[Reading Science] After Australia, the US too?… Controversy over 'Ecstasy' Legalization

MAPS "Proven Effectiveness in Treating Depression and PTSD"
"FDA Approval Application to Be Submitted This Year"

Following Australia, the United States is also pushing for the approval of MDMA (methylenedioxymethamphetamine), commonly known as 'Ecstasy,' as a treatment for depression, sparking controversy. Since many countries, including South Korea, strictly regulate it as a narcotic, specifically a psychotropic drug, significant repercussions are expected.

Ecstasy narcotics. Stock photo. Not related to the article.

On the 20th (local time), the international academic journal Nature reported that the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit academic organization based in Massachusetts, USA, plans to apply for FDA approval of MDMA as a treatment for depression and post-traumatic stress disorder (PTSD) by October. The organization is optimistic about the approval. They claim it is possible to dramatically reduce anxiety disorders and severe stress without addiction symptoms. In fact, in 2021, they announced that in a Phase 3 clinical trial involving 90 PTSD patients, those who received MDMA showed about twice the therapeutic effect compared to those given a placebo. They are currently conducting a second, larger-scale clinical trial, which is also reported to have yielded positive results. The results of the second trial are expected to be released within a few months. Rick Doblin, president of the organization, told Nature, "I don't think there will be any troublesome questions or other issues regarding the clinical results. The results are excellent."

Earlier, the Australian government officially approved MDMA as a PTSD treatment in February under strict handling regulations, which has raised hopes. The organization believes that if MDMA is approved for therapeutic use, it could open the door to the medical use of various artificial chemical substances such as ketamine, ayahuasca, LSD, and psilocybin. In fact, Bloomberg News cited a report from InsightAce Analytics last July, forecasting that if the market for these psychedelic mental disorder treatments becomes legitimized, it could reach $83.1 billion by 2028.

The problem is that many controversies remain. First, FDA approval is still uncertain. For example, MAPS, which advocates for the legalization of MDMA treatment, claims that the therapeutic effect only occurs when MDMA is taken along with their developed psychotherapy method. The clinical trials conducted so far involved two trained therapists strictly managing the participants. However, the FDA generally does not approve such combined therapies, focusing solely on the drug's effect itself. How to manage the manufacturing, distribution, and prescription processes of MDMA is also an issue. Even if MDMA is approved based on MAPS' clinical data, it is doubtful whether pharmaceutical companies will engage in its manufacturing and distribution. MDMA has been used since 1912 but is not patentable, so pharmaceutical companies have little profit incentive. There is also concern that if MDMA is approved and sold, social problems such as abuse and addiction could arise, potentially leading to negative public opinion about psychedelic treatments and institutional setbacks such as approval revocation.