Cannabis Study House - NORML Weekly News in Audio 2006.7.27

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Weekly News in Audio

July 27, 2006

Europe Approves Cannabinoid Blocking Agent For Prescription Use - 'Anti-Cannabis' Pill To Be Marketed As Anti-Obesity Drug

Ruling Expected Shortly In Legal Challenge To US Government's Pot Monopoly

Paris, France:
Europe Approves Cannabinoid Blocking Agent For Prescription Use - 'Anti-Cannabis' Pill To Be Marketed As Anti-Obesity Drug

European regulatory authorities have approved the prescription use of the cannabinoid receptor antagonist SR 141716A, to be marketed by Sanofi-Aventis Pharmaceuticals as an anti-obesity drug under the trade name Acomplia (Rimonabant). The cannabinoid blocker, to be sold as an oral 20 milligram pill, is the first cannabinoid antagonist to be approved for human consumption.

Acomplia will initially be available by prescription in the United Kingdom, though the drug is not expected to become widely available in that country until after it receives market approval from Britain's National Institute for Health and Clinical Excellence (NICE), a process that could take up to two years. Sanofi-Aventis is also planning product launches of Acomplia in Demark, Ireland, Germany, Finland, and Norway later this year.

In clinical trials, daily use of Acomplia led to an average 14 pound decrease in subjects' weight after one year and an additional loss of 2.4 pounds the second year. However, subjects typically regained the weight after they ceased using the drug. Commonly reported side effects of the drug include depression, anxiety, and nausea. More than 15 percent of subjects who tried Acomplia discontinued its use because of the drug's adverse effects.

Acomplia blocks the natural binding of endogenous cannabinoids to the neuronal CB1 receptors, causing subjects to lose their appetites. It is not known whether Acomplia blocks exogenous cannabinoids such as THC from binding to the cannabinoid receptors or whether the body moderates its production of endogenous cannabinoids in patients taking Acomplia. Because the endocannabinoid receptor system is involved in the regulation of several primary biological functions including appetite, body temperature, mood elevation, blood pressure, bone density, reproductive activity, learning capacity, and motor coordination some experts are concerned that the long-term use of Acomplia may eventually contribute to significant adverse health effects.

NORML Executive Director Allen St. Pierre called the regulatory approval of Acomplia ironic.

"Despite decades of clinical and anecdotal reports demonstrating the therapeutic safety and efficacy of inhaled, natural cannabinoids, European regulators have instead rushed to approve a drug that is essentially 'anti-marijuana' without giving serious thought to its potential health and safety risks if used long-term," St. Pierre said.

Sanofi-Aventis is also seeking US approval for Acomplia to market the drug as both a weight loss pill and as a smoking cessation agent. Though the US Food and Drug Administration declined to approve the drug this past February, the company is hopeful that it will receive US approval by 2007.

Sales of Acomplia in Europe are expected to generate $3 billion dollars in revenue, according to company officials. Sanofi-Aventis is the third largest pharmaceutical company in the world.

Washington, DC:
Ruling Expected Shortly In Legal Challenge To US Government's Pot Monopoly

A DEA Administrative Law Judge is expected to rule imminently on whether the US National Institute on Drug Abuse (NIDA) can maintain exclusive control of the production and distribution of cannabis for clinical research.

At issue in the case is whether the DEA in 2004 improperly rejected an application from the University of Massachusetts at Amherst to manufacture cannabis for FDA-approved research. The DEA waited more than three years before officially denying the University's request, stating that the establishment of such a facility "would not be consistent with the public interest."

Respondents in the case - the Multidisciplinary Association for Psychedelic Studies (MAPS) and Lyle Craker, director of the UMass-Amherst Medicinal Plant Program are challenging the DEA's denial. Respondents argued in administrative hearings last year that a private production facility is in the public interest (as defined by the US Controlled Substances Act) because it would encourage competition in the marketplace and promote technological and scientific advancement in the field of medicine.

Currently, all federally approved research on marijuana must utilize cannabis supplied by and grown under contract with the US National Institute on Drug Abuse (NIDA). The UMass-Amherst proposal sought to provide clinical investigators with an alternative, independent source of cannabis for FDA-approved clinical trials.

Several US researchers have complained in recent years that the low quality of NIDA-grown marijuana is insufficient to use in clinical studies evaluating cannabis' therapeutic potential. Others have criticized NIDA's unwillingness to provide cannabis for clinical protocols seeking to investigate the drug's medical uses. In 2004, the agency's Director Nora Volkow stated that it is "not NIDA's mission to study the medical uses of marijuana."

Under federal law, even if the DEA's Administrative Law Judge rules against NIDA's marijuana monopoly, DEA head Karen Tandy can still elect to set aside the ruling.

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