The most innovative businesses in the rapidly developing field of cannabis research may be those who hold licenses from the U.S. Drug Enforcement Administration. These businesses can ethically cultivate, produce, import, export, analyze, and research cannabis depending on the license class.
Only six organizations are now listed as “Bulk Manufacturer Marihuana Growers” with the DEA. According to tight DEA limits, the permit entitles license holders to cultivate and deliver cannabis flower or extract to DEA-licensed researchers engaged in U.S. Food and Drug Administration-approved research.
Some bulk-manufacturing license holders also hold other DEA registrations, such as those for research, in the hopes of creating cannabis-based medicines that the FDA would one day approve.
DEA Registrations for Research
MedPharm Holdings, a Denver-based business with recreational marijuana activities in Colorado and Michigan as well as medical cannabis operations in Iowa, is one organization with a DEA registration to undertake cannabis research.
Although MedPharm is still a rare breed as a state-licensed marijuana company with a DEA research license, business executives anticipate the DEA will eventually give licenses to other cannabis businesses.
The DEA license, according to Duncan Mackie, director of pharmacology and experimental medicines at MedPharm, is the “final gatekeeper.” Before you have a DEA license, “big pharmaceutical businesses like Thermo Fisher won’t even talk to you or sell you a refrigerator.”
Why It’s Important and What’s Being Studied
MedPharm’s activities in the state-regulated market, which include the cultivation of marijuana and the production of vape cartridges, concentrates, topicals, and infused ingestibles like pills and tinctures, help finance its research efforts, which are primarily but not exclusively concentrated on neuropharmacology, including brain inflammation, traumatic brain injuries, Alzheimer’s, Parkinson’s, and other conditions of the like.
Thanks to a Colorado state research license that allowed it to collaborate with organizations like Colorado State University Pueblo, MedPharm was already investigating cannabis and neuropharmacology when it was founded in 2016 with the goal of advancing scientific knowledge. However, MedPharm obtained DEA Schedule 1 federal licensing as a cannabis and cannabinoid research facility in December 2021.
It is now making use of that DEA research registration for a study looking at whether cannabinoids, particularly minor cannabinoids, which are referred to as “very potent anti-inflammatory compounds,” can squelch the inflammation-causing proteins in the brain linked to conditions like Alzheimer’s and Parkinson’s.
The project, for which MedPharm is working with the Institute of Cannabis Research at CSU Pueblo, has received approval from the FDA and the DEA. The corporation and the university will each serve as the study’s principal investigators.
“I believe that having a DEA license definitely improves how they (CSU Pueblo) feel about things. Because the DEA has already given its approval for this, they won’t lose their government money, Mackie added.
At the lab
In order to carry out the study, researchers take brain cells like microglia and place them in a petri dish before inflaming them to simulate the inflammation process that occurs in conjunction with various disorders.
The next step is to test whether specific cannabinoids or cannabinoid combinations degrade proteins that cause inflammation in a petri dish.
What these small cannabinoids do is the question that the research, according to Mackie, aims to address. How does the microglia respond to a dose of various levels of cannabinoids while it is in an inflammatory state, whether they are an isolation or in conjunction with other terpenes or other cannabinoids?
Early Results
Cells can survive large concentrations of the cannabinoids CBD, THCV, and CBN before dying, according to one of the study’s early findings.
“I have to work hard before I experience cell death, which is fantastic. It provides you with a pretty wonderful, sizable therapeutic window, according to Mackie. “You can really ramp up the dose if you aren’t seeing an effect with a very low dose and not see too much cell death, which is extremely beneficial from a drug-discovery, medicinal chemist’s standpoint,” says the researcher.
Additionally, MedPharm intends to investigate cannabis and nutraceutical combinations.
“We’ll be off to the races as soon as we find something that we can really use as our lead compound and build around,” Mackie added.
Time and attitudes are evolving.
However, “races” in drug research might take years and more than $1 billion. Before Epidiolex, GW Pharmaceuticals’ CBD-based epileptic medication, was authorized by the FDA, it took about 12 years and about $1 billion (GW Pharmaceuticals is now a division of Ireland-based Jazz Pharmaceuticals).
But that might also be changing, according to some industry watchers, as the internet has made it quicker to negotiate federal bureaucracy and made it simpler for academics to communicate scientific information.
While the DEA hasn’t jumped on the legalization bandwagon, cannabis business owners and researchers who collaborate with agency representatives claim they are no longer zealous opponents of the industry.
“The environment is shifting. Actually, our DEA agent is very helpful. He offers us fantastic advice and perspective,” Mackie said. He continued by saying that DEA officers had visited the business multiple times and that their top priority is to prevent cannabis from being diverted to the black market.
Even though obtaining a DEA cannabis registration is challenging, it is possible, according to Mackie.
“I don’t understand why people can’t go through as long as you’re doing the right things and you’re following the correct regulations,” Mackie added. “Clearly, there are obstacles. Obtaining the necessary large safes and completing the applications are a headache.
The biggest challenge, according to Mackie, is putting together a scientific team with the necessary skills to complete the work, including administration, maintenance, recordkeeping, and backgrounds in biology, chemistry, and pharmacopeia.
