James Boal, M.D.

MMedical di l MMarijuana ij iin Mi Michigan hi
Four Years Later
James Boal M.D.
Medical Director, Angela Hospice
The Case
• Same effect with other muscle relaxers
• Sees primary physician who suggests
medical marijuana
• Certification by PCP
• Application to state
• Given list of “providers”
• Orders online or by phone
• Delivered by courier to home
States which allow Medical
Marijuana:
• Alaska
• California
• Colorado
• Hawaii
• Maine
• Montana
• New Jersey
• Arizona
• MIchigan
• Nevada
• New Mexico
• Oregon
• Vermont
• Rhode Island
• Washington
• (Washington D.C.)
The Case
• 61 year-old female with a history of
chronic progressive multiple sclerosis
• Not a candidate for immune-modulating
therapy py
• Suffers painful, debilitating spasticity that
interferes with work, sleep
• Neurologist prescribes baclofen, but
patient finds it sedating, causes
“hangover”
Medical Marijuana
•On Nov. 5th , 2008 the state of Michigan
passed Proposition 1, a legislative
initiative to allow individuals with certain
medical conditions to use and cultivate
marijuana for medical purposes.
Passed by 63% of the vote.
What is Marijuana?
• Dried flowers and leaves of the plant
cannabis sativa. (roots and stems have no
pharmacoactive agents)
• Marijuana contains over 400 chemicals 60
• Marijuana contains over 400 chemicals, 60
of which are called cannabinoids.
– delta-9-tetrahydocannabinol. (9-THC)
– Cannabidiol (CBD)
– Cannabinol (CBN)
10/30/2012
1

Delta-9-THC
• Highly lipophilic drug that causes hallucinogenic effects
by binding to cannabinoid receptors in the central
nervous system, liver, innervation of blood vessels.
(CB1) It also binds in the Immune system, and peripheral
nerve endings (CB2).
• Smoked form of THC has rapid bioavailability and onset
(minutes), but also short lasting effects (1-2 hours).
• Oral THC peaks 1-3 hours after ingestion, but lasts up to
eight hours.
– Marinol (Dronabinol) – Schedule III
– Cesamet (Nabilone) – Schedule II
History cont…
• 1996 California and Arizona vote to legalize
marijuana for medicinal purposes.
• In 1997 the Clinton administration authorized the
NNational ti l AAcademy d of f SSciences i IInstitute tit t of f
Medicine to research potential medical benefits
of marijuana.
• The 1999 report did find some benefit to the use
of cannabinoids which are found in Marijuana.
What has Marijuana
Been Indicated For?
Appetite Stimulation
Nausea Control
Pain Management
Muscle Spasticity
Seizure control
Glaucoma
History of Marijuana Use
• Long history of use for hallucinogenic effects.
• Was an accepted and used drug in the medical
community early in the twentieth century.
• Made illegal by Congress in 1942
• Placed as a Schedule 1 drug under the
Controlled Substances Act of 1970
Relevant Literature
• Janet E. Joy, Stanley J. Watson, Jr., and
John A. Benson, Jr. Marijuana and
Medicine Assessing the Scientific Base.
National Academy of Sciences 1999
• “Therapeutic Role of Marijuana”, American
College of Physicians, a position paper,
2008
Use for Appetite Stimulation
• THC has been shown to improve appetite
and give modest weight gain in AIDS
related wasting.
– Woolridge, “Cannabis use in HIV for Pain and Other Medical Symptoms”, Journal
of Pain and Symptom management 2005, 29 (4)
• But, it was shown to be less effective than
Megace 800mg TID.
– Mayo Clinic Report, May 13, 2001.
10/30/2012
2

Use for Nausea
• Studies of chemotherapy patients with nausea
and vomiting showed THC to be equal or
superior to compazine and metoclopromide.
• No available studies compare with 5-HT3 drugs
(Zofran, ( Kytril, y Anzamet) ) in chemotherapy py
patients.
– Musty R, Rossi R “Effects of Smoked Cannabis and Oral delta 9 THC on Nausea and
Emesis after Chemotherapy” Journal of Cannabis Therapeutics 2001; 1(1) 5-27
• IOM concluded that cannabinoids are “modest
anti-emetics, effective for those who respond
poorly to typical antiemetics.”
– Joy, JE Marijuana and Medicine: Assessing the Science Base, National
Academy of Sciences, 1999
Use in Epilepsy
• Cannabidiol (CBD) but not THC has been
indicated as a possible treatment for
preventing seizures. CBD has been
shown to prevent or induce seizures
depending on the animal it was tested on.
• No well established human trials
– Robson P. Therapeutic Aspects of Cannabis and Cannabinoids. British
Journal of Psychiatry 2001; 178: 107-15.
Use for Glaucoma
• Cannabinoids have been shown to reduce
intraocular pressure.
– High doses are required to produce any effect.
• Doses that cause significant psychoactive and cardiovascular
effects
– Effect only lasts 33-4 4 hours after use use.
• No long term change in disease course
– Topical form ineffective
• “IOM and AOA have concluded that
there are no increased benefit or
decreased risks compared to current
available treatments.”
“Therapeutic Role of Marijuana, Position paper”
American College of Physicians 2008
Use in Analgesia
• Smoked marijuana has shown effectiveness in
treating cancer pain similar to the effects of
codeine.
– Narrow Therapeutic Window
– Also has been shown to increase a persons sense of
pain.
• The biphasic nature of the drug (stimulation followed by
sedation) increases and then decreases pain.
– Wallace MS, et al. Dose-dependent effects of smoked cannabis on capsaicininduced
pain and hyperalgesia in healthy volunteers. Anesthesiology 2007; 107
Use in Multiple Sclerosis
• Some anecdotal and limited clinical trial data
suggested that THC provided relief from
spasticity and tremor in MS and related
illnesses, however the psychoactive effects
impaired balance and posture among the same
patient group.
– Consroe P, Musty R, Rein J, Tillery W, Pertwee R. The Perceived Effects of Smoked
Cannabis on Patients with Multiple Sclerosis. European Neurology: 38: 44-48.
• “The Society cannot at this time recommend that
medical marijuana be made widely available to
people with MS for symptom management.”
– Recommendations Regarding the Use of Cannabis in Multiple Sclerosis, National
Clinical Advisory Board of the National Multiple Sclerosis Society 2009
Other Claims
Parkinson’s
Alzhiemer’s
Asthma
Solid Body Tumor reduction
Solid Body Tumor reduction
Crime
Economy
Environment
10/30/2012
3

Adverse effects (Acute)
• Psychoactive
– Anxiety / Panic attack
– Hallucinations
– Short term memory impairment
– Acute psychosis
– Delusions
– Decreased motor skills
• Cardiovascular
– Tachycardia
– Orthostatic Hypotension
Marijuana and Schizophrenia
• Meta-analysis of 83 studies involving 22,000
patients found that people who smoked
marijuana developed psychotic disorders an
average 2.7 years earlier than people who did
not use cannabis cannabis.
• “The results…support the hypothesis that
cannabis use plays a causal role in the
development of psychosis in some patients”
• Large, Matthew et. al “Cannabis Use and Earlier Onset of Psychosis”
Archives of General Psychiatry Published online February 7, 2011
Summary of the Data
• Marijuana has been shown to have some benefit
for appetite, nausea, pain.
– However, other drugs that are on the market –
including THC analogs – have similar or superior
results to marijuana.
• Marijuana has side effects and drug interactions
just like any other pharmacologic substance.
Some of which are significant.
Adverse Effects (Chronic)
• Similar to tobacco smoking
– Increased risk of cancers
– COPD
– Bacterial pneumonia
– Pregnancy loss/ stunted fetal growth
• Tolerance and withdrawal (mild)
• Low lethal toxicity
• “Except for the harms associated with smoking, adverse
effects of marijuana use are within the range of effects
tolerated for other medications.”
– Joy JE, Watson SJ, Benson JA. Marijuana and Medicine: Assessing the
Science Base. National Academy of Sciences, Institute of Medicine. Washington,
DC; 1999.
Drug interactions
• Marijuana decreases the blood levels of
certain medications for treating HIV
– Indinavir
– Nelfinavir
– Ritonavir
• Increases blood levels of:
– SSRIs
–Warfarin
– Benzodiazepines
Concerns about the Use of
Smoked Marijuana
• The content of THC can vary from 0.3% to 15%
depending on the breed of plant.
• The multiplicity of chemicals in marijuana marijuana.
• The consistency of drug dosing by smoke
inhalation.
• The use of smoking to administer any drug.
10/30/2012
4

Marijuana Culture
#1 non-prescription drug of abuse
Movies
Museums
Marijuana Music Awards
Recipes involving marijuana
Multiple international organizations
Religious sacrament
Organizations that oppose the use
of Medical Marijuana
• American Medical Association
• American Cancer Society
• American Academy of Pediatricians
• National Multiple Sclerosis Society
• American Ophthalmologic Association
• Food and Drug Administration
• Drug Enforcement Agency
DEA listing
• Marijuana is properly categorized under
Schedule I of the Controlled Substances Act
… The clear weight of the currently available
evidence supports this classification,
including evidence that smoked marijuana
has a high potential for abuse, has no
accepted medicinal value in treatment in the
United States, and evidence that there is a
general lack of accepted safety for its use
even under medical supervision.
DEA position on Marijuana, January 2011
Organizations that Support the use
of Medical Marijuana
• New England Journal of Medicine
• American Academy of Family Physicians
(Limited use)
• American Bar Association
• American Society of Addiction Medicine
• American Psychiatric Association
• Lymphoma Foundation of America
• American Nurses Association
AMA 2009
• Our American Medical Association (AMA) urges that marijuana’s
status as a federal Schedule I controlled substance be reviewed with
the goal of facilitating the conduct of clinical research and
development of cannabinoid-based medicines. This should not be
viewed as an endorsement of state-based medical cannabis
programs, the legalization of marijuana, or that scientific evidence
on the therapeutic p use of cannabis meets the current standards for a
prescription drug product.
• “CSAPH REPORT 3 – USE OF CANNABIS FOR MEDICINAL PURPOSES” AMA
position statement 2009
• "Despite more than 30 years of clinical research, only a small number of
randomized, controlled trials have been conducted on smoked cannabis,"
[Limited studies are] "insufficient to satisfy the current standards for a
prescription drug product.” – Dr. Edward Langston, AMA board member
CBS interview Nov. 11 2009
Federal Drug Law
• Illegal to use or sell marijuana anywhere in
the country
• Illegal to transport the drug
• Ill Illegal l tto bbuy seeds d ffor th the plant
l t
10/30/2012
5

Michigan Medical Marijuana Act
Proposal 08-1
How the Law Works
• A person with a defined “debilitating medical condition” presents to
their physician whom they have a “bona fide” relationship with.
• The attending physician (MD or DO) completes a full assessment of
the patient’s history or states that in their professional opinion that
medical marijuana would help the condition.
• The physician provides sends written certification directly to the
Michigan Department of Health*.
• The department of health registers both an individual to use marijuana
and a “primary caregiver” to grow marijuana in a “closed, locked
facility.”
• The patient receives the drug from the primary caregiver.
• *Department of Licensing and regulatory affairs since April 2011
Protections
• Registered users will not have legal action taken
against them if one:
– Possesses up to 2.5 ounces of Marijuana
– Grows up to 12 plants
– Smokes in front of a child
– Has a registration from another state
• It also protects an individual if one:
– Sells paraphernalia to a registered individual
– Is in the presence of a registered user
– Assists a registered user to take the drug
– Provides marijuana for up to 5 individuals
– Receives compensation for providing the marijuana
Proposal 08 -1 (Michigan)
• The proposed law would:
• Permit physician approved use of marijuana by registered patients
with debilitating medical conditions including cancer, glaucoma, HIV,
AIDS, hepatitis C, MS and other conditions as may be approved by
the Department of Community of Health.
• Permit registered g individuals to ggrow limited amounts of marijuana j for
qualifying patients in an enclosed, locked facility.
• Require Department of Community Health to establish an
identification card system for patients qualified to use marijuana and
individuals qualified to grow marijuana.
• Permit registered and unregistered patients and primary caregivers to
assert medical reasons for using marijuana as a defense to any
prosecution involving marijuana.
Definitions
• “Debilitating Medical Condition”
– “means 1 or more of the following: cancer, glaucoma, HIV +, AIDS,
HCV, ALS, Chron’s Disease, Alzheimer’s, nail patella syndrome, MS,
cachexia (wasting), severe and chronic pain, severe nausea, seizures,
severe and persistent muscle spasms”
– Any other approved condition or treatment by the Department of Health.
• “Enclosed, Locked Facility”
– “closet, room or other enclosed area equipped with locks or other
security devices”
• “Primary Caregiver”
– “A person who is at least 21 years old and who has agreed to assist
with a patient’s medical use of marijuana and who has never been
convicted of a felony.”
Penalty
• If a registered patient or primary care giver
sells to a non-registered individual:
– Up to 2 years in jail and/or
– Up to $2,000 fine
p $ ,
– Plus other violations of state laws.
10/30/2012
6

Registration
• Patients who wish to register need to submit:
– Photo ID
– Written certification from their doctor
– Application fee
– Name, address and date of birth unless you are homeless
– Name, , address and phone p number of the physician p y
– Name, address and date of birth of the primary caregiver.
• List of other users the primary caregiver supplies marijuana to.
• Registrations expire after a year but may be renewed.
• Registrations are to be kept confidential
What Users Cannot do:
• Undertake a task that would constitute negligence or
malpractice
• Use or possess medication:
– In a school bus
– On primary or secondary school grounds
– In a correctional facility
• Smoke marijuana on public transportation or in a public
place
• Operate a motor vehicle
THCF Clinics
• Clinics that are set up in various states to allow
people to have access to marijuana:
– Employ seven doctors With multiple state medical
licences for the purpose of to signing off on medical
marijuana ij use.
– “If a patient's personal care physician is unwilling to
sign off on their registration application packet, we
have one that will." Brian Schreckinger –
spokesperson for THCF
Registration for Minors
• Physician must discuss the risks/benefits
with the patient’s parents or legal
guardian.
– Must consent in writing
– Be willing to be the primary caregiver
– Control the use of the drug by the minor.
• Need written certifications from two
physicians.
The Laws Do Not Require:
Insurance providers to reimburse costs
Employers to make accommodations
for use
10/30/2012
7

Dispensaries
Over 100 dispensaries
In Michigan
April 2011 – Appeals court
Made dispensaries illegal.
Currently before State
Supreme Court.
Where are We Now?
• Michigan has over 121,043 registered
users. (LARA website)
– 2194 doctors have referred
– 55 doctors wrote for 71% of referrals
• 25,199 registered caregiver
• Top Ailments
– Chronic Pain
– Muscle Spasms
– Nausea
– Cancer (2.2%)
New Laws
• June 2012 – State Supreme Court
affirmed that one does not need a
registration card to use medical marijuana
• Aug 2012 – State Appeals court said that
local communities could not ban the
growing of marijuana by registered
caregivers.
10/30/2012
8

My Concerns About Medical
Marijuana Laws.
• The laws are not based not based on current
science and may mislead patients and health
care workers.
• The laws circumvents normal health protections
for any prescribed medication.
Back to the Case
• Pros
– Excellent relief of
spasticity
– No hangover
– Duration of action
(works through night
when used in evening)
– Cannot be combined
with alcohol, other
medications
• Cons
– Cannot work, drive
while “medicated”
– Effect on gait
– Expense
– No direction from PCP
about “dosing”
– Highly variable effects
depending on “blend”
– Overall, disappointed
The End
My Concerns About
Recommending Medical Marijuana
• There are no unique medical properties of medical
marijuana that are not currently available through
prescription canabinoids or multiple other drugs.
• There are no safety regulations for the use of the drug in
our patients. ti t RResearch h ddata t iis still till poor.
• There is a high risk of diversion and abuse.
• It is still against the law.
– “The Act neither protects marihuana plants from seizure nor
individuals from prosecution if the federal government chooses
to take action against patients or caregivers under the federal
Controlled Substances Act.” -MDOCH
The Case
10/30/2012
9