Sunday, November 18, 2007

2007 - Cannabis, Pain, and Sleep

“Cannabis, Pain, and Sleep: Lessons from Therapeutic Clinical Trials of Sativex, a Cannabis-Based Medicine.”

The article “Cannabis, Pain, and Sleep: Lessons from Therapeutic Clinical Trials of Sativex, a Cannabis-Based Medicine” was published in Chemistry & Biodiversity in 2007. I came across this article while searching on PubMed through the Brown University Website. The content of this article is instrumental in establishing marijuana’s use for medicinal purposes. In another article “Medicinal cannabis in oncology” written about earlier, the medicinal uses of marijuana for cancer did not have enough evidence in clinical trials. However, this article presents evidence supporting the medicinal uses of marijuana to treat pain and sleep disorders.

Sativex is the world's first pharmaceutical prescription medicine derived from the cannabis plant, which is a major step in pushing for the legalization of marijuana for medicinal purposes. Sativex, created by GW Pharmaceuticals and marketed in conjunction with Bayer, is a combination of plant-derived delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). While the article “Medicinal cannabis in oncology” argues that there is not enough clinical evidence to support the use of marijuana for medicinal purposes, experience to date with Sativex in a number of Phase I-III studies in 2000 subjects with 1000 patient years of exposure show marked improvement in subjective sleep parameters in patients with a wide variety of pain conditions indlucing multiple sclerosis, peripheral neuropathic pain, intractable cancer pain, and rheumatoid arthritis. Sativex patients and their caregivers have noted to their physicians how the medicine has changed their lives through its ability to allow them more restful sleep, increase their daytime level of function, and markedly improve their quality of life.

In 2005, Canada was the first country in the world to license Sativex, the first plant-based cannabinoid pharmaceutical medicine in the modern era. This approval has huge implications for the future of cannabis law in the US. The Canadian approval of Sativex is noteworthy because it was marijuana plants themselves, not a chemical factory that produced the THC and CBD in Sativex. Almost always, drugs based on primarily natural non-chemical plant derivates fail to get regulatory approval because regulators have an arbitrary source material standard that essentially excludes natural extracts. The pharmaceutical industry and regulatory agencies prefer machine-made drugs. The philosophical underpinnings of modern drug medicine protocols assume that natural substances are substandard, irregular, and hazardous.

In February 2007, GW and Otsuka Pharmaceutical announced an exclusive agreement to develop and market Sativex in the US. Sativex has received permission from the FDA to enter directly into late stage Phase III trials in the US. Approval of Sativex provides more credibility to the idea that cannabis is a legitimate medicine. If plant-based cannabinoids are medicine, this supports the argument that marijuana itself does not belong in Schedule One status, where all drugs are assumed to be without medical value. As Sativex has shown, marijuana clearly has remarkable medical value.


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