A pandemic-spurred easing of prescription rules helped fuel a jump in telemedicine offerings of ketamine, an anesthetic that was once a taboo party drug but has become a buzzed-about tool against depression.
Yet long-term, large-scale studies of ketamine’s medical impact are limited, leaving some experts concerned that an unregulated online boom could result in mishaps or a regulatory crackdown.
“This has to be rolled out slowly,” said Boris Heifets, a Stanford University assistant professor of anesthesiology. “The risk is that we are scaling the fix but not the solution, which is a much more integrated approach to mental health.”
Ketamine has been available in the United States since the 1970s as an anesthetic called a “dissociative” because of the hallucinogenic effects that have helped make it a rave culture drug.
It’s legal for US doctors to prescribe, while some other psychedelics getting renewed attention for mental health uses like LSD or MDMA (also called ecstasy) are classified as having no medical utility and a high risk for abuse.
In this context, recent years have seen an uptick in clinics offering in-person intravenous ketamine treatments for depression, anxiety or chronic pain, though regulations and practices vary across American states.
Then came the pandemic, which resulted in US authorities allowing doctors to remotely prescribe drugs like ketamine that previously required an in-person visit.
Nue Life, which launched about a year ago, is one of those firms. Its CEO Juan Pablo Cappello estimated it has served over 3,000 ketamine patients so far.
“If you actually drill down on the sort of potentials for abuse here, you realize of course they exist, but we’re creating a standard of care to make that quite unlikely,” he told AFP.
For example, he noted clients are instructed to have an adult “babysitter” watch over them for the roughly 90 minutes the drug experience lasts, and he reasoned that people simply looking for ketamine could get it cheaper on the street.
Clients of the service, which costs $1,250 for a package providing six ketamine experiences, are encouraged but not obligated to couple it with therapy, Cappello said.
Heifets, the Stanford researcher, noted that making ketamine more available carries risks—including the chances that authorities would tighten access if an at-home treatment resulted in some sort of tragedy.
‘Change your life’
US regulators in 2019 approved a type of ketamine specifically for adults with treatment-resistant depression, though with stringent rules like requiring patients to be monitored by a health care provider for at least two hours after their dose.
Americans have “a hair trigger for problem-solving through litigation,” Heifets noted of the potential for lawsuits if things go wrong.
He was part of a team that analyzed the real-world effectiveness of intravenous ketamine therapy—which can involve higher doses than the at-home services –- and reported most patients improved, though about eight percent said depressive symptoms worsened after treatment.
“We have very, very little evidence for our understanding of how effective ketamine is for depression at scale,” he added.
Yet for people like 36-year-old New Yorker Philip Markle, who underwent an at-home treatment with a company called Mindbloom, ketamine is a profoundly useful tool.
Over his long battle with depression, the performer and comedian has tried medication, psychedelics like LSD, and talk therapy since the age of 12, but found something unique in ketamine.
Rather than the short-lived sense of change other treatments provided, ketamine imparted a sense of clarity and of helpful self-acceptance -– not the heavy effects he’d experienced with other psychedelics.
“It felt like if any drug could be administered through the mail, and you could do a psychedelic that could change your life, on your own, this would be the one,” he told AFP.
sychedelic medicine is emerging as a promising clinical modality for a range of treatment-resistant mental health disorders. Following its early promise in the 1950s and 1960s and its subsequent decline in the early 1970s (Oram, 2018), the past decade has seen concerted effort to destigmatise and promote the therapeutic benefits of psychedelic-assisted therapies (Noorani, 2020; Sessa, 2012). Clinical trials are yielding encouraging results, leading to excitement from researchers and prominent advocates about new treatment options. With growing evidence demonstrating efficacy and safety, psychedelic compounds are on the cusp of being approved by medical regulators in a number of countries. As rates of mental illness continue to rise globally, psychedelic medicine presents a new paradigm for the treatment of depression, anxiety, addiction and post-traumatic stress disorder (PTSD). Given the novelty of this therapeutic modality, the cultural stigma psychedelics elicit, and the challenges posed to medical research, regulation and implementation, a sociological lens is urgently required to illuminate the societal implications of the so-called psychedelic renaissance (Sessa, 2012) and its incorporation into clinical psychiatry.
The term psychedelic, first used by Humphry Osmond (1957), means ‘mind manifesting’. It describes the ‘classic psychedelics’—lysergic acid diethylamide (LSD), psilocybin, mescaline and n.n–dimethyltryptamine (DMT)—and hundreds of synthetic and naturally occurring compounds that have similar neuropharmacological action and/or subjective effects. Understandings of the therapeutic value of psychedelics are varied and contested, both within and beyond Western medical frameworks. Indigenous knowledges, modern spiritual beliefs and underground therapeutic practices have contributed to contemporary discourses of psychedelic medicine. Yet it is largely the emerging scientific understandings and clinical trial results—at times informed or supported by or even at odds with traditional or alternative perspectives—that have generated large research programmes, institutional legitimacy and public interest. While the field of psychedelic medicine encompasses a diverse range of social actors and a wide variety of interests and influences, in this paper, we focus primarily on formal health care and developments that have followed promising clinical trials investigating psychedelic-assisted therapy for severe mental health conditions.1
Psychedelics are a unique class of psychoactive drugs (Nichols, 2016). Under their effects, users can experience profound mental states often involving ‘a perception of sacredness and a direct intuitive knowledge characterised as ineffable; a sense of transcendence of time and space; experiences of oceanic boundlessness [and] significantly higher levels of peace, harmony, joy, and happiness’ (Winkelman, 2017, p. 3). At higher doses, users commonly report mystical-type experiences and a sense of ego dissolution (Griffiths et al., 2006; Nour et al., 2016). Psychedelics can elicit dreamlike experiences populated with hallucinations, bizarre visions, synaesthesia, childhood memories and personal revelations. These compounds stand in stark contrast to conventional psychiatric pharmacology, which seeks to normalise mood. It is precisely these profound and extraordinary subjective experiences that researchers suggest underpin the therapeutic mechanism (Yaden & Griffiths, 2021). Psychedelic medicine thus presents a radical intervention in mainstream psychiatry. Here we focus primarily on developments in the United States (US), United Kingdom (UK) and Australia, but acknowledge that this is a flourishing research field internationally.
Drawing on emerging literature from the health and social sciences, this article identifies key sociological issues related to the medicalisation of psychedelics. We begin by briefly charting the history and current direction of the field. We then identify and critically examine three key areas of sociological interest: the role of advocacy in the advancement of medical research and the destigmatisation of psychedelic compounds; issues arising from medicalisation and pharmaceuticalisation; and integration into healthcare systems. The challenge psychedelics pose to existing therapeutic models, regulation and monetisation are highlighted, and the socio-political context of the pharmaceutical industry, research, investment and implementation is examined. We also note the longstanding ‘underground’ use of psychedelics and the broader psychedelic cultures that have evolved alongside and in conversation with scientific and medical discourse. However, our primary focus is the field as it is unfolding in medical research settings. The article offers a lens for understanding the implications of psychedelic assisted therapy as an emerging field of psychiatric medicine and psychotherapy.
The anticipated rescheduling of psychedelic compounds following recognition of their medicinal and therapeutic application raises several questions regarding what psychedelic medicine and psychotherapy would look like in practical application. Alongside the questions surrounding medicalisation outlined above, it seems pressing to consider how psychedelic therapies might be integrated into existing healthcare systems. Here we consider this in relation to existing approaches to treating mental health disorders, the regulation of therapeutic substances, and processes of commodification, investment and monetisation.
To what degree psychedelics could be considered medicines in their own right is still unclear (Garcia-Romeu & Richards, 2018). Current knowledge demonstrates that well-structured psychotherapeutic support coupled with high-dose administration maximise the benefits of psychedelics (Garcia-Romeu & Richards, 2018). Current best practice involves intensive screening, psychotherapy, the provision of multiple sessions and structured programmes of integration to ensure insights generated within sessions are assimilated into everyday life (see Johnson et al. (2008) and Garcia-Romeu and Richards (2018) for detailed accounts of therapeutic programmes). These processes, deemed essential for both the safety and efficacy of treatment, present major challenges for the mass roll out of psychedelic therapies into existing healthcare systems. Of these, the labour costs associated with such intensive therapeutic programmes and the connected issue of accessibility are problematic in terms of scalability (Nutt & Carhart-Harris, 2021). It is likely that qualitative differences in healthcare systems and the balance of public/private healthcare provision will determine the degree to which these issues can be mitigated.
Established models of high-dose psychedelic therapies for treatment-resistant mental health disorders are strongly oriented towards a psychotherapeutic approach. This diverges from the dominant pattern whereby psychiatric medications such as antidepressants are taken daily ‘to correct or ameliorate an underlying presumed pathological brain state’ (Grob & Bravo, 2019, pp. 23–24). In the case of depressive disorders, this approach aims to relieve the patient’s symptoms and foster brain function conducive to restructuring core psychological processes with the hope of lasting cognitive change (Harmer et al., 2017). In contrast, high-dose psychedelics are commonly administered over just one to three sessions with the intention of fostering a mental state whereby the patient’s normal psychological defences are loosened and the mind is more open and accepting of new insights and self-reflection (Grob & Bravo, 2019). This therapy is premised on intensive consultation with support staff before, during and after the session to integrate psychedelic experiences into the patient’s everyday life (Grob & Bravo, 2019; Johnson et al., 2008; Richards, 2017). While this approach has demonstrated much promise, prominent researchers highlight difficulties related to scalability, cost and training of therapists as key challenges in making treatment widely available (Carhart-Harris & Goodwin, 2017).
Other forms of psychedelic-assisted therapy currently being investigated may provide alternatives to the intensive psychotherapeutic approach outlined above. Microdosing—the administration of very low, imperceptible amounts of psychedelic compounds (most frequently LSD and psilocybin)—has, over recent years, grown in popularity both as a therapeutic treatment and for general well-being.4 There is much suggestion and some evidence (Hutten et al., 2020) that microdosing psychedelic compounds may have beneficial effects on mood and cognition. While this research is in its infancy, phase 1 trials suggest the feasibility of developing new research programmes to evaluate efficacy (Family et al., 2020).
If future trials suggest that long-term low-dose psychedelic administration is safe and effective, this will prompt significant consideration of the role and importance of psychotherapy. The microdosing model presents a highly attractive alternative for consumers and providers concerned about the cost, accessibility and labour-intensiveness of current approaches. Microdosing has the potential to bring psychedelic therapies into alignment with the mainstay of psychiatric practice, that is, prescribing medicines to be taking daily over long periods. In this respect, we might anticipate the downplaying of the radical proposal prompted by psychedelic-assisted therapies of treating the root causes of mental health problems rather than their symptoms. Furthermore, microdosing seems to be much better suited to monetisation and the interests of both the pharmaceutical and wellness industries. Several products are in production or development, including a ketamine nasal spray by Janssen Pharmaceuticals (already on the market in the US and EU) and a psilocybin nasal spray by US company Silo Wellness (Aday et al., 2020).
Any changes to existing regulatory control of psychedelic compounds are likely to involve complex deliberative processes. The legal and cultural settings in the various countries where psychedelic medicines are proposed will shape processes of reclassification, regulation and control of these compounds (dos Santos et al., 2021). Negotiating the stigmas and remnants of the War on Drugs, the tensions between medicalisation and decriminalisation, as well as the structures of proposed regulation, will challenge authorities and likely have profound consequences for the rollout of psychedelic therapies in the future.
While the mechanics of regulatory and legal frameworks are jurisdiction specific, there are several likely, and not mutually exclusive, common legal pathways. These range from specific medical controls allowing prescription for sanctioned therapeutic use through to processes of decriminalisation and/or legalisation. Noorani (2020) outlines important considerations regarding the difficulty of aligning proposals for medicalisation with arguments for decriminalisation and/or legalisation. He suggests that pro-medicalisation arguments tend towards articulating programmes of psychedelic therapy that delineate frameworks for ‘proper use’ and conditions of ‘abuse’, arguments that are at odds with those advocating for an end to the criminalisation of psychedelic substances (Noorani, 2020). Furthermore, if medicalisation ‘leads to bifurcated scheduling and the approval of diluted therapeutic forms’, there is a concern that those seeking help may be presented with a choice between ‘relatively ineffective but legal psychedelic therapy or more effective but criminalised underground psychedelic therapy’ (Noorani, 2020, p. 38).
Decriminalisation and legalisation present their own problems. Deregulation and a proliferation of psychedelic-assisted therapy raises safety issues regarding the ability for practitioners to safely screen patients and provide high standards of care. This has been a point of concern in the Netherlands where practitioners are administering psilocybin-containing truffles in therapeutic contexts by taking advantage of a legal loophole exempting psilocybin-containing rhizomatic fungi from legal controls (Cantizani Lopez, 2021). Likewise, in the context of decriminalisation, the blurred boundaries between recreational and therapeutic use raise issues for regulating psychotherapeutic practice. These kinds of problems may also arise alongside the off-label prescription of psychedelic compounds. While it is not considered a classic psychedelic, the dissociative anaesthetic ketamine is available off-label for treating depression and anxiety in several countries. However, such practice obviates the need for psychotherapeutic guidelines. While practitioners must follow procedures outlined for moderate conscious sedation, this does not extend to the patient’s ongoing psychological care, a striking point of difference from the rigorous guidelines proposed for classic psychedelic-assisted therapies (Johnson et al., 2008; Richards, 2017).
The pace and detail of regulation will have significant consequences for ways in which psychedelic-assisted therapies might be implemented and integrated into healthcare systems. Advocacy organisations such as MAPS have developed detailed regulatory guidelines for approved treatments (Doblin, 2015). MAPS’ recommendations closely follow the medicalisation model, taking into account ‘misuse (unintentional and/or uninformed), abuse, diversion, and the potential negative effects of information about approved medical use on nonmedical use patterns’ (Doblin, 2015, p. 365). The prominent consensus of medical regulation advocates is for a slow and prudent approach. Yet divergent views exist in the wider psychedelic community. This is evident in the debates surrounding medicalisation versus decriminalisation (Noorani, 2020) and also within the ranks of those advocating a medical approach. For example, a recent application for rescheduling of both MDMA and psilocybin for medical use in Australia revealed divergent perspectives between prominent advocacy organisations. While MMA has already submitted a rescheduling application (MMA, 2020), PRISM has argues that caution and further research is needed before rescheduling is considered (Williams & Bright, 2021).
Commodification, investment and the monetisation
There is little doubt that private interests will play a major role in shaping any future roll out of psychedelic-assisted therapies. With the recent popularisation of psychedelics and the early successes of clinical trials, there has been a rapid market response. Indeed, a prospective industry has developed, pointing to an expansive monetisation of the field. The forms these ventures take will be responsive to the regulatory models that emerge in various jurisdictions and to the character of national healthcare systems. A major concern for researchers, medical professionals and commentators alike is the potential disjuncture between for-profit business models and public health (Noorani, 2020). Disquiet ranges from issues such as the efficacy of large-scale profit-driven psychotherapy through to structural critiques of neoliberal capitalism. Many of those involved in the broader psychedelic movement have long hoped that psychedelic medicine might initiate a radical rethink of mental illness (Giffort, 2020; Richert, 2019). However, several of the emerging for-profit models suggest that discourses of medicalisation and pharmaceuticalisation are strongly entrenched in the mental health field, providing existing frameworks for private interests to both capitalise on and influence the future of psychedelic therapies.
The speculative psychedelic market has rapidly grown. CNBC reports that upwards of $US800 million of venture capital has been invested over the past 4 years (Costa & Shead, 2021). The major players, publicly listed companies Compass Pathways and Atai Life Sciences, are both valued in the billions of US dollars and have attracted interest from billionaire entrepreneurs such as Paypal founder Peter Thiel and German investor Christian Angermayer. Many smaller psychedelic start-ups have also emerged with a range of interests spanning the pharmaceutical, psychotherapeutic and wellness industries. The possibilities of monetisation are expansive and are looking well beyond the more traditional fields of pharmacology, psychotherapy and education. New technologies such as brain interfacing, virtual reality, wellness apps and genetic screening are some possible future applications. The potential of this industry presents an attractive speculative investment opportunity. While this was until only a few years ago limited to entrepreneurs sympathetic to the cause, it is now attracting capital from diverse actors including big business and industry (Hausfeld, 2020b).
Patent applications for psychedelics reflect a major point of contention. In particular, Compass Pathways’ already-granted patent of their psilocybin formulation and their broadly defined patent applications for the administration of psilocybin and the therapeutic conditions of its administration has worried researchers and commentators (Hausfeld, 2020a; Love, 2021). A high-profile public dispute between Tim Ferriss and Christian Angermayer (Angermayer, 2021; Ferriss, 2021) is instructive. Ferriss expressed concerns about patents hindering scientific research and reasonable competition, while Angermayer championed the merits of for-profit competition for effective scaling and delivery. Others have been vocal in encouraging open science as an important principle for research and development. The non-profit medical research organisation Usona Institute—another key player in the synthetic production of psychedelic compounds and psychedelic trials—has followed an alternative model by openly publishing articles on the manufacture of psilocybin (Hausfeld, 2020a). A recent statement calling for open science and open praxis initiated by long-time advocate Robert Jesse has attracted signatures from leading psychedelic researchers, practitioners and organisations (Jesse, 2018). The statement sets out an ethical framework of cooperation and non-interference, representing an alternative vision to competitive business models and aggressive corporate tactics.
Much of the debate surrounding the commodification and monetisation of psychedelic-assisted therapies is set against wider discussions regarding profiteering and ethical conflicts in for-profit pharmaceuticals and mental healthcare provision (Das, 2011; Mosher et al., 2013). At present it seems unlikely that psychedelic medicines will follow the precedents of widespread antidepressant prescription that does not require the coupling of psychotherapeutic care. However, there are some examples, including the off-label administration of ketamine and psychedelic microdosing, which point to the possibility of ongoing and regular drug administration, which would fit with existing commercial pharmaceutical models.
As the psychedelic-assisted therapies proposed by most researchers differ significantly to protocols for antidepressant medication, this will engender novel commercialisation. There are various possible for-profit frameworks that range from individual practitioners administering compounds and psychotherapy in private practice through to largescale business models with standardised protocols and teams of psychotherapeutic personnel. Most critics are concerned with the latter, especially in the case of large organisations who are aiming to patent, control, and brand the entire process—from drug synthesis and development, through to training, administration and psychotherapy. Not only does this raise concerns about monopolisation, but it also threatens the development of heterogeneous, culturally responsive and innovative therapeutic approaches.
Discussions concerning the commercialisation of psychedelic-assisted therapies evoke several underlying sociological issues. Given that psychedelics fit into a well-established and diverse cultural milieu that found much of its character during the 1960s and 1970s counterculture movements, their co-opting into mainstream medicine and psychiatry conflicts with some of the long-held beliefs of these communities. Critically, for many the commodification and monetisation of psychedelics is at odds with their perceived spiritual and social-transformative potential.
These perspectives problematise modernity and capitalism as root causes for the global mental health crisis and for shaping our understandings and treatment of mental illness under the discursive conditions that benefit profit making and capital extraction. Despite these critiques, there are perspectives that, while sympathetic to these idealistic values, prioritise best practice and scalability in the face of inevitable commercialisation. T
he recent flurry of commercial enterprise and investment in this field provides a sobering reminder to those who had hoped that psychedelic-assisted therapies might provide a radical rethink of how society addresses mental illness. Even so, the likelihood of a heterogeneous implementation of psychedelic treatments means that while some aspects are likely to be co-opted into the existing frameworks set by largescale pharmaceutical companies, there will be opportunity for unique and novel approaches to develop that break with the existing paradigm.
reference link :https://compass.onlinelibrary.wiley.com/doi/full/10.1111/soc4.12959