John M. Williams
Picture this — hundreds of dispensaries closed in Colorado, people having to go to a local pharmacy to get their marijuana, then paying out of pocket because their drug insurance policy doesn’t cover it. Add to this, the loss to Colorado of hundreds of millions in annual tax revenue and tourism dollars. All of this could happen, if the proposed rescheduling of medical marijuana to DEA Schedule III is approved, a change supported by Attorney General Phil Weiser and Gov. Jared Polis.
The U.S. Department of Health and Human Services (HHS) recently made an unprecedented recommendation, asking marijuana be moved from Schedule I to Schedule III of the Controlled Substances Act. A letter from Dr. Rachel Levine, HHS Assistant Secretary for Health, to the to the Drug Enforcement Administration (DEA) administrator, indicated the review was in response to a request from President Joe Biden. This is the latest initiative in his drug policy evolution, which has included pardons for drug offenders and support for expanded research opportunities.
Stay up to speed: Sign up for daily opinion in your inbox Monday-Friday
The letter was accompanied by a 250-page treatise which supports the proposed change, while also admitting safety data was scarce, and calling out state programs with inconsistent product standards. Marijuana currently has a Schedule I classification, meaning it has no accepted medical use and a high potential for abuse. Schedule III drugs, like codeine and barbiturates, have a legitimate use and are considered safer, with only a moderate to low potential for dependence.
If this recommendation is adopted, would doctors be able to write prescriptions for marijuana products; such as flowers, concentrates, topicals and edibles? The answer is “maybe,” because federal regulations put it in a gray area. Neither fish nor fowl, marijuana would still be considered a controlled substance, but not an FDA-approved prescription drug, and patients would still need a doctor’s prescription to get it in Colorado. This assumes physicians and other health care providers would be willing to take the risk and accept the liability for writing a prescription for a controlled substance which is not FDA-approved and may cause serious health problems. Federal regulations mandate it can be dispensed by a licensed pharmacist in a DEA-registered pharmacy, or by an individual practitioner, and detailed records must be kept and provided to the DEA.
Thousands of medical marijuana dispensaries in Colorado and the rest of the U.S. may be forced to close, as they would not meet these requirements, resulting in a huge impact on a multibillion dollar industry, which has the potential of reaching the trillion-dollar mark. It also calls into question the legal status of recreational marijuana, which would need to be considered a Schedule III drug as well, and handled similarly. There are presently no “recreational” DEA Schedule II-V controlled substances, so all marijuana sold would have to be considered “medical” and dispensed only with a doctor’s prescription by a pharmacy or an individual practitioner.
If marijuana was moved to Schedule III, could the FDA unilaterally approve it, and declare it a “safe and effective drug?” No, because obtaining FDA approval is a rigorous process, typically taking years, as Phase 1-4 clinical trials are conducted with only 13.8% of drugs submitted receiving final approval. Clinical trials are expensive, and may require the participation of thousands of volunteer subjects, in order to find out if a drug is truly safe and effective. Even after approval, drugs may be subject to recall, and indications for use made more restrictive. There is no quick and easy path to FDA approval, and trying to do this would upend years of important work by the FDA, which has a history of protecting the public from dangerous drugs, such as thalidomide, quinine sulfate and carbinoxamine.
Some of the harmful effects of marijuana are well-known, with others discovered only recently. It can have deleterious effects on the respiratory system, and may also be associated with major cardiovascular events, including: stroke, heart attack, arrhythmias, blood clotting abnormalities and blood vessel disease. Short- and long-term cognitive impairment issues may occur, and there can be serious effects on the neurologic development of young people, with an increased risk for the development of psychosis and schizophrenia. A landmark study involving more than 200,000 young people was published in 2021. It found heavy use of marijuana by teens and young adults with mood disorders was significantly associated with an increased risk of self-harm and death by suicide and homicide. It is a sad irony Dr. Levine, a fellow of the American Academy of Pediatrics and board-certified in adolescent medicine, would not recognize these risks and call them out, as this important study was neither referenced nor included in the bibliography of her report.
Colorado and other states could continue to defy federal controlled substance regulations; however, any expected financial benefits from rescheduling; whether it be tax deductions, new investments or a relaxation of banking restrictions would not likely occur, unless marijuana dispensing was done in a legal manner. Would health care insurance companies, pharmacy benefit managers, Medicare and Medicaid pay for something not yet proven safe and effective, something lacking the purity demanded of FDA-approved drugs? The answer is “no,” because drugs that are not FDA-approved, like marijuana, are rarely covered as a benefit.
The proposed rescheduling could also open the door for the reclassification of other Schedule I drugs, such as “magic mushrooms” and psychedelics that have recently been “legalized” as medical treatments in Oregon and Colorado. This is certainly possible, but like the marijuana example, federal regulations would bring dispensing under the auspices of DEA-registered pharmacies, pharmacists and individual practitioners, rather than “facilitators” and “healing centers.”
FDA-approved medications containing Tetrahydrocannabinol (THC) as well as cannabidiol (CBD), both chemical constituents of marijuana, have been used as appetite stimulants, anti-nausea agents and for pediatric seizure disorders. The argument marijuana must be rescheduled in order to do clinical research is incorrect, as there are currently more than 180 clinical trials in the U.S. studying THC and CBD, and they are actively recruiting volunteers. This is in addition to the 426 studies already completed. Harmful health effects aside, rescheduling marijuana will present a host of unintended consequences.
Though the federal government will ultimately decide whether or not to legalize controlled substances such as marijuana, rescheduling is not the correct path to follow. Politics should not be driving this issue, as the FDA and the entire medical community should have the right to decide whether or not marijuana is a safe and effective prescription drug.
John M. Williams, Sr., MD, MPH is a board-certified public health physician in Colorado and has held a DEA Controlled Substance Registration Certificate for more than 40 years. While practicing occupational medicine, he helped draft the state of Colorado’s “Traumatic Brain Injury Medical Treatment Guidelines.” He is also a former senior medical director for UnitedHealth Group, working in pharmacy benefits management, including prior authorization and appeals determinations.
Recent Comments