PARCR October 10, 2018 Joseph Torchia, MD, MMM Chief Medical Officer Geisinger Holy Spirit

My Bio Chief Medical Officer Geisinger Holy Spirit – 2004 to present Master of Medical Management Carnegie Mellon University – 2011 Doctor of Medicine St. George’s University School of Medicine – 1987 Internal Medicine Residency 1987 – 1990 – Harrisburg Hospital Private Practice Internal Medicine 1990 - 2004

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What is Medical Marijuana Using the whole unprocessed marijuana plant or its basic extracts to treat a disease or symptom. The marijuana plant contains chemicals that may help treat a range of illnesses or symptoms. Over 100 chemicals, known as cannabinoids There are two main types of cannabis plant, the indica and the sativa. Let’s look at how they compare and contrast. Indica has the following effects: Makes you feel heavy Mainly affects your body Contains more CBD Has a dense and short plant structure Sativa, on the other hand, impacts you in these ways: Makes you feel euphoric Mainly affects your mind Contains more THC Has a skinny and tall plant structure Typically, medical pot users will prefer the indica, which is effective for anxiety, migraines and overall pain relief, whereas recreational users go for the sativa.

Main Components of Marijuana Two main chemicals in the medicinal application of marijuana are: 1. Tetrahydrocannabinol – THC – is psychoactive compound in marijuana 2. Cannabidiol – CBD – does not produce psychoactive affects

Medical marijuana has a higher CBD content, so when you’re taking it, you don’t feel the euphoria that’s associated with its recreational counterpart. Recreational marijuana is pot that is used without medical justification. It has more THC as this is what provides users with a ‘high’.

CBD Discovered in 1940 – initially thought not to be pharmaceutically active One of at least 113 cannabinoids identified in hemp plants – 40% of plant’s extract 2018 FDA approved as a prescription drug (Epidiolex) for use limited to two rare forms of childhood epilepsy.

Side effects of CBD Sleepiness Decreased appetite Diarrhea Fatigue Malaise Weakness Sleeping problems

CBD Does not have intoxicating effects like those caused by THC May have an opposing effect on disordered thinking and anxiety produced by THC

CBD Fewer sides effects Less mind-bending effects Less anxiety/paranoid effects Can reduce general anxiety

Side effects of THC Increased heart rate Coordination problems Dry mouth Red eyes Slower reaction times Memory loss High THC use may be connected to long-term negative psychiatric effects. Especially true for adolescents who consume large amounts of THC – increases the risk for psychiatric disorders such as schizophrenia

CBD THC Produce a “high” NO YES Illegal Side effects Almost none Psychoactive side effects Shows on drug test Pain reliever Reduces nausea Eases migraines Reduces anxiety Increases appetite Decreases seizures Anti-inflammatory

History of marijuana as medicine 2900 BC – Chinese emperor references marijuana as a popular medicine 1500 BC – Earliest written reference to medical marijuana 1450 BC – Book of Exodus references holy anointing oil made from Cannabis 30 AD – Jesus allegedly uses anointing oil made with Cannabis 1538 – Hemp used during Middle Ages 1600 – William Shakespeare may have smoked Cannabis "So, did Jesus use cannabis? I think so. The word Christ does mean 'the anointed one' and Bennett contends that Christ was anointed with chrism, a cannabis-based oil, that caused his spiritual visions. The ancient recipe for this oil, recorded in Exodus, included over 9lb of flowering cannabis tops (known as kaneh-bosem in Hebrew), extracted into a hin (about 11? pints) of olive oil, with a variety of other herbs and spices. The mixture was used in anointing and fumigations that, significantly, allowed the priests and prophets to see and speak with Yahweh. Residues of cannabis, moreover, have been detected in vessels from Judea and Egypt in a context indicating its medicinal, as well as visionary, use. Jesus is described by the apostle Mark as casting out demons and healing by the use of this holy chrism. Earlier, from the time of Moses until the later prophet Samuel, holy anointing oil was used by the shamanic Levite priesthood to receive the 'revelations of the Lord'. The chosen ones were drenched in this potent cannabis oil." Results of this study (including 24 pipe fragments) indicated Cannabis in eight samples, nicotine (from tobacco leaves of the kind associated with Raleigh) in at least one sample, and (in two samples) definite evidence for Peruvian cocaine...

History of marijuana as medicine 1611 – 1762 Jamestown settlers bring marijuana to North America George Washington grows Hemp 1840 – Marijuana become mainstream medicine in the West 1889 – Article in The Lancet outlines use of Cannabis for opium withdrawal Early 1900’s – many states outlaw its use 1936 – Bureau of Narcotics urges federal action to control marijuana Marinol approved by the FDA The Jamestown settlers brought the marijuana plant, commonly known as hemp, to North America in 1611, and throughout the colonial period, hemp fiber was an important export. Indeed, in 1762, 'Virginia awarded bounties for hemp culture and manufacture, and imposed penalties on those who did not produce it.’” "[George] Washington's diary entries indicate that he grew hemp at Mount Vernon, his plantation, for about 30 years [approximately 1745-1775]. According to his agricultural ledgers, he had a particular interest in the medicinal use of Cannabis, and several of his diary entries indicate that he indeed was growing Cannabis with a high Tetrahydrocannabinol (THC) content - marijuana." In the 19th Century, marijuana emerged as a mainstream medicine in the West. Studies in the 1840s by a French doctor by the name of Jacques-Joseph Moreau [a French psychiatrist] found that marijuana suppressed headaches, increased appetites, and aided people to sleep.“ Made by Unimed, Marinol is the trade name for dronabinol, a synthetic form of delta-9 tetrahydrocannabinol (THC), one of the principal psychoactive components of botanical marijuana. It was approved in May 1985 for nausea and vomiting associated with cancer chemotherapy in patients who fail to respond to conventional antiemetic treatments. In December 1992, it was approved by FDA for the treatment of anorexia associated with weight loss in patients with AIDS. Marketed as a capsule, Marinol was originally placed in Schedule II."

A CNN program that featured Charlotte's Web cannabis in 2013 brought increased attention to the use of CBD in the treatment of seizure disorders. Since then, 16 states have passed laws to allow for the use of CBD products (not exceeding a specified concentration of THC) for the treatment of certain medical conditions. Charlotte’s Web cannabis is a high-cannabidiol, low-tetrahydrocannabinol Cannabis strain marketed as a dietary supplement. Named after Charlotte Figi, born October 18, 2006 whose story led to her being described as “the girl who is changing medical marijuana laws across America”. Her parents and physicians say she experienced a reduction of her epileptic seizures brought on by a rare seizure disorder in children. She took her first dose of Charlotte’s Web Cannabis at the age of 5.

This is in addition to the 30 states that have passed comprehensive medical cannabis laws, which allow for the use of cannabis products with no restrictions on THC content. Of these 30 states, eight have legalized the use and sale of cannabis products without requirement for a doctor's recommendation.

What is considered a serious condition for the purposes of justifying the use of medical marijuana? Amyotrophic Lateral Sclerosis Autism Cancer Crohn’s Disease Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity Epilepsy Glaucoma

HIV (Human Immunodeficiency Virus) / AIDS (Acquired Immune Deficiency Syndrome) Huntington’s Disease Inflammatory Bowel Syndrome Intractable Seizures Multiple Sclerosis Neuropathies

Parkinson’s Disease Post-traumatic Stress Disorder Severe chronic or intractable pain of neuropathic origin or severe chronic or intractable pain in which conventional therapeutic intervention and opiate therapy is contraindicated or ineffective Sickle Cell Anemia

Conditions added in May 2018 Spastic movement disorders Neurodegenerative disorders Terminal illness Opioid use disorder – alone or in combination with primary therapeutic interventions

Three qualifications under Act 16 Be a resident of Pa Meet the requirements for certification under Act 16 and Have a serious medical condition

Pennsylvania Medical Marijuana Law Medical Marijuana Program (MMP), signed into law on April 17, 2016. Implementation will take 18 to 24 months When fully implemented, the MMP will provide access to medical marijuana for patients with a serious medical condition through a safe and effective method of delivery that balances patient need for access to the latest treatments with patient care and safety.

May 12, 2018 the Health Department published revised regulations May 12, 2018 the Health Department published revised regulations. The revised regulations expanded the qualifying conditions AND included substitute therapy for opiate addiction Ensure that medical marijuana adheres to its chemical labeling so patients receive the correct dosage and form to treat their condition Ensure preparations are pure and potency consistent

Cure Pennsylvania 1866 Fruitville Pike, Lancaster

Process - patients Create a patient profile in the Department of Health patient and caregiver registry must obtain a physician’s certification that you suffer from one of the serious medical conditions Register for and pay for a medical marijuana ID card Use that card to obtain medical marijuana at Pa dispensaries.

Process for caregivers Visit the Patients and Caregivers Registry – create a profile Complete a criminal background check Ensure the patient has certification

Approved forms in PA Pill Oil Topical forms - including gel, cream or ointments Tincture Liquid Vaporization

On July 19, 2018, Auditor General Eugene DePasquale released a report projecting Pennsylvania could generate $581 million per year if it replaces marijuana prohibition with taxation and regulation for adults 21 and older. Eight other states have led the way, and the public strongly supports this modern and humane approach.

What else will the Medical Marijuana Program do for Pennsylvania? The Medical Marijuana Program also includes funding for research institutions to study the use of medical marijuana to treat other serious conditions. In addition, the act establishes an advisory committee that will review these research findings and make recommendations to the legislature for changes to the act. In addition to funding for implementation and research, the act also provides revenue to the Department of Drug and Alcohol Programs for drug abuse prevention, counseling and treatment services, as well as to the Pennsylvania Commission on Crime and Delinquency for distribution to local police departments.

The study of marijuana in clinical trial settings is needed to assess the safety and effectiveness of marijuana for the treatment of any disease or condition. The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of marijuana.

June 2018 statement by Scott Gottlieb, FDA commissioner robust clinical development program careful review through the FDA’s drug approval process critical that the necessary work is done to identify drugs of potential medical benefit and conduct rigorous scientific research FDA remains committed to collaborating with federal and state agencies, researchers and product developers on advancing this type of important and conscientious work.

Wolf Administration Certifies Eight Medical Schools as Medical Marijuana Academic Clinical Research Centers Drexel University College of Medicine, Philadelphia; Lewis Katz School of Medicine at Temple University, Philadelphia; Penn State College of Medicine, Hershey; Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia; The Perelman School of Medicine at the University of Pennsylvania, Philadelphia; University of Pittsburgh School of Medicine, Pittsburgh; Lake Erie College of Osteopathic Medicine-Erie (LECOM); and Philadelphia College of Osteopathic Medicine, Philadelphia.

How can Pennsylvania Make Medical Marijuana Legal when it is not approved by the Federal Government? The federal government cannot force states to criminalize conduct that is illegal under federal law, nor can the federal government force state and local police to enforce federal laws. There are no known cases in any of the 23 states that have authorized the use of medical marijuana of the federal government prosecuting an individual for a small amount of marijuana.

Who will assist the Department in Making Changes to the Medical Marijuana Program in Pennsylvania? The new law creates the Medical Marijuana Advisory Board within the Department of Health. Members include the Secretary of Health; the Physician General; State Police Commissioner; Chair of the State Board of Pharmacy; Commissioner of Professional & Occupational Affairs; President of the Pennsylvania Chiefs of Police Association; President of the Pennsylvania District Attorneys Association; members to be appointed by the Governor and the four legislative caucuses who are knowledgeable and experienced in issues relating to care and treatment of individuals with a serious medical condition, geriatric or pediatric or clinical research. One member appointed by the Governor shall be a patient, a family or household member of a patient or a patient advocate.

Where will Patients Obtain Medical Marijuana? Only a patient or caregiver with an identification card issued by the department can purchase medical marijuana at an authorized dispensary. The department will authorize up to 150 dispensaries across the state.

Can Someone Else Obtain Medical Marijuana on Behalf of a Patient? Yes. When a patient applies to the department for an identification card, he or she can designate up to two caregivers. A caregiver can assist up to five patients. Before obtaining medical marijuana for a patient, a caregiver must also apply for a medical marijuana identification card.

Medical marijuana sales begin!  February 15, 2018 As of July 18, 27 dispensaries are operational with product on hand. Over the next few months, expect up to 81 dispensary locations to open across the state. As of early June, more than 30,400 patients had registered to participate in the medical marijuana program, and nearly 1,000 physicians have registered with the department, more than half of whom have competed the training to become certified practitioners.

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