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In the July 2019 Issue:
- House Votes to Protect State Cannabis Programs
- Amendment Withdrawn to Allow VA Doctors to Recommend Cannabis
- Appeals Court May Intervene on Cannabis Rescheduling
- ASA and Aurelius Data Create Research Platform to Benefit Cannabis Patients
- ASA’s Steph Sherer Creating Global Awareness
- ASA Educates Attorneys on Laboratory Testing
- Activist Profile: Dawn-Marie Steenstra, Maryland
- Action Alert: FDA Extends CBD Public Comment!
House Votes to Protect State Cannabis Programs
The U.S. House of Representatives last month voted to prohibit federal interference with any state cannabis law. The move comes via an amendment to the 2020 spending bill that includes the Department of Justice (DOJ). It prevents the DOJ from expending funds enforcing federal law against individuals complying with state cannabis laws.
The amendment to H.R. 3055 Appropriations Minibus, Commerce-Justice-Science, Agriculture and Interior-Environment, was introduced by Rep. Earl Blumenaeur (D-OR), who sponsored last year’s amendment. Similar to amendments restricting interference in state medical cannabis programs that have been in place since 2015, the latest iteration the first time extends protections to adult-use markets and includes Washington, D.C. and U.S. territories such as Guam and Puerto Rico. The bipartisan floor vote of 267 to 165, including 41 Republicans, was more support than the medical-only amendment received last year. Native American tribal cannabis laws were also shield by a similar amendment, which was passed by a voice vote.
Separately, the House included in appropriations bill for the Treasury Department language to allow banks to work with state-licensed cannabis businesses. Currently, those businesses cannot access financial services because the federal government classifies their proceeds as illicit.
The Senate Appropriations Committee will take up similar spending measures, likely this month. The Senate has approved amendments shielding medical cannabis patients and providers each year since 2014, but the House’s expansion to protect adult-use laws, businesses and consumers may not be matched. Differences between House and Senate appropriations bills are resolved in conference committee.
Amendment Withdrawn to Allow VA Doctors to Recommend Cannabis
A late effort by officials in the Veterans Health Administration to block an amendment that would have allowed their doctors to recommend cannabis to veterans succeeded last month. Rep. Earl Blumenauer (D-OR) withdrew Amendment 198 after VHA officials claimed its passage would create criminal liability under federal law for any doctors who provided state paperwork to their patients.
In a speech on the House floor before withdrawing his amendment, Rep. Blumenauer said veterans “need medical marijuana more than any other category of our citizens,” but “the VA, I’m afraid, has not been as helpful as it should be.”
The VA amendment has been offered repeatedly and often passed at least the House. In 2016, versions of Blumenauer’s proposed amendment to the VA appropriations bill passed both the House and Senate but was removed in conference committee negotiations by House leadership under the direction of then-Speaker John Boehner. Blumenauer noted that Boehner is now a spokesperson for the cannabis industry.
VA officials have not previously objected to the measure. Now they claim VA doctors could be prosecuted for “aiding and abetting” patients in violating federal law, which prohibits medical use even in states that allow it.
In 2002, federal courts ruled in Conant v. Walters that the First Amendment guarantee of free speech protects physicians who recommend cannabis to their patients, though doctors cannot assist patients in obtaining it. Cannabis cannot be prescribed like other medications because it is still classified as a Schedule I substance with no currently accepted medical use.
“After the progress we’ve made on Capitol Hill, it is incredibly frustrating to see an amendment that would provide medical cannabis access to veterans sabotaged,” said David Mangone, ASA’s director of government affairs. “The VA should be working with Congress find a way to help veterans get access to medical cannabis when they might benefit from it.”
The VA has come out in opposition to all medical cannabis legislation for veterans, including bills that would enable research from clinical trials on treating PTSD and chronic pain to simple surveys of veterans’ cannabis use.
Blumenauer’s standalone VA bill has received a committee hearing and is likely to receive a vote on the floor of the House.
Rep. Blumenauer’s speech on the VA amendment.
Appeals Court May Intervene on Cannabis Rescheduling
A federal appeals court has said that it will intervene in a petition to reschedule cannabis for medical use if the federal government again attempts to stall or obstruct it. The U.S. Court of Appeals for the Second Circuit issued the warning in the case of Washington v. Barr, which sought a declaration that the placement of cannabis in Schedule I of the Controlled Substances Act was unconstitutional because it violates the Due Process Clause of the Fifth Amendment, protections guaranteed by the First Amendment, and the fundamental right to travel.
In July 2017, four medical cannabis patients joined other advocates in filing the lawsuit against the federal government in U.S. District Court for the Second District of New York. After the district court judge dismissed the case, saying the plaintiffs needed to exhaust administrative options, such as a rescheduling petition, before taking the government to court, they appealed.
In a 2-1 decision, the appeals court agreed that the petition process has to be pursued first but did not dismiss the case because the DEA’s troubling history of delaying proceedings an average of nine years requires oversight by the court.
In the majority opinion, Judge Guido Calabresi wrote that they were “retain[ing] jurisdiction in this panel to take whatever action might become appropriate if the DEA does not act with adequate dispatch.”
The judges in the majority also noted that “under the unusual health-related circumstances of this case, what has counted as appropriate speed in the past may not count as appropriate speed here,” and that the plaintiffs “should not be required to live indefinitely with uncertainty about their access to allegedly life-saving medication or live in fear that pursuing such medical treatment may subject them or their loved ones to devastating consequences.”
If the government “fails to act with alacrity,” the court could compel it to through a writ of mandamus, or it could sidestep administrative procedure and hear the case on its merits. If the DEA does conduct the review in a timely manner but declines to reschedule cannabis, the administrative process “would generate a comprehensive record that would aid in eventual judicial review.”
Such a review would not guarantee a positive outcome for the plaintiffs, but the judges in the majority wrote that they were “struck by the transformative effects this drug has assertedly had on some Plaintiffs’ lives,” and that they are “troubled by the uncertainty under which Plaintiffs must currently live.” Encouragingly, the judges noted that the growing body of knowledge about cannabis shows that “[i]t is possible that the current law, though rational once, is now heading towards irrationality; it may even conceivably be that it has gotten there already.”
ASA and Aurelius Data Create Research Platform to Benefit Cannabis Patients
On June 12, 2019, Americans for Safe Access (ASA) and Aurelius Data, Inc. (AD), a leading patient-perception data company, announced a research partnership that will gather data on medical cannabis use. The patient-focused initiative will use Aurelius Data’s proprietary AURA platform and analysis tools to compile consumer data on cannabis products and their uses for various medical conditions to create an educational resource for patients and caregivers, providers, and the industry. The insights generated from the platform will be available to users through the AURA mobile application to support product education and best practices.
“ASA is excited to be partnering with Aurelius Data to offer an opportunity for real results and lasting change through research,” said Debbie Churgai, Interim Director of ASA. “Creating a patient-focused community through the AURA platform gives subscribers a way to connect and discover what regimens are working for other patients.”
Advocates, experts, and policy makers have called for more real-world research to understand better how patients use cannabis products in medical treatment. Dr. Amy Abernathy, the Acting CIO of the Federal Drug Administration, commented at the end of May that “real-world evidence derived from electronic health records, personal monitors, administrative data, etc. can be used to address critical questions.”
Julie Armstrong, CEO of Aurelius Data, says the goal of the research partnership with ASA is “to create trust and consistency for patients, and provide a real pathway to effective, standardized treatments." Subscribers will avoid the bias of marketing and advertising by getting access to aggregated information collected anonymously from patients.
"We're very enthusiastic about the potential of this groundbreaking partnership to drive solutions and improve outcomes for cannabis patients and consumers everywhere," said ASA’s Churgai.
ASA’s Steph Sherer Creating Global Awareness
Americans for Safe Access’s President and Founder Steph Sherer, who is now also President of the International Cannabis and Cannabinoids Institute (ICCI), participated last month at conferences in England and Canada.
At the Cannabis Europa Conference in London, England, Sherer was part of panel discussing pioneering efforts at regulating medical cannabis. The conference explored how the plurality of regulation models in Europe can be an asset for EU regulators as they compare how systems work for patients and consider harmonized laws regulating medical cannabis within the EU and the rest of Europe.
At this year's Collision Conference in Toronto, Canada, Sherer was on a panel discussing lessons to be learned from Canada’s experience. Also on the panel were Hilary Black, Chief Advocacy Officer for Canopy Growth Corporation and Sara Brittany Somerset, a cannabis reporter for Forbes. The panel considered what innovations coming out of Canada mean for the industry, for healthcare and for the patient-consumer.
ASA Educates Attorneys on Laboratory Testing
State regulations for laboratory testing of cannabis products will be the focus of an educational panel sponsored by the International Cannabis Bar Association that will include ASA’s Director of Government Affairs David Mangone on July 22. The panel, called Testing Laboratories: Perspectives from the Marketplace, offers Continuing Legal Education credit for attending attorneys at the National Cannabis Industry Association (NCIA) Cannabis Business Summit in San Jose, California.
Among the topics covered was how disparities in standards for how states are regulating testing facilities create uncertainties for consumers and impose financial burdens on cannabis businesses. The panel includes different perspectives, including laboratory operators, manufacturers, attorneys, and patient advocates.
ASA’s Mangone will cover how the industry can establish best practices, including who is best equipped to regulate; whether the same standards should be used across medical, pharmaceutical, and food-grade products; and the lessons that can be learned from other stringently regulated industries.
Activist Profile: Dawn-Marie Steenstra, Maryland
Dawn-Marie Steenstra, LPN, SDC, IC, QA, SCC, became a medical cannabis advocate by accident.
In 2012, she’d just started dating the man who is now her husband, Eric Steenstra, when he invited her to attend the Patients Out of Time Conference with him in Arizona. Up to that point, she’d thought he was just a freelance computer specialist. She had no idea he was one of the leading hemp advocates in the U.S.
As a nurse who had run her own assisted-living facility for 21 years, Dawn was already a strong patient advocate who had learned something about state regulatory processes. But she knew little about medical cannabis.
At the conference, she heard about the latest international research and the experiences of patients, gaining insights about the potential of cannabis to treat the side effects of cancer chemotherapy and a myriad of conditions. She was also introduced to the endocannabinoid system – all things she had not been taught in nursing school.
“As a nurse, I was just sitting there with my mouth open,” she recalls. “In long term, palliative care and hospice, the four drugs provided as a standard in my nursing bag did not work for everyone for pain, anxiety or nausea. I became an advocate that day, a very determined advocate.”
By that point, Dawn was just a little over a year post her own breast cancer treatment, and she’d sat with countless other patients as they faced their own cancer diagnoses and treatment struggles not only at her job, but in her personal life.
“I thought, how can there be this safe, effective treatment that I can’t use? I knew I needed to fight for this not just for myself, but for the countless patients I saw suffering every day."
The American Cannabis Nurses Association was formed at that conference, and Dawn joined immediately. Within months, she was appointed a member of the original board of directors. In that role, she helped write resolutions and gorged on all kinds of cannabis education. Soon thereafter, she got involved in Americans for Safe Access after being introduced to ASA founder Steph Sherer, who knew her husband. That led her to work with ASA on some of the first educational training programs, first with the Cannabis Training Institute, then with the early development of ASA’s Patient Focused Certification (PFC) program.
Then, her home state of Maryland came on board with a medical cannabis program, and Dawn went headlong into lobbying state officials with help from ASA staff.
“They teach you from the ground up how to advocate effectively,” Dawn says. “ASA staff taught me how to write and give testify, how to educate, how to talk to people in a knowledgeable, professional way.”
In 2014, Dawn-Marie worked with members of Maryland’s medical cannabis commission on education for medical professionals and the creation of program regulations. One of her goals was to mandate testing of cannabis products and physician-education standards, so she worked with ASA to organize a meeting about PFC standards for all of the prospective cannabis business applicants to learn. She hoped 100 people might attend, but on the day of the meeting more than 200 showed up, forcing them to change rooms to accommodate the crowd. Based on that meeting and other work for compliance practices, the state commission accepted PFC as the basis for state regulatory oversight and training of the new regulators to come.
Dawn-Marie is now a National Ambassador for United Patients Group and organized their physician-focused Baltimore Conference in 2017. Since 2018, Dawn has also been working as an outreach and engagement coordinator for Mission Dispensaries. Last year, she coproduced with John Malanca the documentary series The Sacred Plant, Season 2, focusing on the East Coast patients and physicians.
“I’m grateful I’m getting to be a force for positive change in all these things, furthering the mission of destigmatizing cannabis,” Dawn says. “At this point, I’m not afraid to debate anyone. They’ll have their tails are between their legs by the time I’m done.”
She has found that cannabis can be the answer to many maladies of her own. After a car accident in 1999 left her with a severe back injury that required cervical fusion, she had been a pain patient for 18 years, treated with a variety of shots, therapy, and pain, antianxiety and muscle-relaxant medications. Because of her nursing license, she was wary of using whole-plant cannabis but asked her doctor if she could try a combination of a full-spectrum CBD oil and Marinol, which is a prescribed synthetic THC drug. He agreed. Within two months, she was completely weaned off all her pharmaceutical medications.
“So many people saw cannabis as a threat to humanity, but it’s a savior. For myself, as well as the patients I now meet with every day.” Dawn-Marie says.
Dawn has been married to Eric Steenstra for three years now, so she has a front-row seat for the development of hemp regulations.
“It’s only a matter of time before the dominoes fall,” she says. “I thought it would be simpler with hemp descheduling, but it’s a mess nationally without regulatory oversight and good manufacturing processes in place.”
She thinks the answer is to deschedule all cannabis and have all the states get together to establish interstate commerce and proper import and export procedures.
“PFC is the answer to the mismatch of state rules,” she says.
She continues to care for serious homebound patients in private practice, and has seen doctors change their opinion seeing the results in her patients.
“This is the greatest moment of all, when a doctor who was afraid or hesitant, suddenly asks for every educational resource I have,” Dawn says. “Of course, the very first resource I refer them to is Americans For Safe Access!”
Action Alert: FDA Extends CBD Comments
The Food and Drug Administration (FDA) has extended to July 16 the comment period on regulating CBD and other cannabis products. If you haven’t already provided public comment, or if you know someone who hasn’t but should, this is your last opportunity. The FDA is asking for feedback on specific areas, including: 1) Health and Safety Risks, 2) Manufacturing and Product Quality, and 3) Marketing/Labeling/Sales. ASA has prepared guidelines to make it easy to submit comments that make a difference. Read the blog here: https://www.safeaccessnow.org/fda_comments_blog. Then submit your comments today!