Cannabis and the Treatment of Neuropathic Pain



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Cannabis and the Treatment of Neuropathic Pain

  • Barth Wilsey MD
  • VANCHCS Pain Clinic
  • Department of Physical Medicine and Rehabilitation
  • UC Davis Medical Center

Disclosure

  • I have no relevant financial interest/arrangement or affiliation with any organizations related to commercial products or services to be discussed at this program

Educational Objectives

  • To describe the history of medical marijuana in the US from the 19th Century to present day
  • To recognize partial legalization versus full legalization of marijuana
  • To understand the contributions of the UC Center for Medicinal Cannabis Research (CMCR)
  • To discuss opportunities for research

Listed in U.S Pharmacopeia 1850-1941

  • Listed in U.S Pharmacopeia 1850-1941
    • marijuana & hashish extracts were the 1st, 2nd, or 3rd most prescribed meds in the US from 1842-1890s

neuralgia

  • neuralgia
  • gout
  • rheumatism
  • tetanus
  • hydrophobia
  • epidemic cholera
  • convulsions
  • chorea
  • hysteria
  • mental depression
  • delirium tremens
  • insanity
  • uterine hemorrhage

Prohibition 1937

California's Proposition 215 1996

  • First statewide medical marijuana ballot initiative to pass in the USA
    • allow possession and cultivation of cannabis for ‘debilitating’ medical conditions if recommended by a physician
      • provide a defense against prosecution under state criminal laws

Who are medical marijuana patients?

  • patient survey
    • pain, insomnia, and anxiety
      • Reinarman C, Nunberg H, Lanthier F, Heddleston T. Who are medical marijuana patients? Population characteristics from nine California assessment clinics. J Psychoactive Drugs. 2011;43:128-135
  • physician survey
    • 94% of patients receiving medical marijuana have chronic pain, and 17% have muscle spasms
      • Kondrad E, Reid A. Colorado family physicians' attitudes toward medical marijuana. J Am Board Fam Med. 2013;26:52-60.

Legal Marijuana, Coming to a Vending Machine Near You

Colorado

    • requires the legislature to address
      • product labeling
      • security requirements for wholesale and retail marijuana establishments
      • workplace drug policies
      • marijuana impairment while driving
      • integrating the existing medical marijuana system into the new commercial market
      • 15 percent excise tax on wholesale marijuana sales

Washington

  • State Liquor Control Board given the assignment for devising a system
      • licensing
      • regulating
      • taxing marijuana growers, processors and retail stores

US Attorney General Response

  • Prevent:
    • distribution of cannabis to minors
    • revenue from going to criminal enterprises, gangs, and cartels
    • diversion of cannabis from states where it is legal under state law to other states
    • use as a cover or pretext for the trafficking of other illegal drugs or other illegal activity
    • violence and the use of firearms in the cultivation and distribution of cannabis
    • drugged driving and the exacerbation of other adverse public health consequences associated with cannabis use
    • growing of cannabis on public lands
    • cannabis possession or use on federal property
  • Cole, J. Guidance Regarding Cannabis Enforcement August 29, 2013, Deputy Attorney General.
  • http://www.justice.gov/iso/opa/resources/3052013829132756857467.pdf

Educational Objectives

  • To describe the history of medical marijuana in the US from the 19th Century to present day
  • To recognize partial legalization versus full legalization of marijuana
  • To understand the contributions of the UC Center for Medicinal Cannabis Research (CMCR)
  • To discuss opportunities for research

Full vs Partial Legalization

  • full legalization has the potential to substitute underground economies with legitimate businesses
      • pharmaceutical companies
      • agribusiness

Full vs Partial Legalization

  • alternatives to full legalization
      • in the Netherlands, the use and sale of small quantities is permitted while production and wholesale distribution is banned
      • penalties for possession of small amounts of marijuana could be reduced and treated as civil rather than a criminal matter (so-called “decriminalization”)
      • production, sale, and use could be permitted but only for medical purposes

Medical Marijuana Laws Get Tougher

Illinois Proposed Medical Marijuana Bill

  • cancer; glaucoma; HIV/AIDS; hepatitis C; amyotrophic lateral sclerosis (ALS); Crohn's disease; agitation of Alzheimer's disease; cachexia/wasting syndrome; muscular dystrophy; severe fibromyalgia; spinal cord disease, including but not limited to arachnoiditis; Tarlov cysts; hydromyelia; syringomyelia; spinal cord injury; traumatic brain injury and post-concussion syndrome; multiple sclerosis; Arnold Chiari malformation and Syringomyelia; Spinocerebellar Ataxia (SCA); Parkinson’s disease; Tourette’s syndrome; Myoclonus; Dystonia; Reflex Sympathetic Dystrophy (RSD); Causalgia; Neurofibromatosis; Chronic Inflammatory Demyelinating Polyneuropathy; Sjogren’s syndrome; Lupus; Interstitial Cystitis; Myasthenia Gravis; Hydrocephalus; nail patella syndrome; or the treatment of these conditions

Educational Objectives

  • To describe the history of medical marijuana in the US from the 19th Century to present day
  • To recognize partial legalization versus full legalization of marijuana
  • To understand the contributions of the UC Center for Medicinal Cannabis Research (CMCR)
  • To discuss opportunities for research

California State Legislature Medical Marijuana Research Act SB847 Senator John Vasconcellos 1999

Approval Process 1997 NIH Workshop

  • Department of Health and Human Services (HHS)
  • DEA
    • Schedule I License
  • FDA
    • Investigational New Drug Application
  • NIDA
    • supplies marijuana grown at University of Mississippi
  • Research Advisory Panel of California

CMCR Neuropathic Pain Studies

  • results have been convergent
    • five studies demonstrated a significant decrease in pain after cannabis administration
      • the magnitude of effect in these studies, expressed as the number of patients needed to treat to produce one positive outcome, was comparable to current therapies

Educational Objectives

  • To describe the history of medical marijuana in the US from the 19th Century to present day
  • To recognize partial legalization versus full legalization of marijuana
  • To understand the contributions of the UC Center for Medicinal Cannabis Research (CMCR)
  • To discuss opportunities for research

Limited Scientific Studies

  • As the legal landscape evolves, the medical one remains confusing
    • fewer than 20 randomized, controlled clinical trials of smoked marijuana for all possible uses
      • these involved around relatively few people in all—well short of the evidence typically required for a pharmaceutical to be marketed in the U.S.

Federal Restrictions on Cannabis Research

  • Schedule I Controlled Substance
      • high potential for abuse
      • no currently accepted medical use in treatment
      • lack of accepted safety under medical supervision
      • use and possession is a federal offense

National Institute of Drug Abuse (NIDA) Supplies Research-grade Cannabis

      • NIDA does not stock purified (a.k.a., Good Manufacturing Practice grade) Δ9-THC or CBD in their drug supply inventory for use in clinical trials
        • not the case with other Schedule I drugs like heroin, LSD, and MDMA
          • which are provided legally by “private U.S laboratories” or easily imported from abroad with federal permission, making marijuana the only Schedule I drug with a single federal provider

Call for Additional Studies

  • 1997: National Institutes of Health
    • Workshop on the Medical Utility of Marijuana
  • 1999: Institute of Medicine
    • Marijuana and Medicine: Assessing the Science Base

Call for Additional Studies

  • American College of Physicians
    • 2008 Position Paper: Supporting Research Into The Therapeutic Role Of Marijuana
      • trod a middle ground between praising and demonizing cannabis
        • stating it is “neither devoid of potentially harmful effects nor universally effective”
        • called for “sound scientific study” and “dispassionate scientific analysis” to find the appropriate balance

The Medical Letter Volume 52 (Issue 1330) January 25, 2010

  • medical marijuana may be effective for treatment of nausea, anorexia, pain and some other conditions
    • but published data supporting its efficacy for treating patients with intractable cancer pain are limited
    • dosage is not well standardized
    • cannabis is often poorly tolerated, especially by older patients

The Harvard Mental Health Letter Volume 26 Number 10 April 2010

  • more is known about the psychiatric risks than the benefits
    • there is not enough evidence to recommend medical marijuana as a treatment for any psychiatric disorder
    • the psychiatric risks are well documented, and include addiction, anxiety, and psychosis

Call for Additional Studies

  • American Medical Association
    • 2009 House of Delegates Report
      • supported review of marijuana's Schedule I status
        • urged an evidence-based review of marijuana's status as a Schedule I controlled substance to determine whether it should be reclassified to a different schedule
        • NIH support of clinical studies on the utility of medical marijuana

NIH Sponsored Studies

  • THC / Dronabinol / Marinol Efficacy Trial of Oral Tetrahydrocannabinol in Patients With Fibromyalgia at Hadassah Medical Organization, Jerusalem, Israel Nabilone / Cesamet Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis at University of Manitoba, Winnipeg, Canada Nabiximols / Sativex A Study of Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer in the United States, the UK and Germany  

NIH Sponsored Studies

  • Cannabidiol (CBD) Cannabidiol for Inflammatory Bowel Disease at Meir Medical Center, Kefar Saba, Israel Smoked / Inhaled Cannabis Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS at New York State Psychiatric Institute, USA.
  • Effects of Vaporized Marijuana on Neuropathic Pain in Spinal Cord Injury at CTSC Clinical Research Center, Sacramento, United States.  

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