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Rescheduling Cannabis-Medicine or Politics?
Bertha K Madras1,2, Paul J Larkin3
1McLean Hospital, Belmont, Massachusetts.
Importance:
In 2023, the US Department of Health and Human Services (HHS) issued a letter to the administrator of the Drug Enforcement Administration (DEA) recommending rescheduling of cannabis (marijuana) from Schedule I to Schedule III under the Controlled Substances Act (CSA). This recommendation marked a significant departure from previous, consistent, and long-standing federal decisions on cannabis scheduling.
Objective:
To critique the arguments made by HHS for recommending marijuana rescheduling.
Evidence:
The HHS secretary (advisor) and US attorney general (decision maker) must consider 8 factors and a 5-part test when deciding whether to reschedule a controlled substance. CSA classification criteria include whether a drug has currently accepted medical use, whether it has abuse potential, and whether use is safe under medical supervision. HHS undermined these established legal scheduling criteria by introducing new, untested criteria.
Findings:
HHS failed to adequately address the adverse effects of cannabis use, including the high prevalence of cannabis use disorder among users, risks associated with youth consumption, growing evidence linking cannabis to psychosis, and other significant concerns. HHS asserted that cannabis is widely accepted as a legitimate form of medicine, despite the reality that only a small fraction of patient-care physicians recommend it for symptom relief, in practices that often diverge from the norms of medical practice. Finally, the US Food and Drug Administration has not approved cannabis as a medicine, as evidence is deficient in several key areas, including data from high-quality clinical trials, standardized cannabis formulations, established purity, defined routes of administration, dosing guidelines, and specific frequencies of use.
Conclusions And Relevance:
The HHS rationale for reclassifying cannabis in myriad forms (edibles, smokables, drinkables, vaping products, suppositories) and potencies relies on a questionable selection of comparator drugs, downplays distinctive adverse events among cannabis users, and claims, unconvincingly, that cannabis has wide acceptance in medical practice supported by scientific evidence.
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