ASA Activist Newsletter - August 2016
August 20, 2016 | William Dolphin
In the August 2016 Issue:
- Appeals Court Says DOJ Can’t Prosecute State-Legal Individuals
- DEA Again Denies Medical Value of Cannabis
- ASA Report Shows Cannabis Can Address Opioid Crisis
- Senate CBD Bill Introduced
- Patient Groups Urge Congress to Act on Medical Cannabis
- ASA to Host California Educational Tour
- Maine Medical Cannabis Business Achieves National Certification
- Activist Profile: Coltyn Turner Family
Appeals Court Says DOJ Can’t Prosecute State-Legal Individuals
The U.S. Court of Appeals for the 9th Circuit a has ruled that the Justice Department cannot prosecute individuals for medical cannabis activities who are in compliance with applicable state laws. The three-judge panel’s unanimous ruling came in response to denied injunctions for defendants in 10 cases in California and Washington who had argued that prosecutors should be prevented from pursuing federal charges because the defendants complied with state law. The court, which covers nine Western states, sent the cases back to their respective trial courts to determine if the defendants had complied with state law, ruling that the DOJ could not proceed if those defendants "strictly complied" with all state regulations.
In 2014, after numerous attempts and extensive lobbying by ASA and other patient advocacy organizations, Congress passed the bipartisan Rohrabacher-Farr amendment to the DOJ budget bill, blocking the DOJ from using budget funds to prevent states from "implementing their own State laws that authorize the use, distribution, possession, or cultivation of medical marijuana." The DOJ argued that meant they could not directly interfere with state governments but could continue to prosecute cases against individuals who participated in those programs.
That interpretation drew incredulous criticism from ASA and the bill's sponsors, and the appeals court ruling emphatically rejected the DOJ argument. The appeals court decision mirrors that of district court Judge Charles Breyer, who last fall lifted a federal injunction that had closed a Northern California dispensary, saying the appropriations measure plainly prohibits such interference with state medical cannabis programs and that to claim otherwise "defies language and logic."
The appeals court agreed, finding that "at a minimum, [Rohrabacher-Farr] prohibits DOJ from spending funds from relevant appropriations acts for the prosecution of individuals who engaged in conduct permitted by the State Medical Marijuana Laws and who fully complied with such laws."
The judges ruled that “If DOJ wishes to continue these prosecutions, Appellants are entitled to evidentiary hearings to determine whether […] they strictly complied with all relevant conditions imposed by state law on the use, distribution, possession, and cultivation of medical marijuana.”
As ASA Government Affairs Director Mike Liszewski noted a year ago, “The language of the amendment and numerous statements clarifying the intent of the bill's sponsors make it clear that DOJ is barred from interfering with conduct that is legal under a given state's medical marijuana law.”
Text of the Ninth Circuit ruling
DEA Again Denies Medical Value of Cannabis
Administration Rejects Petition from State Governors
A rescheduling petition filed by the governors of Rhode Island and Washington State was the latest to be rejected by the Drug Enforcement Administration (DEA). Despite advance reports that federal officials intended to relax the classification of cannabis, on August 11, 2016, the DEA announced it will remain in Schedule I, the most restrictive category. The DEA said the decision reflects yet another determination by the Department of Health and Human Services (HHS) that “marijuana has a high potential for abuse, has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision.”
The DEA did act to end the monopoly on research cannabis that has been maintained by the National Institute on Drug Abuse, which controls the one federally authorized cultivation facility in the U.S. at the University of Mississippi. But the decision keeps the federal government at odds with the consensus opinion of scientific experts, as well as the 27 states and other jurisdictions that have enacted laws that currently allow more than 2 million Americans to legally obtain and use cannabis for medical treatment.
The DEA action was denounced by a wide range of advocates and elected officials, as seen in statements from several members of Oregon’s Congressional delegation. Sen. Ron Wyden said “the DEA is keeping federal law behind the times," while Sen. Jeff Merkley said “It’s clear now that Congress must take action to end the confusing patchwork of state and federal laws and regulations.” Rep. Earl Blumenauer’s statement noted that “Keeping marijuana at Schedule I continues an outdated, failed approach—leaving patients and marijuana businesses trapped between state and federal laws.”
The Controlled Substances Act, the 46-year-old law that classifies drugs in the US according to their risk and efficacy, requires an 8-Factor Analysis to be used for determining which schedule a drugs belongs in. ASA conducted an independent 8-Factor Analysis that found cannabis is currently misclassified.
“The DEA focused on outdated information from last century, animal research, and surveys, while misinterpreting several studies reporting non-serious adverse events as an indication of a serious potential for harm,” said ASA Chief Scientist Jahan Marcu, PhD. "What’s more, they disregarded dozens of clinical trials and thousands of published scientific articles that didn’t fit their political agenda for regulating medicine. It’s like the last 20 years of research never happened.”
The news of the DEA decision came the day after the National Conference of State Legislators called on Congress to remove marijuana from its current status. Many professional health organizations such as the American College of Physicians and the American Academy of Pediatrics have also called for changing its classification, as have members of Congress. In a June letter to the U.S. Attorney General and the DEA, Sen. Elizabeth Warren (D-MA) and seven others pressed for immediate action, noting that federal law creates a host of problems for licensed cannabis businesses and clinical researchers.
"While many have speculated that placing cannabis in Schedule II would lead to a Big Pharma takeover, it's actually the Schedule I status that is making this possible,” said Mike Liszewski, ASA’s Government Affairs Director. “The HHS 8-Factor Analysis states drugs containing cannabinoids can be placed in Schedules II-V, while cannabis remains in Schedule I."
For many years, patient advocacy groups such as ASA, the Epilepsy Foundation, and others have appealed to federal officials to reclassify cannabis to reflect its modern medical uses, including a group letter sent to the DEA in April.
“This decision is further evidence that the administrative process for rescheduling cannabis is broken and unworkable,” said ASA Executive Director Steph Sherer. “It is up to Congress to rectify this situation by passing the CARERS Act.”
Introduced in 2015, The Compassionate Access, Research Expansion, and Respect for States (CARERS) Act (S. 683, H.R. 1538) would reschedule cannabis and allow states to establish medical cannabis programs and product safety regulations without federal interference.
ASA's 8-Factor Analysis
DEA’s 8-Factor: Rescheduling Denial
DEA’s Rescheduling Denial Press Release
\Medical Cannabis Access for Pain Treatment: A Viable Strategy to Address the Opioid Crisis
CARERS Act Fact Sheet
American Academy of Pediatrics Statement on Rescheduling
American College of Physicians position paper
National Conference of State Legislators resolution
ASA Report Shows Cannabis Can Address Opioid Crisis
ASA in July released a report on why medical cannabis can be a better option than opiod painkillers for the millions of Americans suffering from chronic pain. The report, Medical Cannabis Access for Pain Treatment: A Viable Strategy to Address the Opioid Crisis, is aimed at educating legislators and health practitioners on the role medical cannabis can play in easing the overdose epidemic. As opioid prescriptions have increased over the last two decades, fatal overdoses have quadrupled.
In July, President Obama signed the Comprehensive Addiction and Recovery Act (CARA), a bill more focused on treating drug abuse and preventing overdoses than ensuring patients receive safer effective treatment options.
ASA’s report outlines research data indicating cannabis can be an effective painkiller that reduces opiod use and provides recommendations for elected officials and physicians. First, Congress can pass the Compassionate Access, Research Expansion, and Respect States (CARERS) Act (S.683) to harmonize federal and state laws. Second, state lawmakers should ensure chronic pain is included as a qualifying condition for participating in their state medical cannabis program. Lastly, state medical boards can promote medical cannabis education.
“Patients across the US are successfully using cannabis to treat pain with fewer opioids,” said ASA Executive Director Steph Sherer. “It is not a coincidence that unintentional overdose deaths from prescription painkillers decrease by 25 percent after states establish medical cannabis programs.”
ASA’s report, which was delivered to all members of Congress, shows that access to medical cannabis for pain treatment could help address both accidental overdoses and opiate addiction. That idea has support in Congress from Senator Elizabeth Warren (D-MA), who in February called on the Centers for Disease Control (CDC) to collaborate with states and other federal agencies on the exploration of “alternative pain relief options” including medical cannabis.
Chronic pain is the most common condition for which patients use medical cannabis, but a quarter of the states with relatively robust programs exclude it from their qualifying conditions. Some are rethinking that in response to the overdose epidemic. In June, Vermont Governor Pat Shumlin signed legislation adding chronic pain to the state’s condition list, saying, “At a time when opioid addiction is ravaging our state and drug companies continue to urge our doctors to pass out painkillers like candy, we need to find a more practical solution to pain management.”
Senate CBD Bill Introduced
In July, four members of the Senate Judiciary Committee introduced the Cannabidiol Research Expansion Act (S. 3269), which would ease research barriers and create a narrow exemption from federal prosecution for certain seizure patients. The bill would allow universities and others to register with the federal government to conduct research on the cannabis component cannabidiol (CBD) and create a “Safe Harbor” for the parents and legal guardians of children with intractable epilepsy who are using pure CBD as a treatment. No other patients would be protected, and no amount of THC would be permitted.
“As a parent of a child with intractable epilepsy, I appreciate any action to address the needs of seizure patients and their families,” said Beth Collins, ASA Senior Director of Government Relations and External Affairs. “Unfortunately, the bill would not do enough, as many patients with intractable epilepsy, including my daughter, need THC to control their seizures. Congress needs to do something to help them and the millions of patients with other conditions, too.”
Senate Bill 3269 was introduced by Sens. Dianne Feinstein (D-CA), Chuck Grassley (R-IA), Patrick Leahy (D-VT), and Tom Tillis (R-NC). In contrast, the Compassionate Access, Research Expansion, and Respect States (CARERS) Act (S. 683/H.R. 1538) would do far more, not only lifting several federal research barriers but protecting all patients participating in state medical cannabis programs.
Patient Groups Urge Congress to Act on Medical Cannabis
On July 12, Americans for Safe Access (ASA) delivered a letter on behalf of 13 patient-based organizations to key members of Congress, urging action on medical cannabis. The letter asks ranking members of committees in the House and Senate to allow a vote on the Compassionate Access, Research Expansion, and Respect States (CARERS) Act (S.683, H.R. 1583).
The letter was signed by Americans for Safe Access, Citizens United for Research in Epilepsy (CURE), Danny Did Foundation, Epilepsy Foundation, Finding a Cure for Epilepsy and Seizures (FACES), Hope4Harper, Hope for Hypothalamic Hamartomas, Lennox-Gastaut Syndrome (LGS) Foundation, National Multiple Sclerosis Society, National Women’s Health Network, Realm of Caring, The Michael J. Fox Foundation, and Tuberous Sclerosis Alliance.
“The Epilepsy Foundation strongly supports the CARERS Act, and we thank all the members of Congress who have signed on to this important legislation,” said Phil Gattone, president and CEO of the Epilepsy Foundation. “Lifting federal barriers to cannabis research would allow families and providers considering this treatment option to have the information they need to make educated decisions, while supporting safe, legal access to medical cannabis.”
More than 300 million Americans live where medical cannabis laws are at odds with federal law. The CARERS Act would allow state medical cannabis programs to continue without federal interference, move cannabis from Schedule I to Schedule II and eliminate other research barriers, remove the compound CBD from the schedule entirely, create access to banking services for medical cannabis businesses in states where it is legal, and allow Veterans Health Administration physicians to write medical cannabis recommendations.
In the Senate Judiciary Committee, Sens. Chuck Grassley (R-IA) and Patrick Leahy (D-VT) received the letter, as did Reps. Joe Pitts (R-PA) and Gene Green (D-TX) in the Subcommittee on Health of the House Committee on Energy and Commerce.
ASA to Host California Educational Tour
California’s new medical cannabis regulations are the topic of an educational tour of the state hosted by Patient Focused Certification, a project of Americans for Safe Access. At 11 meetings across the state, cannabis industry stakeholders will learn what to expect from the regulations to be issued by the new Bureau of Medical Cannabis Regulation (BMMR) and get practical advice for how to meet and exceed these requirements. The BMMR will be implementing a state licensing program and product safety protocols under the Medical Marijuana Regulation and Safety Act (MMRSA) passed earlier this year.
Attendees at the PFC events will learn the general regulatory requirements for manufacturing, cultivation, dispensing, and laboratory operations, as well as operating procedures, policies, and training recommended for each. PFC staff have been working with state policymakers to develop laws and regulations and with the American Herbal Products Association and the American Herbal Pharmacopoeia to create industry standards.
The educational events run from Aug. 28 to Sept. 15, as follows: Hopland 8/28, Sacramento 8/29, San Jose 8/30, Monterey/Santa Cruz 8/31, Oakland 9/1, Humboldt County 9/10, Trinity County 9/11, San Diego 9/12, Los Angeles 9/13, Riverside 9/14, Fresno 9/15. Register for a city near you and receive $50 credit for future PFC services.
Maine Medical Cannabis Business Achieves National Certification
ASA’s Patient Focused Certification (PFC) program has awarded the first certification for Cultivation, Manufacturing, and Dispensing to a medical cannabis business. Remedy Compassion Center of Auburn, Maine was certified last month by PFC. the only nonprofit, third-party certification based on quality standards issued by the American Herbal Products Association (AHPA) and the American Herbal Pharmacopoeia (AHP). Remedy Compassion Center is the first medical cannabis operation in New England to participate in the PFC program.
“This achievement demonstrates Remedy Compassion Center’s commitment to producing and distributing cannabis medicines of the highest quality, purity, and safety for their patients”, said Kristin Nevedal, PFC Program Director. “Remedy Compassion Center has become a model for other cannabis operations and regulators in Maine.”
The State of Maine’s overall product safety requirements were judged deficient in ASA’s 2016 State of the States Report, rating an ‘F’ for the state as a whole. In the absence of state rules, Remedy Compassion Center has implemented the best practices outlined under PFC certification and their commitment to producing high quality cannabis products.
“The PFC program has helped us attain the highest levels of quality and consistency in our products, which has given caregivers and practitioners confidence in recommending cannabis therapies. As a result, our business has increased by 40% over the past year,” said Tim Smale, Remedy‘s owner and director. “The program has also saved us potentially thousands of dollars by ensuring we were prepared for regulatory inspections.”
Recently, ASA announced a joint collaboration with the American Association of Laboratory Accreditation (A2LA) to expand the PFC program by offering a new accreditation program based on the requirements of both ISO/IEC 17025 and the PFC program.
The PFC program reflects the best-practice guidelines included in the AHP Cannabis Monograph and the AHPA Recommendations for Regulators. Since those guidelines were released in 2012 and 2013, components of these recommendations have been included in several states’ regulations.
Remedy Compassion Center joins a growing list of PFC-certified cannabis businesses. Since the program was officially launched in 2015, those include Harvest of Tempe in Arizona, Sonoma Lab Works, Berkeley Patients Group, Humboldt Green Farms, Humboldt Hills Farms and Peace in Medicine in California, New Mexicann in New Mexico, and The Werc Shop and Dockside Co-op in Washington.
Activist Profile: Coltyn Turner Family
Coltyn Turner climbed a mountain last weekend. Two years ago, at age 14, he was largely confined to a wheelchair, unable to walk for more than a minute. The difference has been cannabis. Coltyn lives with Crohn’s Disease, an inflammatory bowel disease (IBD) he was diagnosed with in 2011 that can be as painful as it is debilitating. Morphine, oxycontin and codeine were among the many medications doctors prescribed, along with asacol, prednisone, methotrexate and others that were unsuccessful at controlling his condition. The end of the line came with Humira, an immunosuppressant that triggered first a false positive for tuberculosis on a skin test and then signs of cancer. Those side effects led his doctors at the Mayo Clinic to conclude he was at a 66% chance of developing T-cell lymphoma, so all treatment was stopped, all western medicines having failed.
Coltyn’s parents, Wendy and Tommy, had heard cannabis can be an option for treating Crohn’s, so they became part of the fight for safe access in their home state of Illinois two and a half years ago. But the process was slow, and Coltyn needed help immediately, so the Turner family made the hard choice to split up, with Coltyn and his father moving to Colorado Springs on March 4, 2014, without Wendy and the other three kids. After six months, Wendy was able to move out with two of the children, leaving behind not just their oldest daughter but five generations of family roots.
The move proved worth it. After just seven months of using strictly cannabis, a colonoscopy revealed that Coltyn was in remission. Getting the pediatric recommendation was challenging, with the doctor threatening to turn them over to child protective services if they didn’t comply with the treatment plan. Now the doctor consults with Wendy about new patients and how they might use cannabis, and the Mayo Clinic is following his progress closely. But some in the medical establishment remain skeptical or fearful. The American Journal of Gastroenterology rejected the case study on Coltyn his doctor submitted because it was about cannabis.
The dramatic turnaround Coltyn experienced left him and his family determined to educate others about cannabis as a treatment option. They created a Public Service Announcement on facebook that went viral, and now more than two dozen people a week reach out to them on social media. They fought for research money to go to how cannabis can treat IBD, helping secure $1.3 million in Colorado, where Coltyn was the first patient enrolled at Denver Children’s Hospital. Currently, Coltyn travels to conferences for speaking engagements and is featured in an ad being run in Arkansas in support of the medical initiative there. Documentary filmmakers will be premiering a film about him, Illegally Alive.
He may no longer be stuck in a wheelchair, but now he is legally confined to the State of Colorado. Travel means breaking the law to transport his medicine. After a year in remission, the family chanced a trip back to Illinois to visit grandparents and friends. As law abiding citizens, they left his cannabis in Colorado. Within a week, a flare up of his condition had put him in the hospital. Back in Colorado using cannabis, he returned to remission.
“We would like to go home,” says Wendy. “The whole world can’t move to CO. Your zipcode should not determine your health.” Or as Coltyn says, he’d rather be illegally alive than legally dead. Climbing mountains instead of being carried to bed.
ACTION ALERT: Help Pass National Cannabis Legislation
The current Congressional interest in the opioid addiction epidemic provides a unique opportunity for us to gain support to pass the Compassionate Access Research Expansion and Respect the States (CARERS) Act. And we need YOU to help leverage this document to help us pass this important piece of legislation!
Congress is on summer break and now is the perfect time for you to arrange meetings in your district offices. With four simple steps you can help educate and inform legislators of the growing need for an alternate treatment for the millions of patients suffering from pain every day.
Here’s how you can help:
- Step 1: Send this pre-written email to request an appointment with your members of Congress
- Step 2: Print out and bring ASA’s latest report, Medical Cannabis Access for Pain Treatment: A Viable Strategy to Address the Opioid Crisis, with you.
- Step 3: Print out and take with you, a copy of the CARERS Act Fact Sheet.
- Step 4: Meet with your Members of Congress on the importance of the CARERS Act and medical cannabis as an alternate treatment.
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