Marihuana new regulation policies and early results · Medical Marijuana Law States: 9.1% (6.2) THC...

Marihuana – new regulation policies and

early results?

Alan J. Budney, Ph.D. Geisel School of Medicine

at Dartmouth

CSAM October 16, 2014

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

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)

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.

1936

Reefer Madness

Reefer Madness

2014

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

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?

Marijuana /

Cannabis

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

Schubart et al. (2013); Neisink et al. (2013)

Inverse agonist -

CB1 receptor

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

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?

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

ProCon.org

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)

30-60 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

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.

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

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

How would you rate your knowledge of

herbal marijuana/cannabis effects?

0

20

40

60

80

100

120

140

160

0 1 2 3 4 5 Comprehensive None

0

100

200

300

400

0 to 2 3 to 5

Knowledge

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

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).

DEA Cannabis Seizures (Potency)

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

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



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



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

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 1983.

• 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!!

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

Products

Alternative Methods & Products

Edible Products

What about Vaping marijuana?

e-cig Use Rapidly Increasing (MMWR 2013)

No prevalence data, but,

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)

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

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)

National Data: Risk – Use ?

2013 (MTF)

Does Liberalizing Cannabis Laws Increase Use (Williams et al., 2014)

Australian Household Survey: 5 waves (1998-2010)

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

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)

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

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.

Do Medical Marijuana Laws Impact Teen Intent to

Use (Palamar et al., 2014)

N = ~10,000 HS seniors (MTF data base 2007-2011)

- 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.

Colorado Marijuana Use

Do Medical Marijuana Laws Impact Perception of

Risk: Colorado vs. NMML States (Schuermeyer et al., 2014)

Do Medical Marijuana Laws Impact Use:

Colorado vs. NMML States (Schuermeyer et al., 2014)

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


Accidents (Anderson et al., 2013)

Ages 15-19



Ages 20-39



Ages 40 +


Accidents (Masten et al., 2014)

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

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?

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).

Colorado Data

Review of Overall Impact

28 studies

Main findings reviewed according to

- illegal cannabis use;

- other public health issues;

- crime

- neighborhood disadvantage

Conclusions: All Inconclusive!

Sznitman et al. 2014

Cannabis for Therapeutic Purposed and Public Health

Advertising

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??

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?

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

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

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).

• 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!

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….

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

How Science Reporting Works

THE END!!

Marihuana new regulation policies and early results · Medical Marijuana Law States: 9.1% (6.2) THC...

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