Download Medical Marijuana Pros and Cons

Marijuana in Colorado
Scott Humphreys, MD
Associate Medical Director
Colorado Physician Health Program
April 10, 2015
8TH ANNUAL
NEUROMEDICINE CONFERENCE
The Medical Center of Aurora
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Cannabis
• Complex alkaloid mixture of more than 400
compounds derived from the Cannabis sativa
plant
• 60 different compounds described with activity
on the cannabinergic system
• Most abundant cannabinoids are
– Delta-9 tetrahydrocannabinol (most psychoactive)
– Cannabidiol
– Cannabinol
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History of Marijuana
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History of Marijuana
• 6000 BC – Cannabis seeds used as food in
China
• 4000 BC – Textiles made of hemp in China
• 2727 BC – first recorded medicinal use in
Chinese Pharmacopoeia
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History of Marijuana
• 1400 BC to AD – trade moves product
through India, Mediterranean countries,
Europe – numerous medicinal uses
reported
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History of Marijuana
• 3rd century Rome – Used for sails and
ropes
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History of Marijuana
• 1378 – Emir of the Ottoman Empire makes the
first edict against eating hashish or smoking
cannabis – 1st “War on Drugs”
• 1798 – Napoleon declared total prohibition on
marijuana after realizing much of the Egyptian
lower class were habitual smokers
• 1868 – Egypt – 1st modern country to outlaw
cannabis ingestion
• 1890 – Hashish made illegal in Turkey
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History of Marijuana
• Introduced to North America in 1600s by
Puritans – Hemp for ropes, sails, clothing;
cannabis a common ingredient in
medicines, sold openly in
pharmacies…..lucrative
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History of Marijuana
• 1937 – Marijuana Tax Act (MTA) – transfer
of cannabis illegal throughout US except
for medicinal and industrial use, expensive
excise tax and detailed logs required
• 1969 – MTA found to be unconstitutional
since it violated 5th Amendment privilege
against self-recrimination
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History continued
• 1970 – Controlled Substance Act – classified cannabis as
having:
–
–
–
–
–
High abuse potential
No medical use
Not safe to use under medical supervision
All use proscribed by law
(i.e. a Schedule I drug)
• 1975 – FDA establishes Compassionate Use Program:
– Glaucoma
– Multiple Sclerosis
– Cancer (Cachexia, Nausea)
• 1986 – Dronabinol placed into Schedule II by DEA
• 2003 – Canada – 1st country in world to offer medical
marijuana to patients
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Epidemiology
• By 2001 more than 12 million Americans
(about 5% of the population) were using
marijuana on a monthly basis (average of
18.7 joints)
(SAMHSA, 2002)
• 39% of adult male arrestees and 26% of
adult female arrestees tested positive for
marijuana, as did 53% of the juvenile male
and 38% of the juvenile female arrestees
(DEA, DAWN, ADAM, 2003)
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High Rates of Past Year Dependence or Abuse on
Marijuana (Comparison to other Drugs Among
Persons 12 or older, 2010)
Source: SAMHSA, 2010
NSDUH
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In 2009, Reports of Past Month Use of Marijuana
Among 12th Graders Exceeded that of Cigarette for the
First Time in the Survey’s History
SOURCE: University of Michigan, 2011 Monitoring the Future Study
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Changes in Attitude Lead to Changes in Use:
Marijuana Use and Perceived Risk in 12th Graders,
(1975 to 2010)
Past
PastYear
YearUse
use
Perceived
Perceived Risk
Risk
60
50
30
20
10
09
07
05
03
01
99
97
95
93
91
89
87
85
83
81
79
77
0
75
Percent
Percent
40
Source: The Monitoring the Future study, the University of Michigan
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Proportion of sample dropping out
between ages 16 and 18
Early Marijuana (and other drug) Use Linked to Dropping Out of School
Source: Bray et al. Health Economics, 9(1), pp. 9-18, 2000.
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Cannabis Use and Later Life Outcomes are Dose Dependent
% welfare dependent
(ages 21-25)
400+
300 to
399
200 to
299
% Unemployed (ages 21-25)
100 to
199
1 to 99
Mean personal income
In thousands of NZ dollars
at age 25
% gained university degree
by age 25
Never
Number of occasions
using
Cannabis ages 14-21
Source: Fergusson and Boden. Addiction, 103, pp. 969-976, 2008.
Addiction: About 9% of cannabis users may
become dependent
Percent of users who
Become addicted
Comparative Prevalence of
Dependence
Among Different Drug Users
*
* Nonmedical Use
pp.244-268 (1994)
*
Source: Anthony et al. Exp. Clin. Psychopharmacol. 2(3),
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PHARMACOLOGY OF MARIJUANA
THC CONCENTRATIONS
• - ordinary; average of 3 percent THC
• - sinsemilla; average of 7.5 percent THC,
can be 24 percent
• - hashish; averages 2 to 8 percent THC,
can be 20 percent
• - hash oil; averages 15 to 50 percent
THC, but can be 70 percent+
Source: 2006 NIDA Report
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Blasting – Dabs (90%)
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Butane (Infused) Hashish Oil - BHO
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Butane cans and mind altering substance;
what could go wrong?
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Metabolism of Marijuana
• Massive first pass metabolism via the oral
route – only 10-20% reaches systemic
circulation unchanged – takes 30 – 60
minutes to achieve an effect – key side effect
on CNS can be dysphoria rather than
euphoria
• Via the lungs – onset of action within seconds
– “high” experienced with serum
concentration of 3 ng/ml, produced by as
little as 2-3 mg D9-THC, average “joint”
contains 0.5 – 1.0 g of cannabis
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Drugs Can be Chemical Imposters
(THC mimics a natural brain chemical)
Brain’s Chemical
Drug
Anandamide
THC
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COGNITIVE EFFECTS OF
MARIJUANA
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Marijuana and Cognitive Impairment
Messinis et al. Neurology 2006;66:737
Use of 4 joints or more per week resulted in
a decrease in mental test performance,
subjects who smoked regularly for a decade
or more did the worst
Long-term marijuana users were impaired
70% of the time on a decision making test,
compared to 55% for short-term users and
8% for non-users
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Marijuana and Cognitive Impairment
Pope et al. JAMA 1996;275:521
Heavy marijuana use (daily for at least one
month) is associated with residual
neuropsychological effects even after a day of
supervised abstinence from the drug
Unknown whether this is due to residue of
drug in the brain, withdrawal effects or frank
neurotoxic effect of the drug
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5 years later…
Pope et al, Arch of Gen Psych
•
•
•
•
Heavy users (5000+ lifetime uses)
Control group
28 day washout
Cognitive differences 1 week out but these
resolved by 1 month cessation
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Microcog and Habituated MJ Users
Hart et al; 2001 Neuropsychopharmacology
18 MJ users – avg 24 joints/wk
Within participant double-blind design
Prior to testing 1 joint (0%, 1.8% or 3.9% THC)
Subjective feelings of being “high” correlated with
THC concentration
• Premature responses were increased and time to
finish
• But, no sig difference in cognitive flexibility, mental
calculation or reasoning.
•
•
•
•
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Cog decline childhood to mid-life
(Meier et al, PNAS 2012)
•
•
•
•
•
•
Prospective study (n-1037)
Followed from birth to age 38
Neuropsych testing 13yo and 38yo
Controlled for years of education
6pt decline in IQ in heavy users!
Finding further suggest most of the
damage is likely done in adolescence and
not fully restorable
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Marijuana and Driving
•
•
•
•
•
•
•
- impairment dose related
- 60% failed field sobriety test 2 1/2 hours after moderate smoking
- impairment documented 3-8 hours later (Hollister, 1986)
- low amounts, diminished ability to perceive and respond to changes on
the road
- did not make appropriate speed adjustments
-induces drowsiness and impairs judgment (Mathias, 1996)
- with alcohol, performance worse
)
(SAMHSA/NHTSA
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The Lower Baseline Cerebellar Metabolism in
Marijuana Abusers is likely to Result in Motor
Deficits
Control
Marijuana Abuser
Cerebellum/Whole Brain
1.2
1.15
1.1
p < 0.01
1.05
1
0.95
0.9
0.85
0.8
Control
Abuser
Source: Volkow et al., Psychiatry Research: Neuroimaging, 67, pp. 29-38 (1996).
Marijuana and Driving
Sewell et al. Am J Addictions 2009;18:185-193.
• Laboratory tests and driving studies show
that cannabis may acutely impair several
driving-related skills in a dose related fashion
• Effects between individuals vary more than
for alcohol because of tolerance, differences
in smoking technique, and different
absorptions of THC
• More pronounced with highly automatic
driving functions; less with complex tasks
that require conscious control – opposite
from that seen with alcohol
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MJ level vs. BAL
• Studies of sobriety tests suggest 5ng/mL =
0.8BAL
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Effects of Marijuana Intoxication and Pilot
Performance
Am J Psychiatry 1985;142:1325-1329
• Ten experienced licensed private pilots
trained for 8 hours on a flight stimulator
landing task
• Each smoked a THC cigarette (19 mg)
• 24 hours later their mean performance on
the flight task showed trends toward
impairment in all variables, some tasks
showed significant impairment
• Despite the deficits, the pilots reported no
awareness of impaired performance
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MEDICAL CONSEQUENCES OF MJ USE
Marijuana use and Cancer risk
• Marijuana smoke contains several of the
same carcinogens and co-carcinogens as
tobacco smoke
• Benzo[α]pyrene, a procarcinogenic polycyclic
aromatic hydrocarbon, is present in
marijuana tar at higher concentrations than
in tobacco tar
• Marijuana smoking involves inhalation of 3
times the amount of tar as tobacco smoke
• Exposure is magnified due to differences in
smoking a “joint” versus cigarette
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Cancer Studies involving Marijuana
• Studies are small in number and are
retrospective in nature
• Confounded by concomitant use of tobacco
• Confounded by underreporting of marijuana
use because such use is often illegal
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Cannabis use and risk of Lung Cancer
Aldington et al. Eur Respir J. 2008;31:280-286
• Case-controlled study of lung cancer in adults
< 55yrs of age in New Zealand
• 79 cases of lung cancer and 324 controls
• Risk of lung cancer increased 8% for each
joint-yr (1 joint/day for one year) of cannabis
smoking after adjustment for confounding
variables including tobacco
• Risk increased 7% for each pack-yr tobacco
• “Long-term cannabis use increases risk of
lung cancer in young adults”
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Head and Neck Cancers
Zhang et al. Cancer Epidemiol Biomark Prev 1999;8:1071-1078.
• Retrospective, case-controlled study, 173
proven cases of head and neck cancer and
176 controls matched with respect to age,
sex, race, education, tobacco, alcohol use
• Risk of cancer 2.6 fold greater in cannabis
users than non-users
• 3-fold greater increase in those < 55 yrs
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Other Cancers
• Sidney et al. Cancer Causes Control
1997;8:722-728.
– In a cohort study – among non-tobacco smokers,
ever-marijuana smokers had increased risk for
prostate cancer - RR=3.1, and cervical cancer RR=1.4
• Efird et al. J Neurooncol 2004;68:57-69
– Another cohort study found an increased risk of
malignant primary adult-onset glioma for evermarijuana smokers – RR=1.9
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Marijuana’s Impact on the
Cardiovascular System
• Tachycardia is a common side effect of using
smoked marijuana
• The risk of a heart attack is 5X higher than
usual in the hour after smoking MJ
• According to Harvard Researchers
Psychiatric Times 27(1) - 2010
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MARIJUANA ABUSE AND
DEPENDENCE
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Marijuana and Addiction
• Approximately 10% of regular marijuana
users become addicted to it
• Compared with 15% for alcohol, 32% for
nicotine and 26% for opiates
• Newer studies to revisit this are warranted
due to the much higher concentrations of
THC (up to 28%) available now compared to
the 1970s
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The number of adults with
substance use disorders is
trending upward and expected
to double by the year 2020
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Colorado ranks 5th in the nation
for adolescent marijuana use.
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MEDICAL MARIJUANA
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MMJ IS NOT GOING ANYWHERE
BECAUSE IT IS TAXED LESS THAN
RECREATIONAL MJ
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MMJ vs FDA Approved Medications
• Marijuana purchased from dispensaries has not been formally
investigated for safety and efficacy
• No standardizations for therapeutic dosing have been
established
• THC content can range in strength
• Marijuana is not monitored/regulated for purity
(contaminants include pesticides, molds, herbicides)
• Unlike FDA approved drugs – no post marketing surveillance
• MJ is not subject to liability regulations
• MJ has bypassed the Colorado Prescription Drug Monitoring
Program (despite being a Schedule I drug)
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ASAM’s Observation
“Pharmaceutical companies are responsible for
the harms caused by contaminated or
otherwise dangerous products and tobacco
companies can be held accountable for harm
caused by cigarettes, yet MMJ dispensaries
distribute cannabis products about which
very little is known including their
source………Efforts are being made to stem
the epidemic of prescription drug abuse,
including FDA-mandated risk management
plans required for prescription medications,
yet cannabis distribution sites proliferate in
many states, virtually without regulation.”
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The Hippocratic Oath
• First……….do no harm
• The practice of medicine is a
privilege……. not a right!
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1975 Compassionate Use – not based on any
research
• Glaucoma - #1 cause of blindness
• 1992 – American Academy of Ophthalmology’s
Committee on Drugs – no scientific verifiable
evidence that the use of marijuana is safe and
effective in the treatment of glaucoma
• 1997 – NEI – no studies have demonstrated that
marijuana can safely and effectively lower IOP any
more than a variety of drugs on the market
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Glaucoma
• 1999 – Institute of Medicine – although IOP can
be reduced by using cannabinoids and marijuana,
the effect is too short lived and requires too high
doses.
• There are too many side effects to recommend
lifelong use in the treatment of glaucoma
• Would have to smoke 10-12 “joints” per 24 hours
to maintain low IOP through out the day
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Research Issues
• MJ is a Schedule I drug – a barrier to conducting prospective RCTs,
DB w/ placebo
• Studies are short - two weeks average, ranging from a few hours to
one year
• Most studies conducted with oral TCH preps rather than smoked
cannabis
• Most studies exclude anyone with a history of major psychiatric
disorder other than depression and/or history of substance abuse
• Most studies done to date:
– Short in length (average two weeks)
– Small N (lacking power)
– Retrospective in nature
– Confounded by uncontrolled variables
• Concomitant tobacco use
• Co morbid illnesses
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The fact that it is a botanical does not
preclude scientific investigation
•
•
•
•
•
•
Digitalis purpurea – fox glove - CHF
Papaver somniferum – opium poppy
Atropa belladonna – nightshade -IBS
Ephedra sinica – ephedrine - hypotension
Salix alba – willow tree - ASA
Taxis brevifolia – Pacific Yew tree – breast
cancer
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“Rocky Mountain High” Colorado
November 2000
Coloradoans passed Amendment 20
A small enterprise was envisioned
Colorado Department of Public Health and
Environment was tasked with implementing and
administrating the Medical Marijuana Registry
program
March 2001
Colorado Board of Health approved rules and
regulations
June 2001
MMJ Registry began accepting applications for
Registry Identification Cards.
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The Flood Gates Opened
• February 2009
– Obama administration indicated that Medical
Marijuana prosecution would have low priority
• October 2009
– Obama administration will not seek to arrest medical
marijuana users and suppliers as long as they conform
to state laws
• Applications increased dramatically
– September 2009 – 3,523 applications received/month
– December 2009 – 10,585 applications received/month
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The Expansion of Amendment 20
Storefront “Medical” Marijuana dispensaries
sprouted like weeds! (Pun intended)
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“There are more medical
marijuana dispensaries in
Denver than Starbucks and
liquor stores combined”
The Denver Post
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September 30, 2009
• 19,691 new patient
applications received
• 17,356 patients with
valid ID cards
• 73% male, average
age 40, 8 minors <18
• 57% in the
Denver/metro area
• 67% have designated
primary care-giver
• Over 800 different
physicians have
signed for patients in
Colorado
June 2010
• 99,559 new patient
applications received
• 88,900 patients with valid
ID cards
• 71% male, average age
39, 24 minors <18
• 58% in Denver/metro
area
• 66% have designated
primary care-giver
• Over 1,100 different
physicians have signed for
patients in Colorado
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Rules and Regulations
• “Patient will be deemed to have established
an affirmative defense to such allegation”
(possession of marijuana) where:
• Patient was previously diagnosed by a
physician as having a debilitating medical
condition
• Patient was advised by his or her physician,
in the context of a bona fide physicianpatient relationship, that the patient might
benefit from the medical use of marijuana in
connection with a debilitating medical
condition
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The Medical Practice Act
• Physicians should maintain adequate malpractice
coverage – let the buyer beware!
• Physicians should be able to evaluate for SUDs
• Physicians should engage in continuing education
– No certification available for MMJ practice!
• Physicians should only practice within their scope
of expertise
• A retired radiologist evaluating pain conditions?
• A psychiatrist recommending MMJ for a pregnant female
with Braxton Hicks contractions?
• An occupational medicine physician making MMJ
recommendations for HIV/AIDs patients?
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SB 109 - 2010
• Defines a bona fide relationship (MD-Patient)
• Physician must have unrestricted medical and
DEA licensure
• Addresses physician conflict of interest –
physician can not be employed by the
dispensary
• Allows CMB to examine care of providers
• Two physicians need to independently
examine those < 21 years old.
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Physicians Recommending Medical
Marijuana
• Should get a thorough history - medically,
psychiatrically and substance abuse – keep a
chart and have a patient/physician
relationship
• Should receive no pecuniary remuneration
from caregivers or dispensaries
• Will need to attempt to decide what level of
marijuana use is most appropriate
• Will need to recommend patients not drive
etc. when under the influence
• Should warn patients to avoid exposing
children and adolescents to marijuana
smoke
• Will need to follow patients closely for side
effects and unintended consequences
• Obtain informed consent
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Legalization of Recreational MJ
• January 1, 2014 – Recreation sales started
• Definitely popular but hard to assess
difference in use from illicit to legal
recreational
• Still federally illegal
• VA, University, Denver Health have zero
tolerance policies
• Any institution accepting federal money may
be at risk of losing that federal support
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How will CPHP Evaluate and
Monitor?
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Assess for Abuse and Dependence
•
•
•
•
C – CUT Down?
A – Do people ANNOY you?
G – Do you feel GUILTY?
E – Have you needed an EYE opener?
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DSM V Criteria
• Taking the substance in larger amounts or for
longer than the you meant to
• Wanting to cut down or stop using the
substance but not managing to
• Spending a lot of time getting, using, or
recovering from use of the substance
• Cravings and urges to use the substance
• Not managing to do what you should at work,
home or school, because of substance use
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DSM V Criteria (cont)
• Continuing to use, even when it causes problems
in relationships
• Giving up important social, occupational or
recreational activities because of substance use
• Using substances again and again, even when it
puts the you in danger
• Continuing to use, even when the you know you
have a physical or psychological problem that
could have been caused or made worse by the
substance
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DSM V (cont)
• Needing more of the substance to get the
effect you want (tolerance)
• Development of withdrawal symptoms,
which can be relieved by taking more of
the substance
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Urine Monitoring
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U/A’s are for SCREENING
• Show whether the client has used
cannabinoids within the past 1-90 days
• Does provide a quantitative level but
clinical significance is not direct
• Can monitor to show use has stopped –
values drift to zero
• Complicated by the fact that cannabinoids
are stored in the fat
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U/A’s (cont)
• Intitally immunoassay
• Confirmed by gas chromatography-mass
spectrometry
• Tests for THC-COOH
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Blood Monitoring
• Assesses for THC in the blood stream
• Directly related to the amount of active
rather than stored psychoactive substance
(THC)
• Detectable blood levels up to 2 weeks
after use in heavy users – leeching
• DUI in Colorado – 5 nanograms/ml
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Other Monitoring THC
• Saliva
• Hair
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Complete Eval
•
•
•
•
•
Workplace and personal collaterals
Personal interview
Tissue testing
Cognitive screening/testing
Assessment for comorbid conditions
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Physicians Using MMJ
• The Colorado Physician Health Program Policy
– Physicians suffering from a debilitating condition
requiring “treatment” with marijuana will be
considered unsafe to practice medicine with
reasonable skill and safety.
– This is due to significant cognitive impairment
associated with the use of MJ
– This is also due to the fact that it is virtually
impossible to establish a stable dose/serum level
due to variable concentrations of THC
– The CMB/DORA are also examining this issue
– No case law exists regarding this issue
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Physicians Using MJ
• Assess for substance disorder
• Counsel regarding risks – legal,
occupational, personal and health
• Advise client to stop using
• Tissue testing – often ongoing
© Colorado Physician Health Program 2015 All Rights Reserved
Please do not reproduce or use without written permission of CPHP
Contacting CPHP
Phone
• 303-860-0122 or 800-927-0122
Office Hours:
• 8:30 a.m.- 4:30 p.m.
• Monday – Friday
After Hours Clinical Emergencies:
• Pager: 303-916-8837
For additional information visit the CPHP
website:
• www.CPHP.org
© Colorado Physician Health Program 2015 All Rights Reserved
Please do not reproduce or use without written permission of CPHP