Transcript January 2012 Wayne State Law School Symposium on Marijuana

Law School Marijuana Symposium
January 27, 2012
Jesse Vivian, RPh, JD
Professor of Pharmacy Practice
College of Pharmacy and Health Sciences
2144 Applebaum
Office Phone: 313-577-5389
E-Mail: [email protected]
WebPage: http://jessevivian.net
Pharmacognosy
• The discipline of finding active ingredients in humans
from natural plant resources
–
–
–
–
Digoxin --from purple Foxglove
Caffeine --from Camellia sinensis (tea) and Cocoa plants
Camphor –from Camphor tree bark
Codeine --from Papaver somniferum (poppy seeds)
• Other natural sources
– Conjugated Estrogens (Premarin) --horse urine
The problem with Marijuana is:
• We don’t know what it is scientifically
– It has 400 different chemicals in its makeup
– We don’t know which of the cannabinoids does what
• Some known basic types of cannabinoids
– Δ-9 Trans Tetrahydrocannabinol (THC)
– Δ-8 Trans-Tetrahydrocannabinol (also THC)
– Cannabichromene (CBC)
– Cannabidiol (CBD)
– Cannabicyclol (CBL)
– Tetrahydrocannabivarin (THC)
• Synthetic cannabinoids (500 x THC strength)
• Other Entities of potential activity:
– Terpenoids
– Terpenes
•
–
http://www.420magazine.com/forums/cannabis-facts-information/76763-marijuanacannabinoids-thc-cbd-cbn.html
We don’t even know how to spell it—marihuana- Latino spelling
–
MICHIGAN MEDICAL MARIHUANA ACT (333.26421 - 333.26430)
No Good Science on Activities of
Various ingredients
• Many varieties of Hemp plants and each one has
different characteristics
– Most Common Hemp Plant: Cannabis Sativa)
• Cannabinoids
– Type, quantity, quality affect different chemical receptors
in human brain and other body organs
• Other Components (ex:Terpenes)
– Essential oils of plant material
• At Lest 16 Terpenes known to be in vast
majority of analyzed marijuana samples.
– No scientifically accepted theory on how
various Terpenes affect cannabinoids
Some More Science
• The high lipid-solubility of cannabinoids results in their
persisting in the body for long periods of time.
• Even after a single administration of THC, detectable
levels of THC can be found in the body for weeks or
longer (depending on the amount administered and the
sensitivity of the assessment method).
• A number of investigators have suggested that this is an
important factor in marijuana's effects, perhaps because
cannabinoids may accumulate in the body, particularly
in the lipid membranes of neurons
http://www.ncbi.nlm.nih.gov/pubmed/3529128
Some More Science
• Researchers have now confirmed that THC exerts its
most prominent effects via its actions on two types of
cannabinoid receptors, the CB1 receptor and the CB2
receptor, both of which are G-Protein coupled receptors.
The CB1 receptor is found primarily in the brain as well
as in some peripheral tissues, and the CB2 receptor is
found exclusively in peripheral tissues.
•
http://en.wikipedia.org/wiki/Cannabinoid_receptor
Scientific Fact:
• The type of plant, the
weather, the soil, the time of
harvest, and other factors
determine the strength of
marijuana
• Division of Alcohol and Drug Abuse
• http://www.well.com/user/woa/fspot.htm
Some Science Technology
• Gas Chromatograph analysis of two samples:
Michigan Testing Authority (MTA), Kalamazoo
Junk Science
• Daubert (Dilbert)?
• First Sample:
Junk Science
• Second Sample:
Compare Claimed Effects
Note Scales on
Y-axis are
different in the
two samples
and that there
is no
description of
what these
indexes are
measuring
Note lack of description of how X-axis is determined
Other Problems with Marijuana
• Michigan must be a Latino state because we are the only
ones who spell it marihuana.
• MICHIGAN MEDICAL MARIHUANA ACT (333.26421 333.26430)
• Pushing dealing Underground
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–
–
–
From whence does it come?
What are you buying? (Thousands of names for different strains)
How was it grown/harvested/dried?
Is it contaminated with something?
» It is NOT a DRUG
» It is not a drug of ABUSE
» It is not a GATEWAY Drug
Opinion
• Forced closure of dispensaries was an activity where
the consequences were not thought out carefully
– NOW BUYERS HAVE TO BUY UNDERGROUND where there are
no market forces-integrity and availability of a particular product
exist.
– In dispensaries the market force “let the buyer beware” governs
return purchasers
– Some people like Kroger meats, others like Meijer’s
– Prohibitionn and Abortion
FDA Pharmacy Law and Standards
• A state licensed pharmacist is
– entrusted by the state and federal governments to be a gatekeeper
– How has to guarantee the drugs dispensed to patients
• are safe and effective for their intended uses as approved by the FDA—HHS
(DEA—DOJ)
• that they have been made in clean sterile facilities as required by the very
strict CGMP regulations of the FDA,
• that the supply of drugs come only from manufacturers or distributors that
are licensed by the FDA to distribute prescription only drugs and not from
some “grey or black” market suppliers—like Canada
• that if these standards are breached the pharmacist’s license will be revoked
• and the pharmacist could be prosecuted for criminal misdeeds as well as
face civil liabilities if patients are harmed by drugs not compounded is
compliance with any of these mandates
DEA Pharmacy Law and Standards
• If the drugs a pharmacist dispenses are classified as
Schedule 2-5 controlled substances by the DEA,
– The pharmacist is required to make sure the dispensing is for a
legitimate medical purpose
– that the patient has a legitimate relationship with the prescribed
– that the prescription was written within the normal course of
practice by the prescriber
– that the pharmacist has taken reasonable precautions to
determine the drugs will not be diverted for illegitimate uses
– take precautions to insure CS drugs are stored in a manner so
as to prevent diversion, meaning having security measures in
place to prevent burglary and robberies—two of the fastest
growing crimes in the nation.
Federal Schedule I Substances
•
•
•
•
NOT DRUGS!
marijuana, heroin, LSD, peyote, methaqualones, ecstasy
Federal Definition of CS 1 substances
“have a high potential for abuse, have no currently
accepted medical use in treatment in the United States,
and there is a lack of accepted safety for use of the drug
or other substance under medical supervision.”
• http://www.deadiversion.usdoj.gov/schedules/
The problem with marijuana is
contextual
Drug Poisoning Deaths in the United States, 1980–2008
•
•
NCHS Data Brief ■ No. 81 ■ December 2011
http://www.ibhinc.org/pdfs/DrugPoisoningDeathsintheUS19802008.pdf
“For the first time in U.S. history, deaths from prescription drugs
outnumber deaths from motor vehicle crashes. Prescription drug
overdoses are at fault for nine out of ten drug poisonings as reported
by the Centers for Disease Control (CDC). Opioid analgesics were
involved in more than 50% of all drug poisoning deaths in 2008. The
Fix provides an overview of the latest CDC report and what is being
done to manage this growing problem. Xanax, OxyContin and Vicodin
are the top three drugs considered most dangerous based on the
number of drug-involved emergency room visits reported in 2009.”
http://www.ibhinc.org/newsandpubs.html
» Whole story in: The Fix: America's Killer Med Crisis
» http://www.ibhinc.org/pdfs/TheFixAmericasKillerMedCrisis.pdf
Context
•In California, more people die in car accidents while
intoxicated with prescription drugs than while inebriated
with alcohol.
http://www.adp.ca.gov/youth/prescriptiondrugs.shtml
“Drug deaths now outnumber traffic fatalities in U.S., data
show: Fueling the surge are prescription pain and anxiety
drugs that are potent, highly addictive and especially
dangerous when combined with one another or with other
drugs or alcohol. Los Angeles times, September 17, 2011
http://articles.latimes.com/2011/sep/17/local/la-me-drugs-epidemic-20110918
Question: if you are intoxicated with any
substance and cause a traffic fatality,
what difference does it make wheat you
were inebriated with?
Surveys
• Michigan Pharmacists Association (General Council)
– April 2010
• 63% independent pharmacists said the would dispense marijuana
if it was not illegal under federal law and that the quantity and
quality of the products were standardized
» Irony: Same % of voters pased the MMMA
– Non Published Research compiled by Schools of Medicine, Social
Studies and Pharmacy suggests a majority believe there could be a
medical benefit for some patients
– Montana (allows medical marijuana) Pharmacists said no to
dispensing marijuana in their pharmacies
» All 12 of them
http://missoulian.com/news/local/article_e1924bca-74ca-11df-9269001cc4c002e0.html
Standardization
• Apply to DEA for a Schedule I controlled substance
analytical laboratory for analyzing samples brought from
caregivers
• Good House Keeping Stamp of Approval
– Qualitative Analysis
– Quantitative Analysis
– Contamination Analysis
• Certification of results
– Funded from fees paid by caregivers
Don’t Smoke: bad habit
• Onset of Action—Too Slow
– Edibles
– Marinol (Dronabinol), delta-9-tetrahydrocannabinol (Δ9-THC)
• Onset of Action—Almost as fast as smoking
– Tincture of Marijuana
– Compounding Demonstration
1. One ounce of Everclear plus
one gram marijuana
2. Store in dark warm place
--avoid medicine and
liquor cabinets
3. Shake every couple days
4. Let set for about a month
(drink the Everclear while
waiting)
5. Strain
6. Two drops under tongue
7. Adjust dose as necessary
Questions