Virtual Lectures Planning Committee Disclosure Summary

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1 VIRTUAL LECTURES THE ROLL OF MEDICAL CANNABIS: IS IT TIME TO BURN ONE DOWN? MFMER Virtual Lectures Planning Committee Disclosure Summary As a provider accredited by ACCME, College of Medicine, Mayo Clinic (Mayo School of CPD) must ensure balance, independence, objectivity and scientific rigor in its educational activities. Course Director(s), Planning Committee Members, Faculty, and all others who are in a position to control the content of this educational activity are required to disclose all relevant financial relationships with any commercial interest related to the subject matter of the educational activity. Safeguards against commercial bias have been put in place. Faculty also will disclose any off label and/or investigational use of pharmaceuticals or instruments discussed in their presentation. Disclosure of these relevant financial relationships will be published in activity materials so those participants in the activity may formulate their own judgments regarding the presentation. Relevant financial relationship(s) with industry: None References to off-label and/or investigational usage(s) of pharmaceuticals or instruments in their presentation: None Listed below are individuals with control of the content of this program who have disclosed: Program Speaker Thomas Pittelkow, D.O., M.P.H. Program Planning Committee Curtis Hanson, M.D. Bobbi Pritt, M.D., MSc, DTMH Sharon Preuss Melissa Peterson MFMER

2 Thomas Pittelkow, D.O., M.P.H. Senior Associate Consultant, Pain Clinic Department of Anesthesiology-Pain Medicine Mayo Clinic Rochester, Minnesota MFMER The roll of medical cannabis: Is it time to burn one down? Thomas P. Pittelkow, D.O., M.P.H. Division of Pain Medicine Department of Anesthesiology and Perioperative Medicine October 4, MFMER slide-4

3 Disclosures Relevant Financial Relationship(s) None Off Label Usage Medical cannabis is not FDA-approved Products produced by: Minnesota Medical Solutions Leafline Labs 2016 MFMER slide MFMER slide-6

4 2016 MFMER slide-7 Learning Objectives Identify the key cannabinoids, receptors, and basic physiology of medical cannabis Specify conditions where use of medical cannabis is potentially indicated Articulate role of medical cannabis in pain treatment algorithm 2016 MFMER slide-8

5 Medical Potential Over 20,000 published articles on cannabinoids Evidence for symptom relief Nausea and vomiting chemotherapy Pain neuropathic/central Muscle spams - MS Spasticity - MS Cachexia HIV/AIDS Mental health anxiety, PTSD, etc. Significant potential role in chronic pain and multiple chronic health conditions 2016 MFMER slide-9 Framework History Physiology Rx Cannabinoids Minnesota Registry Indications Pain Spasticity Considerations Summary 2016 MFMER slide-10

6 Case 35 year-old Female, MN resident Hormone receptor positive, HER-2 negative, metastatic breast carcinoma Metastases to the liver, lung and bone Multiple symptoms Cancer-associated pain, mixed-type Nausea Anorexia Insomnia Fatigue 2016 MFMER slide-11 Reflection Would you certify this patient? 2016 MFMER slide-12

7 2016 MFMER slide-13 Patient perspectives Social media Traditional medication side effects Stigma of strong medicine Fears dependence, addiction Mistrust Natural medicine Alleviate suffering Hope 2016 MFMER slide-14

8 Physician considerations Adequate current medication regimen? Expert for complex symptom management? Pharmacotherapy interactions? Psychosocial and financial domains? Prior substance abuse/dependence? Routine follow-up? 2016 MFMER slide MFMER slide-16

9 History of Cannabis and Opioids Early use in China 3000 B.C. O Shaughnessy - Testing in disease; Therapeutic potential 1800 s 1900 s 1937 Marihuana Tax Act 1940 Synthetic form devised THC identified psychoactive component 1964 Controlled Substances Act 1970 CA 1 st state to legalize medical cannabis 1996 CO and WA 1 st state to legalize recreational cannabis B.C. Reference to opium elixir 1500 s Opium elixir for analgesia 1804 Opium extracted from poppy 1817 Morphine marketed in Germany 1900 s Synthetic morphine equivalents devised 1914 Harrison Act - Prohibited Rx of opiates to addicts 1970 Opioid receptors discovered 1975 Endogenous opioids - endorphins 1990s Increase in opioid prescriptions 1999 Rise of opioidrelated deaths 2016 MFMER slide-17 Anatomy of a Cannabis Plant 2016 MFMER slide-18

10 What makes those buds so special? Nearly 500 natural compounds in the Cannabis sativa plant Over 70 cannabinoids Delta-9-tetrahydrocannabinol (THC) Psychoactive component Euphoria, hallucinations, tachycardia, anxiety Cannabidiol (CBD) Analgesia Neuroprotective Anti-inflammatory Anandamide Endogenous cannabinoid Glutamatergic and GABA-ergic Pain, muscle tone, emotion 2016 MFMER slide-19 The Endocannabinoid System CB1 receptor (THC) CB2 receptor (CBN) ecb = endocannabinoid; produced by the body CBD - Cannabidiol Inhibits the breakdown of anandamide (FAAH) Microglial cell activation 2016 MFMER slide-20

11 The Endocannabinoid System CB1 receptor (THC) Primarily in brain, spinal cord, peripheral nerves, GI and reproductive tract CB2 receptor (CBN) Highly expressed in immune tissues Regulate cytokine release? Role in pain 2016 MFMER slide-21 Microenvironment Direct inhibitor: ACh, DA, Glut Indirect effect: GABA, NMDA, μ, 5-HT 2016 MFMER slide-22

12 Fountain of Youth Trends Pharmacol Sci Oct;30(10): MFMER slide MFMER slide-24

13 Cannabis derived products Dronabinol (Marinol ) Nabilone (Cesamet ) Nabiximols (Sativex ) Cannador Epidiolex 2016 MFMER slide-25 Dronabinol (Marinol ) Synthetic THC (no CBD) Oral capsule Schedule III Controlled Substance FDA approved indications: Treatment of anorexia associated with weight loss in patients with AIDS Treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments 2016 MFMER slide-26

14 Nabilone (Cesamet ) Synthetic analogue of THC Oral capsule Schedule II Controlled Substance FDA approved indication: Treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional therapy 2016 MFMER slide-27 Nabiximols (Sativex ) Oromucosal spray Not available in the USA Whole plant extract (phytocannabinoid) 1:1 ratio of THC:CBD 100 microliter spray (2.7mg THC, 2.5mg CBD) Approved for pain treatment in >24 countries Phase 3 clinical trials in US 2016 MFMER slide-28

15 Cannador THC:CBD combination (~2:1 ratio) Oral capsule Phytocannabinoid Prominent psychoactive side effects Not available in the USA 2016 MFMER slide-29 Epidiolex Liquid formulation of pure plant-derived cannabidiol (CBD), no THC Treatment of pediatric epilepsy syndromes Dravet, Lennox-Gastaut, Infantile Spasms Phase 3 clinical trials 2016 MFMER slide-30

16 The Reviews Cannabinoids for Medical Use: A Systematic Review and Meta-analysis JAMA. 2015;313(24): Medical Marijuana for Treatment of Chronic Pain and Other Medical and Psychiatric Problems: A Clinical Review JAMA. 2015;313(24): The Effects of Cannabis Among Adults With Chronic Pain and an Overview of General Harms: A Systematic Review Ann Intern Med. 2017;167: The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research The National Academies Press, MFMER slide-31 The Evidence of Cannabinoid Efficacy Conclusive quality evidence Chronic pain (neuropathic) Spasticity (MS) Nausea, chemotherapy-induced Moderate quality evidence Improved short-term sleep outcomes Limited quality evidence Weight gain in serious illness (HIV, Cancer) Improved symptoms of anxiety or PTSD JAMA. 2015;313(24): JAMA. 2015;313(24): Ann Intern Med. 2017;167: The Health Effects of Cannabis and Cannabinoids. National Academies Press MFMER slide-32

17 2016 MFMER slide-33 Current Cannabis State Laws 2016 MFMER slide-34

18 Minnesota Medical Cannabis Program 2016 MFMER slide-35 Minnesota 11 Qualifying Conditions Cancer associated with severe/chronic pain, nausea or severe vomiting, or cachexia or severe wasting Glaucoma HIV/AIDS Tourette s Use Syndrome of medical cannabis products is experimental Amyotrophic Lateral Sclerosis (ALS) Seizures, including those characteristic of epilepsy Severe and persistent muscle spasms, including those characteristic of Multiple Sclerosis Crohn s Disease Terminal illness, with a life expectancy of less than one year, if the illness or treatment produces severe/chronic pain, nausea or severe vomiting, cachexia or severe wasting Intractable pain Post-Traumatic Stress Disorder 2016 MFMER slide-36

19 Minnesota Certification Physicians, physician s assistants, and advanced practice registered nurses MDH will not maintain or publish a list of practitioners who certify Practitioners do not have to participate in certifying patients Practitioners will not determining strength of medical cannabis Practitioners must have registry account 2016 MFMER slide-37 Minnesota - No Prescription Needed Federal policy dictates that physician who prescribes marijuana or other Schedule I drugs to a patient may be stripped of his or her federal license to prescribe drugs and prosecuted Recommend or certify 2016 MFMER slide-38

20 Minnesota - Medical Cannabis Industry 2016 MFMER slide-39 Minnesota Dispensary Pharmacist works with patient to determine an appropriate cannabis dose Disease Symptoms Tolerable side-effects MN 2 nd state to use pharmacists to dispense No guidelines for pharmacists to dose different medical conditions Based on genetic strain THC:CBD 2016 MFMER slide-40

21 Minnesota Methods of Delivery Edibles capsules, solutions, tinctures Topicals balm, bars, patches Vaporization prefilled cartridge, oil Start low, go slow 2016 MFMER slide-41 Mayo Clinic Policy Establish a medical relationship Full assessment of the patient's medical history and current medical condition Disclose experimental nature of therapeutic use of medical cannabis; risk, benefits, and side effects; Tennessen warning Patient will have regular follow-up for qualifying health condition with certifier 2016 MFMER slide-42

22 2016 MFMER slide MFMER slide-44

23 Organizational support IOM, AMA, ACP, ASAM Support more research Develop of safe and reliable delivery systems Reclassification of Class I status Apply established research standards 2016 MFMER slide-45 Pills, joints, and the Volcano Many ways for ingestion Different mediums = different [THC] Flowers/buds 2-10% Hash 30% Shatter 80% Bioavailability large first pass effect PO 10-20% Inhalation 30-50% THC metabolized by CYP2C9 and CYP3A MFMER slide-46

24 Research - Pain 2016 MFMER slide-47 Pain Treatment Early Years Research in animal models beneficial effect Chemical, mechanical, thermal pain stimuli Chronic pain of neuropathic and inflammatory origin Endocannabinoids exert synergistic antinociceptive effects when combined with NSAIDs Functional interplay between endocannabinoid and opioid receptor systems in modulating analgesic responses British Jour of Pharmacology (16): Trends in Pharm Sci (5): Eur J Pharmacol :75-83 Pain : MFMER slide-48

25 Pain Treatment Rx Cannabinoids Nabiximols reduced neuropathic pain in patients Traumatic peripheral nerve injury (allodynia) Multiple sclerosis Dronabinol provided modest analgesic effects in multiple sclerosis Orally administered cannabis extract (THC) effective in pain relief Analgesic efficacy of smoked cannabis in treating neuropathic pain Clin Rehab (1):21-9. Anaesthesia (5): BMJ ;329(7460):253. Lancet ;362(9395): Neurology ;65(6): MFMER slide-49 Synergistic Effect with Opioids Lesser of two evils Chronic pain stable systemic opioid therapy Inhaled vaporized cannabis Significant decrease in pain with cannabis Either-or model States with medical cannabis laws - 25% lower mean annual opioid-overdose mortality Better together Opioid with cannabinoid receptor agonist reduced nerve injury-induced allodynia Clin Pharmacol Ther (6): JAMA Intern Med (10): Br J Pharmacol (16): MFMER slide-50

26 Research - Spasticity 2016 MFMER slide-51 Cannabis as Treatment for Spasticity Most trials have been in patients with multiple sclerosis Multiple studies showing benefit in reduction of MAS and functional gains Decrease in sleep disruption Precise ratio of THC:CBD is not clear? Safety and potential long-term effects on cognitive function Eur J Neurol (9): Mult Scler (2): Neurol Res (5): MFMER slide-52

27 High times for research Challenges with separation of social and medical policies Funding for cannabis research Growing body of evidence supporting benefit Studies with little-to-no benefit demonstrate that cannabis is relatively safe Low-moderate doses are typically well tolerated, especially when spread over time 2016 MFMER slide MFMER slide-54

28 Risks? Marijuana doesn t have any risks it s a flower. It s not like morphine. Dispensary Owner 2016 MFMER slide-55 Expectations, Risks, and Drug Interactions Common side effects Dizziness Tiredness Confused Lose touch with reality Memory impairment Trouble concentrating Driving impairment Addiction Stroke, MI, mental health disorders Drug Interactions Evidence for synergy with opioids Benzodiazepines and other sedatives Antidepressants Warfarin and anticoagulants NSAIDs (COX2- selective) Not recommended for pregnant or nursing women 2016 MFMER slide-56

29 So, that s what the future looks like Expansion of state-based approval with variety of laws and regulations Ongoing research and clinical trials Anti-proliferative effect Responsibility to stay current with legislation, regulations, and medical advancement in respective area of practice Encourage regular collaboration with patients and pharmacists Dosages Side-effects Symptom control 2016 MFMER slide-57 What happened 35 yo Female with metastatic breast cancer Continues to get treatment Holistic and natural care focus Rick Simpson cannabis (C. indica) IDD for pain (turned off) 2016 MFMER slide-58

30 In Summary Medical cannabis Delta-9-tetrahydrocannabinol (THC) Cannabidiol (CBD) Best evidence depends on perspective Intractable central/neuropathic pain MS associated spasticity and pain related to muscle spasms There is no formally accepted role for the use of medical cannabis in typical treatment algorithm If all else fails 2016 MFMER slide MFMER slide-60

31 Interesting Reads University of California San Diego, Medical Cannabis Research Center Health Canada document for physicians: Minnesota Department of Health A Review of Medical Cannabis Studies The University of Washington Alcohol and Drug Abuse Institute. The American Cancer Society, Marijuana and Cancer. ndminerals/marijuana The National Cancer Institute at the National Institutes of Health. Cannabis and Cannabinoids. International Association for Cannabinoid Medicines, The National Academies of Sciences, Engineering, and Medicine. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (2017) MFMER slide-61 References Izzo AA, et al. Non-psychotropic plant cannabinoids: new therapeutic opportunities from an ancient herb. Trends Pharmacol Sci Oct;30(10): Whiting PF, et al. Cannabinoids for Medical Use: A Systematic Review and Meta-analysis. JAMA Jun 23-30;313(24): Hill KP. Medical Marijuana for Treatment of Chronic Pain and Other Medical and Psychiatric Problems: A Clinical Review. JAMA Jun 23-30;313(24): Pacher P, et al. The endocannabinoid system as an emerging target of pharmacotherapy. Pharmacol Rev Sep;58(3): Wade DT, et al. A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms. Clin Rehabil Feb;17(1):21-9. Notcutt W, et al. Initial experiences with medicinal extracts of cannabis for chronic pain: results from 34 'N of 1' studies. Anaesthesia May;59(5): Aggarwal SK and CD Blinderman. Cannabis for symptom control #279. J Pall Med May;17(5): Carter GT, et al. Cannabis in palliative medicine: improving care and reducing opioid-related morbidity. Am J Hosp Palliat Care Aug;28(5): Abrams D and M Guzman. Cannabis in cancer care. Clin Pharmacol Ther Jun;97(6): Wilsey B, et al. The Medicinal Cannabis Treatment Agreement: Providing Information to Chronic Pain Patients Through a Written Document. Clin J Pain Dec;31(12): Pacher P, et al. The endocannabinoid system as an emerging target of pharmacotherapy. Pharmacol Rev Sep;58(3): MFMER slide-62

32 References Svendsen KB, et al. Does the cannabinoid dronabinol reduce central pain in multiple sclerosis? Randomised double blind placebo controlled crossover trial. BMJ Jul 31;329(7460):253. Zajicek J, et al. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet Nov 8;362(9395): Rog DJ, et al. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology Sep 27;65(6): Wilsey B, et al. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain Jun;9(6): Serpell M, et al. A double-blind, randomized, placebo-controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment. Eur J Pain Aug;18(7): Abrams DI, et al. Cannabinoid-opioid interaction in chronic pain. Clin Pharmacol Ther Dec;90(6): Bachhuber MA, et al. Medical cannabis laws and opioid analgesic overdose mortality in the United States, JAMA Intern Med Oct;174(10): Wilsey B, et al. Low-dose vaporized cannabis significantly improves neuropathic pain. J Pain. 2013;14(2): Noyes R Jr, et al. Analgesic effect of delta-9-tetrahydrocannabinol. J Clin Pharmacol (2-3): Noyes R Jr, et al. The analgesic properties of delta-9-tetrahydrocannabinol and codeine. Clin Pharmacol Ther (1):84-9. Johnson JR, et al. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage (2): MFMER slide-63 References Johnson JR, et al. An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics. J Pain Symptom Manage Aug;46(2): Portenoy RK, et al. Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial. J Pain (5): Novotna A, et al. A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex( ) ), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur J Neurol (9): Notcutt W, et al. A placebo-controlled, parallel-group, randomized withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term Sativex (nabiximols). Mult Scler (2): Collin C, et al. A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurol Res (5): Wilsey B, et al. The Medicinal Cannabis Treatment Agreement: Providing Information to Chronic Pain Patients via a Written Document. Clin J Pain (12): Koppel BS et al., Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology Apr 29;82(17): Fife TD et al. Clinical perspectives on medical marijuana (cannabis) for neurologic disorders. Nuerol Clin Pract Aug;5(4): Schrot RJ and JR Hubbard. Cannabinoids: Medical implications. Ann Med. 2016, Feb 25:1-14. (Epub ahead of print) Bolognini D and RA Ross. Medical cannabis vs. synthetic cannabinoids: What does the future hold? Clin Pharmacol Ther Jun;97(6): MFMER slide-64

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