are routinely held in cases involving drivers involved in serious crashes or who have been cited for driving under the influence of drugs or alcohol at least three times over three years. Monson's lawyer, David Michael, said she was singled out because she uses cannabis for her pain.

Branch said the hearing officer should have gathered more information before issuing a summons to Monson. Monson and another California woman, Angel Raich, sued U.S. Attorney General John Ashcroft because they feared their cannabis plants would disappear after federal agents seized them in 2002.

(Source: Associated Press of 14 January 2005)

News in brief

Germany: Acquittal of medical cannabis user
On 19 January the court of Mannheim acquitted a multiple sclerosis patient who was accused of illegal possession of cannabis. 600 grams of cannabis had been found at the home of the 41 year old defendant, who used it against symptoms of his disease since 15 years. Judge Ulrich Krehbiel used strong words against criminal prosecution of severely ill persons who use cannabis medicinaly. "Why don't we allow a man with such a heavy burden some good days," he said. Before, Dr. Hans-Michael Meinck, professor of neurology at the University of Heidelberg, had confirmed the efficacy of cannabis in the treatment of the patient's ataxia. Ataxia is a movement disorder that may be found in MS. (Sources: Die Welt of 20 January 2005, Rhein-Neckar-Zeitung of 20 January 2005)

USA: Cannabis and workplace
The Oregon Court of Appeals ruled on 12 January that the federal Drug-Free Workplace Act does not prohibit workers in Oregon from using cannabis for medical purposes. It said that a positive drug test based on a urine sample does not prove that a worker used or possessed marijuana at work. (Source: Associated Press of 13 January 2005)

Science: CBD and immune system
Italian researchers investigated the effects of cannabidiol (CBD) on the production of interleukin-12 and interleukin-10 in macrophages. Cannabidiol is the main non-psychoactive cannabinoid of the cannabis plant. It increased the production of interleukin-12 and decreased the levels of interleukin-10, which can be regarded as an anti-inflammatory effect. (Source: Sacerdote P, et al. J Neuroimmunol 2005;159(1-2):97-105)

Germany: Cannabis and driving
The Federal Constitutional Court, the highest German court, declared unconstitutional the enforcement of a law, which defines motorists with any detectable level of THC in the blood as being under the influence of cannabis. The court said that the prosecution of persons who test positive for trace levels of THC without being impaired, was not the legislative intent of the law. It noted that scientists usually do not assume the existence of an acute effect with blood concentrations below 1 ng/ml THC. The judges decided on a case of a man who was driving while having a THC concentration below 0.5 ng/ml in his blood. He had admitted to have smoked cannabis 16 hours before the ride and was taken away his driving licence by the authorities. (Source: Press release of the German Federal Constitutional Court of 13 January 2005)

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