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STARSEED IS…A GLOBAL CANNABIS COMPANY

Medical CannabisDr. Peter M. Blecher, M.D.,C.M, DAAPM, DCAPM

Chief Medical OfficerStarseed Medicinal, Inc.

Medical DirectorCPM Centre for Pain Management

cannabinoids & the elephant in the room

history science, safety & evidence

societal costs workplace impact

cost-savings to society & benefit plans

emerging insurance coverage2

Used since antiquity for healing and medical powers

Only in 19th century, powerful and emerging tobacco lobby had cannabis production restricted, and then criminalized

In the U.S., became seen as drug of choice for the marginalized… social stigma, and way to ‘control’ these groups

Complete ban on production at start of last century; exception of WW I-II, where Congress temporarily allowed massive hemp production during war effort:

hemp by far most robust material for ropes, sails and paper word ‘canvas’ in fact, is derived from ‘cannabis’

Since end of WWII, ongoing politicized fight in West3

Cannabinoids are compounds that act on cannabinoid receptors naturally found in the human body

Endocannabinoids are cannabinoids that are naturally produced in the body

Phytocannabinoids are cannabinoids produced by the cannabis plant

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Synthetic Cannabinoids(Made in a lab)

Endocannabinoid Receptors

(brain & immune cells)

Phytocannabinoids(Produced by plants)

Endocannabinoids(Naturally made in the body)

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-

-

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Signaling system

Important regulatory functions involved in:

Pain Appetite & digestion Sleep-wake cycle Psychiatric disease

… just to mention a few

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Ref: www.CCIC.net8

Williamson EM, Evans FJ. Cannabinoids in clinical practice. Drugs. 2000 Dec;60(6):1303-14. Review. PubMed PMID: 11152013.

Cannabis 1000:1Diazepam 100:1Morphine 70:1Cocaine 15:1Alcohol 10:1Digoxin 2:1

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“A smoker would theoretically have to consume nearly 1,500 of cannabis within fifteen

minutes to induce a lethal dose”

The Report of the National Commission on Marihuana and Drug Abuse; Marihuana: A Signal of MisunderstandingCommissioned by President Richard M. Nixon, March, 1972

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Cannabis (Sativa, Indica, or Ruderalis)

‘Marijuana’ (dried leaves and flowering heads)

Isolated pure compounds

Cannabinoids

Psychoactive

Δ8-THC cannabinol (weak)

Inactive >60 compounds

Kalant 2001

Non-cannabinoids:

Non-psychoactive

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100+ cannabinoids

350+ terpenes / flavonoids

Fast onset of action when inhaled – shorter duration

Slower onset of action when ingested – longer duration

A theory that all the various compounds present in the plant work together in a cooperative manner to yield the best results1

1 Russo, E. B. (2011), Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. British Journal of Pharmacology, 163: 1344–1364

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Δ9-THC the receptors

Causes psychoactive effects of cannabis

Effective for relief of chronic nerve pain, muscle spasms, controlling nausea and stimulating appetite

CBD receptor activity

Not psychoactive and does Notcause sedation

Anti-inflammatory, possible pain killer, may help with nausea, vomiting, seizures, anxiety and depression

Appears to opioid reward1

1 Lucas, P, Walsh, Z, et al; Substituting Cannabis for Prescription Drugs, alcohol and other substances among Medical Patients:The impact of Contextual Factors. Drug Alcohol Review; 2016 May; 35(3):326-33

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Δ9-THC the receptors

Causes psychoactive effects of cannabis

Effective for relief of chronic nerve pain, muscle spasms, controlling nausea and stimulating appetite

CBD receptor activity

Not psychoactive and does Notcause sedation

Anti-inflammatory, possible pain killer, may help with nausea, vomiting, seizures, anxiety and depression

1 Lucas, P, Walsh, Z, et al; Substituting Cannabis for Prescription Drugs, alcohol and other substances among Medical Patients:The impact of Contextual Factors. Drug Alcohol Review; 2016 May; 35(3):326-33

The ratio of (cannabidiol) to (tetrahydrocannabinol) in the plant influences the therapeutic effects

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Chronic musculoskeletal & neuropathic pain

Arthritic inflammation

IBS / IBD

Certain anxiety, PTSD and sleep disorders

Seizures (Dravet Syndrome)

Further information available in Health Canada’s document “Information for Health Care Professionals: Cannabis and the Cannabinoids”

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Nausea and vomiting due to chemotherapy (CINV)

Anorexia due to HIV or other treatments

Appetite stimulant

Motor disorders (Parkinson’s, Huntington's, Tourette’s)

Spasticity due to MS

Further information available in Health Canada’s document “Information for Health Care Professionals: Cannabis and the Cannabinoids”

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Heart rate / rhythm Peripheral circulation Myocardial infarction (?) Stroke

Health Canada's document Information for Health Care Professionals; Cannabis (marihuana, marijuana) and the cannabinoids

Respiratory Psychiatric Neurocognitive Carcinogenic Gastrointestinal Reproductive

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1 Reis JP, Auer R, Bancks MP, et al. Cumulative lifetime Marijuana use and incident cardiovascular disease in middle age: The Coronary Artery Risk Development in Young Adults (CARDIA) study. Am J Public Health 2017; 107 (4):601-606

Among younger individuals, does more than 25 years of cannabis use increase the risk of developing coronary artery disease?

This well-done government-funded, population-based, (prospective) cohort study, took into account traditional risk factors, did not find an association between chronic cannabis use and cardiovascular events

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Recent study on opiate abuse looking at health data reported by large insured U.S. employers1

According to CDC, 2M Americans abuse opiates2

16,000 die every year from Rx opiate OD3

Sales of opiate Rx in U.S. ∧4x from 1999 – 20104

259M opiate Rx written in 2012 – enough for every American adult to have their own bottle5

1. Castlight Health commissioned report. “The Opiate Crisis in America’s Workforce”. 20162. Centers for Disease control and Prevention (CDC); Prescription Opiate Data 3. CDC. Opioid Data Analysis (2013). 4. CDC. Morbidity and Mortality Weekly Report. 5. CDC. Opioid Painkiller Prescribing.

Simply put – prescription crisis is getting , not better

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47,055 people died of accidental drug overdose

29,467 from opioid-related drugs, including Rx meds

Overdose now leading cause of accidental death

4/5 who become addicted start out with a legal Rx

Substance-abuse disorders affect 20.8M Americans

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Cannabinoids exhibit analgesic effects and potentiate the anti-nociceptive effects of opioids

Animal models demonstrate THC greatly enhancesanalgesic effects of morphine in a synergistic fashion

Reports suggest in opiate use, when synergistically using cannabinoids

Dr. Oz… “reefer rehab”

Health Canada's document Information for Health Care Professionals; Cannabis (marihuana, marijuana) and the cannabinoids 23

Opiate abuse costs the U.S. economy nearly $56B1

Opiate abuse costs employers $10B from absenteeism – 2

1. American Society of Addiction Medicine (ASAM). Cited in: Workforce. “Pain Points”. 2. Ibid 3. Ibid

Opiate-addicted employees cost employers that of non-addicted employees in overall benefit costs3

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Spring 2017....

1 Volkov, N.D., Collins, F.S., The Role of Science in Addressing The Opioid Crisis. ‘Special Report’; NEJM. May 31, 2017:1-4

Opioid misuse and addiction is an ongoing and rapidly evolving public health crisis, requiring innovative scientific solutions… in response, NIH is joining with private partners… to find innovative medications and technologies to treat opioid addiction… [and] to manage chronic pain…

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Medical cannabis takes big bite out of pharmaceutical sales: 1

Cannabis can be effective Sx treatment for conditions such as , , , , ,

, , , and …2

Americans spent on Rx medication to treat the above conditions in 2016

expected to grow to

1. New Frontier Data: Cannabis Sales Impact Big Pharma; May 21st, 20172. National Academies of Science

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Three conditions drove highest Rx drug spend in 2016: 1

chronic pain ($14.3 billion) PTSD ($10.6 billion) sleep disorders ($6.13 billion)

The Rx drug use for these, falls an average of 11% in States with legalized medical cannabis

And keep in mind… there is coverage for medical cannabis in ANY of these jurisdictions - this is ALL 100% out-of-pocket by patients themselves!…

1. New Frontier Data: Cannabis Sales Impact Big Pharma; May 21st, 201727

If medical cannabis legalized nationally, 11% decline in overall Rx drug use equates to estimated $4.4 billion in reduced Rx spend -

Between 2016 and 2020, 11% reduction in Rx drug spending would be a

Again – this is without ANY federal, state, or third party coverage for medical cannabis

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Implementation of medical cannabis laws has reduced opioid prescribing in US jurisdiction where it occured1

Rx filled for opioids decreased by 2.11 million annualized doses

And this is based on populationo again – NO coverage for cannabiso population with little disposable income

1. JAMA Int. Med. Published online April 2, 2018 29

- Comprehensive review of clinical, peer-reviewed literature by NASEM determined that:

“conclusive evidence” that cannabis can be used to treat chronic pain

cannabis use rising fastest in population >50 y.o. – group most likely to have the conditions for which evidence for cannabis benefits is strongest

1. National Academies of Sciences, Engineering, and Medicine; January 201730

Cannabis intoxication, like with potentially sedating or psychoactive substance, can affect and impair judgment and coordination, memory, learning, and attention

Cannabis as ‘medicine’ should be conflated with being impaired at work

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Cannabis intoxication, like with potentially sedating or psychoactive substance, can affect and impair judgment and coordination, memory, learning, and attention

Whether prescription or otherwise, agent can be abused: Gravol®, Benadryl® and Tylenol®

… overdose deaths seen daily in ERs

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Cannabis intoxication, like with potentially sedating or psychoactive substance, can affect and impair judgment and coordination, memory, learning, and attention

Imodium® - “poor-man’s methadone”… the “lope cocktail”

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Compared to Alcohol – observed differences in ‘judgment impairment’…alcohol appears significantly worse 1

One can test positive days or weeks after useo Cannabis impacts individuals differently o THC levels do not correspond accurately with impairment levelso You cannot predict a person’s impairment level based on THC level

Like other psychoactive medications – titration and ‘steady state’ is critical…

1 Cannabis & Cannabis Resin: Pre-Review Report. World Health Organization Expert Committee on Drug Dependence. 38th meeting. Geneva Report; 14-18 November, 2016

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In studies use, MVA Odds Ratio (OR) for DACU is ; that is, an 18% increase risk

This compares to an MVA OR of for a BAC >50 mg/dL, which is considered an acceptable BAC… that is …. - deemed

1 Capler, R., Bilsker, D., Van Pelt, K., & MacPherson, D. Cannabis Use and Driving: Evidence Review; Canadian Drug Policy Coalition (CDPC);Simon Fraser University; January 31, 2017

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The rate of cannabis-related driving offences in Canada remains low, in comparison to those related to alcohol 1

Widely publicized results of large case-controlled observational study by the National Highway Traffic Safety Association in the U.S. in 2015 did find an increased rate of MVAs in drivers who had used cannabis 2

1 Cannabis & Cannabis Resin: Pre-Review Report. World Health Organization Expert Committee on Drug Dependence. 38th meeting. Geneva Report; 14-18 November, 2016

2 Compton, R., Berning, A. Drug and Alcohol Crash Risk. 2015 Feb. (Traffic Safety Facts Research Note. DOT HS 812 117).Washington, DC: National Highway Traffic Safety Association

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Recently published meta-analysis of US traffic fatalities from 1985 –2014, and their relationship to medical marijuana laws (MMLs) using data from the 1

On Average, MML States had traffic fatalities than non-MML states

MMLs were associated with reductions in traffic fatalities in

1 Santaella-Tenorio, J., Mauro, CM, et al; ‘US Traffic Fatalities, 1985 – 2014, and Their Relationship to Medical Marijuana Laws”A J P bli H lth 2017 F b 107(2) 336 342

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Focus should be on , and (in specific and limited circumstances) vaporization, and not on “lighting plants on fire”….

This is the future of cannabis as medicine…

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Focus should be on , and (in specific and limited circumstances) vaporization, and not on “lighting plants on fire”….

is…

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Multiple taskforces have debunked Cannabis as ‘gateway drug’ Poverty & poor social connectivity is gateway1

Is Cannabis addiction even possible?...

1 Lopez-Quintero, Perez de los Cobos, Jose, Hasin, D.S et al (2011). Probability and predictors of transition from first time use to dependenceon nicotine alcohol, cannabis and cocaine, Drug Alcohol Dependency, 115(1-2), 120-130.

Of course its possible!

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o Irritability and/or anxietyo Insomniao Nausea / poor appetite

Typically occurs after heavy, prolonged use

Symptoms peak a few days / week following cessation of use

long-term health implications of cannabis use similar to not flossing41

Studies indicate that majority of recreational cannabis users do progress to harder drug use o Long-term probability and predictors from first time use to dependence: 1

67.5% - 22.7% -

20.9% - 8.9% -

Cannabis use amongst young teens (ages 12-17) has increased over the past decade, in spite of significantly increasing THC concentrations, , the prevailing view within this group that it is harmful, has 2

1 Meier, M.H. et al, Associations between cannabis use and physical health problems in early midlife: A longitudinal comparison of persistentcannabis versus tobacco users, JAMA Psychiatry, 37(70, 731-740.

2 Compton, W. Deputy Director, National Institute of Drug Abuse, Washington, D.C.; Presentation given at “Innovations in the Science of Cannabis Conference” McMaster University, Michael G. DeGroote Centre for Medical Cannabis Research. Feb 9th, 2018.

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This does not in any way negate the fact that adolescent use of THC demonstrates altered brain function that may be permanent

Preteen and young adolescents are at special risk, and cannabis use of any kind should be clearly and strongly discouraged

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In the Skinner Decision in Nova Scotia, an independent human rights tribunal ruled that a man suffering from chronic pain, with a medical cannabis Rx from his doctor, was required to have his cannabis covered by his employee benefit plan – ‘just like any other medicine’

Previously, Sun Life Insurance had agreed to cover medical cannabis for faculty, students, and employees at two large Ontario universities, based on index case by Jonathan Zaid

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Last year, Loblaw’s, Canada's largest grocery retailer and pharmacy, with over 1,300 Shoppers Drug Mart stores, and 500 in-store pharmacies, announced they will be offering medical cannabis on a PA basis, employees suffering with cancer or MS… > 50,000 employees

CBC News Tuesday May 30th, 2017:

1 Benefits Canada; ‘Benefits & Pension Summit’; 201745

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Medical cannabis coverage is rapidly becoming one of hottest topics in the employee benefits space

Most employers are struggling with cost-containment Biologics & specialty drugs Chronic disease (cancer, diabetes, CAD) Drug addiction – (methadone tx, collateral dz, counselling…) Economic loss associated with employee substance abuse:

Challenge to employers now becomes balancing sustainability of drug plans, against providing needed coverage for necessary treatments1 HR Daily Advisor; Combating Substance Abuse | Employee Benefit Programs; March 12, 2018 47

There is pressing need to take a very different look and approach to managing health / drug benefit plans….

Unsustainable to pay for everything today, , to pay for all new products and services as they launch

HOWEVER, it is this very lack of controls and monitoring that has greatly contributed to the opioid and Rx drug crisis issue today….

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Many of the opioids on the street start off as a legitimate Rx

✘ So me and my colleagues are complicit

They are filled by a pharmacist

✘ So they are complicit

… and paid for by a private drug plan like yours

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So either product is being diverted, or, some members of drug benefit plans are becoming more entrepreneurial

Plan sponsors have both a social / moral, as well as a fiscal / fiduciary obligation to your plans’ members, to better manage opioids While I’m not suggesting that medical cannabis is entire

solution, the less addictive, safer, and opioid-sparing properties can allow for greater cost controls, and significantly improved QoL for members 50

So either product is being diverted, or, some members of drug benefit plans are becoming more entrepreneurial

Plan sponsors have both a social / moral, as well as a fiscal / fiduciary obligation to your plans’ members, to better manage opioids National Safety Council Survey of >500 HR decision makers: 1

, “so that employees can avoid taking opioids”

1 National Safety Council Survey; http://www.nsc.org/NewsDocuments/2017/Media-Briefing-National-Employer-Drug-Survey-Results.pdf51

Opioids and other chronic pain meds Biologics and other high cost specialty (IBS) drugs

(e.g. Remicade®, Humira®, Cimzia® )… and more coming on line

Mental health medications

The benefits to an employer of instituting medical cannabis coverage on employee plan are:

Not to mention the downstream effects of all the iatrogenic disease by the above medications

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Paramedical costs (physio, chiro, massage….) Mental health counselling Drug addiction counselling Absenteeism & Presenteeism

Additional benefits to an employer of instituting medical cannabis coverage on employee plans are:

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Emphasis on CBD-predominant or ‘balanced’ formulations Truly medically-based & validated delivery systems

- MDIs, vaporizers, gel capsules, injectables, transdermals, sublingual sprays, gums, lozenges

HSA with annual limits allowing for allocated spend without need to limit clinical indications (healthcare discussion between MD | patient). Alternative is scaring patient away, and disease progression

Start with responsible and limited approach, and expand coverage over time

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It is recognized that opioids - both those obtained through legal Rx means, as well as those obtained from ‘the street’ - are destroying lives, families, and some workplaces

Opioid-sparing effect of cannabinoids is becoming well-established, can reduce opioid abuse, save on pharmaceutical expenditure, and, may save on overall insurance costs

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Public, employee and union pressure will increasingly demand insurance coverage for emerging cannabinoid medicines, as leading companies come onboard

Employers & insurers who are early adopters, will likely receive ‘first mover’ advantage, and be viewed as proactive force in combatting the opioid epidemic, and if early data and indicators hold, may enhance their own bottom lines

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Insurers and plan sponsors must partner with socially responsible LPs, as a way to inform, educate and help safely manage plan member use

Employers must demand a commitment by industry to the development of superior evidence-based, cannabis medicines

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STARSEED IS…A GLOBAL CANNABIS COMPANY

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