American College of Emergency Physicians s4

1 PLEASE NOTE: THIS RESOLUTION WILL BE DEBATED AT THE 2017 COUNCIL MEETING. RESOLUTIONS ARE NOT 2 OFFICIAL UNTIL ADOPTED BY THE COUNCIL AND THE BOARD OF DIRECTORS (AS APPLICABLE). 1

2 3 4 RESOLUTION: 53(17) 5 6 SUBMITTED BY: Georgia College of Emergency Physicians 7 8 SUBJECT: Supporting Research in the Use of Cannabidiol in the Treatment of Intractable Pediatric Seizure Disorders 9 10 PURPOSE: Directs ACEP to publicly and officially state support for scientific research to evaluate the risks and benefits of 11 cannabidiol in children with intractable seizure disorders who are unresponsive to medications currently available. 12 13 FISCAL IMPACT: Budgeted committee and staff resources. 14 15 WHEREAS, Cannabidiol (CBD), one of the active cannabinoids found in cannabis sativa (marijuana), which unlike 16 tetrahydrocannabinol (THC), is believed not to have intoxicating or psychotropic effects due to its low affinity for central nervous 17 system cannabinoid type I (CB1) receptors; and 18 WHEREAS, CBD appears to inhibit glutamate release resulting in downregulation at glutamatergic synapses which may 19 contribute to lowering seizure thresholds; and 20 21 WHEREAS, Antidotal reports and limited studies of children with a history of intractable seizures, such as those due to 22 Dravet syndrome and Lennox-Gastaut syndrome, which are unresponsive to currently available anti-elliptic medications have had 23 significant improvement following use of CBD; and 24 25 WHEREAS, There has been little formal research meeting current scientific standards because of previous federal restrictions 26 allowing for studies as to the potential risks and benefits of CBD in children for seizure control; and 27 28 WHEREAS, The National Institutes of Health have approved scientifically valid studies, and the Food and Drug 29 Administration Center for Drug Evaluation and Research (CDER) has approved Investigation New Drug (IND) applications for 30 phase 2/3 clinical trials for CBD for children with certain intractable seizure disorders; therefore be it 31 32 RESOLVED, That ACEP go on record supporting scientific research to evaluate the risks and benefits of Cannabidiol in 33 children with intractable seizure disorders who are unresponsive to medications currently available. 34References 35 1. Gloss D, Vickrey B. Cannabinoids for epilepsy. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD009270. DOI: 36 10.1002/14651858.CD009270.pub3. 37 2. Welty TE, Luebke A, Gidal BE. Cannabidiol: Promise and Pitfalls. Epilepsy Currents. 2014;14:250- 252. doi:10.5698/1535-7597- 38 14.5.250. 39 3. Press CA, Knupp KG, Chapman KE. Parental reporting of response to oral cannabis extracts for treatment of refractory epilepsy. 40 Epilepsy Behav. 2015; 45:49-52. 41 4. Tzadok M, Uliel-Siboni S, Linder I, et al. CBD-enriched medical cannabis for intractable pediatric epilepsy: The current Israeli 42 experience. Seizure. 2016 Feb;35:41-4. 43 5. Hussain SA, Zhou R, Jacobson C, et al. Perceived efficacy of cannabidiol-enriched cannabis extracts for treatment of pediatric epilepsy: 44 A potential role for infantile spasms and Lennox- Gastaut syndrome. Epilepsy Behav. 2015 Jun;47:138-41. 45 6. Rubio M, Valdeolivas S, Piscitelli F, et al. Analysis of endocannabinoid signaling elements and related proteins in lymphocytes of 46 patients with Dravet syndrome. Pharmacol Res Perspect. 2016 Apr; 4: e00220. 47 7. Devinsky O, Cilio MR, Cross H, et al. Cannabidiol: pharmacology and potential therapeutic role in epilepsy and other neuropsychiatric 48 disorders. Epilepsia. 2014 Jun;55:791-802. 49 8. Devinsky O, Marsh E, Friedman D, et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. 50 Lancet Neurol. 2016 Mar;15:270-8. 51 9. Zuardi AW, Crippa JA, Hallak JE, et al. A critical review of the antipsychotic effects of cannabidiol: 30 years of a translational 52 investigation. Curr Pharm Des. 2012;18(32):5131-40. 53 54 Current Clinical Trials (www.clinicaltrials.gov) Resolution 53(17) Supporting Research in the Use of Cannabidiol in Intractable Pediatric Seizure Disorders Page 2 55 A. Cannabidiol (CBD) and Pediatric Epilepsy (NCT02447198), University of Colorado, Denver. 56 B. Epidiolex and Drug Resistant Epilepsy in Children (CBD) (NCT02397863), Augusta University 57 C. Study of Cannabidiol for Drug-Resistant Epilepsies (NCT03014440), Children's Hospital of Pittsburgh, Geisinger Clinic 58 D. Treatment of Drug Resistant Epilepsy (Cannabidiol) (NCT02461706), University of Florida 59 60 61 Background 62 63 This resolution calls for ACEP to publicly and officially state support for scientific research to evaluate the risks and benefits of 64 cannabidiol in children with intractable seizure disorders who are unresponsive to currently available anti-elliptic medications. 65 66 Most states have passed laws approving the use of medical marijuana. Only four states, Idaho, South Dakota, Nebraska, and 67 Kansas, do not have laws enacted on medical marijuana. Some states have tightly controlled medical marijuana statutes and have 68 CBD-specific laws that allow for the use of cannabis extracts that are high in CBD and low in THC. 69 70 Legal Medical Marijuana States – CBD Specific 71 States with CBD Specific laws Signed Qualifying Condition Alabama 2014 Debilitating epileptic conditions Florida 2014 Cancer, muscle spasms, seizures, terminal illness (>12 mo.) Georgia 2015 AIDS, Alzheimer’s, amyotrophic lateral sclerosis, autism, cancer, Crohn’s, hospice care patients, mitochondrial disease, multiple sclerosis, Parkinson’s, sever or end state peripheral neuropathy, seizure disorder, sickle cell disease, Tourette’s Indiana 2017 Treatment resistant epileptic conditions, including Dravet syndrome and Lennox-Gastaut syndrome Iowa 2014 AIDS/HIV, amyotrophic lateral sclerosis, cancer, cancer- related chronic pain, Crohn’s disease, multiple sclerosis, Parkinson’s, intractable epilepsy, terminal illness, untreatable pain Kentucky 2014 Intractable epilepsy Mississippi 2014 Intractable epilepsy Missouri 2014 Intractable epilepsy North Carolina 2014 Intractable epilepsy Oklahoma 2015 Pediatric epilepsy South Carolina 2014 Dravet syndrome, Lennox-Gastaut syndrome, refractory epilepsy Tennessee 2014 Intractable epilepsy Texas 2015 Intractable epilepsy* Utah 2014 Intractable epilepsy Virginia 2015 Intractable epilepsy Wisconsin 2014 - Any “medical condition” for which a physician recommends expanded it Wyoming 2015 Intractable epilepsy (defined as epilepsy that “does not respond to other treatment options”) 72 73 *The Texas law was signed in 2015; the language of the law calls for a physician’s prescription rather than a doctor’s recommendation, as it is 74 written in other state laws. 75 76 This level of legislative activity on the part of most of the nation’s states appears to challenge the Drug Enforcement Agency’s 77 position of listing marijuana as a Schedule I drug with “no currently accepted medical use and a high potential for abuse.” 78 79  In July of 2017, the Senate Appropriates Committee passed an amendment to add a clause to the 2018 Commerce, Justice, 80 Science and Related Agencies budget that would block the Department of Justice (DOJ) from using federal funds to prosecute Resolution 53(17) Supporting Research in the Use of Cannabidiol in Intractable Pediatric Seizure Disorders Page 3 81 state-legal medical marijuana operations. This is in line with the current protections under the Rohrabacher-Farr amendment 82 (H.R. 2578), voted on annually, which has similar protections for the use of state-legal medical marijuana. 83  In May 2017, President Trump signed H. R. 244 into law. This contained a provision (Division B, section 537) that the DOJ 84 would not use funds to prevent implementation of medical marijuana laws by states and territories. However, there are mixed 85 messages from the Administration on its stance of enforcing laws regarding illegal drugs and conflicts between state and 86 federal law. 87  The National Academies of Sciences, Engineering and Medicine conducted a comprehensive study on the health effects of 88 therapeutic and recreational cannabis use, looking at research publications since 1999. One of the recommendations in their 89 report, published in January 2017, called for developing a comprehensive evidence base on the effects of cannabis use 90 including prioritized research streams for unstudied and understudied health endpoints, such as epilepsy in pediatric 91 populations. 92  On July 19, 2016, the Drug Enforcement Administration (DEA) denied a petition to initiate rulemaking proceedings to 93 reschedule marijuana from Schedule I of the CSA to any other schedule. 94  In fiscal year 2015, the NIH supported 281 projects totaling over $111 million on cannabinoid research. Within this 95 investment, 49 projects ($21 million) examined therapeutic properties of cannabinoids, and 15 projects ($9 million) focused on 96 CBD (Cannabidiol). Cannabinoid research is supported broadly across NIH Institutes and Centers (ICs), with each IC 97 supporting research specifically focused on the impact of cannabinoids on health effects within their scientific mission. 98  In 2015, the American Academy of Pediatrics reaffirmed their policy statement opposing legalization of marijuana for 99 recreational or medical use. In their statement, the AAP opposed medical marijuana outside of the usual FDA approval 100 process of pharmaceutical products, but supported the further study of pharmaceutical cannabinoids. 101  The AMA policy remains against marijuana legalization, but in 2013, they reaffirmed their policy Cannabis for Medicinal Use 102 H-95.952 which calls for further and well-controlled studies of marijuana and cannabinoids in patients with serious conditions 103 for its medical utility. The AMA also supports reducing criminal penalties and urges Congress and the DEA to review the 104 status of marijuana as a Schedule I controlled substance, noting it would support rescheduling if doing so would facilitate 105 research. According to its 2014 advocacy statement on cannabis, the AMA urges legislatures to delay initiating full 106 legalization of any cannabis product until further research is completed on the public health, medical, economic, and social 107 consequences of use of cannabis and, instead, support the expansion of such research. The AMA will also increase its efforts to 108 educate the press, legislators, and the public regarding its policy position that stresses a “public health,” as contrasted with a 109 “criminal,” approach to cannabis. 110  President Obama did not legalize marijuana at the national level, but in 2009 a Department of Justice memo from the Attorney 111 General to the nation’s U.S. Attorneys advised them not to expend federal resources to prosecute individuals in states that have 112 legalized medical marijuana. 113  The Institute of Medicine’s 1999 study concluded that THC, the active ingredient in marijuana, may have medicinal potential 114 and should be subjected for further research. 115 116 ACEP Strategic Plan Reference 117 118 None. 119 120 Fiscal Impact 121 122 Budgeted committee and staff resources. Resolution 53(17) Supporting Research in the Use of Cannabidiol in Intractable Pediatric Seizure Disorders Page 4 123 Prior Council Action 124 125 Since 2009, there have been 16 resolutions submitted to the Council regarding the use of marijuana. None of these resolutions have 126 pertained to research in the use of cannabidiol in the treatment of pediatric seizure disorders. 127 128 Resolution 27(14) National Decriminalization of Possession of Marijuana for Personal and Medical Use not adopted. Directed 129 ACEP to adopt and support policy to decriminalize possession of marijuana for personal use, support medical marijuana programs, 130 and encourage research into its efficacy, and have the AMA Section Council on EM submit a resolution for national action on 131 decriminalization for possession of marijuana for personal and medical use. 132 133 Amended Resolution 19 (14) Cannabis Recommendations by Emergency Physicians not adopted. The original resolution called for 134 ACEP to support emergency physician rights to recommend medical marijuana where it is legal; object to any punishment or denial 135 of rights and privileges at the state or federal level for emergency physicians who recommend medical marijuana; and support 136 research for medical uses, risks, and benefits of marijuana. The amended resolution directed ACEP to support research into the 137 medical uses, risks, and benefits of marijuana. 138 139 Resolution 16(09) Legalization and Taxation of Marijuana not adopted. This resolution requested ACEP to support, endorse, and 140 advocate for the legalization and taxation of marijuana and for a trust fund to be established using tax revenue from marijuana sales 141 that would fund research and treatment of drugs and alcohol dependence. 142 143 Prior Board Action 144 145 None. 146 147 148 Background Information Prepared by: Loren Rives, MNA 149 Senior Manager, Academic Affairs 150 151 Reviewed by: James Cusick, MD, FACEP, Speaker 152 John McManus, MD, FACEP, Vice Speaker 153 Dean Wilkerson, JD, MBA, CAE, Council Secretary and Executive Director