Medications,Meds Reassessing the U.S. Drug Classification Framework: A Transition from Prejudice to Research

Reassessing the U.S. Drug Classification Framework: A Transition from Prejudice to Research

Reassessing the U.S. Drug Classification Framework: A Transition from Prejudice to Research


In 1971, President Nixon launched a conflict that would transform the United States: The War on Drugs. As a crucial component of that initiative, he implemented the Controlled Substances Act (CSA), which empowered the Drug Enforcement Administration (DEA) to classify contemporary controlled substances into 5 “schedules” based on their “medical use, potential for abuse, and safety or dependence liability.” These schedules range from Schedule I, indicating substances with no accepted medical use and the highest risk, to Schedule V, consisting of relatively low-risk substances with extensive medical applications. What commenced as a protective measure for American society is now in dire need of reform concerning our perception and regulation of drugs. Initially, the U.S. drug scheduling system does not align with its own criteria for safety and medical use based on our current knowledge of these substances. Moreover, it generates a cyclic issue that actively obstructs research and the advancement of potentially life-saving treatments. Not only should many of these substances be classified differently, but the “accepted medical use” criterion should be stricken from the CSA.

The U.S. drug schedules are antiquated and inconsistent with the existing body of research, resulting in misaligned risk and benefit profiles, along with numerous other issues such as hindering medical research and obstructing innovative treatments. For instance, marijuana (a Schedule I substance) has an addiction rate of roughly 10 percent, implying that about 10 percent of users develop a marijuana use disorder. This stands in comparison with cocaine (Schedule II) and benzodiazepines (Schedule IV), which exhibit addiction rates of 20 percent and 44 percent respectively. Psychedelics, many classified as Schedule I (e.g., LSD, psilocybin, peyote), are not considered addictive because they exhibit little to no dependence risk. Furthermore, in terms of safety, psychedelics have an exceedingly low mortality rate, with rare fatalities often linked to polydrug use. Marijuana (Schedule I) also presents a relatively low isolated mortality rate of 4 percent, increasing to 18 percent when used alongside other substances. In contrast to Schedule II drugs like fentanyl, responsible for over 70 percent of drug overdose deaths in 2022, many Schedule I drugs seem significantly safer with lower mortality risks. Even when compared to unscheduled substances like alcohol, some Schedule I drugs appear to be less harmful and less addictive. Clearly, the existing scheduling system does not correspond with scientific evidence.

Inconsistencies also exist concerning medical use, where more clinically relevant substances are often unexpectedly more stringently regulated than their less relevant counterparts. Lacking adequate evidence, it becomes challenging to quantitatively assess the extent of clinical applications that a specific substance has. Nevertheless, looking at clinical applications broadly, marijuana contains various components (e.g., THC and CBD) that are commonly utilized in clinical environments, such as for treating seizures, anorexia, chemotherapy-induced nausea and vomiting, and neuropathic pain. There is also increasing evidence that Schedule I psychedelics, particularly psilocybin, have therapeutic potential in addressing a range of psychiatric disorders like depression, anxiety, and substance use disorders. This contrasts sharply with cocaine (Schedule II), which, apart from being more dangerous than marijuana and psychedelics (as previously noted), has comparatively limited clinical applications. Although these drug schedules were initially shaped by social stigmas rather than scientific rigor, current evidence underscores their relative risks much more effectively, rendering these misclassifications indefensible.

Arguably, the most significant drawback of these drug scheduling standards is that they culminate in a vicious cycle that actively obstructs research and medical innovation. Higher-scheduled drugs encounter greater hurdles to research, with laboratories often struggling to obtain clearance for their studies due to restricted annual production. This especially constrains research into the potential clinical applications and safety of Schedule I drugs, resulting in their continual classification as Schedule I substances. How can psilocybin-assisted therapy be implemented in clinical settings if the very barrier to its clinical application is that we aren’t utilizing it in the clinic to begin with? While numerous studies are beginning to reveal psilocybin’s therapeutic effectiveness, this process has been relatively gradual, and there currently seems to be no federal-level discussion regarding down-scheduling psilocybin or enhancing its availability for research. Previous attempts have also faced federal opposition, despite the mounting evidence of psilocybin’s therapeutic promise. If access to research on Schedule I drugs becomes more attainable and effective, even if it only leads to a modest decrease in psychiatric mortality, the cumulative effect over time could save many lives. These research limitations are also the reason we still have a limited understanding of how psychedelic drugs assist patients. Understanding their underlying mechanisms of action could potentially unlock novel, more effective therapeutic strategies, which, regrettably, is challenging under the present drug scheduling framework.

While President Nixon labeled drug abuse as “public enemy number one,” the true public enemy is the