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IN THIS ISSUE
- ASA Second Annual National Conference
- New scientific review of epilepsy and medical cannabis
- PTSD study approved by HHS, Michigan adds it to conditions
- Maryland lawmakers pass competing bills
- Utah & Alabama pass CBD-only bills
- PFC for Seattle dispensary
- Activist Profile: Melissa Fults, Arkansas
- Action Alert: Support HR 689 & HR 710
Advocates in DC for ASA’s Second Annual Conference
Policy experts, doctors, patients, and other medical cannabis stakeholders are gathering in Washington, D.C. April 5-7, 2014 for ASA’s second annual Unity Conference, "Navigating Medical Cannabis in the Mainstream."
"With medical marijuana moving more into the mainstream, patients and advocates are coming together to learn about the science and how to utilize increased attention on cannabis to bring about meaningful change," said ASA Executive Director Steph Sherer. "This conference is not just for patients and advocates, however; it's also for lawyers, doctors, policymakers, and key stakeholders in the effort to establish medical cannabis as one of the public health issues of our time."
The opening day of the conference, Saturday, April 5th, will feature panels on the history of botanical medicines in the U.S., the future of regulation and product safety, an assessment of the different state medical marijuana laws and how they're working for patients, and the myths and facts of CBD (cannabidiol), one of the plant's primary chemical compounds that works well for some patients with intractable seizure disorders.
On Saturday evening, ASA will host its awards banquet, honoring individuals and groups that have made extraordinary contributions to the advancing safe access. On Sunday, April 6, ASA will hold a panel discussion on deepening our understanding of cannabis as a medicine, as well as several skills building workshops. On Monday, April 7, ASA will host an 11am press conference on the Capitol grounds, which will be followed by a briefing for Hill staff from Noon-1pm, and a lobby day to bring the issues of medical marijuana to Members of Congress.
Among the featured speakers at the conference are Sebastopol Mayor Robert Jacob, American Herbal Pharmacopoeia Executive Director Roy Upton, anesthesiologist Dr. Stephen Corn, M.D., cannabis researcher Dr. Jahan Marcu, PhD., University of Massachusetts Amherst Botany Professor Lyle Craker, Center for Regulatory Effectiveness Director Jim Tozzi, author Martin Lee, and Criminal Justice Policy Foundation President Eric Sterling.
National Medical Cannabis Unity Conference: http://www.safeaccessnow.org/the_national_medical_cannabis_unity_conference
Comprehensive Review of Epilepsy and Medical Cannabis Released by AHP
The medical research group American Herbal Pharmacopoeia (AHP) last month issued a comprehensive review of the science and history behind using cannabis to treat epilepsy and seizure disorders. Cannabis in the Treatment of Epilepsy is part of the AHP’s much larger Therapeutic Compendium of cannabis treatments that goes to press later this spring.
Its free pre-publication release into the public domain comes in response to the media attention and discussion of parents seeking out medical cannabis for their children with seizure disorders, including a statement last month from the Epilepsy Foundation calling for increased access and research.
CNN correspondent Dr. Sanjay Gupta’s follow-up documentary last month again focused on children with rare and severe seizure disorders that were not controlled by conventional medication but were alleviated by cannabis extracts rich in Cannabidiol (CBD), a cannabinoid with antispasmodic and other therapeutic effects but little psychoactivity.
In December, the U.S. Food and Drug Administration approved clinical trials for children with intractable epilepsy of Epidiolex®, a dose-controlled cannabis extract that is also primarily CBD.
Last month also saw legislators in Alabama and Utah pass laws that would ostensibly allow the legal use of CBD extracts, though neither contains provisions for obtaining or making the medicine.
"Releasing this section of the monograph into the public domain at this time provides clinicians, patients, and their caregivers with a single document that comprehensively summarizes the scientific knowledge to date regarding cannabis and epilepsy," said Dr. Ben Whalley, Director of Research at the School of Pharmacy, University of Reading in the U.K., who co-authored the review.
The AHP’s forthcoming Therapeutic Compendium is part two of its authoritative Cannabis Monograph, which adds cannabis to the herbal pharmacopeia of recognized botanical medicines. The first part of the monograph, Cannabis Inflorescence:Standards of Identity, Analysis, and Quality Control, set standards for quantifying the identity, purity, quality, and botanical properties of cannabis.
PTSD Study Approved by HHS, Michigan Adds it to Conditions
A long-delayed study on using cannabis to treat Post Traumatic Stress Disorder (PTSD) in veterans was approved by the federal Department of Health and Human Services last month, and health officials in Michigan added the condition to the list of those for which patients may qualify to register with the state’s medical cannabis program.
The University of Arizona study will measure the efficacy of smoked and vaporized cannabis in treating symptoms of PTSD in 50 veterans. The study is to be conducted by Suzanne Sisley, M.D., who will be one of the featured speakers this weekend at Americans for Safe Access’ National Unity Conference in Washington, D.C.
The letter of approval from HHS allows the study’s backer, the Multidisciplinary Association for Psychedelic Studies (MAPS), to purchase research cannabis from the National Institute on Drug Abuse (NIDA). MAPS has been seeking access to research cannabis for over 22 years without success. The PTSD study received FDA approval long ago, but NIDA is the only legal source of research cannabis, and they had refused to release any for the veterans. The PTSD study must still receive clearance from the Drug Enforcement Administration.
The difficulty in obtaining access to research cannabis has been true for a number of other FDA-approved studies, leading DEA Administrative Law Judge Mary Ann Bittner in 2011 to rule that an additional cultivation site license should be issued to Prof. Lyle Craker of the University of Massachusetts at Amherst. That ruling was ignored, just like the 1988 administrative law ruling from Chief Judge Francis Young that said cannabis should be immediately rescheduled and made available for medical use. NIDA’s mission is to sponsor research on drug abuse and addiction, so it has been reluctant to allow access for studies that would show medical benefit.
The Veterans Health Administration estimates as much as 20 percent of those who served in Iraq and Afghanistan have PTSD, and more than 7 million Americans suffer from the condition. Preclinical research indicates cannabis can be effective at treating anxiety and other symptoms of PTSD, and many people with the disorder report being helped by cannabis.
Maryland Lawmakers Pass Competing Medical Cannabis Bills
The two houses of the Maryland legislature passed medical cannabis bills last month. The Maryland House of Delegates passed HB 881 first, but the Senate’s SB 923 would create a more feasible program.
The Maryland Senate passed by a vote of 45-1 the bill that would authorize the Natalie M. LaPrade Medical Marijuana Commission to regulate the cultivation of cannabis and its distribution to patients through licensed "medical marijuana treatment centers."
Both the House and Senate bills would fix the flaw in the state’s existing law that has prevented it from being implemented. Under it, the only way a patient could gain access to medical cannabis would be if an "Academic Medical Center" was willing to distribute it, but none have been willing to jeopardize federal research funding to do so.
The state’s medical marijuana commission has issued draft regulations for the current law, and Governor Martin O'Malley indicated in January that he would sign legislation to fix the current program.
ASA and Maryland patient advocates worked with legislators to expand the number of physicians qualified to participate and increase patient access. ASA urged the Senate to include a provision to allow veterans who receive their medical care from the Veterans Health Administration to enroll in the program, as VHA physicians are not allowed to authorize medical cannabis use. The Senate bill directs the Commission to study the issue and make recommendations.
Alabama and Utah Each Enact CBD-only Bills
Utah and Alabama each enacted laws last month making allowance for limited medical use of CBD extracts of cannabis. Neither state law makes any provision for making or obtaining the medicine.
The Utah statute, known as “Charlee’s Law” for a 6-year-old girl with a seizure disorder who died while waiting for it to pass, allows only oils containing 0.3% THC or less and at least 15% CBD. The Utah law makes such cannabis preparations legal, but not any other form of cannabis.
The Alabama law, SB 174, known as Carly's Law for a 3-year-old girl with a rare form of epilepsy called CDKL5, creates only an affirmative defense for patients and caregivers, and only patients with seizure disorders diagnosed by the University of Alabama-Birmingham's Department of Neurology are covered, and then only if they receive a prescription. Because CBD and other cannabis extracts are federally classified as Schedule I substances, no medical professional may legally write a prescription for them.
Utah lawmakers have expressed hope that CBD extracts such as that made by the Stanley brother’s Realm of Caring in neighboring Colorado might be imported, but Colorado state law expressly forbids taking cannabis products out of state. Alabama is separated by several states and many hundreds of miles from anywhere medical cannabis is currently legally distributed.
The most recent guidelines from the US Department of Justice specify that any transport of cannabis products across state lines remains a federal enforcement priority. Compliance with state medical cannabis laws provides no protection from federal prosecution, and all uses and distribution of cannabis remain illegal under federal law.
The bill differs from other successfully implemented medical cannabis laws in many ways. While every other medical cannabis bill in the country allows access to a number of conditions, SB 174 only creates legal access for patients with seizure disorders who have been diagnosed by the University of Alabama-Birmingham's (UAB) Department of Neurology.
GW Pharmacueticals has recently won FDA approval for a limited trial of Epidiolex® for 150 pediatric patients spread between six research hospitals in the US, including the UCSF Benioff Children’s Hospital in San Francisco and the NYU Langone Medical Center in New York. University of Alabama at Birmingham could apply to be another named center for the Epidiolex study, but as an FDA-approved study, state law would have no bearing on the legal status of participating patients or their caregivers.
Seattle Dispensary First in Washington State to Achieve National Certification
The first medical Cannabis dispensary in Washington State, Dockside Co-op of Seattle, was certified as meeting the operational standards set by the American Herbal Products Association (AHPA). The Patient Focused Certification (PFC) program, a project of Americans for Safe Access, is a nonprofit, third-party certification that verifies the quality and reliability of products sold at licensed medical cannabis businesses.
"In the face of failure by state legislators to develop sensible dispensary regulations in Washington State, the Patient Focused Certification program encourages the industry to adhere to important safety and quality standards," said Maria Moses, Co-founder and Director at Dockside Co-op, which has been located in the Fremont neighborhood of Seattle for more than 3 years. "This program gives the industry a baseline to affirm what we're doing right and to improve upon the service we provide to patients."
Today's certification comes a week after legislators abandoned efforts to establish statewide medical cannabis regulations in Washington. It is estimated that more than 200 medical marijuana dispensaries are currently licensed and operating in the City of Seattle.
With more than one million qualified medical marijuana patients in 20 states and the District of Columbia, a new industry has developed to meet the needs of this rapidly growing population. The PFC program ensures adherence to the regulatory guidelines AHPA and AHP have established for the purity and identity of the products being sold and the methods for producing and distributing them. Many states and localities have created regulations to govern the location, size, taxation, and even the ownership and management of the businesses and organizations that serve patients.
The AHPA recommendations for state regulators provide standards for manufacturing, packaging and labeling, dispensary operations, and laboratory practices. AHPA has since issued standards for commercial medical cannabis products, as well as the reliability and quality of related services. More recently, AHP released a cannabis monograph that set standards for the plant's identity, purity, quality, and botanical properties.
The Patient Focused Certification process is overseen by a review board of scientists, doctors, and industry and regulatory experts. It includes a scheduled physical audit, a staff training audit, a complaint process and at least one surprise audit annually. PFC-certified products and businesses will exhibit the PFC seal on their marketing, promotions and packaging to help patients make educated purchasing decisions.
ASA has been offering trainings to the medical marijuana industry for over a decade and holds a permit from the District of Columbia for mandatory industry trainings. PFC industry trainings are co-produced with the Cannabis Training Institute (CTI) and certify cultivators, manufacturers, distributors, and laboratory technicians to ensure adherence to AHPA and AHP standards. Such trainings are mandatory in some states, including Arizona, Connecticut, Massachusetts, Nevada, and the District of Columbia. Following a successful beta phase over the past few months, the program is now available to the medical cannabis industry in all 20 states and the District of Columbia.
Pending PFC applications in six states include Harvest of Tempe in Arizona; BASA and Peace in Medicine in California; Werc Shop Laboratories in California and Washington; Remedy Compassion Center in Maine; New Mexicann and Page Analytics in New Mexico; and The CPC and Solstice Co-op in Washington.
Patient Focused Certification (PFC) program: http://PatientFocusedCertification.org
AHPA Standards: http://safeaccess2.org/sites/patientfocusedcertification/standards-development/apha-guidelines
AHP Cannabis monograph (Abridged version): http://www.safeaccessnow.org/ahp_cannabis_monograph_preview
ACTIVIST PROFILE: Melissa Fults, Arkansas
Melissa Fults got involved with medical cannabis activism as the result of seeing what her son went through after a car accident in 1999 when he was in high school. The injuries from her son’s crash required five neck surgeries and two for his back and left him with chronic pain. After 13 years of opiates and other medications – oxycodone, valium, centrex, Ambien and an anti-depressant -- he had become what Melissa describes as a “zombie” who was vomiting blood daily. His doctor told him the medications were killing him.
When he discovered medical cannabis taken as capsules could let him reduce or eliminate other medications without the serious side effects, his life was transformed. After he stopped the heavy regimen of opiates, he was able to not only get the high school diploma he couldn’t complete but now has a full scholarship to a four year college, where he is pursuing a degree in psychology with plans to get a Ph.D.
But the Fults family lives in Arkansas, where any use of cannabis remains illegal, even for suffering patients such as Melissa’s son. When Melissa heard a medical cannabis initiative had been submitted a few years ago, she and her husband knew they had to get involved.
“It’s just a matter of saving my son,” Melissa says.
She says their personal life is all about advocacy now, 24/7. The medical cannabis initiative of two years ago narrowly lost, but she and her husband are working hard to get another one on the ballot this year. They are traveling the state, having educational meetings, gathering signatures, and talking to everyone they can about the importance of safe access.
“The advocacy work has been a huge, life-altering experience,” Melissa says. “I’m a walking encyclopedia on medical cannabis now.”
Arkansas advocates are focused on fundraising right now so they can hire signature gatherers to meet the July 7 deadline for submitting signatures. Melissa says they currently need about 55,000 more to make the ballot this fall, and that’s more than the volunteer team can manage.
To find out how to help, go to the website for Arkansans for Compassionate Care at arcompassion.com.
Arkansans for Compassionate Care: http://arcompassion.com/
ACTION ALERT: Support HR 689 and HR 710
Contact your representative today with ASA’s easy online tool and urge support for two federal bills that will end the federal conflict with state medical cannabis programs: HR 689 and HR 710.
The States’ Medical Marijuana Patient Protections Act (HR 689) would move cannabis out of Schedule 1 of the Controlled Substances Act and allow for medical research to be controlled by an agency other than the National Institute of Drug Abuse. The Truth in Trials Act (HR 710) would allow anyone in compliance with state law who faces federal charges to offer evidence of the medical necessity for their use of cannabis.
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