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Erratum: Making psychedelics into medicines: The politics and paradoxes of medicalization

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Journal of Psychedelic Studies
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Tehseen Noorani at University of Auckland
Tehseen Noorani
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ERRATUM: MAKING PSYCHEDELICS INTO
MEDICINES: THE POLITICS AND
PARADOXES OF MEDICALIZATION
TEHSEEN NOORANIp
Department of Anthropology, Durham University, Durham, UK
ERRATUM: Journal of Psychedelic Studies 4 (1) (2020) 34–39
DOI: 10.1556/2054.2019.018
On p. 37 of the article, ‘ketamine’was accidentally included in a list:
“Not anticipated by the US Controlled Substances Act, such bifurcations have been created
on an ad hoc basis, for cannabinoids, gamma hydroxybutyrate, and ketamine (Ismail Lourido
Ali, personal communication, June 19, 2019), offering the FDA a legal mechanism by which
to create markets for tightly regulating licit use while avoiding concerns with or backlash
from rescheduling substances in toto.”
This paragraph listing should not include ‘ketamine’. Thus, the paragraph should read as
follows:
“Not anticipated by the US Controlled Substances Act, such bifurcations have been created
on an ad hoc basis, for cannabinoids and gamma hydroxybutyrate (Ismail Lourido Ali,
personal communication, June 19, 2019), offering the FDA a legal mechanism by which to
create markets for tightly regulating licit use while avoiding concerns with or backlash from
rescheduling substances in toto.”
Editorial
Open Access. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial
4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution,
and reproduction in any medium for non-commercial purposes, provided the original author and source are credited, a link to
the CC License is provided, and changes –if any –are indicated.
Journal of Psychedelic
Studies
5 (2021) 1, 55
DOI:
10.1556/2054.2021.10000
© 2021 The Author(s)
ERRATUM
pCorresponding author.
E-mail: tehseen.n.noorani@durham.ac.uk
Available via license: CC BY-NC 4.0
Content may be subject to copyright.
... Screening clients can help mitigate the risks of psychedelic assisted therapy by making sure the client is healthy enough to ingest a psychedelic substance and has few risk factors for psychosis (Byock, 2018;Nutt, 2019). In many clinical trials, clients with suicidal ideation and psychosis are screened out in order to mitigate any risk of adverse reaction to psychedelics (Byock, 2018;Curtis et al., 2020;Johnson et al., 2008;Noorani, 2019;Nutt, 2019; DocuSign Envelope ID: 3C7A8DBE-AAE6-4D58-8EF0-3CB3289E4259 Reiff et al., 2020;Tai et al., 2021). Making sure clients are not on medications that can interfere or react with psychedelics can be just as important as screening for medical history of high blood pressure or psychosis to mitigate risk (Johnson et al., 2008). ...
... The second is to create a strong therapeutic alliance (Mithoefer et al., 2016). Preparatory sessions include an intake with medical history and other screening criteria as well as multiple sessions to discuss the client's presenting problem (Curtis et al., 2020;Noorani, 2019). This helps the client and clinician to work together to build goals as well as create collaborative attachment (Flückiger et al., 2018). ...
... There are no studies currently discussing online psychedelic assisted therapy (Thal et al., 2021). While clinical trials are being conducted with a number of substances and diagnoses, all clinical trials are, as of yet, conducted in person in a laboratory setting ( (Brennan & Belser, 2022;Byock, 2018;Curtis et al., 2020;Luoma et al., 2020;Nichols & Walter, 2020;Noorani, 2019;Nutt, 2019;Penn, Dorsen, et al., 2021). As telehealth has become mainstream and psychedelic assisted therapy is quickly becoming a celebrated modality, it is important to consider the implications of online delivery of psychedelic assisted therapy and the harms it can effect upon clients (Appleton, et al., 2021;Williams et al., 2021). ...
Implementing Psychedelic Assisted Therapy in Telemental Health: A Systematic Review
Thesis
Full-text available
  • Mar 2023
Psychedelic assisted therapy is having a renaissance. After some first furtive steps in the mid part of the 20th century and subsequent criminalization, psychedelics are once again being studied for their benefits to physical and mental health (Curtis et al., 2020). At the same time, the Covid-19 pandemic forced many providers into the adoption of telemental health, which opened the door for mobile apps in the therapy space, including psychedelic assisted therapy (Chiauzzi, et al., 2020; Wing 2021). Psychedelics are generally regarded to be safe, but there are specific risks to both psychedelic assisted therapy and telemental health (Doblin, 2000; Nichols & Walter, 2020; Paparelli et al., 2011; Shore et al., 2018). The purpose of this systematic literature review was to evaluate prior research on psychedelic assisted therapy and telemental health; specifically, the focus was on reviewing literature on the efficacy, safety, and best practices of both psychedelic assisted therapy and telemental health which could be used to inform the development of best practices for delivering psychedelic assisted therapy via telemental health. The participants were from diverse ethnic backgrounds and studies originated worldwide. The results showed specific variables that lead to safe and effective psychedelic assisted therapy and telemental health such as set and setting, informed consent, and the therapeutic relationship. The findings synthesized these variables into best practices for clinicians which include technology, clinician training, a three-phase framework, and mind body interventions.
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... Vol:. (1234567890) their everyday lives in a meaningful way. This is a novel challenge that arises as a consequence of trial participation, and it has already been acknowledged that some participants seek additional support in integration after the session(s) provided by the trial [58], p. 35, [59], p.6): i.e., it is not simply that the participants did not achieve the optimum possible benefit at the trial end date, but that the trial initiated but did not complete a process of psychological work -sometimes referred to as the unfolding process [35,60] -that participants could not opt out of, but had to find external help in concluding. 9 Although the protocols and procedures of a clinical trial might impose a fixed and linear timeline, this larger therapeutic process resulting from psychedelic drug induced effects may not coincide seamlessly with the endpoint of a clinical trial. ...
... By holding a wider perception of post-trial care as extending beyond posttrial access, and treating this provision as a site of research, we will thereby increase our understanding of the best, most cost-effective practice for repeated drug sessions, minimizing relapse, and providing appropriate long-term support to those who need it. 18 Currently, time spent on post-drug integration within the framework of trials is minimal, leading to a lack of data on best practice for "good integration" [58]. We know that participants feel it important to be able to talk through and about their psychedelic experiences with others who have been through the same, long after the conclusion of a trial [48]. ...
When the Trial Ends: The Case for Post-Trial Provisions in Clinical Psychedelic Research
Article
Full-text available
  • Nov 2023
The ethical value—and to some scholars, necessity—of providing trial patients with post-trial access (PTA) to an investigational drug has been subject to significant attention in the field of research ethics. Although no consensus has emerged, it seems clear that, in some trial contexts, various factors make PTA particularly appropriate. We outline the atypical aspects of psychedelic clinical trials that support the case for introducing the provision of PTA within research in this field, including the broader legal status of psychedelics, the nature of the researcher-therapist/participant relationship, and the extended time-frame of the full therapeutic process. As is increasingly understood, the efficacy of psychedelic-assisted psychotherapy is driven as much by extrapharmacological elements and the cultural therapeutic container as by the drug itself. As such, we also advocate for a refocusing of attention from post-trial access to a broader concept encompassing other elements of post-trial care. We provide an overview of some of the potential post-trial care provisions that may be appropriate in psychedelic clinical trials. Although the World Medical Association’s Declaration of Helsinki calls on researchers, sponsors, and governments to make provisions for post-trial access, such provision may feel impracticable or out-of-reach within psychedelic trials that are already constrained by a high resource demand and significant bureaucratic burden. We show how conceiving of post-trial provision as an integral site of the research process, and an appropriate destination for research funding, will serve to develop the infrastructure necessary for the post-legalisation psychedelic medicine ecosystem.
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... Perhaps the clearest implication of our findings is the potential benefits of the long-term maintenance of the therapeutic alliance beyond the timeline of typical clinical trials. Although this potential has long been recognized in traditional and historical approaches to work with psychedelics, the incentives associated with commercialization and medicalization may attempt to reframe PAT as a medicine administration procedure and to undermine the importance of therapeutic support [70]. It will be important to continue to investigate and empirically validate the role of the therapeutic alliance and to attempt to develop cost-effective approaches that incorporate these findings. ...
The therapeutic alliance between study participants and intervention facilitators is associated with acute effects and clinical outcomes in a psilocybin-assisted therapy trial for major depressive disorder
Article
Full-text available
We examined if the therapeutic alliance between study participants and intervention facilitators in a psilocybin-assisted therapy (PAT) trial changed over time and whether there were relationships between alliance, acute psilocybin experiences, and depression outcomes. In a randomized, waiting list-controlled clinical trial for major depressive disorder in adults (N = 24), participants were randomized to an immediate (N = 13) or delayed (N = 11) condition with two oral doses of psilocybin (20mg/70kg and 30mg/70kg). Ratings of therapeutic alliance significantly increased from the final preparation session to one-week post-intervention (p = .03, d = .43). A stronger total alliance at the final preparation session predicted depression scores at 4 weeks (r = -.65, p = .002), 6 months (r = -.47, p = .036), and 12 months (r = -.54, p = .014) post-intervention. A stronger total alliance in the final preparation session was correlated with higher peak ratings of mystical experiences (r = .49, p = .027) and psychological insight (r = .52, p = .040), and peak ratings of mystical experience and psychological insight were correlated with depression scores at 4 weeks (r = -.45, p = .030 for mystical; r = -.75, p < .001 for insight). Stronger total alliance one week after the final psilocybin session predicted depression scores at 4 weeks (r = -.85, p < .001), 3 months (r = -.52, p = .010), 6 months (r = -.77, p < .001), and 12 months (r = -.61, p = .001) post-intervention. These findings highlight the importance of the therapeutic relationship in PAT. Future research should explore therapist and participant characteristics which maximize the therapeutic alliance and evaluate its relationship to treatment outcomes. Trial registration: Registration: Clinicaltrials.gov NCT03181529. https://classic.clinicaltrials.gov/ct2/show/NCT03181529.
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... Led by this seeming panacea-like quality, people might be seeking the psychedelic experience with high expectations of finding (instant) treatment and (enduring) relief from their sufferings. Both researchers and users worry that psychedelics are increasingly constrained by capitalist logics and the persevering 'quick-fix' ideology of the pharmaceutical industry (Dumit & Sanabria, 2022, 295;Noorani, 2020). As a counterpoint to this narrative, the title of this article reflects a spreading trope in both the broader, transnational psychedelic milieu and in the Danish psychedelic community, where I conducted fieldwork in 2020 and 2021, asserting that psychedelics are 'no magic pill'. ...
‘Psychedelics are no magic pill’: the narrative and embodied dimensions of psychedelic integration in Denmark
Article
Full-text available
  • Mar 2024
Within recent years, an increasing number of people and researchers in the Global North have become interested in psychedelic substances and their therapeutic application. While much of the current media attention and research effort mainly concentrate on the therapeutic potential and actions of the individual's acute psychedelic experience, this article explores the user‐perceived, therapeutic dynamics of psychedelics in a more long‐term perspective by charting the lived experiences and practices of ‘integration’ among psychedelic users in Denmark. Based on ethnographic fieldwork from November 2020 to June 2021, I offer a dual typology of self‐related integration as narrative and experiential‐somatic . Combining the two, I argue that psychedelic integration in contemporary Denmark can be viewed as a processual self‐transformation of the users' experiential orientation where understandings and/or modes of being from the acute psychedelic experience are woven into, prolonged, and/or embodied in their everyday existence .
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... Unlike Lea and colleagues and other studies that focused on online communities, we ask to what extent scientific and spiritual narratives are endorsed by community members. In doing so, we contribute to the ongoing debate regarding the confluence of scientific and spiritual knowledge within the psychedelic experience and literature, as brought forth by scholars who positioned the mystical experience as a key factor explaining psychedelics' effects on health and well-being (Griffiths et al., 2011;Johnson, Hendricks, Barrett, & Griffiths, 2019;Noorani, 2020). The struggle to accommodate science and spirituality, two incompatible ontological and epistemological systems based on different assumptions, methods, and truth criteria, is genuine (M. ...
Microdosing psychedelics: The segregation of spiritual and scientific narratives within the r/microdosing online community
Article
Full-text available
  • Sep 2023
Background and aims Microdosing psychedelics refers to the practice of repeatedly ingesting doses that do not reach the threshold for perceptual alterations. This practice has gained attention from mass media, businesses, and the general public, as evidenced by the proliferation of online communities dedicated to it. In this contribution, we examine the content generated within the online community r/microdosing from its creation on October 16, 2013, until the day of data collection on October 31, 2020. Our aim is to examine the narratives reflected by users' contributions, specifically the compatibility or incompatibility of spiritual and scientific narratives. Methods In this contribution, we used text analysis techniques and examined the content generated within the online community r/microdosing from its creation on October 16, 2013, until the day of data collection on October 31, 2020. Results We clearly identified a topic that reflects a spirituality narrative as well as a topic that we coined as “neuro-cognition” and that reflects a scientific narrative. These topics were typically not present within the contributions of the same users, suggesting that the scientific and spiritual narratives are segregated within the r/subreddit community. Conclusion Our approach emphasizes the potential of text analytic techniques for uncovering the cultural repertoire surrounding a particular practice, in our case, the practice of microdosing psychedelics.
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Psychiatric risks for worsened mental health after psychedelic use
Article
  • Mar 2024
  • J PSYCHOPHARMACOL
Background Resurgent psychedelic research has largely supported the safety and efficacy of psychedelic therapy for the treatment of various psychiatric disorders. As psychedelic use and therapy increase in prevalence, so does the importance of understanding associated risks. Cases of prolonged negative psychological responses to psychedelic therapy seem to be rare; however, studies are limited by biases and small sample sizes. The current analytical approach was motivated by the question of whether rare but significant adverse effects have been under-sampled in psychedelic research studies. Methods A “bottom margin analysis” approach was taken to focus on negative responders to psychedelic use in a pool of naturalistic, observational prospective studies ( N = 807). We define “negative response” by a clinically meaningful decline in a generic index of mental health, that is, one standard error from the mean decrease in psychological well-being 4 weeks post-psychedelic use (vs pre-use baseline). We then assessed whether a history of diagnosed mental illness can predict negative responses. Results We find that 16% of the cohort falls into the “negative responder” subset. Parsing the sample by self-reported history of psychiatric diagnoses, results revealed a disproportionate prevalence of negative responses among those reporting a prior personality disorder diagnosis (31%). One multivariate regression model indicated a greater than four-fold elevated risk of adverse psychological responses to psychedelics in the personality disorder subsample ( b = 1.425, p < 0.05). Conclusion We infer that the presence of a personality disorder may represent an elevated risk for psychedelic use and hypothesize that the importance of psychological support and good therapeutic alliance may be increased in this population.
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Psychedelics in PERIL: The Commercial Determinants of Health, Financial Entanglements and Population Health Ethics
Article
Full-text available
  • Mar 2024
The nascent for-profit psychedelic industry has begun to engage in corporate practices like funding scientific research and research programs. There is substantial evidence that such practices from other industries like tobacco, alcohol, pharmaceuticals and food create conflicts of interest and can negatively influence population health. However, in a context of funding pressures, low publicly funded success rates and precarious academic labor, there is limited ethics guidance for researchers working at the intersection of clinical practice and population health as to how they should approach potential financial sponsorship from for-profit entities, such as the psychedelic industry. This article reports on a reflective exercise among a group of clinician scientists working in psychedelic science, where we applied Adams’ (2016) PERIL (Purpose, Extent, Relevant harm, Identifiers, Link) ethical decision-making framework to a fictionalized case of corporate psychedelic financial sponsorship. Our analysis suggests financial relationships with the corporate psychedelic sector may create varying degrees of risk to a research program’s purpose, autonomy and integrity. We argue that the commercial determinants of health provide a useful framework for understanding the ethics of industry-healthcare entanglements and can provide an important population health ethics lens to examine nascent industries such as psychedelics, and work toward potential solutions.
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TESCREAL hallucinations: Psychedelic and AI hype as inequality engines
Article
Full-text available
  • Sep 2023
Background and Aims While many scholars have called attention to similarities between the earlier SSRI hype and the ongoing hype for psychedelic medications, the rhetoric of psychedelic hype is tinged with utopian and esoteric aspirations that have no parallel in the discourse surrounding SSRIs or other antidepressants. This utopian discourse provides insight into the ways that global tech elites are instrumentalizing both psychedelics and artificial intelligence (AI) as tools in a broader world-building project that justifies increasing material inequality. If realized, this project would undermine the use of both tools for prosocial and pro-environmental outcomes. Methods My argument develops through rhetorical analysis of the ways that industry leaders envision the future of medicalized psychedelics in their public communications. I draw on examples from media interviews, blog posts, podcasts, and press releases to underscore the persuasive strategies and ideological commitments that are driving the movement to transform psychedelics into pharmaceutical medications. Results Counterfactual efforts to improve mental health by increasing inequality are widespread in the psychedelics industry. These efforts have been propelled by an elitist worldview that is widely-held in Silicon Valley. The backbone of this worldview is the TESCREAL bundle of ideologies, which describes an interrelated cluster of belief systems: transhumanism, Extropianism, singularitarianism, cosmism, Rationalism, Effective Altruism, and longtermism. Conclusions This article demonstrates that TESCREALism is a driving force in major segments of the psychedelic pharmaceutical industry, where it is influencing the design of extractive systems that directly contradict the field's world-healing aspirations. These findings contribute to a developing subfield of critical psychedelic studies, which interrogates the political and economic implications of psychedelic medicalization.
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Beyond the psychedelic hype: Exploring the persistence of the neoliberal paradigm
Article
Full-text available
  • Sep 2023
Background and Aims Advocates of psychedelic medicine have positioned psychedelics as a novel therapeutic intervention that will solve the mental health crisis by liberating individuals from their entrenched habits and limiting beliefs. Despite claims for novelty, the psychedelics industry is engaging in the same profit-oriented approaches that contributed to poor clinical outcomes with SSRIs and other earlier pharmaceuticals, which threatens to undermine their purported clinical benefits. Methods We present evidence that the liberatory rhetoric of psychedelic medicalization promotes neoliberal, individualised treatments for distress, which distracts from collective efforts to address root causes of suffering through systemic change. Drawing examples from the psychedelics industry, we illustrate how the discourse of psychedelic medicalisation subjects socially-determined distress to psychotropic intervention through the mechanisms of depoliticisation, productivisation, pathologisation, commodification, and de-collectivisation. Results Rather than disrupting or subverting the psychopharmaceutical status quo, the psychedelic industry's current instantiation aligns with and upholds key facets of neoliberal ideology by adhering to the same facilitative mechanisms that scholars identified in the antidepressant industry. We identify these common mechanisms in examples unique to the psychedelics industry, including the search for psychedelic analogues and political lobbying to reschedule psychedelics. Conclusion We demonstrate how a neoliberal mental health paradigm that individualises and interiorizes mental distress cannot meaningfully resolve suffering with ubiquitous origins in the current sociopolitical environment, which is characterised by inequality, precarity, exploitation, and ecological collapse. As a result, psychedelics must decouple from neoliberal incentives, and demonstrate efficacy, if they are to facilitate durable improvements in well-being and prosocial outcomes.
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