The Green Light - Medicinal Cannabis in New York (Presentation Version)
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
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
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
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
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
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
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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40. Nabilone. In: Lexi-drugs online [database on the Internet]. Hudson (OH): Lexicomp, Inc.; 2013 [updated 20 Nov 2014; cited 27 Jan 2015].
Available from: http://online.lexi.com. Subscription required to view.
41. New York State Assembly Bill 6357. 2013 Mar 26. Available from <http://assembly.state.ny.us/leg/?sh=printbill&bn=A06357&term=2013>.
42. New York State Department of Health. New York State Medical Marijuana Program. Dec 2014. Available from:
<http://www.health.ny.gov/regulations/medical_marijuana/>.
43. ProCon. Medical Marijuana Pros and Cons. Last updated 11/13/2014. Available from: <http://medicalmarijuana.procon.org/>.
44. Schenberg EE,de Castro Comis MA, Rassmussen Chaves B, da Silveira DX. Treating drug dependence with the aid of ibogaine: A retrospective
study. Journal of Psychopharmacology (2014);28(11):993-1000.
45. Tylš F, Páleníček T, Horáčeka J. Psilocybin – Summary of knowledge and new perspectives. European Neuropsychopharmacology
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46. Wallace M, Schulteis G, Atkinson JH, Wolfson T, Lazzaretto D, Bentley H, et al. Dose-dependent Effects of Smoked Cannabis on Capsaicin-
induced Pain and Hyperalgesia in Healthy Volunteers. Anesthesiology (2007);107(5):785-96.
47. Wilsey B, Marcotte T, Deutsch R, Gouaux B, Sakai S, Donaghe H. (2013). Low-Dose Vaporized Cannabis Significantly Improves Neuropathic
Pain. J Pain, 14(2):136-48.
48. Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. (2008) A Randomized, Placebo-Controlled, Crossover Trial of
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54
Legal disclaimer: any opinions given herein do not necessarily reflect those of the Albany College of Pharmacy and Health Sciences or MVP Health Care or their respective Associates.
Cannabis is the preferred industry term for the plant and its derived products!
Legislature still contains names such as marijuana and marihuana, but these are both slang terms
Using slang terms demeans the professionalism and credibility of the cannabis industry
A new species was said to have been found in 2014 in Australia, but it was a hoax (High Times Magazine)
800-900AD – Ibn Wahshiyah made this claim
Cannabis sativa as illustrated in Köhler's book of medicinal plants from 1897
Cannabis has a long history of medicinal use in the USA, and it was at one point approved by USP!
NY became the 23rd state to approve legislature to legalize medicinal cannabis – California was the first (1996)
1937 - The American Medical Association (AMA) opposed the act because the tax was imposed on physicians prescribing cannabis, retail pharmacists selling cannabis, and medical cannabis cultivation/manufacturing
William Randolph Hearst was influential in the passage of his act (hemp was poised to provide competition to paper made from tree pulp, and he and the du Pont family had large timber assets and interests)
Dravet Syndrome is also called Severe Myoclonic Epilepsy of Infancy (SMEI)
Parents even contacted a European pharmaceutical company testing a canine antiseizure medication
The first seizures with Dravet Syndrome usually start before the age of 1
In the second year, myoclonic seizures, muscle spasms, and status epilepticus (seizures that last more than 30 minutes or come in clusters)
Charlotte was unable to independently do most activities of daily living, such as eating, drinking and walking.
Seizures were affecting her cognitive development
She was DNR
In Colorado: The average patient in the program is 42 years old. There are 39 patients under the age of 18.
Low THC, high CBD cannabis was rare in CO because it can’t really be used recreationally
The strain the Stanleys used was called “Hippie’s Disappointment”
Realm of Caring Foundation was founded to provide Charlotte’s Web access to parents with children with debilitating conditions
Have satellite offices in CA and FL (FL is strictly advocative since FL has no laws in place)
Receiving 1 dose of 3-4mg/lb of oil twice a day with food
After treatment, her seizures usually only happen at night when she is sleeping
* - MANY STEPS FOR PARENTS TO GET CHARLOTTE’S WEB:
Establish an account through the Patient Portal on the website
Fill out Realm of Caring Confidentiality Agreement
Get on the Colorado waitlist
Establish residency
Get doctors to sign red card application
Send in Medical Cannabis Registry Card application (also known as red card) to the Colorado Medical Marijuana Registry.
Send Realm of Caring copies of application, certified mail receipt and return receipt via Patient Portal
View the orientation video
View the dosing calculation video
Wait for notification from Realm of Caring that meds are ready
Pick up medication at dispensary
* - “Some aspect” is usually some type of high CBD, low THC cannabis preparation like Charlotte’s Web
The estimates of CA and WA are based off of the per capita registration in OR.
Estimate of ME is based off of per capita registration in Vermont.
Only one study was completed after 1981… so this report definitely leaves a lot to be desired! Most studies were said to be too small to be able to generalize data to the public as a whole, and this is why the IOM recommended larger studies be done!
Can’t be blinded – patients will know that they are smoking THC-containing cannabis!
Primary outcome measures included ratings of chronic pain and the percentage achieving 30% reduction in pain intensity
Alkaloids in the placebo cigarettes had been extracted by the lab at National Institute on Drug Abuse (NIDA)
Inclusions: Adults with at least 30mm on the VAS; stable health; no current substance abuse (including tobacco; stable medication regimen for pain and HIV for at least 8 weeks prior to enrollment (using conventional meds); prior cannabis use (6x/lifetime) but no additional cannabis was not allowed during any study phases
Exclusions: non HIV neuropathy; received isoniazid, dapsone or metronidazole 8 weeks prior to study; currently not on HAART
Remember – cannabis is only being used for symptom control.
There is no treatment to “cure” neuropathic pain at its source!
Sedation was most noteworthy side effect
7-day outpatient pre-intervention phase: researchers established patient eligibility;
2-day inpatient lead-in phase: patients acclimated to the inpatient General Clinical Research Center and obtained baseline measurements;
5-day inpatient intervention phase: patients received either 3.56% THC cannabis cigarettes or placebo cannabis with alkaloids extracted;
7-day outpatient post-intervention phase: patients continued to record pain ratings each day
Both hips, both elbows, both knees max of 30 points on Ashworth
Ashworth measured 45 minutes after treatment
Patients could be on stable disease modifying therapy (interferon beta +/- glatiramer) if longer than 6 months prior
Inclusions: At least 3 Ashworth points at an elbow, hip or knee; no cannabis use within 30 days
Exclusions: Major psychiatric disorder other than depression; ANY substance abuse; asthma/COPD; recent medication changes; use of benzodiazepines; severe neurological condition other than MS (epilepsy, head trauma)
Foltin: Verbally signaled to “Get ready” (5 sec), “inhale” (5 sec), “hold in lungs” (10 sec) “exhale and wait” before repeating puff cycle (40 sec wait)
* - Worst-case scenario sensitivity analysis (assuming that the seven patients who withdrew would not have shown any treatment effect):
Cannabis reduced average scores on the modified Ashworth scale by 2.22 points (p < 0.001)
Cannabis reduced the VAS of pain by 4.28 points (p = 0.009)
These findings suggest that dropouts had no meaningful effect on the results
Effect = (change in cannabis – change in placebo)
Positive values mean decreases (so cannabis decreased or slowed all of these things)
Higher scores of spasticity = more spasticity
Insignificant decrease in spasticity in placebo
Significant decrease in cannabis smoking group
Cannabis use decreased spasticity an additional 2.74 points vs. placebo on the modified Ashworth scale
Cannabis reduced VAS scores by 5.28 points
2 week treatment duration – 6 treatment days
Small sample size unavoidable due to DEA restrictions on access
Blinding psychoactives is almost impossible
Hard to standardize doses
mg or mg/kg is very hard to standardize for smoked products, because people smoke differently
No high quality trials of cannabis edibles have been completed (would be much easier to standardize doses)
Recalled twice by Assembly, final form passed 6/19/2014
Regulations have not been approved yet!
Medicinal cannabis will NEVER be first-line therapy – it will be an adjunct to treatment resistant patients
Patient must have a bona fide relationship with their physician
in some states, this usually means over 1 year of regular visits and follow-up
In others, it may require 4+ visits to doctor
Neurologists, oncologists and HIV/AIDS specialists will likely be doing most of the prescribing
Pain can’t be regular pain from a sprained ankle or something – it must be neuropathic in origin!
Patients may purchase a new supply of medicinal cannabis up to 7 days prior to the 30 day mark on the prior supply
This is just a proposed flow chart for neuropathic pain, but it would work with any other approved condition!
Patient must be on standard Rx treatment while on medicinal cannabis, but may be titrated off it at the discretion of the Prescriber
The fee may be waived for low-income patients if they provide proof of burden
Credit card companies will not allow patients to purchase medicinal cannabis with their cards!
Medicinal cannabis use will be considered a disability for the purposes of NY’s anti-discrimination laws
Employers will not be allowed to fire employees for using medicinal cannabis
NYS may issue cards for patients (adult vs. minor), caregivers, Manufacturer employees and Dispensary employees similar to these in NJ
Other states have cards specific for home-growers, specifying how much plant material (mature or immature) they can have
These fees are relatively low, to encourage businesses to apply
Start-up costs will be approximately $20,000,000 per manufacturer, claim industry analysts.
Manufacturer applications will not get much consideration unless the firm has over $2,000,000 in assets (land and capital)
The demand for these few dispensaries will likely overpower the supply, and waitlists will be long
In comparison, Arizona (population of 6.7 million) has over 100 dispensaries!
A busy cannabis dispensary in Denver can handle about $25,000 a day in cash
"It's crazy, we have secured rooms, and within those secured rooms we have secured locking safes and sometimes within those safes we have money safes" – Brian Ruden, Colorado dispensary owner
American Express spokesperson has stated “American Express does not allow card acceptance for medical marijuana”
Contradictory statements and a lot of reluctant banks makes for difficulties for cannabis companies
An acceptable name would be something like “DP-27”
An unacceptable name would be something like “Charlotte’s Web” or “DP-420”
The CBD oil and Colorado Cannabis Co. oil would NOT be allowed in NYS per proposed guidelines in their current packaging
They would need to have to be renamed with alphanumeric combinations, and all graphics must be removed if they are stylized in any way.
Packaging must be plain and discrete.
New York State will set ALL prices – only State with the capability to do this
Product labels must include:
(1) the name, address and registration number of the registered organization;
(2) the medical marihuana product form and brand designation;
(3) the single dose THC and CBD content for the product set forth in milligrams (mg);
(4) the medical marihuana product lot unique identifier (lot number or bar code);
(5) the quantity included in the package;
(6) the date packaged;
(7) the date of expiration of the product;
(8) the proper storage conditions;
(9) auxiliary labels
Keep in original container, keep secured, don’t resell or transfer, might impair driving, keep away from children, medicinal use only, pregnancy/breastfeeding warning (contact MD)
Names must be letters and numbers, and cant relate at all to cannabis culture!
Cant be smoked by patients – IOM study found that cannabis cigarettes, because they are unfiltered and because users inhale deeper and hold the smoke longer, deposits up to 4x as much tar as regular cigarettes.
Increased risk of respiratory infections, especially in immunocompromised patients
Pharmacists licenses prohibit them from dispensing the drug, because it’s a Schedule I!
THE 7 DAY RULE FOR NYS CONTROLS DOES NOT APPLY! Patients can pick up supplies 7 days early each month!
Cant sell any retail store items, paraphernalia or other items unless your get approved by DOH
Look how plain and boring it must be
No signage, no neon
New York has a population of 19.5 million and will have a maximum of 20 dispensaries, which will be the lowest per-capita dispensary:population ratio of any medical cannabis state in the USA
This would be ok in NY as long as you cant see the display cases from the outside
Advertising must be minimal and discrete, but décor can be similar to this, if desired
Multiple layers of security and alarms to safeguard Staff, Facilities and Products.
Why so few? Pharmacists should be at the point of dispensing in ALL states!
Rhode Island added a clause in their regulations to allow pharmacists to counsel on correct use without discipline for counseling on how to use a federally illegal substance!
This is not present in NY legislature (yet)
“A practitioner, nurse, or pharmacist shall not be subject to arrest, prosecution or penalty in any manner, or denied any right or privilege, including, but not limited to, civil penalty or disciplinary action by a business or occupational or professional licensing board or bureau solely for discussing the benefits or health risks of medical marijuana or its interaction with other substances with a patient.” (Rules and Regulations Related to the Medical Marijuana Program, RI, updated 2012)
In California, the annual tax revenue from dispensaries is up to $105 million
Excise tax of 7% in New York will be levied on gross receipts and paid by the Manufacturers and Dispensaries
22.5% goes to county were the medical cannabis was produced
22.5% goes to county were the medical cannabis was dispensed
5% goes to Office of Alcohol and Substance Abuse Services for prevention, counseling and treatment services
5% goes to the Department Criminal Justice Services for discretionary grant program related to enforcement of the this title
Remainder goes to New York State’s medical cannabis trust fund
Michigan surplus was $6.3M and Arizona surplus was $5.5M
Most states operate at a surplus.
The beginning years will generally be in the red due to implementation costs/infrastructure delays (NJ)
Slang terms tying medicinal cannabis to street cannabis (especially in media reports or by politicians or other high-ranking officials) only lessens the professional credibility of the medicinal cannabis movement.
So does users posting videos of themselves smoking cannabis on social media sites like YouTube®
So does sensationalizing the benefits and claiming cannabis is a cure-all miracle drug with no adverse effects
So does the lay public acting like they are experts in the field
Gonsales vs. Raich
Two patients and their caretakers from California sued the federal government claiming that by enforcing the CSA, DEA agents violated the Federal Commerce Clause, medical necessity doctrine and Due Process Clause of the Fifth, Ninth, and Tenth Amendments to the Constitution of the United States
A footnote in the Gonsales vs. Raich judgment acknowledged the potential benefits of medicinal cannabis, stating:
“We acknowledge that evidence proffered by respondents in this case regarding the effective medical uses for marijuana, if found credible after trial, would cast serious doubt on the accuracy of the findings that require marijuana to be listed in Schedule I.”