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In the May 2021 Issue
- Americans for Safe Access Achieves ISO 17065 Accreditation
- Video of ASA’s 2021 Unity Conference Available Online
- Federal Agencies Take Steps to Aid Cannabis Research
- House Passes SAFE Banking, Key Bills Reintroduced
- Alabama Lawmakers Enact Medical Cannabis Program
- Mississippi Supreme Court Invalidates Medical Cannabis Initiative
- Activist Profile: Philippe Lucas PhD, Victoria, Canada
- Action Alert: Urge Your Rep to Cosponsor the VA Research Act
Americans for Safe Access Achieves ISO 17065 Accreditation
The Americans for Safe Access PFC Program has achieved accreditation to the ISO/IEC 17065:2012 standard for certifying bodies (Certificate #5284.01), becoming the first and only compliance program to obtain international accreditation for cannabis. ISO accreditation certifies that the program’s policies and procedures have been vetted and validated by a team of auditors from an internationally recognized organization. Third party certifications are common in many legal industries and markets, and governments often use them to ensure the safety of products and services.
“ISO accreditation is a crucial step in the acceptance and integration of cannabis into our society as a real medicine,” said PFC Director Heather Despres. “This validates the work that ASA has been doing through the PFC program since its launch in 2014 and puts weight behind the PFC seal for the companies that we have certified.”
PFC standards incorporate all state, federal and international cannabis and product laws and regulations. In the PFC certification process, businesses are given recommendations for improvement and are allowed to make the necessary changes in their procedures and facilities. Preparation for licensing and regulatory inspections can help companies avoid fines, recalls or stalled licensing.
“Patients can have confidence that the PFC seal means that products are safe and accurately labeled,” said ASA Executive Director Debbie Churgai. “The PFC seal indicates quality along the supply chain.”
In 2009, ASA began working with American Herbal Products Association (AHPA) to create Recommendations and for Regulators and with the American Herbal Pharmacopeia to publish Cannabis Inflorescence Monograph. These established the first product safety standards available for cannabis. In 2011, ASA incorporated the Code of Federal Regulations sections relating to Good Agricultural (Collection) Practices, Good Manufacturing Practices, and Good Laboratory Practices to create the PFC standards for laboratories, cultivation, manufacturers and distribution centers.
ISO/IEC stands for the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Together these form the standard setting body that has developed over 23,752 standards, including those for management systems, quality management, information security management, information technology, and occupational health and safety.
Video of ASA’s 2021 Unity Conference Available Online
Last month’s National Medical Cannabis Unity conference, No Patient Left Behind, is now available to watch online. Highlights of panels and presentations from ASA’s 9th annual conference include removing barriers to housing, healthcare and employment; kids and cannabis; controlling cannabis cost; federal standards for testing; changing federal law; and addressing veterans’ issues.
ASA has also added ways to connect with speakers on the Unity 2021 Speakers page.
“We’re happy to make the most accessible ASA conference yet even more accessible by sharing the video archive free online,” said ASA Executive Director Debbie Churgai. “Check it out to see where we think medical cannabis is heading and hear more about our No Patient Left Behind campaign.”
Federal Agencies Take Steps to Aid Cannabis Research
Two federal agencies took positive steps in this month to advance cannabis research. The National Institute on Drug Abuse (NIDA) designated 5mg of THC as the basic unit of dosing in an effort to standardize medical cannabis research. Prior to this, researchers have used variable amounts as a “dose,” making it difficult to compare between studies. The Drug Enforcement Administration (DEA) also took a long-awaited step toward expanding medical cannabis research. Groups who applied under the Obama administration for authorization to grow cannabis for federally approved research are finally being notified that they will be able to do so.
House Passes SAFE Banking, Key Bills Reintroduced
Several important medical cannabis bills that Americans for Safe Access has championed in previous sessions of Congress are back under consideration.
On April 19, the House passed the SAFE Banking Act (introduced by Rep. Ed Perlmutter, D-CO), which would ease federal restrictions on financial institutions so they can do business with state-licensed cannabis operators.
On April 30, Rep. Lou Correa (D-CA) reintroduced the Veterans Medicinal Cannabis Research Act, which would direct the Secretary of Veterans Affairs to conduct clinical trials on the effectiveness of cannabis in treating chronic pain, PTSD, sleep disorders, spasticity and agitation, as well as its potential for reducing dependency on alcohol and opioids and improving general quality of life. The bill attracted over 115 cosponsors in the last session of Congress.
In the Senate, Sen. Brian Schatz (D-HI) introduced the Veterans Medical Cannabis Safe Harbor Act on April 16. If enacted, the bill would create a federal “safe harbor” for legal cannabis use by veterans living in states with legal medical access. It would also authorize the VA to study the effects of medical cannabis on veteran health and health conditions.
ASA has worked closely with legislative offices and veterans organizations to build support for each of these bills. ASA also launched a veterans campaign this year urging the Secretary of the VA to permit veterans to discuss cannabis with their VA physicians and to subsidize medical cannabis and related treatment for veterans. More on this effort can be seen on ASA’s blog.
House and Senate versions of the MORE Act, which passed the House last year, are likely to be reintroduced in the next few weeks. The MORE Act would remove cannabis from Schedule I of the Controlled Substances Act and impose a federal tax on retail cannabis that would fund both cannabis job training programs and the expungement of criminal records related to marijuana offences.
Alabama Lawmakers Enact Medical Cannabis Program
In May, Alabama established a medical cannabis program when Governor Kay Ivey signed Senate Bill 46. Patients with medical conditions ranging from cancer and chronic pain to depression and panic disorder can qualify to possess up to a 70-day supply by registering with the program. Recommending physicians must complete a 4-hour certifying course in medical cannabis. The state will license cultivators, manufacturers and retail dispensaries to provide safe access.
Mississippi Supreme Court Invalidates Medical Cannabis Initiative
A voter-approved initiative to legalize medical cannabis in Mississippi has been overturned in a 6-3 state supreme court decision that declared the state’s entire initiative process to be defective. A Mississippi mayor had brought the procedural challenge, arguing that voter initiatives can no longer qualify for the ballot due to a change in the number of Congressional districts in the states. Mississippi’s number of districts was reduced from 5 to 4, but state law stipulates that the signatures needed to qualify an initiative for the ballot must come from each of the 5 districts. That technicality led the majority of the court to invalidate the entire law, even though they acknowledged that the will of both the legislature and voters was clear. Dissenting justices argued that the 5 districts are defined in state law, so a change in federal Congressional districting is irrelevant to satisfying Mississippi’s requirements.
Activist Profile: Philippe Lucas PhD, Victoria, Canada
When Philippe Lucas got a hepatitis C diagnosis as a college student in 1995 he could not have imagined it would put him on a path to becoming a groundbreaking patient advocate and being named ASA’s 2021 Cannabis Researcher of the Year.
At that time, hepatitis C didn’t even have a name. It was just non-Hep A, non-Hep B -- an incurable progressive disease that slowly destroyed the liver. The disease advanced slowly enough that many people who received the diagnosis as older adults didn’t need to worry about that. But Philippe had unknowingly contracted it through a blood transfusion during surgery at 12, so liver failure was a real possibility by the time he reached his 40s or 50s. Soon after his diagnosis, he developed symptoms including nausea and appetite loss. When he asked his doctor if he was dying and what he could do to fight it, giving up alcohol and tobacco was the answer.
“I’m French Canadian, so those were my drugs of choice,” Philippe says. “But I was resigned to giving them up and went cold turkey.”
He turned to cannabis to manage the withdrawal and cravings. It proved effective, but he was worried about how it might affect his liver, so he started looking up the medical research on cannabis. What he found shocked him.
“The research contradicted what the government had told me,” Philippe says. “I discovered that cannabis was helpful for not just my symptoms but also viral infections themselves. It wasn’t the lesser of two evils—it was helpful!”
Within a few months, Philippe was feeling better physically, emotionally, and psychologically than he had in a long time. But in the late 1990s, finding a safe, consistent supply of cannabis was not easy.
“I thought, if college students have trouble getting cannabis, what’s a 65-year-old woman with cancer going to do?” Philippe remembers. “After looking at the compassion clubs that were developing elsewhere in North America, like Denis Peron’s in San Francisco and the BCCCS in Vancouver led by Hilary Black, I decided to start one to help patients.”
The Vancouver Island Compassion Society (VICS), one of Canada’s first dispensaries, opened its doors in 1999. Philippe would serve as its executive director for the next decade. The research he conducts today started with things he heard from the patients at VICS.
“We saw an influx of patients with HIV and Hep-C resulting from their IV drug use,” Philippe says. “They had cannabis recommendations for those conditions, but they shared with us that it was reducing their cravings for opioids, meth and alcohol. I realized that was flipping the script on the gateway theory. Cannabis is exactly the opposite. It’s an exit drug.”
Patients’ patterns of cannabis use and its impact on the use of other substances became the focus of his research as he progressed through a master’s degree to his PhD at University of Victoria. Lending support to the Multidisciplinary Association for Psychedelic Studies (MAPS), Philippe got a chance to visit Israel to share his experiences with policy-makers, eventually doing the same in Uruguay, Columbia, Australia, Portugal, and elsewhere.
He has now published over two dozen academic articles on medical cannabis and the patient experience and serves as vice-president, Global Patient Access & Research at Tilray, the world’s largest international cannabis company. But the road to these successes has not lacked struggle.
Within a year of opening VICS, local police raided the facility and Philippe’s home, resulting in three counts of drug trafficking. As his case was working its way through the courts, a separate constitutional challenge to Canadian law by cannabis patients resulted in courts declaring an exception must be made for medicinal use.
Philippe qualified as one of the country’s first legal patients, but the process was cumbersome, entailing a 32-page application, certification by both his primary care physician and two specialists, and an 18-month wait for processing.
“What the government had established was not viable for cancer patients or many others who are seriously ill,” Philippe says. “Their ‘access regulations’ were an oxymoron --they were designed to stop people from having access.”
Nor had the government established a way for qualifying patients to legally obtain cannabis except by cultivating it, which takes time, skill, location, and physical wherewithal. As a result, Philippe continued to provide cannabis illegally through VICS, even as he awaited sentencing on the trafficking counts.
Philippe had pled guilty to all, just as he had cooperated openly and completely with police, explaining how VICS operated and why. When it came time for sentencing in 2002, the judge granted Philippe an absolute discharge, praising his principled work doing for patients what Health Canada had failed to do. That ruling paved the way for future dispensaries in Canada.
Nonetheless, police returned to raid VICS’s production and research facility a few years later, ironically seizing the low-THC hemp plants VICS had developed as a placebo for medical trials.
Philippe’s experience with the courts had made him all the more interested in the Ed Rosenthal case that led to the founding of Americans for Safe Access in 2002.
“I was incredibly inspired by what I saw ASA doing,” Philippe says.
He reached out to ASA founder Steph Sherer and ultimately co-founded Canadians for Safe Access, modeled on ASA, to advance reforms there. It would become the largest medical cannabis patient rights organization in Canada. He would go on to present about his work and research at ASA conferences, and now serves on ASA’s Advisory Board.
After 10 years, Philippe left VICS to focus on municipal community building, winning election to city council and then regional government as he continued his PhD work. He also became the second fulltime employee at Tilray, where he now leads a variety of international patient research projects, working with scientists at NYU, Columbia, and UC San Diego, as well as in Australia, Canada and the EU.
“Being part of the healing process for patients at VICS was a unique experience, but only a few thousand could benefit,” Philippe says. “Now, working with Tilray and internationally, I have the privilege of helping tens of thousands of patients around the world.”
Cost coverage for medical cannabis is now one of Philippe’s primary concerns. All major insurers in Canada offer coverage as an option for employee plans, and all Canadian police and military veterans have the cost of medical cannabis covered by Veterans Affairs Canada through Blue Cross. Covering medical cannabis creates a new cost for insurers, but each year that coverage has increased, there has been a significant decline in the number of prescriptions for opioids and benzodiazepines in Canadian veterans.
“In 25 years, we’ve gone from illicit substance to essential service, but stigma remains an ongoing challenge,” Philippe says. “One in 5 doctors have recommended cannabis to a patient, which is great, but that also means 4 in 5 have not. Most general practitioners are still not considering it.”
Via surveys, prospective studies and clinical trials, Philippe continues the work of translating the voice and experience of patients into data that inform policies and increase safe access to medical cannabis for patients in need.
“Nearly everything we know about medical cannabis is because brave, determined patients shared their experiences,” Philippe says.
Action Alert: Urge Your Rep to Cosponsor the VA Research Act
Contact your member of the House of Representatives and urge them to co-sponsor HR 2916 – The VA Medicinal Cannabis Research Act.
Rep. Lou Correa (CA-46) reintroduced this important legislation on April 30 at ASA’s Unity conference. The bill would direct the Secretary of Veterans Affairs to conduct clinical trials on medicinal effectiveness of cannabis in treating conditions disproportionately affecting veterans. ASA worked with Rep. Correa to add the language of this bill to the MORE Act before it was passed by the House last December.
The VA Medicinal Cannabis Research Act had over 115 cosponsors last session, and we need at least that many again to ensure passage. Contact your member of Congress today and urge them to co-sponsor this bill for veterans. Take action now at safeaccessnow.org/va_research.