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IACM-Bulletin of 13 April 2008

Spain: Positive results of a study with the cannabis extract Sativex in Catalonia

On 9 April the government of Catalonia published positive results of its pilot programme to evaluate the oral cannabis extract Sativex as a treatment in different patient groups. According to the press release almost half of the patients who received Sativex responded well by reporting improvement of their symptoms. A total of 207 patients were included with the following therapeutic indications: 32 with neuropathic pain due to multiple sclerosis, 54 with spasticity due to MS, 47 with neuropathic pain due to different medical conditions (other than MS), 41 with diagnosed anorexia-cachexia syndrome due to cancer or AIDS, and 33 with nausea and vomiting due to chemotherapy treatment.

The pilot programme commenced in January 2006 by order of the Head of the Catalan Health Department and was finished in December 2007. The project has involved the participation of over 40 doctors in 6 hospitals in the Barcelona Area. According to Marina Geli, the head of the Catalan health department, in the case of patients suffering from anorexia-cachexia associated with AIDS up to 53 per cent of these regained their appetite. The number of patients in the study suffering from multiple sclerosis who went from having unbearable pain to suffering tolerable pain went down from 66 per cent to 35 per cent.

More at:
production.investis.com/gwp/pressreleases/currentpress/2008-04-09/
www.420magazine.com/forums/international-cannabis-news/74830-study-spain-underlines-therapeutic-use-cannabis.html

(Sources: Press release of GW Pharmaceuticals of 9 April 2008, www.420magazine.com of 11 April 2008)

Science: THC effective in obsessive compulsive disorder according to case reports

Researchers from Berlin, Germany, reported two cases of obsessive compulsive disorder successfully treated with oral THC to the American Journal of Psychiatry. Both patients, a 38-year-old woman and a 36-year-old man, were refractory to conventional treatment such as neuroleptics and antidepressants. After the first patient had informed her physicians that smoking of cannabis relieved her symptoms, 10 mg THC three times daily was added to the ongoing treatment with clomipramine, which resulted in a significant decrease of symptoms within 10 days. The second patient received dronabinol, which was slowly increased up to a dose of 10 mg THC twice daily, also in addition to his ongoing treatment. A significant reduction of symptoms was observed within two weeks.

Obsessive compulsive disorder is a psychiatric anxiety disorder most commonly characterized by a subject's obsessive, distressing, intrusive thoughts and related compulsions (tasks or "rituals") which attempt to neutralize the obsessions. Many patients do not respond well to conventional medications, which also may cause significant side effects. Based on the observation that THC is effective in treating tics in Tourette's syndrome and the observation that Tourette's syndrome may be genetically linked to obsessive compulsive disorder, researchers hypothesized that THC might also reduce their symptoms.

Here is a link to a letter to the editor.

(Source: Schindler F, Anghelescu I, Regen F, Jockers-Scherubl M. Improvement in refractory obsessive compulsive disorder with dronabinol. Am J Psychiatry. 2008 Apr;165(4):536-7.)

Science: Preliminary results of a study with Sativex in neuropathic pain due to multiple sclerosis

On 8 April GW Pharmaceuticals announced preliminary results of a Phase III placebo-controlled study of its cannabis extract Sativex in 339 patients with central neuropathic pain due to multiple sclerosis, who have achieved inadequate pain relief with existing therapies. The primary efficacy endpoint in the study was the proportion of patients whose pain reduced by at least 30 per cent as measured on a 0-10 numerical rating scale. 50 per cent of Sativex patients experienced a pain reduction of at least 30 per cent. However, although the difference between the Sativex and placebo groups was clearly in favour of Sativex, it failed to reach statistical significance due to an unexpectedly large placebo response.

After the negative results were announced, shares of GW Pharmaceuticals lost more than a quarter of their value within one day. This study is one of three Phase III trials for Sativex underway in 2008, each of which targets a distinct indication. The other EURopean Phase III study in MS spasticity, requested last year by the UK regulator in order to gain approval in this indication is on track to report later this year. According to the press release GW’s regulatory strategy is to file Sativex for approval in MS spasticity in EURope and cancer pain in the United States.

(Sources: Press release of GW Pharmaceuticals of 8 April 2008, Independent of 9 April 2008)

Germany: Lead poisoning due to adulterated cannabis

In recent months several cases of lead poisoning were observed in Germany, mainly in the region of Leipzig. Some cases also occurred in other places, such as Munich and Vienna, Austria. According to a report published in the New England Journal of Medicine 29 patients were admitted to four different hospitals in the greater Leipzig area with classic signs and symptoms of lead intoxication, which had not occurred in Germany in recent decades. All patients were regular cannabis users and lead was detected in cannabis of some patients.

A criminal investigation was begun to find the causer of the lead adulteration. Lead was obviously added to the drug by drug traffickers to increase weight and profit. An anonymous screening program for cannabis users was started and further 95 subjects were found, who had blood levels of lead that required treatment. The Drug Commissioner of the Federal Government, Sabine Baetzing, issued a warning on cannabis that may be adulterated by lead. Several German organisations called for the possibility for cannabis users to grow their own for personal use to reduce the risks of cannabis use.

The article is available at:
content.nejm.org/cgi/content/full/358/15/1641

(Source: Busse F, Omidi L, Leichtle A, Windgassen M, Kluge E, Stumvoll M. Lead poisoning due to adulterated marijuana. N Engl J Med 2008;358(15):1641-2.)

News in brief

Holland: Maastricht
On 1 April a district court in Maastricht overturned a municipal decree stating that cannabis bars must refuse foreigners as clients. French, Belgians and Germans must now be allowed in. A distinction by 'residency' is not permitted on grounds of the ban on discrimination in Article 1 of the constitution unless there are reasonable, objective grounds justifying it. There was no question of this here, the judge found. (Source: NIC News Bulletin of 2 April 2008)

Science: Fibromyalgia
Compared with healthy subjects 22 patients with primary fibromyalgia had increased blood levels of anandamide. Researchers assume that patients with fibromyalgia "might benefit from pharmacologic manipulation of endocannabinoid signalling." (Source: Kaufmann I, et al. Psychoneuroendocrinology. 2008 Apr 4 [Electronic publication ahead of print])

Science: Dependency
Researchers of the Columbia University in New York reported on two cases of cannabis dependence, who were treated with oral THC. They conclude that given "that agonist agents have been found to be effective for opiate and nicotine dependence, the clinical utility of dronabinol for cannabis dependence is a reasonable approach." (Source: Levin FR & Kleber HD. Am J Addict 2008;17(2):161-4.)

Science: Neuropathic pain
British researchers conclude from animal studies that the cannabinoid-2 receptor in the thalamus, a brain region, may have a functional role in neuropathic pain. (Source: Jhaveri MD, et al. EUR J Neurosci 2008;27(7):1722-30.)

Science: Neuropathic pain
It was shown in animal studies that activation of the CB2 receptor in the spinal cord may reduce pain after nerve injury. (Source: Romero-Sandoval A, et al. Anesthesiology 2008;108(4):722-34.)

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