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Chronic Cannabis

Chronic Cannabis

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Published by: James on Jan 03, 2010
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Chronic Cannabis Usein the Compassionate InvestigationalNew Drug Program:An Examination of Benefitsand Adverse Effectsof Legal Clinical Cannabis
Ethan RussoMary Lynn MathreAl ByrneRobert VelinPaul J. BachJuan Sanchez-RamosKristin A. Kirlin
ABSTRACT.
The Missoula Chronic Clinical Cannabis Use Study wasproposed to investigate the therapeutic bepnefits and adverse effects of prolonged use of “medical marijuana” in a cohort of seriously ill pa-tients. Use of cannabis was approved through the Compassionate Inves-tigational New Drug (IND) program of the Food and Drug Administra-tion (FDA). Cannabis is obtained from the National Institute on Drug
Ethan Russo, Robert Velin, and Paul J. Bach are affiliated with Montana Neuro-behavioral Specialists, 900 North Orange Street, Missoula, MT 59802 USA (E-mail:erusso@blackfoot.net).MaryLynnMathreandAlByrneareaffiliatedwithPatientsOutofTime,1472FishPond Road, Howardsville, VA 24562 USA (E-mail: Patients@medicalcannabis.com).Juan Sanchez-Ramos is affiliated with the Department of Neurology, University of South Florida, Tampa, USA.Kristin A. Kirlin is affiliated with the Department of Psychology, University of Montana, Missoula, MT 59812.Address correspondence to: Ethan Russo at the above address.Journal of Cannabis Therapeutics, Vol. 2(1) 2002
2002 by The Haworth Press, Inc. All rights reserved.
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Abuse (NIDA), and is utilized under the supervision of a study physi-cian. The aim of this study is to examine the overall health status of 4 of the7survivingpatientsintheprogram.Thisprojectprovidesthefirstop-portunity to scrutinize the long-term effects of cannabis on patients whohaveusedaknowndosageofastandardized,heat-sterilizedquality-con-trolled supply of low-grade marijuana for 11 to 27 years.Results demonstrate clinical effectiveness in these patients in treatingglaucoma,chronicmusculoskeletalpain,spasmandnausea,andspasticityof multiple sclerosis. All 4 patients are stable with respect to theirchronic conditions, and are taking many fewer standard pharmaceuticalsthan previously.Mild changes in pulmonary function were observed in 2 patients,while no functionally significant attributable sequelae were noted in anyother physiological system examined in the study, which included: MRIscans of the brain, pulmonary function tests, chest X-ray, neuropsy-chological tests, hormone and immunological assays, electroencepha-lography, P300 testing, history, and neurological clinical examination.These results would support the provision of clinical cannabis to agreater number of patients in need. We believe that cannabis can be asafe and effective medicine with various suggested improvements in theexisting Compassionate IND program.
[Article copies available for a fee from The Haworth Document Delivery Service: 1-800-HAWORTH. E-mail ad-dress:<getinfo@haworthpressinc.com>Website:<http://www.HaworthPress.com>
2002 by The Haworth Press, Inc. All rights reserved.]
KEYWORDS.
Cannabis, medical marijuana, hashish, investigationalnew drug, compassionate use, NIDA, FDA, herbal medicine, analgesia,spasticity, chronic pain, glaucoma, multiple sclerosis, epidemiology,history of medicine, drug policy
 INTRODUCTION 
The Missoula Chronic Clinical Cannabis Use Study was proposed toinvestigatethetherapeuticbenefitsandadverseeffectsofprolongeduseof “medical marijuana” in a cohort of seriously ill patients approvedthrough the Compassionate Investigational New Drug (IND) programof the Food and Drug Administration (FDA) for legal use of cannabisobtained from the National Institute on Drug Abuse (NIDA), under thesupervision of a study physician. The aim was to examine the overallhealth status of 8 surviving patients in the program. Four patients wereabletotakepart,whilethreewishedtoremainanonymous,andonewas
4 JOURNAL OF CANNABIS THERAPEUTICS
 
too ill to participate. Unfortunately, that person, Robert Randall, suc-cumbed to his condition during the course of the study. Thus, 7 surviv-ing patients in the USA remain in the Compassionate IND program.Despitetheobviousopportunitytogeneratedataontheuseofcanna-bis and its possible sequelae in these patients, neither NIDA, otherbranchesoftheNationalInstitutesofHealth,northeFDAhaspublishedan analysis of information from this cohort. An examination of the con-tents of the National Library of Medicine Database (PubMed), andsearch engines of NIDA employing multiple combinations of keywords failed to retrieve a single citation. The Missoula Chronic Canna-bisUseStudythusprovidesauniqueandimportantopportunitytoscru-tinize the long-term effects of cannabis on patients who have used aknown dosage of standardized, heat-sterilized quality-controlled sup-ply of low-grade medical marijuana for 11 to 27 years.Theresultsarecomparedtothoseofpastchronicusestudiesinanef-fort to gain insight into the benefits and sequelae of this controversialagent in modern health care.
 PREVIOUS CHRONIC CANNABIS USE STUDIES
The first systematic modern study of chronic cannabis usage was the
 Indian Hemp Drugs Commission Report 
at the end of the 19th century(Kaplan 1969; Indian Hemp Drugs Commission 1894). The Britishgovernment chose not to outlaw cultivation and commerce of the herbafterascertainingthatithadnegligibleadverseeffectsonhealth,eveninchronic application.Similar conclusions were obtained in the “LaGuardia Report” of 1944 (New York, NY), Mayor’s committee on marihuana (Wallace,and Cunningham 1944), which was the first to employ clinical and sci-entific methods of analysis.Three important systematic epidemiological studies undertaken byresearch teams in the 1970’s exhaustively examined medical issues inchronic cannabis use, but remain obscure due to limited press runs andout-of-print status. The first of these was
Ganja in Jamaica: A Medical Anthropological Study of Chronic Marihuana Use
(Rubin and Comitas1975). Therapeutic claims for cannabis were mentioned, but the focusofstudywason“recreationaluse.Sixtymenwereincludedinahospitalstudy of various clinical parameters if they had maintained a minimumintake of 3 spliffs a day for a minimum of 10 years. Jamaican ganja“spliffs” formed of unfertilized female flowering tops (sinsemilla) tend
 Russo et al. 5

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