The U.S. Department of Health and Human Services made headlines late Friday when it released hundreds of pages of documents laying out its rationale for recommending that cannabis be rescheduled.
The big news, of course, as Cannabis Wire reported, was that the agency suggests moving cannabis from Schedule I to Schedule III under federal law – in other words, from a category for substances with no medical use to a category for substances with a medical use.
But tucked into those pages are myriad other data points and perspectives worth surfacing, as they collectively formed the foundation for HHS’ recommendation.
Here are some highlights:
(Note: Below, HHS is used as shorthand for material compiled by HHS’ Office of the Assistant Secretary for Health, and FDA is shorthand for material compiled by the FDA’s Center for Drug Evaluation and Research.)
HHS took the Americans for Safe Access “State of States” report into consideration. This report “grades” states on medical cannabis program barriers to access, for example, and approved conditions. ASA was formed more than 20 years ago to advocate for medical cannabis patients.
The Cannabis Regulators Association, or CANNRA, also provided insights. “Most jurisdictions have ‘Seed to Sale’ tracking, however, based on data provided by the Cannabis Regulators Association (CANNRA) only nine jurisdictions track amounts dispensed to patients,” HHS notes. The founding president of CANNRA, Norm Birenbaum, is a Senior Public Health Advisor at the FDA’s Center for Drug Evaluation and Research. The Center worked on the recommendation, largely to assess whether cannabis has a “currently accepted medical use.”
The University of Florida conducted a “systematic review of the medical literature” on cannabis “under contract” with the FDA. Among the noteworthy conclusions noted by FDA: the “FDA did not identify any safety concerns described in the UF report that would indicate the medical use of marijuana poses unacceptably high safety risks for the indications evaluated for its therapeutic effect.”
A National Academies of Sciences, Engineering, and Medicine (NASEM) report published in 2017 factored into FDA’s assessment that cannabis has therapeutic uses for pain. The committee behind the report, titled The Health Effects of Cannabis and Cannabinoids, looked at more than 10,000 studies published since 1999. It’s worth noting that NASEM has formed a new cannabis-focused committee, as Cannabis Wire has reported, and it’s likely that their findings, when published, will further inform cannabis policy in the U.S. This committee is focused on “regulatory frameworks for the cannabis industry using a health equity lens.”
Two state medical cannabis programs served as case studies: Maryland and Minnesota. “We considered patient survey data from Maryland and Minnesota in more depth than the other 35 states because they had available survey data and were able to provide the results and/or data to FDA. Therefore, these two states were used as an approximate representative sample of safety data from jurisdictions with state-legalized use of marijuana for medical purposes,” FDA wrote.
HHS acknowledged early criticisms of federal restrictions on cannabis. In a section titled “Federal History of Marijuana Control,” HHS references the American Medical Association’s opposition to the Marihuana Tax Act of 1937, the first federal cannabis control effort. They write that “Dr. Walter L. Treadway of the Division of Mental Health at PHS (the precursor to the National Institute of Mental Health) provided testimony to Congress” before it passed the bill.
HHS quotes Treadway’s testimony: cannabis “does not produce dependence as in opium addiction. In opium addiction there is a complete dependence and when it is withdrawn there is actual physical pain which is not the case with cannabis. Alcohol more nearly produces the same effect as cannabis in that there is an excitement or a general feeling of lifting of personality, followed by a delirious stage, and subsequent narcosis. There is no dependence or increased tolerance such as in opium addiction. … As with alcohol, it may be taken a relatively long time without social or emotional breakdown. Marihuana is habit forming although not addicting in the same sense as alcohol might be with some people.”
Eight major medical organizations’ perspectives were considered. The groups ranged from the American Academy of Family Physicians to the American Academy of Neurology.
“Most of these organizations did not arrive at a firm recommendation for use of marijuana in their specialty, but some acknowledged there may be preliminary evidence showing marijuana may have some therapeutic benefits,” the FDA noted. “Additionally, a number of organizations recommended rescheduling of cannabis from Schedule I to Schedule II to facilitate less barriers to quality research.”
