Safer Solutions: How Designating Substances as Schedule I Harms Research
Medical innovation is full of surprise findings. For example, Viagra—now ubiquitous for treating erectile dysfunction—was originally developed to treat high blood pressure and a heart condition called angina. But its blockbuster status in both sales and pop culture is due to researchers’ discovery that it was better at causing erections than treating angina. That’s right—pharmaceutical (and sitcom) gold arose from the realization that a side effect could revolutionize patient care for a medical problem with no pharmaceutical solution at the time.
Research is always necessary for pharmacological innovation, whether a new drug discovery happens by chance or via calculated inquiry. However, federal law makes it harder for scientists to study some substances than others. The Controlled Substances Act (CSA) classifies substances into five schedules based on their potential for abuse and whether they can be used for medical purposes. Substances with the highest abuse potential and no currently accepted medical use are listed as Schedule I.
As policymakers push to designate more substances as Schedule I, it’s important to understand the ramifications this has on research. Researchers must register with the Drug Enforcement Administration (DEA) to study any scheduled substance; however, those interested in Schedule I substances must complete a separate, more onerous registration process. This extra restriction discourages scientific inquiry, which can slow progress toward understanding the potential therapeutic uses of Schedule I substances.
Challenges of Studying Schedule I Substances
Before a researcher can study a Schedule I substance, they must navigate a maze of administrative hurdles. Any study that involves obtaining, synthesizing, or distributing a Schedule I drug requires approval from the DEA as well as from the researcher’s institution and state. Clinical trials using Schedule I substances may also require Food and Drug Administration approval. This is true for any quantity and application of a Schedule I substance, even if the study requires extremely small quantities and/or doesn’t involve human participants. These administrative barriers—many with competing timelines—add to the complexity of the approval process. Even if each part of the process were manageable on its own, stacking them adds time and costs to getting a study greenlit.
Procuring substances for study is another challenge, as most research and pharmaceutical-grade chemical manufacturers are not licensed to produce Schedule I substances. For example, even in states where it’s legal to purchase cannabis for recreational or medical use, researchers can only obtain cannabis from a small number of authorized growers whose products are different from what consumers can buy in legal dispensaries. This limits the real-world applicability of cannabis studies.
Securing funding to research Schedule I drugs is another challenge. Federal funding can’t be used to conduct research that “promotes the legalization of any drug or other substance included in Schedule I” unless substantial evidence of its medical value exists. Quite the circular dilemma. Private funders and foundations often shy away from funding Schedule I substance research because of the “dangerous” reputation of these substances.
Is “No Currently Accepted Medical Use” Forever?
One of the two characteristics qualifying a substance as Schedule I is that it has “no currently accepted medical use.” But how can an accepted medical use be found if research on Schedule I substances is so severely limited? Science and medicine are constantly evolving, and finding new uses for existing medications is common. One example is thalidomide, originally used to treat morning sickness but later found to cause severe birth defects. The drug was banned for this reason; however, researchers eventually discovered its effectiveness in treating leprosy, HIV, and a form of bone marrow cancer, leading to its reintroduction into medical use.
Psychedelics provide additional instructive examples. Decades ago, psychedelics showed great promise as medical treatment. But once they were placed on Schedule I in the 1960s, most research into potential medical uses of psychedelics ceased. It took until the 2000s for this research to resume. As Dr. David Nutt—a prominent neuropsychopharmacologist and psychedelics researcher—told us, “There was never any need to take psychedelics out of medicine. Making them Schedule I in no way benefited patients and was, I believe, an attempt to eliminate all knowledge of them in medicine.” Dr. Nutt also noted that Schedule I status complicates any attempt to prove a substance’s medical effectiveness, often “doubling the cost and time needed to conduct research.”
Good Intentions, Harmful Consequences
While substance scheduling may intend to improve public safety, the significant harms associated with criminalizing possession and use of scheduled substances may outweigh the harms of the drugs themselves—and the inability to research Schedule I substances properly has its own set of harmful consequences.
On top of limiting research into substances’ general medical potential, Schedule I status slows research on their use, including harms and potential treatments. This is concerning, as policymakers often push emerging substances onto Schedule I before researchers understand how they interact with the body and how to treat overdose and dependence.
Medical innovation and research have extended our lifetimes and improved our health in endless ways, but research is unpredictable and nonlinear. Just because a substance seems more harmful than helpful today doesn’t mean researchers won’t discover new uses for it in the future. Given the many regulatory barriers to researching Schedule I substances, it’s hard not to wonder what we don’t know about the roughly 300 substances currently designated as Schedule I.