Last month’s announcement from the US Department of Justice confirms something people have known for millennia: cannabis has undeniable therapeutic benefits. Rescheduling to Schedule III is a major step forward towards more research into cannabinoid safety and efficacy, allowing us to better understand the plant’s medicinal value through a modern and scientific lens.
Due to prohibition, the cannabis industry has been operating under incredibly challenging circumstances–DEA raids and seizures, IRS rule 280E taxes, and continued legal obstacles. This historic decision to reschedule cannabis is a small step in the right direction. But we need to continue to work toward full legalization, criminal justice reform, and access to safe and fair banking.
Joining us today is Phylos’ Chief Scientific Officer, Dr. Alisha Holloway, PhD, to discuss the impact of rescheduling cannabis to Schedule III to researchers.
Stef: Alisha, let’s start off with some background on why rescheduling is important for research.
Alisha: We know cannabinoids have therapeutic benefits - humans have had cannabis as part of their cultures for thousands of years. Yes, since 1970 Cannabis has been a Schedule 1 controlled substance in the US, which puts huge burdens on studying cannabis medicine and breeding plants. Cannabis researchers had to maintain schedule I DEA licenses, build large safes to house their research material, and had access to just a few low THC cannabis cultivars. Cannabis plants make hundreds of potentially medically relevant cannabinoids and other metabolites. With rescheduling, we can move faster to study the therapeutic benefits of cannabinoids. We can also breed plants with consistent combinations of cannabinoids or other metabolites that will be the source of effective medicines.
President Biden called for the HHS and DEA to consider rescheduling of Cannabis in 2022. We were all excited by this public announcement and when I learned about the Coalition for Cannabis Scheduling Reform (CCSR) in 2023, I immediately jumped on board to help out.
Stef: What approach has the CCSR taken to supporting scheduling reform?
Alisha: The CCSR is a diverse group of people from every area of the industry who are committed to a data-driven approach to supporting cannabis rescheduling. Attorneys contributed to knowledge of the legal issues while scientists and educators took a deep dive into what is known about the safety of cannabis. It was all hands on deck to quickly gather the information and synthesize it into an informative white paper that was shared with the HHS.
Related CCSR’s statement on LinkedIn: “Our coalition looks forward to submitting public comment on the proposed rule, which is built upon a foundation of unassailable scientific evidence. The federal government has conducted a thorough review and recognized that cannabis has therapeutic value and low abuse potential – a critical step forward. We are confident that Schedule III will be implemented in the coming months.” Read the full statement on LinkedIn.
Stef: You just completed a clinical trial on THCV. How would (if at all) this trial have been conducted differently if cannabis was rescheduled prior?
Alisha: Rescheduling is just the first step in opening up cannabis for research. For our study, we worked with a partner that had a state license to produce cannabis products. If more academic researchers could work with cannabis, we would have a greater diversity of formulations that could be generated and easier access to medical monitoring facilities. Our study was a well-designed distributed trial, which means participants took the products at home and then used a phone app to supply self-reported data. If we partnered with a medical facility, we could have collected biometric data, which is often more powerful than self-reported data.
Related: THCV Increases Energy And Motivation Without Marijuana’s ‘Munchies’ Effect, Double-Blind Study Finds, Marijuana Moment
Stef: What studies are you hoping to see in the industry after rescheduling?
Alisha: We are just starting to look beyond THC and CBD to understand the effects of rare or minor cannabinoids. We need preclinical and clinical trials of individual cannabinoids and then we need to start studying them in combination and as whole botanical extracts. For example, a great study by the Vandrey lab has shown that adding limonene to THC products reduces the anxiety induced by taking THC. And our study showed that combining THCV with THC reduced the fatigue and munchies that people get with THC alone.
Stef: And my last question–what would you like to study after rescheduling?
Alisha: Humans have used cannabis in so many different ways for millenia. I want to move beyond THC and understand mood states and effects that we can get from the hundreds of other metabolites produced by the plant. As a breeding company, we really need to understand the efficacy of rare cannabinoids so that we can focus our breeding efforts on developing plants that will ultimately be used in effective products for consumers.
Alisha Holloway, PhD, Chief Scientific Officer at Phylos, is a data scientist and population geneticist with expertise in genomics and statistical analysis of big data. She held an assistant professor appointment at UC San Francisco School of Medicine, where she was the founding director of the Gladstone Institutes Bioinformatics Core Facility. She earned a PhD focused on molecular evolution at the University of Texas in Austin.
The Coalition for Cannabis Scheduling Reform (CCSR) unites cannabis companies and organizations with prominent legal and scientific experts to advance cannabis scheduling reform. Learn more about the Coalition for Cannabis Scheduling Reform on the CCSR website or their LinkedIn page.
Due to prohibition, the cannabis industry has been operating under incredibly challenging circumstances–DEA raids and seizures, IRS rule 280E taxes, and continued legal obstacles. This historic decision to reschedule cannabis is a small step in the right direction. But we need to continue to work toward full legalization, criminal justice reform, and access to safe and fair banking.
Joining us today is Phylos’ Chief Scientific Officer, Dr. Alisha Holloway, PhD, to discuss the impact of rescheduling cannabis to Schedule III to researchers.
Stef: Alisha, let’s start off with some background on why rescheduling is important for research.
Alisha: We know cannabinoids have therapeutic benefits - humans have had cannabis as part of their cultures for thousands of years. Yes, since 1970 Cannabis has been a Schedule 1 controlled substance in the US, which puts huge burdens on studying cannabis medicine and breeding plants. Cannabis researchers had to maintain schedule I DEA licenses, build large safes to house their research material, and had access to just a few low THC cannabis cultivars. Cannabis plants make hundreds of potentially medically relevant cannabinoids and other metabolites. With rescheduling, we can move faster to study the therapeutic benefits of cannabinoids. We can also breed plants with consistent combinations of cannabinoids or other metabolites that will be the source of effective medicines.
President Biden called for the HHS and DEA to consider rescheduling of Cannabis in 2022. We were all excited by this public announcement and when I learned about the Coalition for Cannabis Scheduling Reform (CCSR) in 2023, I immediately jumped on board to help out.
Stef: What approach has the CCSR taken to supporting scheduling reform?
Alisha: The CCSR is a diverse group of people from every area of the industry who are committed to a data-driven approach to supporting cannabis rescheduling. Attorneys contributed to knowledge of the legal issues while scientists and educators took a deep dive into what is known about the safety of cannabis. It was all hands on deck to quickly gather the information and synthesize it into an informative white paper that was shared with the HHS.
Related CCSR’s statement on LinkedIn: “Our coalition looks forward to submitting public comment on the proposed rule, which is built upon a foundation of unassailable scientific evidence. The federal government has conducted a thorough review and recognized that cannabis has therapeutic value and low abuse potential – a critical step forward. We are confident that Schedule III will be implemented in the coming months.” Read the full statement on LinkedIn.
Stef: You just completed a clinical trial on THCV. How would (if at all) this trial have been conducted differently if cannabis was rescheduled prior?
Alisha: Rescheduling is just the first step in opening up cannabis for research. For our study, we worked with a partner that had a state license to produce cannabis products. If more academic researchers could work with cannabis, we would have a greater diversity of formulations that could be generated and easier access to medical monitoring facilities. Our study was a well-designed distributed trial, which means participants took the products at home and then used a phone app to supply self-reported data. If we partnered with a medical facility, we could have collected biometric data, which is often more powerful than self-reported data.
Related: THCV Increases Energy And Motivation Without Marijuana’s ‘Munchies’ Effect, Double-Blind Study Finds, Marijuana Moment
Stef: What studies are you hoping to see in the industry after rescheduling?
Alisha: We are just starting to look beyond THC and CBD to understand the effects of rare or minor cannabinoids. We need preclinical and clinical trials of individual cannabinoids and then we need to start studying them in combination and as whole botanical extracts. For example, a great study by the Vandrey lab has shown that adding limonene to THC products reduces the anxiety induced by taking THC. And our study showed that combining THCV with THC reduced the fatigue and munchies that people get with THC alone.
Stef: And my last question–what would you like to study after rescheduling?
Alisha: Humans have used cannabis in so many different ways for millenia. I want to move beyond THC and understand mood states and effects that we can get from the hundreds of other metabolites produced by the plant. As a breeding company, we really need to understand the efficacy of rare cannabinoids so that we can focus our breeding efforts on developing plants that will ultimately be used in effective products for consumers.
Alisha Holloway, PhD, Chief Scientific Officer at Phylos, is a data scientist and population geneticist with expertise in genomics and statistical analysis of big data. She held an assistant professor appointment at UC San Francisco School of Medicine, where she was the founding director of the Gladstone Institutes Bioinformatics Core Facility. She earned a PhD focused on molecular evolution at the University of Texas in Austin.
The Coalition for Cannabis Scheduling Reform (CCSR) unites cannabis companies and organizations with prominent legal and scientific experts to advance cannabis scheduling reform. Learn more about the Coalition for Cannabis Scheduling Reform on the CCSR website or their LinkedIn page.