Psychedelic Therapies: Psychiatric Breakthrough or Just an Excuse to Get High? (Part 2)
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In the last article, we took a deep dive into the promising aspects of psychedelic therapies — what they are, how they work, and most importantly, how they are targeting completely new parts and processes of the brain in order to achieve dramatic, lasting results for patients. While it may be easy to look at all of this and deem psychedelics to be a miracle of modern psychiatry, it’s imperative to address the more controversial dimensions of this treatment method. As we’ve seen, psychedelic therapies are not without their challenges, particularly in the realms of societal stigma, cultural appropriations, and safety concerns. These issues underscore the complex ethical, social, and regulatory landscapes that these therapies inhabit.
The Stigma of Schedule 1 Classification
Psychedelic substances, including psilocybin and MDMA, often carry a heavy burden of stigma in the United States, largely due to their classification as Schedule 1 drugs under Nixon’s Controlled Substances Act. Introduced in 1970, the Controlled Substances Act (CSA) was part of President Nixon’s larger “war on drugs.” This legislation categorized drugs into schedules based on their perceived medical use and potential for abuse. Psychedelics like LSD and psilocybin were placed in Schedule I, which is reserved for substances considered to have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. However, despite the empirical sounding language and scientific associations we still hold toward the CSA today, the classification of these substances was influenced more by political motivations to curb countercultural movements rather than grounded in scientific assessments of their risks and benefits. This political origin of drug scheduling has contributed significantly to ongoing stigma, as the public often perceives these legal classifications as based on solid scientific evidence. The repercussions of this stigma affect not just public perception but also regulatory and research hurdles that delay potential therapeutic advancements.
In the 1980s, First Lady Nancy Reagan furthered the stigma towards psychedelic drugs when she launched the “Just Say No” campaign, aimed at discouraging children and young adults from engaging in illicit drug use. This campaign was part of a broader societal push towards zero-tolerance policies regarding drug use, which further entrenched the stigma around psychedelics. It framed drug use as a moral failing rather than a health issue, significantly impacting public perception and policy for decades. The simplicity and memorability of the “Just Say No” slogan helped embed a lasting fear and misunderstanding about all illicit drugs, including psychedelics, cementing a cultural narrative that equated drug use with criminal behavior and social decay. As a result, many Americans today view the introduction of psychedelic substances into therapy settings with a sense of suspicion — a belief that these efforts are simply a way to allow the modern counterculture to “get high” in a legal and socially-accepted way.
Cultural Controversy and Sacred Traditions
The rise in the popularity of psychedelics for therapeutic use has sparked a critical discussion on the appropriation of substances that are sacred to many indigenous cultures. Many psychedelic substances such as psilocybin (found in magic mushrooms), ayahuasca (a brew used traditionally in the Amazon), and peyote (used primarily by Native American communities) hold significant cultural, spiritual, and medicinal importance in various indigenous traditions around the world. These communities have used these substances for centuries in ritualistic and healing contexts, embedded within specific ceremonial practices that are integral to their cultural and spiritual identity.
The use of these substances in such contexts is often intended not only for personal healing but as a means of connecting with spiritual realms, ancestors, or the natural world, which is central to the community’s worldview. The rituals and ceremonies surrounding their use are carefully structured, involving specific preparations, prayers, songs, and guidance from experienced elders or shamans who understand the profound and often unpredictable effects of these substances. The mainstreaming of these sacred medicines risks commodifying and decontextualizing them, stripping away their cultural heritage and potentially exploiting the very communities that have stewarded these practices for generations.
“Biopiracy” and the Over-Harvesting of Sacred Plants
Many of the plants used to create psychedelic medicines are found only in specific ecosystems throughout the world, and they have been carefully protected to avoid overuse by non-indigenous users with little understanding of how to grow, harvest, and use the plants responsibly and sustainably.
There’s growing concern that biopiracy — the commercial exploitation of natural resources, or knowledge of the indigenous and local communities without fair compensation — is occurring. Indigenous communities that have preserved and practiced traditional knowledge about these psychedelics often benefit the least from the global interest in these substances. Which brings up an additional important point — the plants themselves are not the only precious resource related to the healing power of psychedelics. The therapeutic efficacy of psychedelics is profoundly influenced by ‘set and setting’ — the mindset of the individual and the physical and social environment in which these substances are used. Neglecting these factors can not only diminish the therapeutic outcomes but can also lead to adverse experiences. The traditional use of psychedelics within structured, culturally embedded rituals inherently honors the importance of set and setting, providing a framework that modern clinical practices must understand, respect, and integrate to ensure patient safety and optimize therapeutic results.
Recent Setbacks and Safety Concerns
In the most recent developments regarding MDMA-assisted therapy, a critical vote by an FDA advisory panel has highlighted significant concerns, casting a shadow over the future of this treatment method. The advisory panel voted 10–1 against approving MDMA for PTSD treatment due to several issues, including concerns about unblinding in the studies, adverse cardiovascular effects, and insufficient data on the potential for abuse. This advisory panel was the first to review a psychedelic-assisted therapy in the United States, marking a significant moment in the ongoing discussion about such treatments. Although the FDA is not bound to follow the panel’s recommendations, it typically takes them into serious consideration. The outcome of this meeting has been seen as a substantial setback for advocates of psychedelic medicine, particularly because it might jeopardize the approval of MDMA-assisted therapy. This is a significant issue for clinical psychiatry, which has not seen a new treatment approved for PTSD in over 25 years.
While disappointing, the vote was not made without consideration of some serious concerns that must be addressed by clinical researchers in order for psychedelic therapies to overcome their decades-long stigma in American policy and culture. The advisory panel cited issues including allegations of therapist misconduct during MDMA sessions, have sparked a broader discussion about the ethical and safety considerations of psychedelic-assisted therapies. These concerns underscore the need for stringent protocols and careful monitoring to safeguard patient safety and maintain the integrity of the therapeutic process. Chief among them were:
Insufficient Blinding: A concern that has dated back to the beginning of clinical trials with psychedelics, there was a significant issue with maintaining blinding in the studies due to the noticeable effects of MDMA. In order for a drug to receive clinical approval, it is critical that the patients and doctors in the study not know if they receive the drug or a placebo. Since most people could clearly tell when they experienced psychedelic effects (or not), it made it difficult to ensure unbiased results.
Long-Term Use: The panel raised doubts about the long-term safety of MDMA, especially given that the trials only covered three sessions of MDMA-assisted psychotherapy. As the race to get psychedelic therapies approved moves as fast as possible, long-term follow-up data (which inherently take a long time to collect) have been scarce. Concerns about unexpected long-term risks, as well as the more expected issues like cardiovascular risks and other physical side effects, were not fully addressed in the available data. The panel was also cautious about the broader implications of approving a drug with such profound psychoactive effects without more robust evidence of its safety and efficacy over longer periods.
Potential for Misuse: There were concerns about the potential for abuse of MDMA and the adequacy of safeguards to prevent this. The sensational nature of the therapy raised fears about its potential misuse outside of controlled clinical settings, which are frequently highlighted as a result of the stigma instituted by the CSA and subsequent “war on drugs”. Given that accurate evaluation of misuse risks often require long-term follow-up data and wide-scale deployment, it can be difficult to evaluate them in controlled studies.
(Lack of) Diversity among the Subjects: The panel noted that the demographic makeup of the study participants was not sufficiently diverse (most people who participated were white and came from relatively high socioeconomic backgrounds), which limits the generalizability of the findings across different populations. This lack of diversity in clinical trials could mean that the effects and safety of MDMA might not be well understood across different racial, ethnic, or socioeconomic groups, which is crucial for evaluating a treatment intended for widespread use.
Therapist Misconduct: There were alarming allegations related to the misconduct of therapists during the sessions, specifically involving instances of sexual assault on patients under the influence of MDMA. These serious allegations highlight the vulnerability of patients during therapy and the critical need for stringent ethical guidelines and oversight (because no matter how promising or beneficial something may be, there will always unfortunately be people who truly suck, taking advantage of vulnerable individuals and casting fear on every therapist using MDMA for therapeutic gain).
Bringing It All Together
Hopefully these two articles have painted a complex picture of psychedelic therapies, because the topic is far from a black-and-white issue. The potential for never-before-seen therapeutic benefits must be carefully balanced against ethical considerations and societal implications. While the promise of these treatments in addressing deep-seated psychological issues is undeniable, the path forward requires a conscientious approach that respects both the cultural origins of these substances and the safety of those seeking healing. We don’t just want to be able to use these therapies for good right now; we want to create a foundation that allows us to integrate them into a sustainable and responsible treatment protocol that can be safely used to heal people for generations to come.
Diving Deeper
For those interested in exploring the ethical, cultural, and regulatory landscapes of psychedelic therapies further, numerous resources are available:
- “Singing to the Plants” by Stephan V. Beyer explores the rich traditions of Amazonian shamanic practices, providing insight into the sacred use of psychoactive plants.
- The Council on Spiritual Practices offers guidelines and discussions on the responsible use of psychedelics within spiritual and therapeutic practices. Check out their website, or this companion website created by UC Berkeley Center for the Science of Psychedelics, for a vast collection of information and resources about the responsible and respectful use of sacred plants and traditions.
Call to Action
As we navigate the complexities surrounding psychedelic therapies, your voice and engagement are crucial. Share your thoughts, experiences, or concerns about the use of psychedelic therapies in clinical and cultural contexts. Engage in discussions, participate in forums, and contribute to a balanced understanding of these powerful therapeutic tools. Your insights can help shape a responsible and respectful approach to integrating psychedelic therapies into mainstream medicine. Share this conversation, and let’s collaboratively forge a path that honors both the science and the sacredness of these practices.
