To ‘Shroom or not to ‘Shroom?

Lopsided Research And Policy Within Psychedelics Increases Potential Harms


Lori Bruce, MA, MBE, HEC-C

Publish date

To ‘Shroom or not to ‘Shroom?: Lopsided Research And Policy Within Psychedelics Increases Potential Harms
Tag(s): Editor's pick
Topic(s): Drugs

Whether due to industry pressure, media hype, or a sense of optimism over a handful of recent clinical trials, the FDA may approve MDMA-assisted psychotherapy for PTSD by the end of 2023 and is considering approval of psilocybin-assisted therapy for depression in the months to follow.

Cities and states throughout the US are also creating pathways to recreational and therapeutic experiences. Oregon’s psilocybin program permits anyone 21 or older to obtain psilocybin as long as they complete a preparation session with a state-licensed guide. Colorado’s 2023 law permits healing centers for supervised use of psilocybin and allows ibogaine, mescaline, and DMT for personal use, and California will vote this month on whether to permit the cultivation and use of several psychedelics. Other cities and states have passed or are pursuing similar measures, and this enthusiasm is matched by predictions of a massive global market, perhaps reaching over $8 billion by 2028.

Members of the public generally assume regulatory advancements of this magnitude would be informed by a careful risk/benefit analysis, but research and policy communities have both largely sidestepped the nature and prevalence of the risks of psychedelics.  The public has a right to more balanced information about psychedelics.

Why use psychedelics?

Psychedelics may provide a heightened state of consciousness or a profound spiritual experience. Promising outcomes for various disorders may also be possible; some veterans with otherwise intractable PTSD have experienced symptom relief through ibogaine and psilocybin. Others have similarly experienced notable symptom reduction in trauma after a single dose of MDMA, and some patients at end-of-life find their fear of death is greatly reduced through psychedelics.

Given the limited efficacy of current psychiatric treatments, perhaps this news can’t come soon enough. However, governments have a duty to protect their constituents from harms – or at least inform them of risks and unknowns – and the current speed of deregulation promises that many constituents will not be fully informed, resulting in pronounced and sometimes enduring harms whether they access psychedelics recreationally or within a study or clinical setting.

What’s not to love about the state of psychedelics?

Many psychedelic studies either underreport adverse events or fail to record them at all. This is especially concerning since a recent large survey of people who reported difficulties after a trip found “long-term adverse effects of psychedelic use… can persist for weeks, months, or even years.” The study found that about one-third of study participants reported problems lasting over twelve months, and for a sixth, problems persisted over three years. Difficulties included long-term states of anxiety, fear, social disconnection, existential struggle, or experiences of detachment from one’s own body or reality.

More generally, for every problem psychedelics can heal, it may also cause.

Positive responses also seem to wash out in larger studies; in a recent randomized, controlled, double-blind psilocybin study, nearly one-third were in remission from treatment-resistant depression at 3 weeks, but that difference diminished by 12 weeks. Additionally, suicidal ideation and self-harm rates were notably higher in the groups with higher doses. Psychedelics are clearly not a magic pill, and it sometimes takes an extended period for someone to come to terms with whether their “bad trip” was redeeming or too profoundly damaging.

Additionally, few know that one of the most cited MDMA studies on PTSD had several violations of study protocol, including nonconsensual touching of one subject during her psychedelics session by the research therapist, resulting in the subject experiencing even more debilitating trauma than when she qualified for the study. Participants may only have hazy memories of their session – a condition that increases vulnerability – but this abuse was confirmed by extensive video footage. Likely due to the drug’s empathogenic mechanisms, the therapist then pressured the subject into a month-long sexual relationship – yet the published study has no mention of these harms.

Mainstream medicine isn’t immune to sexual assaults (as recently uncovered in Virginia, Manhattan, and Queens), and the psychedelics community similarly needs to come to terms with sexual predators. More broadly, boundary violations are believed to have a pronounced history within the psychedelics movement and yet few US jurisdictions require public education, training, certifications, or abuse reporting mechanisms to reduce harms whenever possible.

But what about consent and minimizing harms?

This leads to another conundrum within psychedelics: how can we meaningfully provide informed consent when possibilities include a profound cessation of trauma, deep spiritual transformation, or a long-term shattered sense of self? How can a consent form articulate how users may be emotionally pliable for several weeks after their experience, thus more vulnerable to social manipulation?

Consent and screening may also be conducted by guides who are financially incented to approve them (especially since many guides need funds to pay off their costly training programs).

It’s widely known that the frequency of harms can be reduced (not eliminated) with careful attention to the user’s mental preparedness and the conditions supporting the experience (the oft-cited “set and setting”). But even the most impeccable psychedelics use will still result in a certain percentage of anticipated long-term and debilitating harms, which need to be articulate to potential users.

Some scholars discuss how the LSD studies of the ‘60s actually had low efficacy. This may perhaps be the case for psychedelics under study today, and this uncertainty may explain why many advocates are rushing to establish profitable centers now – before clinical trials provide more nuanced data. It’s more likely, though, that certain psychedelics will provide some measure of relief for certain individuals, perhaps hinging on genetics, gender, user’s mindset, and dosage.

In sum, research findings are preliminary; IRBs haven’t been requiring PIs to measure harms; and editors and reviewers are failing to insist on explicit documentation of study limitations. Some users will experience debilitating harms and we’re largely unable to predict who is most apt to suffer. Public understanding on these issues is limited, and there’s no infrastructure to help users find ethical guides or report those who harm. Challenges to informed consent are also currently unresolved. Despite these and other challenges, access to psychedelics continues to increase.

How should we move forward?

The research and regulatory communities now need to play catch-up.  Researchers should design studies to track and report both benefits and harms and list the most recent harm predictions on consent forms. IRBs should help to hold researchers accountable. Journal editors and reviewers should ensure manuscripts report limitations, including lack of harms, study size limits, and the need for long-term findings.

Policymakers should require public education and consider limits to public access under the conditions I have described. Given the speed and scope of the current regulatory rollout in light of limited understanding, policymakers should perhaps even consider establishing a psychedelics injury compensation program for those harmed during all forms of legally permissible use (including recreational, research, and clinical use). Over time, if psychedelics meet the projected hype, and appropriate infrastructure is established, the costs of the injury compensation program should decrease.

Are you using psychedelics with your patients or research subjects?

“Be sure to discuss harms as well as unknowns, benefits, and alternatives; the consent form alone should not do this work for you. Additionally, remain up to date on the latest findings and consider support resources such as the Fireside Project (a hotline for emotional support during and after psychedelic experiences) and Sage Integrative Health (which provides psychedelic integration circles).”

Are you considering trying psychedelics yourself?

Be sure to understand the contraindications, risks, alternatives, and long-term harms. Recognize that psychedelics, when paired with supportive therapy, may be a tool to facilitate profound healing – but the “trip” itself may be a very destabilizing experience with some of the effects described above. Check your local laws and seek a thoroughly vetted guide with whom you have rapport – and someone who is not a die-hard advocate, but more of a neutral party focused on your interests and well-being. And if you’ve had a suboptimal outcome, please seek support services. Finally, please consider sharing your experience with others to help balance the public hype around these complicated substances.

Lori Bruce, MA, MBE, HEC-C is the Associate Director of the Interdisciplinary Center for Bioethics at Yale University.

Views expressed are her own.

The author has received compensation for organizational ethics and harm reduction consulting within psychedelics.

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