2/26/17. Medical Marijuana: Current Uses & Controversies. Learning Objectives. History of medical Cannabis

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Medical Marijuana: Current Uses & Controversies Joseph Rosales, MD Hematology &

History of medical Cannabis 6000 BCE Cannabis seeds as food in Ancient China

Controversy/Legalization 3 1350-1800 BCE Egyptians use marijuana to treat sore

1 Medical Marijuana: Current Uses & Controversies Joseph Rosales, MD Hematology & Medical Oncology May 18, Learning Objectives History of medical cannabis History of medical Cannabis 6000 BCE Cannabis seeds as food in Ancient China Basic science/chemistry 4000 BCE Hemp used for textiles Approved medical uses Controversy/Legalization BCE Egyptians use marijuana to treat sore eyes BCE Indians use marijuana for insomnia, headaches, GI complaints and pain 4 1

2 History of medical Cannabis Herodotus ( BCE) Pliny the Elder (77 AD) Dioscorides (40-90 AD) Claudius Galen de Alimentorum Facultatibus Hemp cakes, if eaten in moderation, produce a feeling of wellbeing, but taken in excess they lead to intoxication, dehydration and impotence 5 6 WB O Shaughnessy - Born in Limerick, Ireland in Studied medicine at University of Edinburgh - Helped treat cholera 1829 by using IV fluids and electrolyte repletion - Moved to India 1833 Cannabis indica is probably the most satisfactory remedy for migraines. - Sir William Osler, MD - Bengal Dispensatory and Bengal Pharmacopeia - Introduced medical marijuana to Europe 7 8 2

3 Basic Science & Chemistry of Marijuana 9 10 Indica Sativa Cannabinoids Δ9-THC Psychotropic Analgesic Appetite Stimulant Anxiety & Paranoia CBD Non-psychoactive Calming Anti-inflammatory

4 Brain Muscle GI Tract Pancreas Liver Adipose Tissue T- Cells B-Cels Monocytes Tonsils Spleen

5 17 18 Smoking Approved Medical Uses Vaporization Oral ingestion Oral-mucosal Rectal

21 22 Approved uses for Cannabis in WA MAINE Epilepsy/seizure disorders Glaucoma Multiple Sclerosis Muscle Spasticity Nausea/Vomiting from AIDS/Cancer ILLINOIS Cancer Glaucoma HIV/AIDS Hepatitis C

6 21 22 Approved uses for Cannabis in WA MAINE Epilepsy/seizure disorders Glaucoma Multiple Sclerosis Muscle Spasticity Nausea/Vomiting from AIDS/Cancer ILLINOIS Cancer Glaucoma HIV/AIDS Hepatitis C ALS Crohn Disease Agitation due to Alzheimer s Disease Muscular Dystrophy Severe Fibromyalgia Tarlov Cysts Hydromyelia/Syringomyelia Rheumatoid Arthritis Fibrous Dysplasia Multiple Sclerosis Arnold-Chiari Malformation Parkinson s Disease Tourette s Syndrome Myoclonus/Dystonia RSD/CRPS Neurofibromatosis 23 SYMPTOMS Chronic Pain/Spasticity Nausea/vomiting Anorexia/Weight Loss/Muscle Wasting DISEASES Cancer HIV/AIDS Multiple Sclerosis Glaucoma Crohn s Disease Hepatitis C Chronic Renal Failure on Hemodialysis Post-Traumatic Stress Disorder 6

Chronic and severe pain From: Cannabinoids for Medical Use: A Systematic Review and Meta-analysis 28 studies, n=2454 13 nabiximols, 4 smoked THC, 5 nabilone, 3 THC oromucosal spray, 2 dronabinol, 1

7 Chronic and severe pain From: Cannabinoids for Medical Use: A Systematic Review and Meta-analysis 28 studies, n= nabiximols, 4 smoked THC, 5 nabilone, 3 THC oromucosal spray, 2 dronabinol, 1 oral THC Placebo controlled 3 cancer pain, 3 diabetic neuropathy, 2 fibromyalgia, 2 HIV-associated neuropathy, MS, RA, musculoskeletal RESULTS: Average number of patients who report >30% reduction in pain was greater with cannabinoids than placebo (OR 1.41, CI ) JAMA. 2015;313(24): doi: /jama Figure Legend: Improvement in PainOdds indicate 30% or greater improvement in pain with cannabinoid compared with placebo, stratified according to cannabinoid. The square data markers indicate odds ratios (ORs) from primary studies, with sizes reflecting the statistical weight of the study using random-effects meta-analysis. The horizontal lines indicate 95% CIs. The blue diamond data markers represent the subtotal and overall OR and 95% CI. The vertical dashed line shows the summary effect estimate, the dotted shows the line of no effect (OR = 1). Copyright 2015 American Medical Association. 25 Date of download: 7/23/2015 All rights reserved. Nausea/vomiting 28 studies, n= Nabilone, 3 dronabinol,1 nabiximol, 4 levonantradol, 6 THC 8 vs placebo, 20 vs active comparator (prochlorperazine, chlorpromazine, metoclopramide, ondansetron) RESULTS: Higher incidence of complete response with cannabinoids than placebo RESULTS: Similar efficacy to prochlorperzine, chlorpromazine, metoclopramide

8 Spasticity (MS or Paraplegia) From: Cannabinoids for Medical Use: A Systematic Review and Meta-analysis 14 studies, n= nabiximols, 3 dronabinol, 1 nabilone, 4 THC/CBD, 1 smoked THC All placebo-controlled; none with comparator RESULTS: Non-statistically significant improvement in spasticity in favor of cannabinoids Ashworth scale for spasticity improvement greater for cannabinoids vs placebo JAMA. 2015;313(24): doi: /jama Figure Legend: Change in Ashworth Score for Cannabinoid Compared With Placebo, Stratified According to CannabinoidThe square data markers indicate mean differences from primary studies, with sizes reflecting the statistical weight of the study using random-effects metaanalysis. The horizontal line indicate, 95% CIs. The blue diamond data markers represent the subtotal and overall weighted mean difference and 95% CI. The vertical dashed line shows the summary effect estimate, the solid vertical line shows the line of no effect (mean difference = 0). Copyright 2015 American Medical Association. 29 Date of download: 7/23/2015 All rights reserved. Appetite Glaucoma 4 studies, n=255 (HIV/AIDS) Dronabinol 3 with placebo, 1 with megestrol acetate Dronabinol showed trend towards increased appetite/weight gain vs placebo Megestrol showed greater weight gain than dronabinol Clinical trial in Anorexia Nervosa (Andries, et. al, 2014) Dronabinol 5mg/day resulted in 0.73kg increase in 4 weeks Historical/Observational Decreased intraocular pressure Duration: 4 hours 1 study, n=6 TCH, CBD (oral & mucosal) No difference in IOP Concerns: THC can lower BP/IOP

$Crohn s Disease Post-Traumatic Stress Disorder N=21, refractory to - steroids - immune therapy - anti-tnf Placebo High-THC Cannabis Cigarettes Partial Response 4/10 40% 10/11 90% Complete Response$

9 Crohn s Disease Post-Traumatic Stress Disorder N=21, refractory to - steroids - immune therapy - anti-tnf Placebo High-THC Cannabis Cigarettes Partial Response 4/10 40% 10/11 90% Complete Response 1/10 10% 5/11 45% Naftali, et. al., J. Clin. Gastro. Hepatol., patients weaned from steroid dependency 33 No randomized clinical trial Observational study of 80 patients shows improvement of PTSD symptoms with marijuana (Greer, 2009) Observational study of 2276 patients shows higher symptom rates in marijuana users (Wilkinson, et. al, 2014) Study shows CBD decreases anxiety in those with and without anxiety disorder (Crippa, et. al., 2009) CBD shown to decrease symptoms of social anxiety disorder (Bergamaschi, et. al., 2011) 34 Unallowed Diagnoses (in WA) Tourette s Syndrome ADHD/OCD Alzheimer s Disease Neuropathic Pain Mania/Depression

10 Acute Cannabis Poisoning Cannabinoid Hyperemesis Syndrome Natural Cannabis Anxiety/Psychosis Sedation Hallucination Memory deficits Acute psychosis Scleral Injection Tachycardia/Tachypnea Hypertension Tremors Synthetic Cannabinoids Hypokalemia Nausea/Vomiting Seizures Agitation Violent Behavior Coma 37 First mentioned patients with cyclic nausea/vomiting associated with THC - 7/9 improved with cessation of THC Several case studies over the last 10 years case study case series case study 38 Legal Status Schedule I Marijuana (cannabis) Heroin LSD Ecstasy Methoqualone Peyote Schedule II Cocaine Methamphetamine Opioids Adderall/Ritalin Dexedrine

41 42 The prosecution of significant traffickers of illegal drugs, including marijuana continue to be a core priority in the Department s efforts against narcotics and dangerous drugs.

11 41 42 The prosecution of significant traffickers of illegal drugs, including marijuana continue to be a core priority in the Department s efforts against narcotics and dangerous drugs. prosecution of individuals with cancer or other serious illnesses who use marijuana as part of a recommended treatment regimen or those caregivers in clear and unambiguous compliance with existing state law who provide such individuals with marijuana, is unlikely to be an efficient use of limited federal resources

The Ogden memo was never meant to shield such activities from federal enforcement and prosecution, even when those activities purport to comply with state law.

PROHIBITS: Sales to minors Sales to criminal enterprises, gangs, cartels Diversion to other states where marijuana is illegal Used as a cover for trafficking other illegal drugs Violence/firearms in

12 The Ogden memo was never meant to shield such activities from federal enforcement and prosecution, even when those activities purport to comply with state law. Persons who are in the business of cultivating, selling or distributing marijuana, and those who knowingly facilitate such activities, are in violation of the controlled substances act. PROHIBITS: Sales to minors Sales to criminal enterprises, gangs, cartels Diversion to other states where marijuana is illegal Used as a cover for trafficking other illegal drugs Violence/firearms in cultivation of marijuana Drugged driving Marijuana growth on public/federal property If state enforcement efforts are not sufficiently robust to protect against the harms set forth the federal government may seek to challenge the regulatory structure itself in addition to continuing to bring individual enforcement actions, including criminal prosecution, focused on those harms

49 50 Practical considerations Establish patient/physician relationship Identify indication for medical marijuana We (the DEA) support research on marijuana and its components that complies with

13 49 50 Practical considerations Establish patient/physician relationship Identify indication for medical marijuana We (the DEA) support research on marijuana and its components that complies with applicable laws and regulations to advance our understanding about the health risks and potential therapeutic benefits of medications using marijuana or its components or derivatives. Document attempts at other medications Fill out certificate for medical marijuana 51 Document patient s use and results 52 13

Washington State DOH SB 5052 Defines medical vs recreational marijuana Medical Endorsement Consultant Certificate Patient Authorization Database Larger amounts No sales tax Arrest protection for

effects. Cannabis is currently a schedule I drug according to the US Government, which means it has a high potential for abuse and no acceptable medical use.

14 Washington State DOH SB 5052 Defines medical vs recreational marijuana Medical Endorsement Consultant Certificate Patient Authorization Database Larger amounts No sales tax Arrest protection for patient/surrogate Review Cannabis contains >70 cannabinoids, the most abundant of which are THC and CBD, which activate receptors along the endocannabinoid pathway, resulting in its varied effects. Cannabis is currently a schedule I drug according to the US Government, which means it has a high potential for abuse and no acceptable medical use. Studies have shown benefit of cannabis in several specific indications, including nausea/vomiting, chronic pain, spasticity/seizures and anorexia Review Medical cannabis is legal in 24 states and Guam and Washington DC, though indications vary. Difficulties lie in standardization of THC/CBD content, with much available product being inaccurately labeled. Physician recommendations for cannabis must follow strict guidelines for documentation, with a standardized authorization form. Governmental policy appears headed in the direction of leniency with regards to cannabis use

15 Thank You

Medical Marijuana Martin P. Eason MD, JD Associate Chief of Staff for Education Mountain Home VA Medical Center. Disclosure.

Medical Marijuana Martin P. Eason MD, JD Associate Chief of Staff for Education Mountain Home VA Medical Center Controversies in Pain Management Conference Johnson City, TN November 13, 2015 Disclosure