January 24, 2002
Clinical Trials on Pot for Head Trauma Planned for U.S.
Iselin, NJ: Phase III human trials on the effectiveness of the synthetic marijuana derivative Dexanabinol for the treatment of Traumatic Brain Injury (TBI) are pending for the first time in the U.S., according to a recent press release by the Pharmos Pharmaceutical corporation.
"The U.S. arm of the study [is] planned to begin in 2002 pending the submission and acceptance of an IND [Investigational New Drug application]," the release states. "Completion and enrollment is anticipated in 2003."
Presently, nine nations - Belgium, England, Finland, France, Germany, Israel, Italy, the Netherlands and Spain - are taking part in the ongoing, worldwide study.
A previous Phase II trial of 67 Israeli patients by Pharmos demonstrated that Dexanabinol reduced mortality and eased intracranial pressure in patients suffering from severe head injuries. A 1998 U.S. Army rat study also reported that the administration of Dexanabinol five minutes after the onset of nerve gas-induced seizures significantly reduced brain damage.
Similar research conducted by scientists at the National Institutes for Mental Health found that naturally occurring cannabinoids THC and cannabidiol (CBD) are neuroprotective in animals. A 1999 report by the National Academy of Sciences' Institute of Medicine (IOM) called cannabis' neuroprotective qualities the "most prominent" of its potential therapeutic applications.
For more information, please contact Paul Armentano, NORML Director of Publications and Research, at (202) 483-5500.
DEA's Hemp Foods Ban Ignores Justice Department's Findings, Failed to Assess Policy's Impact on Industry
Washington, DC: New DEA regulations criminalizing the possession and manufacture of any edible hemp seed or oil products containing trace amounts of THC were approved despite objections from the Department of Justice (DOJ) and without ever accounting for the new policy's impact on U.S. markets.
"Hemp products intended for human consumption have THC at levels too low to trigger a psychoactive effect and are not purchased, sold or marketed with the intent of having a psychoactive effect," states a March 2000 DOJ memo from John Roth, Chief of the Narcotics and Dangerous Drugs Section of the DOJ, to then-DEA Acting Administrator Donnie Marshall. The letter, obtained this week through the Freedom of Information Act, continues: "[These products] are explicitly excluded from regulation under the Controlled Substances Act. ... We consider this well settled law. Thus, it appears we are not able to regulate or prohibit the importation of 'hemp' products based on any residual or trace content of naturally occurring THC."
Nevertheless, contrary to the DOJ's legal assertions, the DEA issued an "interpretive rule" in October immediately banning all edible items containing hemp seed or oil found to have negligible levels of THC. Under the new rule, manufacturers have until February 6 to "dispose" of such products or face criminal prosecution under the federal Controlled Substances Act.
In addition, newly acquired information obtained by the Hemp Industries Association (HIA) - which recently filed a brief with the Ninth Circuit Court of Appeals urging the court to enjoin the DEA ban - indicates that the DEA is only now evaluating the size of the U.S. hemp market and the ban's potential financial impact upon it. According to the HIA, the DEA recently hired a northern Virginia consulting firm to investigate the size and scope of the domestic hemp foods market, which the HIA estimates has doubled every year for the past five years. All attempts by the HIA to initiate dialogue with the DEA in the months preceding the ban were ignored, the association says.
For more information, please contact Allen St. Pierre, NORML Foundation Executive Director, at (202) 483-8751. A copy of the DOJ's memo to the DEA is available online at: http://www.votehemp.com.
French Justice Minister Calls for Pot Decriminalization Debate
Paris, France: French Justice Minister Marylise Lebranchu called on politicians to begin debating the merits of marijuana decriminalization after a newly released study reported that approximately half of all teens have tried the drug.
"I think that starting the debate would not be a bad thing because it has never been started properly," Lebranchu told Inter radio, adding that the issue "will have to be taken to a conclusion one day." The Justice Minister made her comments following the release of an annual report by the national Drugs and Drug Addiction Observatory that found almost 60 percent of boys and 43 percent of girls aged 18 have already tried pot. Among adults, the study reported that 16 percent of the population had experimented with the drug.
A previous report released in November by the European Monitoring Center for Drugs and Drug Addiction (EMCDDA) estimated that just over 20 percent of French adults and some 40 percent of teens had tried the drug, despite the fact that the country maintains some of the strictest anti-drug laws in Europe. Under French law, drug use is punishable by up to one year in jail and drug possession - including marijuana - is punishable by up to ten years in jail (though first-time pot offenders may be let off with only a warning).
Currently, only a handful of European Union nations criminally prosecute marijuana offenders. Last year, Belgium, Luxembourg and Portugal all enacted policies decriminalizing pot, while Great Britain's government announced that it would federally reclassify marijuana so that its possession was no longer an arrestable offense.
For more information, please contact either Allen St. Pierre or Paul Armentano of The NORML Foundation at (202) 483-8751.
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