by on By Mason Marks*
The COVID-19 pandemic is triggering a national mental health crisis. Millions may experience prolonged grief due to the loss of friends or family, depression from unemployment and social isolation, and post-traumatic stress disorder from working on the frontlines as healthcare providers or undergoing treatment as patients.
Our healthcare system is unprepared. It lacks the funding to provide prolonged psychotherapy at scale, and traditional psychiatric drugs, such as selective serotonin re-uptake inhibitors (SSRIs), are ineffective in up to fifty-five percent of people. Consequently, when the pandemic becomes a national mental health crisis, many will be left without relief. However, there are promising alternatives.
The experimental drugs psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) can reduce the symptoms of several mental health conditions including depression and anxiety disorders. In 2018, I published an article titled Psychedelic Medicine for Mental Illness and Substance Use Disorders: Overcoming Social and Legal Obstacles in the NYU Journal of Legislation and Public Policy. It analyzes the barriers to medical use of these drugs. For instance, healthcare providers may stigmatize patients who discuss psilocybin and MDMA, and the U.S. Drug Enforcement Administration (DEA) claims they are highly addictive and without accepted medical applications. The DEA limits the amount of psilocybin and MDMA that U.S. laboratories can produce each year and restricts who may synthesize and study them.
Since 2018, a few things have changed. After the release of popular books and documentaries, the stigma surrounding the study and use of psilocybin and MDMA has been reduced. The U.S. Food and Drug Administration (FDA) granted breakthrough therapy status to psilocybin-based treatments for major depressive disorder and treatment resistant-depression, and MDMA-assisted psychotherapy entered Phase 3 clinical trials, the last stage before FDA approval, for treating post-traumatic stress disorder.
These developments will facilitate the commercial availability of psilocybin and MDMA-based therapies. However, in light of the negative impact COVID-19 is having on the nation’s mental health, and the ineffectiveness of existing psychiatric drugs, innovative drug therapies cannot come soon enough. In a new article titled Drug Regulation for the COVID-19 Mental Health Crisis, which is forthcoming in the Administrative Law Review, I argue that the DEA and FDA should alter their regulation of psilocybin and MDMA to make them available immediately to researchers and those impacted by COVID-19.
Psilocybin and MDMA belongs to a controversial class of drugs call the psychedelics, which are known to alter mood, perception, and cognition. Other members of this group include lysergic acid diethylamide (LSD), peyote, and ayahuasca. Indigenous cultures have used psychedelics for centuries, and in the 1950s, scientists studied their therapeutic properties. However, their use became stigmatized in the 1960s due to their association with countercultural movements.
In 1966, Harvard psychologist Timothy Leary encouraged people to “Turn On, Tune In, and Drop Out.” A few years earlier, his professional colleagues accused him of promoting recreational drug use and conducting experiments involving psychedelics that lacked scientific rigor. When combined with other developments, such as linking psychedelic drug use to increasing opposition to the Vietnam War, these events triggered a political backlash against psychedelics. Misinformation and fear regarding their safety quickly drowned out scientific claims regarding their therapeutic potential, and the federal government implemented a series of punitive drug control measures.
In 1970, Congress passed the Controlled Substances Act (CSA), placing psychedelics in Schedule I, the most heavily restricted category of drugs. The CSA granted the U.S. Attorney General authority to schedule and re-schedule controlled substances, and when President Nixon established the DEA by executive order in 1973, that power was delegated to the agency. These events launched the U.S. War on Drugs that continues today despite being widely viewed as a policy failure that contributes to illicit drug markets, violence, mass incarceration, and drug overdose deaths.
In recent years, frustration with the effectiveness of existing psychiatric drugs has prompted researchers to investigate psychedelic treatments for mental illness, and a growing body of scientific evidence undermines the DEA’s classification of these drugs. For instance, in 2016, a team at Johns Hopkins showed that a dose of psilocybin significantly reduced depression and anxiety in people with life-threatening cancer diagnoses. In 2018, researchers at Imperial College London demonstrated that two doses of psilocybin decreased symptoms of treatment-resistant depression. In both studies, the benefits persisted for six months. A 2018 study published in The Lancet Psychiatry showed that MDMA-assisted psychotherapy significantly reduced symptoms of post-traumatic stress disorder in veterans and first responders.
These and other clinical trials suggest that psilocybin and MDMA are safe when administered in supportive settings. Unlike SSRIs, they act quickly and their effects are often long-lasting. These qualities make them promising candidates for addressing the COVID-19 mental health crisis. Moreover, they weaken the DEA’s assertion that psilocybin and MDMA have no currently accepted medical applications. Nevertheless, their Schedule I status makes them illegal to possess or prescribe and very difficult to study.
Despite psilocybin’s Schedule I status, several U.S. cities have decriminalized it. Last May, Denver became the first, and Oakland quickly followed suit. In 2020, Santa Cruz became the third U.S. city to decriminalize psilocybin. Similar measures are under consideration in Chicago, Washington, D.C., and the State of Oregon.
In light of these developments, and the urgent need for effective psychiatric treatments, the DEA should re-schedule psilocybin and MDMA. It is unclear how the Trump Administration might respond to this proposal. On one hand, the DEA’s new acting administrator, Timothy Shea, has a background as a federal prosecutor, which might suggest he would oppose easing restrictions on psychedelic research and use. On the other hand, Trump favors policies that promote innovation, and one drug company developing psilocybin-based treatments, Compass Pathways, is backed by libertarian entrepreneur and Trump ally Peter Thiel. However, recent reports suggest Thiel may be distancing himself from Trump over the Administration’s COVID-19 response.
Regardless, the DEA should use its scheduling power to move psilocybin and MDMA from Schedule I to Schedule III or IV, which would ease research restrictions, promote innovation in the mental health space, and allow doctors to prescribe psychedelics once they become FDA approved. Accordingly, the FDA should further expedite approval of therapies based on psilocybin and MDMA. Psilocybin has already completed FDA-sanctioned Phase 1 clinical trials for safety, and MDMA has completed Phase 2 clinical trials for safety and efficacy. In light of the unfolding COVID-19 mental health crisis, the FDA could issue emergency authorizations for their use.
Emergency use authorizations are issued for health conditions resulting from Chemical, Biological, Radiologic, and Nuclear (CBRN) threats. Under section 564 of the Food Drug and Cosmetic Act, the FDA Commissioner can allow the use of unapproved medical products to treat or prevent serious or life-threatening conditions caused by CBRN agents when there are no adequate, approved, and available alternatives.
In March, the FDA issued an emergency use authorization for the controversial drug hydroxychloroquine. In May, it issued a similar authorization for remdesivir. The FDA took these actions without strong evidence that the drugs could effectively treat COVID-19. At the time, there were no existing drug treatments, and COVID-related deaths were rising quickly (they now approach 100,000).
Some public health experts estimate the developing mental health crisis may cause up to 75,000 American deaths by suicide and drug overdose. Existing psychiatric drug treatments are inadequate to prevent these losses because they are too often ineffective. An emergency use authorization for psilocybin and MDMA could save lives by providing symptomatic relief to those who do not respond to, or cannot access or afford, traditional therapies.
Some experts argue that the FDA’s emergency authorization for hydroxychloroquine was concerning. Doctors Caleb Alexander, Aaron Kesselheim, and Thomas J. Moore point out that the agency did not reference any clinical trials on which it relied in issuing the authorization. Though such criticisms are valid, they should not be viewed as indictments of the process for issuing emergency use authorizations. Though there may have been little evidence supporting the use of hydroxychloroquine, there is substantial evidence that psilocybin and MDMA can treat depression and anxiety disorders. Although psychedelics have not been tested in people affected by COVID-19, they have been tested in people who have experienced trauma, anxiety, depression, and grief (including first responders, a population that the virus heavily impacted).
The pandemic caught the United States off guard. Unless American cities, states, and federal agencies act now to provide effective treatments, the country will be equally unprepared for the mental health crisis that follows. Psychedelic medicines are well-tolerated, they act quickly and produce prolonged benefits, and they fill an urgent unmet need for innovative mental health treatments. It would be irresponsible not to explore their full potential considering the stakes.
* Mason Marks (J.D., M.D.), is an Assistant Professor of Law at Gonzaga University, the 2020-21 Edmond J. Safra/Petrie-Flom Center joint fellow-in-residence at Harvard University, and an affiliated fellow at Yale Law School’s Information Society Project.