This document outlines proposed regulations for medical cannabis in New York state. It discusses the history of cannabis use, clinical studies on cannabis treating conditions like HIV neuropathy and multiple sclerosis spasticity, and a case study on a child named Charlotte treated with CBD oil. The presentation then reviews New York's proposed regulations, including requirements for prescribers, patients, manufacturers, approved cannabis products and dosages. Key requirements include physicians completing a training course, manufacturers being licensed and meeting production standards, and allowing only oil, vaporized and capsule formulations with a maximum 10mg THC per dose.

1. The Green Light
Medicinal Cannabis in New York
Authored/Presented by Dave Porter, Pharm.D Candidate
via Albany College of Pharmacy and Health Sciences
Thursday, February 12th, 2015

2. Presentation Outline
• Background
• History
• A Case Study: Charlotte’s Web
• Science and Studies
• Proposed NYS Regulations
• Legal Challenges
• Conclusions
• Q&A Session
2

3. But First…
• Things I WILL NOT be doing in this presentation:
– Arguing for the legalization of recreational cannabis
– Supporting use of medicinal cannabis by non-patients
– Using street slang like pot, bud, kush, dope, chronic, etc.
• Things I WILL be doing in this presentation:
– Presenting a professional evidence-based viewpoint,
supporting a reclassification of cannabis to Schedule II
– Reviewing published clinical studies
– Reviewing New York’s proposed regulations (2014)
– Withholding personal opinions, unless prompted
3

4. General and Historical Background
• The cannabis plant (Cannabis sativa, C. indica and
C. ruderalis) is an annual flowering herb
– It has more than 60 unique compounds (~480 total)
– Δ-9-tetrahydrocannabinol (THC) is psychoactive
– Cannabidiol (CBD) is not; may oppose some THC effects
• Earliest recorded use of medicinal cannabis (“ma”)
dates back to 2900BC – Chinese Emperor Fu Hsi
– Emperor Shen Nung discovers healing property (2700BC)
• Used as sacramental, medicinal or recreational drug
– Arab physician Ibn Wahshiyah – potentially poisonous?
4

5. 5

6. History in the USA
• 1851 – United States Pharmacopoeia (USP) lists Cannabis
sativa as a legitimate drug with many uses
• 1864 – USP described methods of extracting alkaloids
• 1911 – Massachusetts is first State to ban cannabis outright
• 1937 – Marijuana Tax Act placed a tax on cannabis products
• 1970 – Controlled Substances Act; Schedule I classification
• 1996 – California legalizes cannabis for medicinal purposes
• 1998 – 105th Congress upholds Schedule I classification
• 1999 – IOM’s Marijuana and Medicine report
• 2002-2005 – Gonsales vs. Raich trial
• 2012 – WA and CO legalize recreational cannabis
• 2014 – New York passes the Compassionate Care Act 6

7. Case Study – Charlotte Figi
• Charlotte is a 5 year old female with Dravet Syndrome, a
rare and severe form of profoundly treatment-resistant
epilepsy. She suffers ~300 grand mal seizures per week.
Unable to walk, talk and eat independently. Parents have
tried all anti-seizure drugs indicated for Charlotte’s
condition, as well as some experimental ones, to little or no
effect. Brain damage and cognitive decline noted. Last-
line brain surgery or induction of a medical coma?
• Parents found a video of a boy with severe epilepsy treated
and controlled with an oil high in cannabidiol (CBD)
• Parents met with >100 doctors before they found two who
would recommend medicinal cannabis to treat Charlotte7

8. Case Study – Charlotte Figi

9. • Charlotte’s Parents obtained oil (“R4”) high in CBD
– Seizure rate decreased from 300/week to 1-2/week
• High CBD/Low THC cannabis was rare in Colorado
• Parents contacted the Stanley family, who own one
of the largest cannabis dispensaries in Colorado
– They modified one of their existing strains of product to
be even higher in CBD
Case Study – Charlotte Figi
– They called it “Charlotte’s Web”
– Extracted into oils called “Alepsia”
and “Realm Oil” (~30:1 CBD:THC)
– Realm of Caring Foundation

10. Case Study – Charlotte Figi
• Charlotte today:
– Only has 2-3 seizures/month and regained the
ability to walk, talk, eat, and lead a normal life
• “Charlotte’s Web” is now nationally known
– Featured by Dr. Sanjay Gupta (CNN’s Weed)
– 9,000 patients on the waiting list as of
September 2014*

11. Prevalence of Use and Legal Status
• 23 States (plus the District of Columbia and Guam)
have legislature in place for medicinal cannabis
– Some States have legalized it recently, but have no
programs implemented yet (MD, MN, NH, NY)
• Estimates of over 2,000,000* medicinal cannabis
patients in the USA in October 2014
– Some States have voluntary registration (CA, ME) or do
not have any registration policies (WA)
• 11 States (AL, FL, IA, KY, MS, MO, NC, SC, TN, UT,
WI) have passed laws legalizing some aspect*
11

12. The Institute of Medicine Report (1999)
• The Clinton Administration tasked the IOM with
investigating alleged “gateway effects” of cannabis
– Published a 170 page report – Marijuana and Medicine
– “Gateway effect” greatly questioned (tobacco/alcohol)
– Cannabis treats chronic pain and physical symptoms
with a different MOA in the brain than current drugs
– A lack of concrete recommendations and conclusions,
but many statements calling for additional research*
• 15 out of 18 total recommendations!
– “The acute side effects of marijuana use are within the
risks tolerated for many medications” 12

13. Clinical Trial Evidence
• “Cannabis in painful HIV-associated sensory
neuropathy” – Abrams et al. (2007)
• Prospective, randomized placebo-controlled trial
– Adults with HIV and an average baseline daily pain score
of 50mm on the 100mm visual analog scale (VAS)
• 223 screened, 55 randomized, 50 completed (25/25)
– Primary outcome: ≥30% reduction in VAS pain intensity
– Patients were randomly assigned to smoke 3.56% THC
cannabis cigarettes or placebo cigarettes lacking
alkaloids TID x 5 days
13

14. Clinical Trial Evidence
• Results:
– 50 patients completed the trial
– ≥30% reduction in pain variables reported by 53% in the
cannabis group vs. 24% in the placebo group (p=0.04)
– Median reduction of pain on the VAS was 34%,
compared to 17% in placebo group (p=0.03)
– Median 72% pain reduction with the first cannabis
cigarette vs. 15% with placebo (p<0.001)
– No serious adverse events were reported
• Mild: Anxiety, sedation, disorientation, confusion, dizziness
• No patients left the study due to adverse effects
14

15. 15Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy:
A randomized placebo-controlled trial. Neurology (2007)68:515-521.

16. Clinical Trial Evidence
• “Smoked cannabis for spasticity in multiple
sclerosis” – Corey-Bloom et al. (2012)
– Randomized, placebo-controlled crossover trial
• 196 screened, 37 randomized, 30 completed trial
• Patients could be cannabis-naïve or experienced
– Primary outcome: change in spasticity on the modified
Ashworth scale (a sum of 6 individual joint scores)
• 0 = no increase in muscle tone
• 1 = slight increase (catch and release during motion)
• 2 = slight increase (catch and minimal resistance)
• 3 = more marked increase during motion
• 4 = considerable increase in tone; passive movement difficult
• 5 = rigid flexion and extension
16

17. Clinical Trial Evidence
• Participants smoked either a placebo or a cannabis
cigarette (4% THC), using the Foltin Puff Procedure
– 3 visits per treatment phase
• Phase 1 was followed by 11-day washout, then
patients crossed over to opposite group for phase 2
• Results:
– Cannabis use decreased spasticity an additional 2.74
points vs. placebo on the modified Ashworth scale
– Cannabis reduced VAS scores by 5.28 points
– 7 dropouts did not affect results in sensitivity analysis*
17

18. Clinical Trial Evidence
18Adapted from Corey-Bloom J, Wolfson T, Gamst A, Jin S, Marcotte T, Bentley H, Gouaux B. Smoked cannabis for spasticity in multiple sclerosis: a
randomized, placebo-controlled trial. CMAJ (2012);184(10):1143-50.

19. 19Corey-Bloom J, Wolfson T, Gamst A, Jin S, Marcotte T, Bentley H, Gouaux B. Smoked cannabis for spasticity in multiple sclerosis: a randomized, placebo-
controlled trial. CMAJ (2012);184(10):1143-50.

20. Study Limitations
• Small sample sizes in all studies
– Restrictive nature of Schedule I research
• Difficult to blind the subjects
– Not difficult for patients to realize they ingested THC…
• Most studies haven’t included patients who were
cannabis-naïve at onset of trial
– Abrams et al. (2007) didn’t have authorization from NIH
to expose naïve patients to cannabis
• Difficult to standardize the cannabinoid doses
– Foltin Puff Procedure used in most clinical trials
20

21. New York State Bills and Regulations
• New York Assembly Bill A06357
– Introduced 3/26/2013, passed 6/19/2014
– Introduced by Assembly member Richard Gottfried (D)
– Passed Senate on 6/20/2014
– Signed into law by Gov. Andrew Cuomo on 7/5/2014
– Regulations drafted 12/18/2014
• Title 10 of Official Compilation of Codes, Rules and
Regulations of the State of New York was amended
to include §80-1: Medical Use of Marihuana
21

22. Requirements for Prescribers
• Must have a medical license in good standing in NYS
• Must complete a NYSDOH-approved 4 hour course
– This course WILL NOT count for CE credit
– Course must include pharmacology, CI’s, W/P’s, ADR’s,
OD/abuse prevention, DDI’s, dosing, and the approved
products and their routes of administration
– Course would be somewhat similar to a buprenorphine
prescribing course to treat opioid dependence
• Eligible Prescribers may issue Certifications to
eligible Patients and/or Caregivers
– Must include a statement saying other treatment
options have not provided adequate relief to the Patient

23. Requirements for Prescribers
• Prescribers must be qualified to treat ≥1 of the following
chronic health conditions:
1. Cancer
2. HIV/AIDS
3. Epilepsy
4. Neuropathies
5. Amyotrophic lateral sclerosis (ALS)
6. Huntington’s disease
7. Parkinson’s disease
8. Multiple sclerosis (MS)
9. Inflammatory bowel disease (IBD)
10. Damage to spinal cord nervous tissue with intractable spasticity
• The Commissioner may add or remove approved conditions
and must decide by January 2016 to add PTSD, muscular
dystrophy, Alzheimer’s, dystonia, and rheumatoid arthritis

24. Disease-Accompanying Symptoms
• One or more of the conditions must include:
1. Severe or chronic pain causing a substantial limitation
of function
24
2. Severe nausea
3. Seizures
4. Cachexia or wasting
syndrome
5. Severe or persistent
muscle spasms
• The Commissioner may add or remove disease-
accompanying symptoms

25. Prescribing or Recommending?
• Prescribers can’t prescribe medicinal cannabis on
an Official New York State Prescription Blank, but
they can “recommend” it on separate forms
• On the recommendation form must be written:
– Patient-specific information (like a regular prescription)
– Authorized cannabis brand and formulation
– Dosing information for patient’ proper use
– Any limitations to the use of the approved product
– The total amount of product that can be dispensed
• Quantity can NEVER exceed a 30 day supply!
• Prescriber must retain records for 5 years 25

26. 26
Grant I, Atkinson JH, Gouaux B, Wilsey B. Medical Marijuana: Clearing Away the Smoke. The Open Neurology Journal (2012);6:18-25.

27. Requirements for Patients or Caregivers
• Prescriber-issued Certifications expire in ONE year
– Terminally ill certifications last until death or revocation
• Patients or Caregivers must register with NYSDOH
to be added in registry and pay annual fee of $50*
• Dependent Patients may appoint TWO Caregivers
– Each approved Caregiver can have FIVE Patients
– Persons under 18 require approved Caregivers ≥21
• Patient may not vaporize Products in public places
or any place that has banned smoking cigarettes
• Purchasing party must pay cash to buy products27

28. Example Registration Cards (New Jersey)
28

29. Requirements for Manufacturer Applications
• Each Applicant must pay fees to submit Application
– Application fee is a nonrefundable $10,000
– Registration fee is a refundable $200,000, if approved
• Each Manufacturer must submit:
– Standard operating procedures (SOPs)
– Disposal, security and control procedures
– Product details
– Architecture plans
– Quality assurance plans
– Lab test protocols
29

30. Requirements for Manufacturer Applications
• Must renew Certification every 2 years (same fees)
– Renewal must be received no less than FOUR months
before Manufacturer Certification expiration
– Applicant must include all complaints received, SOPs
changes, lab test reports and theft/loss reports
– Applicant must include quality assurance summary for
all Products tested in prior year, and any shortage dates
• The Commissioner can reject or void Certifications,
Applications (including renewals) at any time and
without advance notice if NYSDOH believes that
medicinal cannabis endangers public health! 30

31. Requirements for Manufacturers
• FIVE Manufacturers will be established in New York
– NYSDOH expects over 100 Applications
• Each Manufacturer can produce up to FIVE Products
– Samples of which must be retained for future testing
– Must have at least one cannabis Product that is high in
CBD and low in THC (think “Charlotte’s Web”)
– Must have at least one cannabis Product that has an
approximately 1:1 ratio of THC and CBD.
• A Manufacturer may have up to FOUR contracted
Dispensaries, setting a maximum of 20 in the State
31

32. Requirements for Manufacturers
• Manufacturer must be able to ensure the
availability of a ONE YEAR supply of all Products
• All records must be readily available for inspection
• Manufacturers can ONLY hire union workers ≥21!
• Manufacturer may work with
banks to manage taxes and
money accounts*
– In Colorado, suitcases or strong-
box safes stuffed with cash are
delivered to government offices

33. Some Difficulties With Banking
• Financial institutions disallow payment for illegal drugs
– Federal Law states the businesses cannot deposit their
cannabis revenues at their banks (money laundering?)
• 2009 – Deputy AG David Ogden stated companies in
states with legal cannabis won’t be prosecuted
– 2011 – Deputy AG James M. Cole stated this memo wasn’t
intended to shield cannabis companies from the Feds
• 2014 – AG Eric Holder stated banks could work with
cannabis industries and won’t be prosecuted
– Financial Crimes Enforcement Network: banks may choose
– Must still file Federal “suspicious activity reports”
33

34. Approved Medicinal Cannabis Products
• Each brand must have a total THC and CBD
concentration within 5% of labeled value (mg/dose)
• Brand names must be alphanumeric combinations!
• Maximum of 10mg THC per dose!
• Approved dosage forms:
– Extract in oil for SL administration
– Extract for vaporization (metered and uniform doses)
– Extract in a capsule for ingestion
– Edible food product only by Commissioner approval
34

35. Approved Products*

36. Approved Medicinal Cannabis Products
• Product label must include ALL these alkaloids:
– Tetrahydrocannabinol (THC)
– Tetrahydrocannabinol acid (THCA)
– Tetrahydrocannabivarin (THCV)
– Cannabidiol (CBD)
– Cannabinadiolic acid (CBDA)
– Cannabidivarine (CBDV)
– Cannabinol (CBN)
– Cannabigerol (CBG)
– Cannabichromene (CBC)
– Any other cannabinoid component at >0.1%
36

37. Auxiliary Labels
• “Medical marihuana products must be kept in the original
container in which they were dispensed and removed from the
original container only when ready for use by the certified
patient”;
• “Keep secured at all times”;
• “May not be resold or transferred to another person”;
• “This product might impair the ability to drive”;
• “KEEP THIS PRODUCT AWAY FROM CHILDREN (unless medical
marihuana product is being given to the child under a
practitioner’s care”); and
• “This product is for medicinal use only. Women should not
consume during pregnancy or while breastfeeding except on the
advice of the certifying practitioner, and in the case of
breastfeeding mothers, including the infant’s pediatrician.”
37

38. Unapproved Medicinal Cannabis Products
• NO RAW PLANT MATERIAL FOR SMOKING!
– NYS is trying to cut down on statewide smoking rates!
• NO RAW PLANT MATERIAL FOR INGESTION!
– Edibles must be premade and prepackaged
• NO FLASHY BRAND NAMES OR ADVERTISEMENTS!
• NO REFERENCES TO 420 CULTURE!
• NO MOLD OR CONTAMINANTS!
• NO ADDITIVES UNLESS PHARMACEUTICAL GRADE!
• NO STATING YOUR PRODUCT IS MOST EFFECTIVE!
38

39. Unapproved Cannabis Products
39

40. Dispensing Facilities (Dispensaries)
• NYS PHARMACIST MUST BE ON SITE WHEN OPEN!
– Must counsel all Patients, like in a pharmacy
– Medication information sheets must be given
• Dispensaries cannot sell non-cannabis products
without prior NYSDOH approval
• No Product, food or drink may be consumed within
• Patients/caregivers must show certification to enter
– May only fill a 30 DAY SUPPLY at a time, and may NOT
break manufacturer packaging
• Must report all sales to NYSDOH 40

41. Dispensary Exterior (New Jersey)

42. Dispensary Interior (California)

43. Dispensing Facilities (Dispensaries)
• Sufficient security measures must safeguard Facilities
and Products and must include the following items:
– Perimeter alarm
– Motion detectors
– Lighting around the perimeter of the facility
– Video cameras at all entries/exits and at product storage
– 24 hour recording capability (≥90 days of storage space)
– A duress alarm (for forced shut down of security)
– A panic alarm (to alert police of emergency situation)
– A hold-up alarm (to signal police to the robbery)
– Automatic voice dialer, that will send prerecorded message
– Failure notification for security (notification within 5 minutes)
– Backup generator for power outages
– Capability to take clear, color photos with 9600dpi resolution
– Back-up alarm system for non-operational hours
43

44. Other States Involve Pharmacists
• Connecticut (2012)
– Only pharmacists can have dispensary licenses
– Pharmacists must check and send records to the PMP
– Dispensary workers must be registered pharmacy techs
• Minnesota (2014)
– Only pharmacists can dispense cannabis to Patients or
Caregivers and counsel on its proper use
• Rhode Island (2006)
– Legal literature safeguarding RPh licensure (counseling)
• Illinois, Maryland, Minnesota, New Hampshire
– Must have a pharmacist sitting on advisory boards 44

45. Miscellaneous Points
• Under NO circumstances can cannabis products
manufactured in New York be taken out of NYS!
• These proposed regulations would sunset SEVEN
years after the approval date if not reapproved
• Cannabis tax of 7% (paid by Facilities)
• Manufacturers can NOT give free samples
• NY Manufacturers can’t dispense from same facility
• No Product may be delivered without DOH approval
• Only female plants can be used for extraction
45

46. Some Dollars and Cents
• Medicinal cannabis programs have mixed success
• Successes:
– Arizona received $7.9 million in taxes and fees from April
2011 – June 2012 (cost the state just $2.4M to run)
– Michigan took in $9.9M in 2012, spending just $3.6M
– Oregon siphoned $900K in 2005, Nevada proposed
siphoning $700,000/year for substance abuse education
• Disappointments and failures-to-launch:
– Rhode Island took in $566,655 in fees but spent
$589,086 in the 2011-2012 fiscal year
– New Jersey approved laws in 2010; in 2013, Greenleaf
Compassion Center was the only operating dispensary

47. Summary of Legal Challenges
• Information vs. misinformation
– Fear-mongering (“gateway drug”)
– Supporters sensationalizing benefits
– Internet shock sites and blogs
– Inherent and persistent biases
– YouTube® and Reddit® “activists”
• Topic is very politically charged
– Federal vs. State
– Democrats vs. Republicans
– Boomers vs. Gen X/Millennials
47

48. Summary of Legal Challenges
• Large-scale trials require approval from the FDA
– Cannabis catch-22: restricted in large part because there
isn’t enough research to support medical uses, but
research is difficult to conduct due to tight restrictions!
• Obtaining product for studies is very prohibitive
– National Institute on Drug Abuse (NIDA) is the ONLY legal
body authorized to cultivate large amounts
– Extension site located at the University of Mississippi
– This single site cannot supply enough product for a
large-scale clinical trial (ex. Phase III)
48

49. Summary of Legal Challenges
• California
– Gonsales vs. Raich landmark trial
– SCOTUS ruled that even with favorable State law, the
Federal Government can criminalize medicinal cannabis
production under the Federal Commerce Clause
• Massachusetts
– As recently as 9/2014, DEA agents have visited MDs to
give an ultimatum: sever ties with medicinal cannabis or
have their DEA licenses permanently revoked
• US Attorney General Eric Holder said the Feds will
be laissez-faire (he’s announced his resignation) 49

50. Conclusions
• There is a universally acknowledged lack of large
scale, long term medicinal cannabis clinical trials!
• Politics continue to prevent cannabis research
– Reclassification to Schedule II is paramount for more
research to be approved and completed
• New York’s medicinal cannabis regulations, when
approved, will be the strictest in the nation
• Medicinal cannabis paves the way for a renewed
investigation into the medical accuracy and current
application of the Controlled Substances Act (1970)
50

51. Resources
• New York State Department of Health
– www.health.ny.gov/regulations/medical_marijuana/
• The Marijuana Policy Project
– www.mpp.org
• The Multidisciplinary Association for Psychedelic Studies
– www.maps.org
• ProCon
– www.medicalmarijuana.procon.org
• Dave Porter, Pharm.D candidate
– David.Porter@acphs.edu
51

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