IACM-Bulletin of October 13, 2002

Science Canada — Clinical study with smoked cannabis in HIV/AIDS started

The Community Research Initiative of Toronto and St. Michael's Hospital in Toronto announced on 9 October the start of the first Canadian government-sponsored trial evaluating the appetite enhancing effects of smoked cannabis in HIV/AIDS.

The pilot study under the guidance of Dr. Kevin Gough of St. Michael's Hospital will also test the safety of short-term exposure to different strengths of cannabis, and how cannabis interacts with HIV medications. Secondary questions will include the effects of smoked marijuana on nausea, pain, mood and neuro-cognitive function.

Unlike previous cannabis studies, the Toronto team is conducting the research on an outpatient basis. The study is conducted with a crossover design, meaning that all participants will receive cannabis containing different concentrations of THC at different times including a placebo cannabis with no THC. The results of the pilot study will help determine the design of a larger, multi-centre, clinical trial across Canada.

(Sources: Canada NewsWire of 9 October 2002, Toronto Star of 9 October 2002)

Science Germany/Switzerland — Clinical study with oral cannabis extract in weight loss of cancer patients stopped recruitment

In a large clinical study investigating the efficacy of an oral cannabis extract in cancer patients with appetite and weight loss compared to THC and placebo, that has been conducted in Germany, Switzerland and the Netherlands since November 1999, the principal investigators have now stopped patient recruitment.

In an interim analysis completed in September 2002 there were no relevant differences between patients who had received 5 mg THC daily in a cannabis extract, 5 mg isolated THC or a placebo with regard to appetite and quality of life after six weeks of therapy. A total of 156 patients from 25 study centres, among them university clinics in Aachen, Berlin, Bonn, Jena, Leipzig, and Tubingen had been included into this interim analysis. The results of the final analysis with then 236 patients are awaited for Spring 2003.

In a statement the Co-Chairmenship, consisting of Professor Thomas Cerny, Dr. Florian Strasser (Canton's Hospital St. Gallen/Switzerland), and Dr. Martin Schnelle (Institute for Oncological and Immunological Research, Berlin/Germany), pointed out, that there were also no relevant differences in side effects between the three patients groups, so that "the dose of 5 mg THC daily used in the study was apparently too low."

It is intended to develop a new study protocol which besides a higher dose shall consider further possibilities of improvement. It should be avoided to "draw hasty conclusions since the questions posed in this study are still unanswered and need further studies," the statement says.

(Source: Statement of the Co-Chairmenship of 7 October 2002)

News in brief

Canada — Legal marijuana factory

A group announced on 30 September the official opening of what they call Canada's first marijuana factory. The facility in Vancouver is set up to process 110 cannabis plants into moist dark pellets that dissolve easily in olive oil or butter, to ingest the drug in foods. Michael Maniotis, spokesman for the group, said the factory is run under licences issued by Health Canada that exempt from marijuana laws those who are terminally ill. The THC pills produced at the factory will be given to three licence holders at no cost. (Source: Globe and Mail of 30 September 2002)

UK — Last patient recruited

The Medical Research Council announced that it has recruited the last of 660 patients to a 1.9 million Euro trial, which investigates the efficacy of oral cannabis in multiple sclerosis. Dr John Zajicek of Derriford Hospital in Plymouth is leading the study, which is using the same capsulated cannabis extract as the German/Swiss study in cancer patients (see above). Results will be released in May or June 2003. (Sources: Reuters of 3 October 2002, Independent of 7 October 2002)

USA — New Mexico

According to a recent poll in New Mexico, 72 percent of respondents said they would favour "legalizing marijuana use by those who have serious medical conditions, to alleviate pain and other symptoms." (Source: Santa Fe New Mexican of 5 October 2002)

USA — Coalition for Rescheduling Cannabis

A coalition of organizations advocating medical access to cannabis filed a comprehensive rescheduling petition with the Drug Enforcement Administration (DEA) on October 9, 2002. Among the twelve members of the coalition are American Alliance for Medical Cannabis, National Organization for the Reform of Marijuana Laws, Jon Gettman and Patients Out of Time. More at:

http:// www.drugscience.org (Source: Press release of Coalition for Rescheduling Cannabis of 9 October 2002)

USA — California

Four plaintiffs in California filed suit in federal court on 9 October against U.S. Attorney General John Ashcroft and Asa Hutchinson, administrator of the Drug Enforcement Administration (DEA) requesting an injunction to stop the federal government from arresting people for medically using marijuana, as permitted under state law. Two of the plaintiffs, Angel McClary Raich and Diane Monson, are patients with serious medical conditions. (Source: CNN of 10 October 2002)

UK — Acquittal

A 45 year old man accused of possessing 55 grams of cannabis escaped punishment on 9. October after he told magistrates he needed the drug for health reasons. He claimed smoking cannabis eased the pain of his crippling spinal condition. The case is believed to be one of the few in which magistrates have accepted medical reasons as a defence to possession of a large quantity of cannabis. (Source: Independent of 10. October 2002)

Science — Convulsions/epilepsy

Endocannabinoids seem to play a natural role in the suppression of convulsions. The endocannabinoid anandamide was found to be an efficacious anticonvulsant in a mouse model of epilepsy. Conversely, a CB1 receptor blocker reduced the maximal seizure threshold, facilitating convulsions, and indicating the presence of an endogenous cannabinoid tone that modulates seizure activity. (Source: Wallace M, et al. Eur J Pharmacol 2002 Oct 11;452(3):295)

Science — Sperm function

Research shows that anandamide is involved in normal sperm function. Sperm require several hours exposure to secretions in female reproductive tracts, before acquiring the capacity to fertilize eggs. Anandamide is present in several of these reproductive fluids. Researchers found that THC in nanomolar concentrations in a culture medium reduced sperm fertilizing capacity. They assume that THC may impact fertility in women who use cannabis. However, researchers do not explain why this does not seem to happen in reality and how nanomolar concentrations of THC can be reached in reproductive fluids under natural conditions. (Source: Schuel H. et al. Mol Reprod Dev 2002 Nov;63(3):376-87)