tue vs ameritox -yasko-brasika_de_george

Mixing Medicine and Marijuana

Scott E Yasko – PRIUMRachel Brozina, esq. – Lester, Norton & BrozinaMichael DeGeorge Jr., PharmD – Ameritox

Rx Drug Abuse Summit – April 22, 2014 – Atlanta, GA

Quick History of Marijuana in the U.S.

• Cannabis was used legitimately at the turn of the century– Primarily used for pain– Use declined with negative public perception and

the development of aspirin and morphine• 1925, League of Nations sign a treaty

restricting use to scientific and medical• Became illegal in 1937 via the Marijuana Tax

Act

The Administration of Marijuana

• Smoke• Oil extract & Butter– Added to and used to make foods

• Tinctures & Tonics– Transdermal, sublingual and ingested

• Vaporized– Heating the plant to inhale the mist– Alternative to smoking

Marijuana in the U.S. Today

• According to CBS News, 51% of Americans support full legalization

• Indicated for diagnoses such as chronic and cancer pain, seizure disorders, etc.– Varies by state– Physicians do not prescribe; they recommend

• Medical Marijuana has potential– Charlotte Figi – Dravet Syndrome– Chaz Moore – myoclonus diaphragmatic flutter

What’s Next?

• Reassess drug scheduling– Schedule I indicates no medicinal use– 1988, DEA ALJ ruled in favor of reclassification

• More robust studies are needed– Red tape surrounding U.S. studies– Leading research coming out of Israel and Spain

Federal versus State Law

U.S. Constitution • Supremacy Clause: generally, federal law

supersedes state law in areas in which Congress has appropriately exercised its power to legislate

•Commerce Clause: generally, Congress has express power to regulate commerce among the states

Federal versus State Law Controlled Substances Act

•Purpose: regulate the manufacture, importation, possession, use, and distribution of certain substances•Execution: five schedules outline the qualifications for a substance to be classified• Schedule 1 substances:

1. High potential for abuse, 2. No currently accepted medical

use in treatment in US, and3. No accepted safety for use of the

substance under medical supervision.

• Prescription cannot be written for substance

U.S. Supreme Court decision: Gonzales v. Raich

•Situation: a caregiver and a patient possessing and using marijuana per California’s Compassionate Use Act sought an injunction to stop government from interfering with their activities•Plaintiffs’ argument: CSA is unconstitutional

as applied to their conduct•Government’s argument: CSA preempts state

law; Congress may regulate and prohibit use and possession of marijuana under Commerce Clause •Decision: Congress has authority to prohibit

possession and use of marijuana, even for medical purposes, under commerce clause. •Rationale: marijuana grown for personal

consumption is likely to create high demand in the interstate market; this diversion into the interstate market interferes with federal government’s interest in eliminating commercial transactions.

USDOJ Memo to U.S. AttorneysAugust 29, 2013

• Urges U.S. Attorneys to exercise their discretion in using federal resources to prosecute individuals using marijuana for medical purposes

• Emphasizes federal policy of enforcing CSA to prevent: 1. distribution of marijuana to minors2. revenue falling into hands of dangerous drug cartels3. diverting medical marijuana from legal states to other states4. state-authorized marijuana activity from being used as a cover for trafficking other

illegal drugs 5. violence in the cultivation and distribution of marijuana6. drugged driving and other adverse public health consequences7. growing marijuana on public or federal lands

21 Jurisdictions Have Legalized Medical Marijuana

• Alaska• Arizona• California• Colorado*• Connecticut• DC• Delaware• Hawaii• Illinois• Maine

• Michigan• Montana• Nevada• New Hampshire• New Jersey• New Mexico• Oregon• Rhode Island• Vermont• Washington*

* Allows for recreational use

Image from Isaac Reese via reason.com

Pediatric Exposure to Marijuana in Decriminalized States

Adapted by CESAR from Wang, G.S., Roosevelt, G., Le Lait, M-C, Martinez, E.M., Bucher-Bartelson, B., Bronstein, A.C., and Heard, K., “Association of Unintentional Pediatric Exposures with Decriminalization of Marijuana in the United States,” Annals of Emergency Medicine, In Press, 2014. For more information, please contact Dr. George Wang at george.wang@childrenscolorado.org.

New Illicit Drug Use- 2012

Substance Abuse and Mental Health Services Administration, Results from the 2012 NationalSurvey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHSPublication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health ServicesAdministration, 2013.

New Illicit Drug Use- 2012

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Substance Abuse and Mental Health Services Administration, Results from the 2012 NationalSurvey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHSPublication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health ServicesAdministration, 2013.

Marijuana use increasing

Adapted by CESAR from Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Detailed Tables, 2013. Available online at http://www.samhsa.gov/data/NSDUH/2012SummNatFindDetTables/Index.aspx

Perceived risk of marijuana

• University of Michigan, 2013 Monitoring the Future Study

Marijuana and poly drug abuse

58% of primary marijuana admissions reported abuse of additional substances

Marijuana and Nonadherence

• Retrospective review of 116,011 urine samples• Patients prescribed hydrocodone (excluding

prn)• May 16, 2011 to May 15, 2012• Broken into three categories for analysis– THC positive as only illicit (n=15,153)– Cocaine positive as only illicit (n=1731)– No illicit detected (n= 99,115)

An analysis of the association between marijauana use and potential nonadherence in patients prescribed hydrocodone. DeGeorge M, Dawson E, et al. American Academy of Pain Medicine annual meeting 2013

Marijuana and Nonadherence

An analysis of the association between marijauana use and potential nonadherence in patients prescribed hydrocodone. DeGeorge M, Dawson E, et al. American Academy of Pain Medicine annual meeting 2013

An analysis of the association between marijauana use and potential nonadherence in patients prescribed hydrocodone. DeGeorge M, Dawson E, et al. American Academy of Pain Medicine annual meeting 2013

Marijuana and Nonadherence

An analysis of the association between marijauana use and potential nonadherence in patients prescribed hydrocodone. DeGeorge M, Dawson E, et al. American Academy of Pain Medicine annual meeting 2013

Marijuana and Nonadherence

Thank You

Scott E YaskoPRIUMNational Account Executive(678) 735-7315syasko@prium.net

Rachel Brozina, esq.Lester, Norton & Brozina, p.c.rachel@lesternortonlaw.com

Michael DeGeorge, PharmDAmeritoxAssociate Director, Medical Affairsmichael.degeorge@ameritox.com