Medical Cannabis Treatments: ?Evidence-based Cannabis Treatments.pdf · • 19 “Qualifying...
Transcript of Medical Cannabis Treatments: ?Evidence-based Cannabis Treatments.pdf · • 19 “Qualifying...
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MEDICAL CANNABIS TREATMENTS: ?EVIDENCE-BASED
• C. Clark Milton, DO, FACOI
• WVOMA 115th Annual Conference
• 02 November 2017
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DOCTOR, DO YOU “PRESCRIBE” MEDICAL MARIJUANA??
• C. Clark Milton, DO, FACOI
• Tri State Med Dental Conference
• 03-06 February 2010
• Big, Sky, Montana
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DEFINE: MEDICAL MARIJUANA • Whole, unprocessed Cannabis plant
or its basic extracts
• Used to treat symptoms of illness or other conditions
• FDA: Has NOT recognized or approved the marijuana plant as medicine
• Unprocessed Plant Material
• Liquid or Oils
• Capsules
• Edibles
• Rectal suppositories
• Oinments, Creams, and Lotions
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CANNABIS AND CANNABINOIDS Cannabis sativa/Indica
400 chemical compounds
66 different cannabinoids
10 groups
Delta9-THC
Cannabinol and cannabidiol
Produced in epidermal glands
All are lipophilic
Amounts vary in growing conditions
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“MEDICAL MARIJUANA”: PHARMACOLOGY
• 2 of 3 forms of cannabinoids
• 1. Endocannabinoids: arachadonic acid neurotransmitter
• 2. Phytocannabinoids: of C. sativa/C. Indica (hundreds) THC and CBD
• 3. Synthetic cannabinoids of THC cogners foundation of the pharmaceutical industry
• THC concentration : 0.2%-30% in hybridized sinsemilla
• 2% 1980: 4.5% 1997: 8.5% 2006
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SCIENCE OF CANNABIS
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INSTITUTE OF MEDICINE:1997 AND 2003
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SUMMARY OF RESEARCH
More than 30 yrs of clinical research
Only small number of randomized, controlled trials of “smoked cannabis”
Short term with a total of about 300 patients
Indicate: reduction in neuropathic pain
Improves appetite and caloric intake
Spasticity relief in MS
Better alternatives are available to Rx glaucoma and chemo-induced N &V
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CANNABINOIDS FOR MEDICAL USE
• Systemic Review and Meta-Analysis
• 79 Trials: (6462 participants)
• Study Selection: “Randomized clinical trials of cannabinoids for the following indications:
• 1. Nausea and vomiting associated with ChemoRX
• 2. Appetite Stimulation in HIV/SIDS
• 3. Chronic Pain
• 4. Spasticity due to MS/paraplegia
• 5. Anxiety/Depression: Sleep Disorder
• 6. Psychosis: glaucoma, Tourette Syndrome
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CANNABINOIDS FOR MEDICAL USE (CONT)
• Most trials showed improvement in “SYMPTOMS”…Did NOT meet statically significance in all trials
• N&V: greater than average showing response comp. with placebo
• Pain: greater than average reduction in numerical pain scale rating
• Spascity: Average reduction
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CANNABINOIDS FOR MEDICAL USE: ADVERSE EFFECTS (AE)
• Common AE:
• Dizziness
• Dry Mouth
• Nausea
• Fatigue
• Somnolence
• Euphoria
• Vomiting
• Disorientation, Drowsiness
• Confusion, Loss of Balance
• Hallucination
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CONCLUSIONS AND RELEVANCE
• Moderate-quality evidence to Support cannabinoid use for Chronic Pain and Spascity
• Low-Quality evidence: Suggesting that Cannabinoids were associated with Improvements in N&V due to ChemoRx, Weight gain in HIV, Sleep Disorders, and Tourettes
• Cannabinoids were associated with an Increase risk of short term AE
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12 JANUARY 2017
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• “Conclusive or Substantial”: Can treat chronic pain in adults
Nausea and vomiting in ChemoRx
Improve reported MS spasticity
“Substantial Evidence” Smoking: worse respiratory S/S
Increase bronchitis
Risk MVC
Low Birth weight pregnancy
Increase psychosis/frequent use
Use at “earlier age” problematic
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• “No Evidence”: In Rx Depressive Disorders and PTSD
• “Limited Evidence”: Associated impaired academic performance and social functioning: nor increased rates of unemployment and low income
Research Barriers: Schedule I
Difficulty “to gain access to quantity, quality, and type of cannabis product necessary to address specific research questions on health effects”
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• Recommendations:
• 1. Develop a comprehensive evidence base on the beneficial and harmful health effects of cannabis use in short and long term
• 2. Improve federal and state public health surveillance efforts
• 3. Develop Research standards and benchmarks: uniform terminology, data set for observational and clinical studies
• 4. Convene expert committee to characterize the barriers to cannabis research: with 11 endpoints; therapeutic effects, CA risk, cardiometabolic risk, respiratory risk, immunological effects, injury and death, issues with pre-, peri, and post natal exposure, psychosocial effects, mental health, problems with use and abuse of other substances
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11 AUGUST 2017: DEA REJECTS PETITION TO RESCHEDULE CANNABIS
TO SCHEDULE II • “Potential for and history of Abuse and Addiction”
• “Lack of accepted Medical Use”
• “Lack of Safety Information”
• Drug failed to meet FDA 5-part test:
• 1. Chemistry must known and reproducible
• 2. Adequate Safety Studies
• 3. Adequate and Well-controlled studies of efficacy
• 4. Drug accepted by qualified Experts
• 5. Scientific evidence must be widely available
• DEA Administrator(acting): Chuck Rosenberg
• Petitioners: G. Raimondo Gov RI: Jay Inslee Gov Washington: Bryan Krumm
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“SMOKED MARIJUANA IS A CRUDE THC DELIVERY SYSTEM THAT ALSO DELIVERS
HARMFUL SUBSTANCES”
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APPROVED CANNABINOID PHARMACEUTICALS IN US AND CANADA
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NATURAL EXTRACT FROM PLANT SOURCE
• THC and CBD (nabiximols) Oraomucosal spray
• Neuropathic pain/spasticity of MS
• Analgesia: advanced CA-mod/severe
• UK, Canada 2010: First Cannabis based med
• US: Phase III trials in CA pain initial results in 2014
• GW Pharm/ Otsuka
• New Drug app: 2013 spasticity of MS
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SIMILAR COMPOUND: NOT IN CANNABIS PLANT
• Synthetic Analogue: similar to THC
• N/V (Refactory) associated the CA Rx
• 1985 approved but withdrawn 1989: re-approved 2006
• Warning: “Potential to affect mental state of patients”
• Rx: CESAMET: CII
• 1-2mg TID: Max 6mg/day
• Months supply $2250
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SYNTHETIC VERSIONS OF CANNABIS EXTRACTS
• Dronabinol (Synthetic 9-THC)
• N/V CA Rx
• Appetite stim. HIV
• Analgesia neuropathic pain/MS: OFF LABEL
• Approved 1985 CII
• 1999 CIII
• $150 million/yr
• 2.5-10mg/day in divided doses
• $3000/month: Generic $1351
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• Dronabinol: solution for oral use
• CIII
• Anorexia associated with weight loss With AIDS
• N & V associated with CA chemotherapy
• Currently 9,500 Rx for dronabinol
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RECOMMENDATIONS: NOT RX
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• 19 “Qualifying Medical Conditions”
• No smoking: No Personal Growing
• Dept Commerce: license cultivators, processors, testing
• State Med. Board: register physicians and determine education
• Bipartisan 13 member: Medical Marijuana Advisory Board
• “ Up and Running” in 2 years
• Affirmative defense from arrest
• Drug-Free Workplace Policy
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OHIO HB 523: “QUALIFYING CONDITIONS”
• AIDS/HIV
• Alzheimer’s Disease
• ALS
• Cancer
• Chronic Traumatic Encephalopathy
• Crohn’s Disease
• Epilepsy or other Seizure disorder
• Fibromyalgia
• Glaucoma
• HCV
• IBD
• MS
• Pain “either chronic, severe, intractable”
• Parkinson’s Disease
• PTSD
• Sickle Cell Anemia
• Spinal Cord Disease or Injury
• Tourette’s Syndrome
• TBI
• Ulcerative Colitis
• Any other conditions added by St. Med Board
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• Terminal Illness or “Suffer from Cancer”
• HIV/AIDS
• ALS
• Parkinson’s Disease
• Multiple Sclerosis
• Spinal Cord “damage”
• Epilepsy
• Neuropathies
• Huntington’s Disease
• Crohn’s Disease
• Post-traumatic Stress Disorder
• Intractable Seizures
• Sickle Cell Anemia
• “Severe Chronic or Intractable Pain in which conventional therapeutic inerventtion and Opiate Therapy is Contraindicated or has proven Ineffective as determined as part of continuing Care”
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VARIOUS FORMS OF MEDICINAL CANNABIS
• Unprocessed Plant Material
• Liquids or Oils for Vaporization
• Liquid or Oils for Oromucosal Delivery
• Capsules/Pills
• Infused Edible
• Rectal Delivery
• Ointments, Creams, Lotions
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• Smoking (Inhalation): Onset almost immediate: Negative Pulmonary:Cardiovascular: Toxins/Health Efects
• Vaporizing (warm air not flame-180-200 C): ? More efficient cannabinoid extraction: Fewer Negative Pulmonary adverse Effects
• Infused Edibles: Variability: Cannabinoid Ratio, Absorption, Fatty meals,
• Juicing:
• Topical/Transdermal: Creams, Balms, Patches: (Hydrophobic-Not easily skin penetrating) ? Subjective local relief—CBD/CDN 10X’s THC
• Oromucosal:
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