Courtesy of Bud & Mary’s
Audio By Carbonatix
Cannabis studies have come a long way in the past decade, but acquiring a federal permit for clinical trials is still a major pain for prospective researchers. And even if the permit is approved, they still need to procure cannabis to study, which isn’t easy to come by.
Some of those barriers will go down now that Congress has passed the Medical Marijuana and Cannabidiol Research Expansion Act, a bill that is supposed to enable more cannabis production for research purposes. But the DEA moves at a snail’s pace when education and reform are on the line. Denver’s own Bud & Mary’s (previously MedPharm holdings) has been waiting for well over a year on a DEA application to grow cannabis for federally approved research purposes, despite having received state permits years ago, and it’s the only facility in Colorado currently with DEA approval to study medical marijuana.
But slow motion is better than no motion, according to Bud & Mary’s CEO Albert Gutierrez, who says that taking time with each licensing step will eventually lead to more effective and safe cannabis products from Bud & Mary’s brands. We checked in with Gutierrez to learn more about the process of federal cannabis research, how the new act affects Bud & Mary’s, and what sort of research is going on at his facility.
Westword: Why aren’t there many cannabis research facilities in Colorado right now? According to state records, you’re the only one.
Albert Gutierrez: Creating the framework for research has always been at the forefront of the company. We worked collaboratively with the Marijuana Enforcement Division, Colorado Department of Public Health and Environment, DEA and others to have the ability to conduct this important research. The industry as a whole has been focused on getting products out the door to customers and patients, and that’s a great thing. For us, we knew that we needed more than anecdotal evidence to show the efficacy and the medicinal value that the compounds in the plant give. It’s very expensive to create the team, environment and funding to be able to conduct these studies. I know we have a lot of support from the industry in our quest to showcase what cannabis can do, but it is a very expensive and long road to getting there, and for some, it’s just not their focus. For us, it’s worth it.
As a state- and DEA-licensed research facility in Colorado, how does the passage of the Medical Marijuana and Cannabidiol Research Expansion Act affect you?
We are now seeing the demand for cannabis-driven clinical trials, not just observatory research, and those types of studies are even more cost-intensive. The Cannabidiol Research Expansion Act opens the door for more funders to come out of the woods and help us discover the what, why and how behind cannabinoids, terpenes and other components of the plant. This will encourage good, quality research to be done at the federal level rather than just the negative stigmatized data that we have been fed for so long. It also promotes collaboration across organizations that we may not have been able to work with in the federal government, like the Department of Defense and the Veterans Affairs hospitals. It’s quite exciting.
How will the bill affect people trying to conduct research on cannabis? Will this bill’s passage enable more access to better cannabis, or cannabis that isn’t sourced from the University of Mississippi?
Well, Mississippi was the only producer of cannabis for so long, and it was a monopoly. We can now work with providers like Dr. Sue Sisley to obtain better-quality cannabis and leverage that material into studies that will identify how cannabis compounds work in our bodies. Additionally, we will be able to find new mixtures of major and minor cannabinoids that, when combined, could have a positive impact on a symptom or condition. There are hundreds of molecules in the cannabis plant, and we are finding new ones all the time. So I predict that this research will be instrumental in the development of new medicines we didn’t know we could have.
How did DEA research approval affect your research?
Randomized double-blind placebo studies are viewed as the gold standard, and the DEA approval allows us to conduct these types of studies while providing valuable data to the research community that has not been available before. We are able to conduct said studies with higher-quality materials now than we have in previous years – and all of this, coupled with novel dosage forms and an excellent research team, gives the potential for some groundbreaking discoveries to occur.
Last time you spoke with us, Bud & Mary’s was awaiting a decision from the DEA on a production license, as well. Did you end up receiving DEA approval to manufacture?
We are still waiting on this. We have been told by our DEA office that it is just slow-moving, but we look forward to obtaining this license.
Even with DEA licenses, where does the plant’s Schedule I status come in here? How much harder does that designation make your research?
With our current Schedule I license, it makes the barriers somewhat easier to overcome, but we still have several regulating bodies that we have to gain approval from before we can even begin a study. Even state regulators want to know what we are doing and why. There are a lot of eyes on us and checkpoints throughout each study to ensure that the cannabis and cannabis dosage forms are being correctly created, administered and tracked, so we have measures in place to help those watching with being at ease. I don’t think that the Schedule is so much of an issue for us. We have operated in a highly regulated industry for a long time now. There is a lot of red tape everywhere you go, and I think we are just used to that. You have to be able to adapt quickly and adjust in this type of industry, and we are well prepared.
As a researcher, are you more in favor of descheduling or rescheduling cannabis?
Descheduling would be my preference, but we need to do this responsibly. I don’t want to get to a place where companies step in and pollute the industry and the work so many have done to create what we have today. Our goal with our research is to show efficacy and safety so that those who use cannabis for a condition aren’t treated as criminals. It’s time.
How are your Alzheimer’s and dementia studies going?
We are now beginning to look at how minor cannabinoids impact the part of the brain that deals with repairing and development in the brain, the microglia. We can use this data to infer how the minor cannabinoids will impact the brain of those with neurodegenerative diseases, and then compound that into a dosage form for human consumption via clinical trials. I can’t say a lot right now, but definitely stay tuned…because we are just getting started.
