With the federal government considering loosening restrictions on marijuana, more opportunities to conduct cannabis research could open up. Federal and state governments should continue to remove as many regulatory barriers as possible so science can progress.
Marijuana is currently a Schedule I drug, which means it has no accepted medical use and a high potential for abuse, similar to heroin. The designation is ridiculous when 38 states have state-sanctioned medical marijuana programs. President Biden’s Department of Health and Human Services recently recommended to the Drug Enforcement Administration that marijuana be rescheduled to Schedule III, a category that includes drugs with a lower potential for abuse, like ketamine and anabolic steroids. The DEA should agree.
Marijuana researchers today need to obtain a Schedule I license, which requires developing detailed protocols and complying with rules like maintaining a separate storage safe. Until recently, researchers had to obtain marijuana from a single federally sanctioned source at the University of Mississippi, although the DEA in 2021 agreed to authorize additional growers.
Rescheduling marijuana will remove some regulatory barriers. Equally importantly, it will remove stigma, which has led many universities and hospitals to avoid marijuana research for fear of losing federal funding. It could open up more opportunities for federal grants. Large pharmaceutical companies may be more willing to begin researching new cannabis-derived drugs.
Positioning Massachusetts to take advantage of a loosening federal climate will take a concerted effort by state officials.
“If and when it does get rescheduled, Massachusetts needs to be proactive not reactive, and Massachusetts needs to be ready to go with a plan,” said Cannabis Control Commissioner Kimberly Roy.
Massachusetts currently offers a marijuana research license, but only one company has gotten a provisional license and no research facility has opened. Only eight applications have been submitted.
Industry representatives say the license is flawed. It requires detailed disclosures about proposed research with no guarantee of confidentiality, which companies researching new products worry could hurt them competitively. Research facilities must negotiate agreements with their host community and hold a hearing — standard requirements for marijuana businesses but not major research institutions. The fact that there are two separate paths to licensure — federal and state — with different requirements can alienate applicants.
Revising this license type in a way that respects intellectual property and makes it more attractive to companies, nonprofits, and universities should be a Cannabis Control Commission priority.
One major question is how research would be funded. Some states — like California, Colorado, and Michigan — have state-funded cannabis research centers or grants. Scientist Staci Gruber, who runs the Marijuana Investigations for Neuroscientific Discovery program at McLean Hospital, said the lack of state funding puts Massachusetts behind other states.
The state Cannabis Advisory Board’s research subcommittee is recommending putting public funding behind an ambitious research agenda, with topics like assessing marijuana’s impact on various medical conditions, evaluating use of the whole plant versus specific compounds, evaluating use and outcomes in medical compared to recreational users, and examining the impact of certain manufacturing processes on workers. A bill pending in the Legislature would create a public fund to research the application of medical marijuana to specific diseases.
While there are many competing priorities for state dollars, government could contribute in ways other than direct funding, like by encouraging public universities to convene a research effort.
Marion McNabb, president of the research-focused Cannabis Center of Excellence and head of the research subcommittee, said with the large number of colleges in Massachusetts, creating a consortium to advance research locally “would set Massachusetts apart as a leader in the nation.”
One interesting model is an effort by multistate cannabis company Ethos Cannabis. In Pennsylvania, Ethos partners with Brooke Worster, a physician and researcher at Thomas Jefferson University and an affiliated cancer center. Worster designs clinical trials and obtains federal research funding, while staff from Ethos, a state-licensed cannabis company, handle the marijuana and administer the trials. Worster said the model is similar to what pharmaceutical companies traditionally do with academic medical centers but is newer to cannabis. “It’s not reinventing the wheel,” Worster said.
Helen Gomez Andrews and her husband started The High End, a Holyoke-based cannabis growing and manufacturing company that is going through the Massachusetts licensing process. The company will extract oils for marijuana edibles and concentrates, then develop its own chocolates. Once the revenue-generating side of the business opens, Gomez Andrews said they will seek a license for a research lab, subsidized by product sales.
Gomez Andrews said she became interested in research after her daughter, now 13, began using medical marijuana to treat her epilepsy. The family found little research to guide them. “Medical cannabis now, it’s all anecdotal,” Gomez Andrews said. “There’s no official, medical institution-approved research.”
She hopes rescheduling will open more opportunities for funding and partnerships with medical or academic institutions. As Gomez Andrews said, “With all of these great institutions of learning and medicine, Massachusetts should absolutely be the center of the world for cannabis research as well.”
SOURCE & CREDIT: BOSTON GLOBE