MDMA AND PSILOCYBIN FOR MENTAL HEALTH: DECONSTRUCTING THE CONTROLLED SUBSTANCES ACT'S USAGE OF "CURRENTLY ACCEPTED MEDICAL USE".

• Author: Khaled, Nabil Al-

ABSTRACT

MDMA and psilocybin are drugs that exhibit almost never-before-seen relief--including complete remission--from debilitating mental health disorders including Post Traumatic Stress Disorder (PTSD) and Treatment-resistant depression. Doctors, however, are unable to legally prescribe them outside of tightly-controlled research trial settings because of the drugs ' categorization under Schedule I of the Controlled Substances Act (CSA)--the Act's most restrictive schedule--by the Drug Enforcement Agency (DEA). Legal scholarship on the subject, unfortunately, is not commensurate with the pace of recent progress in both the medical and commercial fields. Further, while state and local efforts to decriminalize, regulate, and provide access to MDMA and psilocybin may offer some hope, unless the drugs are reclassified to a less restrictive schedule on the federal level under the CSA, the state-by-state patchwork approach would inevitably create inequities in patient access to these potentially life-saving drugs and expose patients to federal prosecution, notwithstanding their compliance with state or local laws.

This Note examines the federal structural legal barriers that hinder patient access to MDMA and psilocybin. It begins by providing a historical backdrop of the legal and political reasons the drugs were banished to the CSA 's most restricted category, Schedule I, over fifty years ago. It then demonstrates that the DEA, in the decades that followed, exceeded its administrative authority in interpreting the Controlled Substances Act's undefined requirement that Schedule I be reserved for drugs and substances with "no currently accepted medical use. " Concomitantly, federal circuit courts have, by and large, upheld the DEA 's interpretations under Chevron V. Natural Resources Defense Council, a 1984 U.S. Supreme Court decision that requires federal courts to defer to permissible agency constructions of ambiguous federal statutory provisions.

This Note presents aspects of three recent U.S. Supreme Court decisions that clarify the Chevron standard, and argues that the DEA 's interpretation is no longer warranted deference under U.S. Supreme Court law. Ultimately, this Note proposes an alternative statutory interpretation of "currently accepted medical use " that comports both with current Supreme Court jurisprudence and with the CSA's public health purpose.

INTRODUCTION

Jonathan Lubecky, a veteran, recently recovered from Post-Traumatic Stress Disorder (PTSD) that had resulted from traumas he suffered during his deployment in Iraq in 2006. (1) After returning from Iraq and for five years thereafter, (2) his daily reality centered around one goal--how to take his own life. (3) He attempted suicide five times, all near-successful. (4) "When all seemed lost," he turned to the club drug MDMA--but legally--as part of a clinical trial. (5) After only three treatment sessions, his crippling symptoms disappeared. (6) According to Jonathan, MDMA saved his life. (7) His message to fellow veterans battling PTSD: "[MDMA] treatment is the reason my son has a father instead of a folded flag." (8)

Jonathan is not alone. (9) Mental illness is a public health crisis that affects almost one in five Americans annually. (10) Compounding this mass human suffering is a profound economic impact: in 2010, "the global direct and indirect economic costs of mental disorders were estimated at US $2.5 trillion," (11) and that figure is "expected to double by 2030." (12) And the approximately 15 million PTSD sufferers are among the worst off: (13) no disorder-specific drug has been developed since 2002, and those currently available have shown little, if any efficacy. (14) In fact, studies have found that the most commonly used psychiatric drugs--selective serotonin re-uptake inhibitors (SSRIs)--do not alleviate symptoms in up to fifty percent of patients with depression. (15) Prospects for new treatments are dim: pharmaceutical companies reduced research and development of new psychiatric drugs by seventy percent over the last decade. (16)

Put simply, the United States healthcare system is woefully ill-equipped to offer effective treatment for up to twenty percent of its population. (17) Yet two experimental drugs, 3,4-Methylenedioxymethamphetamine (MDMA) and psilocybin, have shown phenomenal promise. (18) In fact, the Food and Drug Administration (FDA) in 2017 granted "breakthrough therapy" status for MDMA-assisted psychotherapy (19) following several recent studies that demonstrated "significant relief' for PTSD patients. (20) One of those studies showed that 67 percent of the participants "no longer met the diagnostic criteria for PTSD" after just two months of treatment. (21) MDMA works by reducing the activity in the amygdala, the fear-processing part of the brain: when the fear is calmed, patients feel safe in processing their traumatic memories with professional therapists with a positive perspective. (22)

As for psilocybin, the FDA granted the same status twice in 2019 for the treatment of severe depression in patients who have not improved from traditional antidepressants. (23) A Johns Hopkins University study published last year found that psilocybin "was four times more effective than traditional antidepressants." (24) Psilocybin profoundly impacts the brain and can have long-term therapeutic effects by "wiping away depressive symptoms" in many patients with major depressive disorders. (25) According to Johns Hopkins University neuropharmacologist Roland Griffiths, psilocybin is distinguishable from traditional pharmaceuticals because it produces "enduring meaning and belief changes .... People feel 'reorganized' in a way they don't with other drugs." (26) And because psilocybin therapy is four times as likely to be effective than SSRIs "with more enduring benefits," (27) Newsweek's October 2021 issue cover hailed it as possibly "the biggest advance in treating depression since Prozac." (28)

Despite having shown promise for almost half a century, (29) MDMA and psilocybin are still not legally available to patients, largely because the federal government, decades ago, hastily categorized them under Schedule I of the Controlled Substances Act (CSA). (30) A drug's placement on Schedule I subjects it to severe restrictions by the Drug Enforcement Administration (DEA) and, as a consequence, researchers' access to that drug is tremendously hindered, delayed, and often cost-prohibitive. (31)

Unique to Schedule I drugs is their legal characterization of having "no currently accepted medical use." (32) Rescheduling a drug from Schedule I to another, less restrictive schedule is a complex administrative process. (33) Essentially, rescheduling proceedings must demonstrate that a drug or substance has a "currently accepted medical use," (34) a process which has been historically administered by the DEA. (35)

Unlike the federal government, many cities and states, seeming to recognize the "untapped resource" that psilocybin and MDMA represent, have either decriminalized the possession of these two drugs or explicitly permitted research into them. (36) The trend began in 2019 in Denver, Colorado, where voters approved a referendum decriminalizing psilocybin. (37) By 2020, Oakland and Santa Cruz, California, (38) Washington, D.C., (39) and Oregon (40) followed suit in what has been dubbed as the "psychedelic renaissance." (41) Chicago and Iowa are among other state and local jurisdictions considering the enactment of similar measures, (42) and California legislators are proposing further reforms. (43) On the research front, in 2021 Texas tasked its state health departments with conducting studies to evaluate the therapeutic efficacy of psilocybin and MDMA research in the treatment of PTSD, depression, anxiety, migraines, and other mental and physical health conditions, (44) following Connecticut's enactment of a similar measure. (45) As of this writing, eleven additional states are proposing similar measures. (46)

These state and local measures are significant for two reasons that may be in tension. On one hand, they demonstrate that many American voters acknowledge the therapeutic effects of certain Schedule I drugs. However, their conflict with the CSA exposes patients who, while acting consistently with state or local law, risk prosecution and incarceration by the federal government "unless federal drug regulation is updated." (47)

Legal scholarship on the subject, unfortunately, has not kept pace with the momentum in both the medical and commercial fronts. (48) Over the last two years, medical research papers on the subject have multiplied: 139 papers were published on psilocybin in 2020, almost twice as many as in 2019. (49) On the commercial front, companies are already seeking patents on psilocybin formulations. (50) As of this writing, three such companies are publicly listed in the United States, and in Canada, more than two dozen are listed, with an estimated collective value of more than $4.5 billion. (51) On the legal front, however, "there is no systematic research being done on psychedelics law." (52) This Note aims to contribute in ongoing efforts to fill this gap. (53)

This Note argues that federal rescheduling is more effective than a patchwork of state laws because, by virtue of the preemption doctrine, federal rescheduling would provide immediate and nationwide relief for suffering Americans. (54) Further, rescheduling is possible under the current statutory framework because current DEA regulations are inconsistent with the plain text of the CSA. (55) Part I of this Note provides the legal and historical backdrop of the CSA and its stymying effects on MDMA and psilocybin research. It then summarizes the legal evolution of rescheduling requirements under DEA regulations that interpret the descriptive language of Schedule I drugs under the CSA. Part II demonstrates the illegality of those regulations in...