Law School Marijuana Symposium January 27, 2012

1. Law School Marijuana SymposiumJanuary 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: jessevivian@wayne.edu WebPage: http://jessevivian.net Pharmaceutical Aspects of Medical Use

2. 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

3. 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 TransTetrahydrocannabinol (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-marijuana-cannabinoids-thc-cbd-cbn.html • We don’t even know how to spell it—marihuana- Latino spelling • MICHIGAN MEDICAL MARIHUANA ACT (333.26421 - 333.26430)

4. 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

5. 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

6. 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

7. 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

8. Some Science Technology • Gas Chromatograph analysis of two samples: Michigan Testing Authority (MTA), Kalamazoo

9. Junk Science • Daubert (Dilbert)? • First Sample:

10. Junk Science • Second Sample:

11. 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

12. 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 • 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

13. 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

14. 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

15. 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.

16. 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/

17. 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

18. 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?

19. 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 intheir pharmacies • All 12 of them http://missoulian.com/news/local/article_e1924bca-74ca-11df-9269-001cc4c002e0.html

20. 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

21. 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

22. Questions

23. THE END THE END