Marihuana new regulation policies and early results?

Transcription

1 Marihuana new regulation policies and early results? Alan J. Budney, Ph.D. Geisel School of Medicine at Dartmouth CSAM October 16, 2014

2 Faculty/Presenter Disclosure Faculty: Alan Budney - GW Pharmaceuticals/Otsuka (past) - National Institute on Drug Abuse - Office of National Drug Control Policy - Center for Medical Cannabis Research

3 Disclosure of Commercial Support Funded by National Institute on Drug Abuse to do clinical and laboratory research related to cannabis abuse / dependence (NIDA and the NIH have supported most of my research activities and travel to conferences, etc. for about 25 years) Consultant / Participant: Office of National Drug Control Policy s marijuana and kids media campaign video trainings and expert panels (small consultation fee) Scientific Review Board: Center for Medical Cannabis Research, State of California (small consultation fee?) Consultant to GW Pharmaceuticals/Otsuka on development of Nabiximols / Sativex (consultation fee)

4 Mitigating Potential Bias GW Pharmaceuticals: no ongoing relationship ONDCP and Center for Medical Cannabis Research: in the past NIDA / NIH funding continues. I disclose their contribution to my research and mention these institutions as a potential conflict of interest in all meetings and publications.

5 1936 Reefer Madness

6 Reefer Madness 2014

7 Reefer Madness 2014

8 Reefer Madness 2014

9 Agenda Quick Overview of Marijuana / Cannabis / Cannabinoids Status of Current Marijuana Laws Changing World of Cannabis: due to Regulation Change? - Potency / Products - Impact on Use, Attitudes, Perceived Risk - Impact on Public Safety - Addiction Physician Knowledge Plea for Common Sense and Rationality

10 Marijuana/Cannabis/Cannabinoids Over 100 compounds ; over 70 phytocannabinoids Delta-9 THC psychoactive compound Dose related effects: - High, euphoria, relaxation - Cognitive impairment (memory, learning, attention, time perspective) - Anxiety, Panic, Hallucinations, Psychosis? - Abuse/Dependence?

11 Marijuana / Cannabis

12 Cannabidiol (CBD) Generally seems to have moderating/opposite effects of THC Shows potential as an anxiolytic Shows potential as an antipsychotic Only one small clinical trial Inverse agonist - CB1 receptor Schubart et al. (2013); Neisink et al. (2013)

13 Synthetic Cannabinoids - Do not contain THC (usually) - Only contain synthetic cannabinoid(s) - Misperceived as synthetic marijuana - Advertised as natural herbs, harmless incense, not for human consumption, or for aromatherapy only - Purchase via the internet, smoke shops and even gas stations

14 Take Home Message Cannabis/Marijuana THC only Synthetic Cannabinoids THC/Marijuana (a) Not all cannabinoids are the same (b) Dose matters and is now much higher (c) Mode of Administration matters Legalization/medicalization/technology = More harmful substance?

15 ProCon.org Current Marijuana Laws Legal Medical Marijuana: 23 States, plus Washington, D.C. 3 States Pending legislation 2 States have legalized recreational use of marijuana (Washington and Colorado) Federal Status: ILLEGAL

16 Current Medical Marijuana Laws: Chaos Fees to get approval : Range: $15-$200 Reciprocal approvals with other States: n=6 Minnesota and New York s rules do not allow smoking of cannabis Allow dispensaries (n~15) Possession Limit: 1oz 24oz (n=19 states) day supply (n=5 states) plants: (mature, immature, seedlings?) Most States discuss plants and ounces, but don t mention oils, wax, shatter, or even edibles

17 Laws and allowable Products Labeled as usable marijuana: Alaska:"usable marijuana" means the seeds, leaves, buds, and flowers of the plant cannabis, but does not include the stalks or roots. VT: Usable marijuana means the dried leaves &flowers of marijuana, and any mixture or preparation thereof, and don t include the seeds, stalks, & roots of the plant. NY: 30 day supply; the card will contain the practitioner's dosing recommendations for the patient NJ: physicians determine how much marijuana a patient needs and give written instructions to be presented to an alternative treatment center.

18 State by State Medical Marijuana Approved Conditions: Cachexia, cancer, chronic pain, epilepsy and other disorders characterized by seizures, glaucoma, HIV or AIDS, multiple sclerosis and other disorders characterized by muscle spasticity, and nausea, Hepatitis C, ALS, Crohn's disease, Alzheimer's disease, anorexia, arthritis, migraine, Parkinson's disease, posttraumatic stress disorder, decompensated cirrhosis, muscular dystrophy, severe fibromyalgia, spinal cord disease (including but not limited to arachnoiditis), Tarlov cysts, hydromyelia syringomyelia, Rheumatoid arthritis, fibrous dysplasia, spinal cord injury, traumatic brain injury and post concussion syndrome, Arnold-Chiari malformation and Syringomelia, Spinocerebellar Ataxia (SCA), Parkinson's Disease, Tourette Syndrome, Myoclonus, Dystonia, Reflex Sympathetic Dystrophy, RSD (Complex Regional Pain Syndromes Type I), Causalgia, CRPS (Complex Regional Pain Syndrome Type II), Neurofibromatosis, Chronic inflammatory Demyelinating Polyneuropathy, Chronic Inflammatory Demyelinating Polyneuropathy, Sjogren's Syndrome, Lupus, Interstitial Cystitis, Myasthenia Gravis, Hydrocephalus, nail-patella syndrome or residual limb pain; terminal illness with a life expectancy of under one year, one or more injuries that significantly interferes with daily activities as documented by the patient's provider, Huntington's disease

19 NH Medical Society Clinical Cannabis Survey, 2014 Survey Goals: Learn about current & anticipated engagement by NH clinicians in use of herbal marijuana for therapeutic purposes Assess clinician understanding of marijuana effects and side effects

20 How would you rate your knowledge of herbal marijuana/cannabis effects? Knowledge 0 to 2 3 to 5 0 None Comprehensive

21 Recreational MJ Laws Washington and Colorado only Laws dramatically different Will keep changing Medical MJ much less regulated! Diversion from Medical to Blackmarket Penalties for violations substantial

22 Potency None of the state policies (except NY) explicitly specify a minimum or maximum potency (or a therapeutic dose) that can be sold, nor do they provide any general guidelines for potency (therapeutic dose).

23 DEA Cannabis Seizures (Potency)

24 Legal Marijuana and Potency Strain Name: Loud Grade: A Smell: very potent and natural smell Taste: orangish taste Potency: 27.50% THC Effects: head high with a body high but it s not a hybrid Reviewed by: Lungs n Green Good Strain For: getting rid of stress and soreness and to feel good Changing the Game : much of what we know is based on smoking marijuana with much lower doses of THC. We know little about high potency or vaporizing

25 Is Increased Potency Related to Changing Laws and Regulations? Hypothesis: MMLs greatly enhance the development and diffusion of high-potency cannabis cultivars and sophisticated technologies of production Sevigny et al. (2014) n = 39,157 marijuana samples seized by law enforcement in 51 U.S. jurisdictions between 1990 and 2010

26 Is Increased Potency Related to Changing Laws and Regulations? Sevigny et al. (2014) Medical Marijuana Law States: 9.1% (6.2) THC Non-Medical Marijuana Law States: 5.6% (4.0) THC Legal allowances for retail dispensaries had the strongest influence, significantly increasing potency by about 1% point on average (only 3 operating dispensaries states at that time). Mediational analyses suggest that this is likely due to overall increase in high potency marijuana (sinsemilla) availability - could (a) could reflect overproduction of medical marijuana being diverted into recreational markets or (b) change in demand for high potency and illegal market competition practices

27 Is Increased Potency Related to Changing Laws and Regulations? How will recreational legalization impact potency???? Current structure of the Colorado law, limits legal possession to relatively small quantities - might this encourage production of higher potency strains. Opening a licit recreational market could change the user base impacting demand

28 Legalization and Potency What we ought to know (Potency Effects) Potency Effects? Studies have not gone above 8% THC, and only one study has gone that high. Confiscated marijuana averaged 12.8% in 2012, 10.1% in 2008; 7.3% in 2007; 4% in Lab studies on cognitive and behavioral effects and clinical survey/epidemiological studies are predicated on lower THC marijuana levels Doses for Medical Conditions are not known or specified Don t know much about high potency cannabis!!

29 Dose and Risk of being a Psychotic Case (Di Forti et al., 2014) Frequent Use of High-Potency Cannabis, Drives the Increased Probability of Psychosis in Cannabis Users

30 Products

31 Products

32 Alternative Methods & Products

33 Edible Products

34 Edible Products

35 What about Vaping marijuana? No prevalence data, but, e-cig Use Rapidly Increasing (MMWR 2013)

36 Vaping Increased Cannabis Use? Perceived as less harmful better taste, no smoke or smell, Less detectable / inconspicuous more effect from the same amount cool to vape? (Rooke et al., 2014)

37 Conclusions: Potency and Product The unfortunate aspect of this arms race is that they re finally turning the drug into everything the U.S. government once said it was.it used to be we could say the government exaggerated the threat of this crazy weed, but these new potent strains belie that. Robert MacCoun, behavioral scientist, marijuana policy expert U.C. Berkeley

38 What are some concerns? How does reduced harm perception (reality) impact use? - oral consumption - vaporizing How does product look / function / route influence use? - perceptions / attitudes - prevalence - age of onset - frequency / amount - direct effects (intoxication / adverse effects)

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40 National Data: Risk Use?

41 2013 (MTF)

42 Does Liberalizing Cannabis Laws Increase Use (Williams et al., 2014) Australian Household Survey: 5 waves ( ) Decriminalization States vs. Not: 63% vs. 55% lifetime use 55% vs. 63% not used by age 18 36% vs. 45% not used by age 40 Difference in difference estimator analyses: - Peak uptake at age 16 rather than at age 18 - Minors who live in a decriminalized policy regime have a hazard rate of uptake that is 12% higher Overall the impact of decriminalization is concentrated amongst minors, who have a higher rate of uptake in the first five years following its introduction

43 Do Medical Marijuana Laws Impact Use (Cerda et al., 2012) NESARC and NSDUH (2004/05) Past yr MJ abuse/dependence (%) 1.27 (1.00, 1.54) 2.61 (1.96, 3.25) OR: 1.81 (1.22, 2.67) Past yr MJ use (%) 3.57 (3.10, 4.03) 7.13 (6.02, 8.24) OR: 1.92 (1.49, 2.47) Past yr MJ abuse/dependence among current users (%) 35.3 (29.5, 41.2) 37.7 (23.7, 51.7) OR: 1.03 (0.67, 1.60)

44 Do Medical Marijuana Laws Impact Teen Use (Wall et al., 2011) NSDUH (2002/08) States with MML had higher prevalence of teen use (8.7 vs. 7.0) States with MML had lower perception of riskiness 8 States that passed MML after 2004 already had higher rates and lower risk perception

45 Do Medical Marijuana Laws Impact Teen Use (Harper et al., 2012) NSDUH (2002/09) 1) Replicated the Wall study 2) Additional goal to explore causal effects 3) Controlling for State specific factors lead to conclusion that they found no evidence of causality 4) Wall et al. (2012): Commentary/Rebuttal: analyses limited to 5 States; results driven by 2 States (Montana, Vermont; inferring no causality by a lack of finding causality is over interpretation.

46 Do Medical Marijuana Laws Impact Teen Intent to Use (Palamar et al., 2014) N = ~10,000 HS seniors (MTF data base ) - 10% of non-users said they would try MJ if legal - 18% of users said they would use MJ more often - significant proportions of subgroups of students normally at low risk for use (e.g., non cigarette smokers, religious students, those with friends who disapprove of use) reported intention to use if legal.

47 Colorado Marijuana Use

48 Do Medical Marijuana Laws Impact Perception of Risk: Colorado vs. NMML States (Schuermeyer et al., 2014)

49 Do Medical Marijuana Laws Impact Use: Colorado vs. NMML States (Schuermeyer et al., 2014)

50 Do Medical Marijuana Laws Impact Fatal Driving Accidents (Sautel et al., 2014) Proportion of Drivers in Colorado vs. NMML States - no difference in alcohol-impaired drivers

51 Do Medical Marijuana Laws Impact Fatal Driving Accidents (Anderson et al., 2013) Ages 15-19

52 Do Medical Marijuana Laws Impact Fatal Driving Accidents (Anderson et al., 2013) Ages 20-39

53 Do Medical Marijuana Laws Impact Fatal Driving Accidents (Anderson et al., 2013) Ages 40 +

54 Do Medical Marijuana Laws Impact Fatal Driving Accidents (Masten et al., 2014)

55 Cannabis-involved Driving in California (Johnson et al., 2012) In 2010, anonymous oral fluid samples and breath tests were obtained from more than 900 weekend nighttime drivers randomly sampled from 6 jurisdictions; compared with similar data from 2007 MM permit holders were significantly more likely (38.9%) than nonpermit holders (7.5%) to test positive for THC

56 ER Visits Related to Marijuana are Increasing DAWN Data Set Is Use of High Potency MJ or Synthetic Cannabinoids or general increased use driving this increase?

57 Colorado Data: Teen Diversion N=80 Teens in Outpt Treatment for SUD 49% obtained MJ > 1 from an MML person These teens are more frequent users, high-using peer networks, report very easy access, more SU problems (Thurstone et al. 2011).

58 Colorado Data

59 Review of Overall Impact Cannabis for Therapeutic Purposed and Public Health 28 studies Main findings reviewed according to - illegal cannabis use; - other public health issues; - crime - neighborhood disadvantage Conclusions: All Inconclusive! Sznitman et al. 2014

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63 Legalization and Tobacco What we ought to know The Tobacco Connection - 70% of marijuana users used tobacco in past month Interaction with nicotine/tobacco Does it is increase the risk of tobacco use? Does using both increase health problems? What about tobacco cannabis combination products? - we know very little other than combining use is one of the more common ways of smoking (blunts, spliffs, chasing, vaping?) WILL COMBINATION PRODUCTS BE LEGAL??

64 Legalization and Poverty What we ought to know Differential impact on disadvantaged populations? - poverty / low socioeconomic status? - lower cognitive functioning? - greater increase in low income population? - greater functional impact on lower functioning persons? ** Does marijuana use have a greater adverse impact on disadvantaged youth and adults?

65 The End and the Beginning We have no experimental data to determine what the effects of legalizing marijuana will have on the individual and society. Social, retrospective, and archival studies continue to accumulate What we can glean from laboratory studies, projection modeling, and basic understanding of principles of behavior would suggest a large, initial, negative impact in many areas In the meantime: perhaps we should use some Common Sense

66 Legalization Givens associated with legalization that should be tested with projection modeling and pre-post designs: - Decreased cost, increased availability - Increased use, lower age of initiation - Increased prevalence of Cannabis Use Disorders - Increased prevalence of associated problems (medical / social) - Increased Treatment Utilization

67 Conclusions - Cannabis / cannabinoid has been trending upward, likely to continue to increase among youth (legal status, price decrease, reduced perception of risk, enticing products, vaping, advertising) - Might be on a trajectory towards becoming a class of substance with more potential for harm (enticing products including edibles, increased potency in those products, more efficient methods of delivery, and surely other modifications that will increase its allure).

68 As legalization is seriously considered, it would be advantageous to go at least six deep when discussing policy, its implications, and the procedures necessary to meet the end goals...to date we have barely begun to scratch the surface of what might make good policy and regulation!

69 Medical MJ: Trojan Horse Calling medical marijuana the "Trojan horse of the new millennium," Andrea Barthwell, deputy director for demand reduction for the White House Office of National Drug Control Policy, criticized the use of medical pot and said the drug is a public-health threat.

70 Is Opinion Changing??? Suffolk University /USA Today poll finds that now only 46% of likely voters support Amendment 64, the constitutional amendment legalizing and commercializing marijuana. 50% of likely voters oppose the measure entirely. That is a marked difference from election night 2012, when 55% of voters supported the measure. Even fewer people 42% of likely voters approve with the way the state is handling the legal change

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72 How Science Reporting Works

73 THE END!!