Comments submitted to the New Jersey
Department of Health and Senior Services
RE: The agency's proposed regulations for the
New Jersey Medicinal Marijuana Program
Director, Office of Legal and Regulatory Affairs, Office of the Commissioner
NJ Department of Health and Senior Services
P O Box 360
Trenton, NJ 08625-0360
My name is Paul Armentano and I am the Deputy Director of NORML, the National Organization for the Reform of Marijuana Laws. I am writing to voice my opposition to several provisions of the nascent New Jersey Medicinal Marijuana Program.
Professionally, I have examined the science surrounding the medicinal use of marijuana and its components since 1995, publishing more than 500 articles and white papers on the subject and authoring the book: Emerging Clinical Applications for Cannabis & Cannabinoids – A Review of the Recent Scientific Literature. I have also served as a consultant for British biotechnology firm GW Pharmaceuticals -- the only company legally licensed in the world to cultivate medical cannabis and perform clinical trials on various preparations of oral spray cannabis extracts. These extracts are legally available by prescription in Canada, the United Kingdom, New Zealand under the trade name Sativex, and are pending approval in Spain, France, Germany, and Italy.
I am concerned with several specific provisions of the Department's draft regulations:
- Patients suffering from chronic neuropathy will be denied legal access to medical cannabis.
Neuropathic pain is produced by damage to the central or peripheral nervous system. An estimated five to ten percent of the population suffers from chronic neuropathy, and few of these patients respond favorably to conventional analgesic medications. Several recently published randomized, double-blind, placebo-controlled trials conclude that inhaled cannabis is safe and effective at relieving this and similar painful conditions. These include:
Ware et al., 2010. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ.
Wilsey et al. 2008. A randomized, placebo-controlled crossover trial of cannabis cigarettes in neuropathic pain. Phytotherapy Research.
Ellis et al. 2008. Smoked medicinal cannabis for neurpathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology.
Abrams et al., 2007. Cannabis in painful HIV-associated sensory neuropathy: a randomized, placebo-controlled trial. Neurology.
Wallace et al., 2007. Dose-dependent effects of smoked cannabis on capsaicin-induced pain and hyperalgesia in healthy volunteers. Anesthesiology.
Placebo-controlled clinical crossover trials are considered to be the 'gold standard' method for assessing the efficacy of drugs under the US FDA-approval process. In light of the findings of these ‘gold standard' studies, it is arbitrary and capricious for New Jersey's Medicinal Marijuana Program to exclude this patient population from a therapy that is well established to alleviate their suffering.
- The proposed rules would arbitrarily limit the number of legally available medical marijuana strains to no more than three distinct varieties.
The efficacy of cannabis as a medicine is derived from its various active therapeutic components, known as cannabinoids. Different strains of marijuana vary in their therapeutic prowess based on the percentages of distinct cannabinoids, such as THC, CBD (cannabidiol), CBC (cannabichromine), THCA, THCV, and CBG (cannabigerol). A recent review by Izzo and colleagues (Non-psychotropic plant cannabinoids: new therapeutic opportunities from an ancient herb. Trends in pharmacological sciences. 2009) identifies an estimated thirty distinct therapeutic properties associated with non-THC cannabinoids. These include: neuroprotective properties, anticancer properties, antidiabtic properties, anti-inflammatory properties, bone stimulant properties, antiepileptic properties, and antibacterial properties. By arbitrarily limiting the strains of cannabis available to patients, DHSS is unduly limiting patients access to many of these therapeutic compounds.
- The proposed rules would arbitrarily limit the production of medicinal cannabis to no more than two providers; it would further limit the distribution of medicinal cannabis to no more than four dispensary facilities.
Finally, it is burdensome and unnecessary to limit patients' access to medicinal cannabis to a total of two providers and four distributors. Marijuana does not possess objective risks to the consumers that warrant such unduly restrictions. As stated in 1988 by no less than the DEA's own administrative law judge, "Marijuana, in its natural form, is one of the safest therapeutically active substances known to man." The plant's compounds are virtually non-toxic to healthy cells and organs, do not depress the central nervous system, and are incapable of causing a fatal overdose. In fact, a 2008 meta-analysis published in the Journal of the Canadian Medical Association (Degenhardt et al. The adverse effects of cannabinoids: implications for use of medical marijuana) reported that cannabis-based drugs were associated with virtually no elevated incidences of serious adverse side effects in over 30 years of investigative use. To place this finding in proper perspective, consider this: taking just a small amount of acetaminophen (Tylenol) over the recommended total daily dose has been conclusively shown to cause liver damage and death. It is arbitrary and unnecessary for DHSS to propose impose restrictions regarding the use of medical marijuana that are more stringent than the regulations already in place governing the distribution and use of other doctor recommended medications, and that violate the legislative intent of the Compassionate Medical Marijuana Act.
For these reasons I recommend DHSS to review and revise these proposed regulations.
NORML | NORML Foundation