The American Journal of Medicine published a piece by researchers who were involved in an federally funded trial on marijuana. They argued that further research into this substance was “critical” because of the many millions of people in legalized states. But they warned that the restrictions of government hindered scientific investigation of its risks and potential.
According to authors at the University of Maryland School of Medicine and Nursing, classifying marijuana as Schedule I substances “traps scientists in a contradiction: To prove medical value studies are required, yet they’re heavily restricted.”
As legalization continues to outpace science, the paper states “reforms are necessary in order to bridge the gap between the scientific evidence and the society’s needs.”
The researchers claim that scheduling marijuana as Schedule III could help speed up studies on the potency of marijuana and prevent reliance upon untested claims. It would also ease restrictions by the U.S. Drug Enforcement Administration. More National Institutes of Health (NIH) funding—along with easier access to government-approved supplies of cannabis—could also accelerate trials, they say.
Commentary: “It is time to revive legislation like the Medical Marijuana Research Act that has been stalled for the past year.” It also encourages scientists to “harness the public’s support to demolish barriers to ensure cannabis risks and benefits are well understood.”
The lead author, Dr. Raya Elfadel Kheirbek of the UMD Medical School, said in an email to MEDCAN24 that the authors’ experience in conducting a multisite, federally-funded clinical trial into the use THC and CBD for agitation treatment in dementia patients at the end of life inspired them to create the article.
Kheirbek stated that “the regulatory and operational complexity we faced when preparing our website for patient enrollment was the source of many concerns” raised in the article. From navigating the DEA licensing process to securing specialized handling and storage procedures, Kheirbek said, “many of the concerns raised in this article were inspired by our own regulatory and operational complexities.” [investigational new drug]”Each step of the process involved long deadlines, unexpected expenses, and many layers of federal, institutional, and state review.”
She said: “These experiences demonstrate why few academic centres are willing or capable of pursuing cannabis-related research in spite of widespread interest from clinical researchers.”
Kheirbek said that even though rescheduling could ease some DEA research burdens it would not be enough to address “systemic underfunding” or institutional hesitancy rooted decades ago in stigma.
Her letter stated that “public health and equity is on the line.” She wrote: “Providers must advise their patients about cannabis without having adequate data. Meanwhile, underserved populations continue to be denied the opportunity to participate in and reap benefits from research.”
In addition to ongoing stigma and scarce institutional funding, the new American Journal of Medicine commentary adds that having to navigate multiple federal agencies—including DEA, the U.S. Food and Drug Administration (FDA), NIH and others—”amplifies complexity” of research.
The limited availability of marijuana approved by the National Institute on Drug Abuse is another obstacle that the article highlights.
“Historically, research cannabis was sourced solely from the University of Mississippi through NIDA, offering low-potency, unrepresentative strains,” it says. In 2016, DEA committed to licensing more growers. However, this commitment “materialized very slowly” with only a small number of suppliers operating by 2025.
The University of Mississippi has been selected by the NIH to host its new Resource Center for Cannabis and Cannabinoid (R3CR) – a cannabis lab that the agency announced originally in 2023.
The National Center for Complementary and Integrative Health, under the NIH (NCCIH), will provide a grant to the College. This partnership with Washington State University and United States Pharmacopoeia is funded by this grant.
Donald Stanford, Assistant Director of University of Mississippi Research Institute of Pharmaceutical Sciences’ Research Institute of Pharmaceutical Sciences said R3CR would bring attention to the “significant changes” in cannabis research.
The NCCIH, a leading agency within the NIH, acknowledged that scientists were concerned about “barriers that have hampered research” on marijuana, due to federal prohibition. These barriers included “complex federal regulations” and insufficient supplies of cannabis.
Meanwhile, DEA earlier this year notified an agency judge that the marijuana rescheduling process is still on hold—with no future actions currently scheduled as the matter sits before the acting administrator, who has called cannabis a “gateway drug” and linked its use to psychosis.
In May, federal Department of Government Efficiency cut funding to Ole Miss for another program which tracks the potency of marijuana confiscated by law enforcement.
The longtime head told MEDCAN24 that his work may still lag behind until funding is resumed, but if the samples cease to flow, a decades’-long record of THC in illicit U.S. marijuana supply will come soon to an end.
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