This Week's News from NORML 6-14

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This Week's News from NORML

• FDA Advisory Panel Says Controversial Cannabinoid Blocker Not Safe For Human Consumption
  
  
• New York: State Assembly, Governor Back Medical Marijuana Measure
  
  
• Cannabinoids Reduce Skin Inflammation
  
  

FDA Advisory Panel Says Controversial Cannabinoid Blocker Not Safe For Human Consumption
Rockville, MD: An independent Food and Drug Administration (FDA) advisory committee determined on Wednesday that the controversial cannabinoid receptor antagonist Rimonabant (also known as Acomplia) is unsafe for human consumption in the United States. The drug's manufacturer, Sanofi-Aventis Pharmaceuticals, is seeking FDA approval to market the drug in the US as a dietary aid.
Members of the FDA's Endocrinologic and Metabolic Drug advisory panel resolved 14-0 that the drug did not possess a "favorable risk-benefit profile" to warrant US regulatory approval. Panelists reported that patients prescribed Rimonabant experienced increased incidences of depression, nausea, vomiting, and suicidal tendencies. Adverse neurological symptoms, including multiple sclerosis, have also been documented in subjects who have taken Rimonabant.
European regulators previously approved the prescription use of Rimonabant, marketed under the trade name Acomplia, in 2006 but are now expected to review their decision. Rimonabant is the first cannabinoid antagonist ever to be approved for human consumption. More than 100,000 European patients have been prescribed Acomplia since its approval last year.
The FDA is expected to make a final ruling regarding whether to approve or reject the drug in July. The agency typically abides by the recommendations of its advisory panels, but it is not legally required to do so.
Rimonabant blocks the natural binding of endogenous cannabinoids (as well as exogenous cannabinoids such as THC) to the neuronal CB1 receptors, causing users to lose their appetites. However, because the endocannabinoid receptor system is intricately involved in the regulation of a broad range of primary biological functions – including appetite, body temperature, mood regulation, blood pressure, bone density, reproduction, learning capacity, and motor coordination – some experts are concerned that the long-term use of Rimonabant or similar drugs may contribute to a host of significant adverse health effects.
In preclinical trials, newborn mice injected with Rimonabant refuse feeding and often die days after birth. Mice genetically bred to lack the CB1 receptor also suffer from numerous health defects such as cognitive decline, hypoalgesia, decreased locomotor activity, and increased mortality compared to healthy controls.
At least one published case study reports that daily use of the drug may have triggered neurological symptoms of multiple sclerosis in a volunteer with no known history of the disease. Mental health side effects, such as depression, are also commonly reported among volunteers administered Rimonabant. FDA panelists reported that using Rimonabant nearly doubled the users risk of attempting suicide.
The FDA has previously rejected requests by Sanofi-Aventis to approve the drug as a smoking cessation agent.
For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at: paul@norml.org.

New York: State Assembly, Governor Back Medical Marijuana Measure
Albany, NY: Members of New York’s state assembly voted 92-52 on Wednesday in favor of legislation that would authorize qualified patients to use medicinal cannabis under a doctor’s supervision.
If approved, Assembly Bill 4867 would allow authorized patients to possess two-and-a-half ounces of cannabis and/or twelve marijuana plants for therapeutic purposes. A similar measure is expected to be debated by members of the Senate imminently.
Democrat Governor Eliot Spitzer, who had previously campaigned against the use of medical cannabis, announced this week that he has reversed his position.
If enacted, New York will become the thirteenth state since 1996 to legalize the use of medical cannabis, and it will be the second state legislature to do so this year.
Similar legislation was recently approved by the Connecticut legislature and is awaiting action by the governor.
For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at: paul@norml.org. To learn more about pending state legislation, please visit NORML’s Take Action Center at: http://capwiz.com/norml2/issues/?style=D.

Cannabinoids Reduce Skin Inflammation
Bonn, Germany: Cannabinoids significantly reduce skin inflammation and may be ideal topical agents for treating various skin diseases such as eczema, according to preclinical data published in the current issue of the journal Science.
Investigators at the University of Bonn in Germany reported that the topical administration of THC significantly reduced inflammation in mice exposed to various chemical irritants. Researchers also reported that mice lacking endocannabinoid receptors demonstrated exacerbated allergic reactions to skin irritants, whereas mice with elevated levels of endocannabinoids showed a decreased reaction.
"These results demonstrate a protective role of the endocannabinoid system in [treating] contact allergy in the skin and suggest a target for therapeutic intervention," authors concluded.
Because cannabinoids are fat-soluble and are not readily absorbed through the skin, topical cannabis-based ointments lack the psychoactivity of inhaled marijuana or oral THC pills (e.g., Marinol).
Clinical trials performed in Europe demonstrate that the application of a cannabis-based ointment can greatly reduce uremic pruritus (mild to severe itching as a result of kidney disease) and xerosis (abnormal dryness of the skin) in hemodialysis patients.
A separate US study reports that the oral administration of THC can relieve pruritis in patients with liver disease.
Cannabis-based ointments were historically used to treat inflammation up until the early part of the 20th century.
For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at: paul@norml.org. Full text of the study, "Attenuation of allergic contact dermatitis through the endocannabinoid system," appears in the June 2007 issue of Science. Additional information regarding cannabinoids and skin inflammation is available in the NORML report "Emerging Clinical Applications for Cannabis and Cannabinoids," online at: http://www.norml.org/index.cfm?Group_ID=7014.