Unlocking Psychedelics’ Medical Potential

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Scholars critique the regulation of psychedelic substances and propose reforms for medical research and use.

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“I am he as you are he as you are me and we are all together,” John Lennon sang in 1967. The lyrics—which Lennon wrote on an acid trip—express the mystical dissolution of self that users of psychedelic drugs often experience.

The federal government effectively banned psychedelics for recreational or medical use in the 1970s. But after decades of strict regulation, a psychedelic revival is underway. Some scholars now advocate regulatory changes to make these drugs available so that patients can take advantage of their medical benefits.

Psychedelics are broadly defined as substances that induce hallucination. Well-known psychedelics include LSD, also called acid, MDMA, otherwise known as ecstasy or molly, psilocybin, the active ingredient in hallucinogenic mushrooms, and DMT, ayahuasca’s active ingredient.

Under the Controlled Substances Act (CSA), the U.S. Drug Enforcement Administration (DEA) regulates all drugs, including psychedelics, through a classification system that considers a substance’s “potential for abuse” and “accepted medical use in treatment,” though the statute does not define either criterion. The DEA classifies psychedelics as Schedule I substances, the most restrictive CSA category.

Psychedelics’ Schedule I classification indicates the DEA’s determination that these drugs have high potential for abuse, lack accepted medical uses, and cannot be used safely even under medical supervision.

Contrary to the DEA’s classification, preliminary research suggests that psychedelics do have profound medical potential. In small studies, psychedelic treatments alleviated symptoms of some of “the most debilitating and costly disorders known to humankind”—such as “addiction, obsessive compulsive disorder, end-of-life anxiety,” and depression—sometimes better than current treatments do. The prospects are so promising that in 2019, Johns Hopkins University opened a specialized research center to study “how psychedelics affect behavior, mood, cognition, brain function, and biological markers of health.”

Despite their medical promise, psychedelics are caught in “a regulatory black hole.” Reclassifying Schedule I drugs requires extensive evidence of “accepted medical use,” such as “adequate and well-controlled studies” demonstrating the drugs’ efficacy and safety. But Schedule I “restrictions on scientific research” often “handcuff researchers, impairing their ability to gather the evidence required to meet those requirements.”

While federal regulation of psychedelics remains stagnant, municipal decriminalization efforts press forward. The cities of Denver; Oakland, California; Santa Cruz, California; and Ann Arbor, Michigan have all passed ordinances decriminalizing some natural psychedelics. This week, voters in District of Columbia and Oregon approved similar measures.

This week’s Saturday Seminar explores the shortcomings of psychedelic regulation and proposals to expand access to psychedelics for medical research and use.

  • Taking psychedelics in a medical setting with trained supervisors could maximize the benefits and minimize the risks associated with the drugs, journalist German Lopez argues. In an article published in Vox, he explains that psychedelics can treat—and potentially even cure—some mental health issues but can also cause accidents and poor psychological experiences. To achieve the benefits and avoid bad outcomes of psychedelic drug use, he proposes allowing people to consume psychedelics only in controlled settings, led by guides that have “a license and liability insurance.”
  • The CSA’s “currently accepted medical use” criterion needs expanding, Matt Lamkin of the University of Tulsa College of Law argues. In a recent article published in the UC Davis Law Review, he suggests that medical use should encompass anything that promotes patient well-being, whether that is traditional treatment and preventative medicine or other benefits, such as “enhancing appearance, cognition, and social functioning.” Lamkin emphasizes that regulating psychedelics under this broader definition would better accomplish the CSA’s aim to promote public health and welfare from potentially dangerous substances, both by expanding access to certain drugs’ benefits and clarifying drug trafficking laws.
  • Psychedelic regulatory reform advocates should take into account “neurodiversity” as a social justice concern, the University of Massachusetts School of Law’s Dustin Marlan argues in a recent Lewis & Clark Law Review. Supporters of the neurodiversity movement, Marlan explains, acknowledge that “there is no single healthy and normal version of the human mind and brain” and advocate respecting neurological differences—including those caused by psychedelics—as a matter of equality. He claims that the use of psychedelics, as well as the effects of the drugs, can contribute to an individual’s identity and lead to a “stigmatized form” of cognitive diversity that society does not traditionally accommodate. Although recognizing that the “brain equality argument” may not hold up in court, Marlan suggests that this perspective could shift public support for ending psychedelic prohibition through ballot initiatives and voter referenda.
  • Psychedelics could be an important tool “to mitigate rising rates of depression, anxiety disorders, suicide, and substance use disorders associated with the COVID-19 pandemic,” Gonzaga University School of Law’s Mason Marks argues. In a forthcoming paper in the Administrative Law Review, he proposes reforms to make psychedelics more widely available. When deciding to reschedule drugs, the DEA should consider broader evidence of medical use such as “case reports, population studies, and clinical trials conducted abroad” and use factors that “promote an objective evaluation of each substance.” In addition, he encourages federal authorities to stop prosecuting the use or possession of natural psychedelics where doing so is legal under state or local laws. Finally, responsibility for drug control should fall to public health agencies, such as the U.S. Food and Drug Administration and the National Institutes of Health, rather than the law enforcement-oriented DEA.
  • In an Albany Government Law Review article, Northern Kentucky University Chase College of Law’s Alex Kreit argues that the CSA’s research restrictions on Schedule I drugs create “a serious and underappreciated flaw” in the law’s design. Because Schedule I substances need to meet the CSA’s strict “currently accepted medical use” standard before they can be studied, this categorization blocks researchers from examining certain drugs that may show promising benefits. Although this medical use standard may make sense for decisions about selling a drug as a medicine, he notes, it “borders on absurd” as a means to stop research on untested substances. Kreit recommends that the U.S. Congress fix this issue by distinguishing between Schedule I substances that have been proven to lack medical benefits and substances that researchers have not properly examined yet.
  • In an article published in the Scientific American, physician Rick Strassman proposes a new CSA Schedule specifically designed for psychedelics. This new category, Schedule IA, would maintain the same security measures and specialized training requirements for administering psychedelics to humans, but loosen restrictions for conducting research in clinical settings, Strassman explains. This regulatory framework would follow existing systems used in medical fields such as psychiatry, neurology, and anesthesiology and would allow researchers to “realize the clinical promise of psychedelic drugs without exposing patients to unnecessary risk.”

The Saturday Seminar is a weekly feature that aims to put into written form the kind of content that would be conveyed in a live seminar involving regulatory experts. Each week, The Regulatory Review publishes a brief overview of a selected regulatory topic and then distills recent research and scholarly writing on that topic.