Medical CannabisA summary review of current developments

Fall 2018

Marcelo Targino, MD, MPH, FACOEM, FACP

Disclosures & opening statements

• I work for Johnson & Johnson.

• I will not be promoting any products or services.

• These slides represent my personal opinion and in no way are an official statement by, or related to any of my work at Johnson & Johnson.

• Although I have a personal opinion on medical marijuana, I have attempted to the best of my ability to present a neutral review of current issues, without trying to persuade.

• This is a broader national overview, and not a in-depth review of current changes in New Jersey.

• These slides are for educational purposes, to be used within this meeting only. They are not to be otherwise shared, distributed or published.

• These slides are part of a presentation, and by themselves are not complete.

You can be pro or con, but you can’t ignore it

47 states now have some type of cannabis access law

http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx

What is going on in NJ?

• According to the New Jersey Department of Health, only 26,806 residents have participated in the state's medical marijuana program since it started in 2012. In 2017, the total number of patients in the program was 11,349. That's less than .2 percent of the state's population.

• Two states on the opposite ends of the country, California and Maine, have the highest percentage of residents in medical marijuana programs at 3.15 percent, according to the Marijuana Policy Project, which estimates there are 2.2 million patients nationwide.

• Of the 31 states where medical marijuana is legal, New Jersey ranks near the bottom in resident participation.

Which conditions in NJ?

• Chronic pain related to musculoskeletal disorders

• Chronic pain of visceral origin

• Migraine

• Anxiety

• Tourette's Syndrome

• Amyotrophic lateral sclerosis

• Multiple sclerosis

• Terminal cancer

• Muscular dystrophy

• Inflammatory bowel disease, including Crohn’s disease

• Terminal illness, if the physician has determined a prognosis of less than 12 months of life.

The following conditions apply, if the patient is resistant to, or intolerant to, conventional therapy:

• Seizure disorder, including epilepsy

• Intractable skeletal muscular spasticity

• Glaucoma

• Post-Traumatic Stress Disorder

The following conditions apply, if severe or chronic pain, severe nausea or vomiting, cachexia or wasting syndrome results from the condition or its treatment:

• Positive status for human immunodeficiency virus

• Acquired immune deficiency syndrome

• Cancer

The nearest dispensaries

Check out what is happening in Maine

• On February 1, 2018, portions of IB 2015, c.5, “Question 1 – An Act to Legalize Marijuana” took effect in Maine preventing employers from firing workers 21 years or older for the use of marijuana (even recreational) outside of the workplace. This also applies to pre-employment testing.

• However, the law also does not affect compliance with federally mandated testing for marijuana such as the U.S. Department of Transportation (DOT) regulations for commercial motor vehicle drivers.

http://www.esrcheck.com/wordpress/2018/02/22/maine-law-requires-employers-stop-drug-testing-marijuana-ignore-use-workplace/

Check outAmazon• >3,000

“CBD”

products

31 States

> 2 million

Are you in the majority of Americans?

• 48% never

• 52% tried it

• 22% use it

• 14% regularly

Most Americans favor legalization

• As of 2017, 94% of Americans favor legalizing medical marijuana.

• As of 2017, 64% of Americans favor complete legalization of cannabis. Both sides of the political spectrum hold this view with 72% Democrats, 67% Independents and 51% Republicans in favor of legalization.

Any Studies?

What do the Surgeon Generals say?

What about work comp issues?

• Courts in New Mexico, Connecticut, Minnesota and Maine have directed workers’ compensation carriers to reimburse injured workers for their reasonable and necessary out-of-pocket medical marijuana costs.

• Other states, Florida and North Dakota, have passed laws specifically stating that medical marijuana treatment is not reimbursable under their workers’ compensation laws.

Some companies just don’t test

• In Denver, in a state with just 3 percent unemployment, 10 percent of employers that screen for drugs had dropped marijuana as of 2016, according to a survey by the Employers Council, which provides corporate legal and human resources services.

• Apple does not perform pre-employment drug testing.

• The US “drug free workplace” rule does not require companies to drug test.

What’s my personal bias?

My biggest pet peeve

• Zofran and levofloxacin

Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray has proved efficacious in the treatment of spasticity in multiple sclerosis and chronic pain. A thorough QT/QTc study was performed to investigate the effects of THC/CBD spray on electrocardiogram (ECG) parameters in compliance with regulatory requirements, evaluating the effect of a recommended daily dose (8 sprays/day) and supratherapeutic doses (24 or 36 sprays/day) of THC/CBD spray on the QT/QTc interval in 258 healthy volunteers. The safety, tolerability, and pharmacokinetic profile of THC/CBD spray were also evaluated. Therapeutic and supratherapeutic doses of THC/CBD spray had no effect on cardiac repolarization with primary and secondary endpoints of QTcI and QTcF/QTcB, respectively, showing similar results. There was no indication of any effect on heart rate, atrioventricular conduction, or cardiac depolarization and no new clinically relevant morphological changes were observed. Overall, 19 subjects (25.0%) in the supratherapeutic (24/36 daily sprays of THC/CBD spray) dose group and one (1.6%) in the moxifloxacin group withdrew early due to intolerable AEs. Four psychiatric serious adverse events (AEs) in the highest dose group resulted in a reduction in the surpatherapeutic dose to 24 sprays/day. In conclusion, THC/CBD spray does not significantly affect ECG parameters. Additionally, THC/CBD spray is well tolerated at therapeutic doses with an AE profile similar to previous clinical studies. (PDF) A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group QT/QTc Study to Evaluate the Electrophysiologic Effects of THC/CBD Spray. Available from: https://www.researchgate.net/publication/264266057_A_Multiple-Dose_Randomized_Double-Blind_Placebo-Controlled_Parallel-Group_QTQTc_Study_to_Evaluate_the_Electrophysiologic_Effects_of_THCCBD_Spray [accessed Sep 25 2018].

Changes up north…

• October 17, 2018

Great overview site:

• https://medicalmarijuana.procon.org/

In summary

• >7 million Americans use cannabis regularly

• >2 million are medical marijuana users

• The evidence is mixed, but leans towards benefit for some conditions

• Compared to other medications, there are a lot fewer deaths

• Legalization presents a continually evolving issue

• Companies have a variety of approaches to marijuana, medicinal and recreational, including not testing

• Work testing issues are only going to become more complex because of conflicting court rulings, state laws and changing recreational laws