Psychedelics can kill: The FDA was right to reject MDMA-assisted therapy

This story has been updated to correct the misspelling of Lykos Therapeutics. We regret the error.

Despite the growing momentum for psychedelic decriminalization, the Food and Drug Administration’s (FDA) recent decision to reject MDMA-assisted therapy by Lykos Therapeutics has effectively brought the “psychedelic renaissance” to a screeching halt. Even more shocking was the subsequent retraction of three peer-reviewed studies by the journal Psychopharmacology. While many advocates — who have fought for decades to legalize these treatments — were left stunned, the public should breathe a sigh of relief.

These drugs, often praised for their potential benefits, can cause harm if their dangers are not fully understood. The risks aren’t just theoretical; they are very real, especially when considering how social behaviors drive unhealthy practices, as evidenced by the case of Joseph Emerson, a commercial pilot involved in a near-catastrophic incident on Oct. 24, 2023. Emerson, a standby employee passenger, engaged in a physical altercation with fellow pilots in the cockpit of an Alaska Airlines jet. He tried to activate the plane’s fire suppression system, risking engine failure and a potential crash.

Investigations revealed that Emerson was using psilocybin mushrooms to cope with severe depression instead of seeking proper medical treatment, largely due to fear of losing his career. Pilots who seek mental health treatment are often grounded for years and face reduced pay.

Because of the overly focused attention on the benefits of psychedelics, researchers and policymakers are not considering how these substances will interact with documented real human behavior. Research shows that stigma around mental illness is the primary reason more than half of the 28 million American adults with mental health issues don’t receive treatment. Stigma actively drives people toward dangerous coping mechanisms like excessive drinking, substance use and self-medication, as in Emerson’s case.

Psychedelic users may be particularly at risk. In fact, a recent publication using nationally represented data found that psychedelic users were more likely to avoid mental health treatment if they perceived stigma. Why is this pattern of self-medication so concerning? Because the risks are substantial. MDMA is highly toxic. A few doses of pure MDMA can lead to hyperthermia, dehydration and even cardiac arrest. Over the past decade alone, more than 500 people have died from MDMA-related overdoses. The situation worsens as people turn to the underground market for these drugs, often purchasing substances laced with other chemicals, such as fentanyl, which significantly increases the likelihood of a fatal outcome.

Moreover, we cannot blindly trust pharmaceutical companies or doctors to prescribe these drugs safely. We’ve seen this issue before with opioids. Initially approved for end-of-life care, opioids were soon prescribed off-label for a wide range of conditions, turning doctors into “opium mills,” creating addicts, and leading to the deaths of an estimated 500,000 people during the opioid epidemic.

A similar pattern is emerging with ketamine. Although initially FDA-approved for specific mental health conditions, ketamine is now being prescribed at alarming rates. Matthew Perry’s sudden overdose may be a tragic example of this pharmaceutical greed, allegedly the result of actions by “two unscrupulous doctors.”

For those advocates worried that the “renaissance” is over, there’s still hope in the form of other clinical trials, particularly those focused on psilocybin, commonly known as magic mushrooms. These trials represent a significant improvement, as classic psychedelics like psilocybin are nontoxic and virtually impossible to overdose on.

Moreover, these treatments do not seem to require the same psychotherapeutic oversight that the Lykos MDMA trial did. Unlike MDMA, which must be synthesized in a lab — introducing the risks of cross-contamination and overdosing — psilocybin can be safely and inexpensively grown at home with minimal environmental impact and at a fraction of the cost.

Additionally, psilocybin decriminalization efforts like those in Colorado, California and Oregon will likely go much further in democratizing and equalizing access to these potentially life-saving drugs, far beyond what monopolistic companies like Lykos, backed by the Multidisciplinary Association for Psychedelic Studies, which has sometimes been described as a “cult,” could ever offer.

However, the underlying stigma problem persists, driving people to self-medicate rather than seek the professional care they need. This situation should be a wake-up call, not just for more ethical research, but for policymakers to take a more thoughtful approach that considers both human behavior and the pharmaceutical greed that has long dominated the field of medicine. The FDA’s rejections were an absolute necessity: The rapidly shifting and poorly conceived psychedelic policies will kill.

Sean M. Viña, Ph.D., is an assistant professor in the Department of Sociology at the University of the Incarnate Word.