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The Mental Health Crisis and FDA Hurdles

Despite promising research, the potential for MDMA, and other psychedelic drugs to help treat mental illnesses depends on the a pending FDA decision

By guest author Raymond J. March
September 15, 2023

The latest Johns Hopkins School of Medicine estimates find that 25 percent of US adults have a diagnosable mental illness. 

This is an alarming increase from 20 percent of adults from 2019-2020. Minors are also experiencing a steep rise in rates of anxiety and depression nationwide. 

Living with a mental illness can be a daily struggle. However, medication, therapy, a support system, and some lifestyle changes can help. Fortunately, some mental illnesses and their effects are not permanent. Mild episodes of mental illness last only a few days or weeks.  

Like most other illnesses and conditions, mental illness has its extremes. About 5 percent of the US population suffers from a severe mental illness, which has the potential to hinder a patient’s quality of life significantly and make daily life an overwhelming challenge. 

Severe mental illnesses can also be challenging to treat—requiring considerably more treatment and with less assurance standard treatments will work. For example, many psychiatric medications can take months to take effect and have concerning side effects even when they help. 

What can be done to help a vulnerable and growing population of patients? Ecstasy, also known as MDMA, provides hope. 

Ecstasy is the primary component of Methyl​enedioxy​methamphetamine (MDMA)—which can help users experience euphoria even when confronted with traumatic experiences. Processing these events is vital to treating post-traumatic stress disorder, which affects 9 percent of the US population and is linked to severe mental illnesses. 

Far from a party drug, ecstasy plays a big part in “a revolution” in treating mental illness. Research published in Nature Medicine, a highly respected academic journal, attests to ecstasy’s ability to help PTSD patients. The Food and Drug Administration granted ecstasy breakthrough therapy status in 2017expediting its process to becoming an approved treatment. Well before then, psychiatrists distributed over 500,000 doses of ecstasy to help soldiers returning from the Vietnam War work through combat-related PTSD. 

Although making psychedelic drugs more available will likely increase how often they’re used—there is surprisingly little risk to overprescribing—especially compared to alternative treatments.

Historically, emergency department visitations due to using MDMA, LSD, and magic mushrooms combined are a small fraction of visitations due to prescription anti-depressant use. Similarly, overdose deaths stemming from prescription medications used to treat mental illness are well documented and increasing. Overdose deaths from psychedelics are extremely rarearguably impossible.  

Despite promising research and a pressing need for more treatments, the potential for ecstasy, MDMA, and other psychedelic drugs to help patients with severe mental illnesses heavily depends on a decision the FDA will need to make soon. 

In June 2023, the agency drafted guidance to create a pathway to approval for psychedelic drugs to treat patients and become recognized treatments (under the supervision of medical professionals). As is customary, the FDA allowed a sixty-day period to receive public commentary. Those sixty days have since passed. 

Previous policy and legal scholars have described preventing MDMA and other drugs from helping to treat psychiatric illnesses as “a reactive, largely blind decision.” Allowing this opportunity to pass would be the same.