Cambridge Quarterly of Healthcare Ethics (2022), 31: 4, 464–471
doi:10.1017/S096318012200007X
ARTICLE
Ethical Issues Regarding Nonsubjective Psychedelics as
Standard of Care
David B. Yaden1*
, Brian D. Earp2,3
and Roland R. Griffiths1,4
1
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland
21224, USA
2
The Yale-Hastings Program in Ethics and Health Policy, Yale University and the Hastings Center, New Haven, Connecticut
06511, USA
3
Uehiro Centre for Practical Ethics, University of Oxford, Oxford OX1 1PT, UK
4
Department of Neuroscience, Johns Hopkins University, Baltimore, Maryland 21224, USA
*Corresponding author. Email: dyaden1@jhmi.edu
Abstract
Evidence suggests that psychedelics bring about their therapeutic outcomes in part through the subjective or
qualitative effects they engender and how the individual interprets the resulting experiences. However,
psychedelics are contraindicated for individuals who have been diagnosed with certain mental illnesses, on
the grounds that these subjective effects may be disturbing or otherwise counter-therapeutic. Substantial
resources are therefore currently being devoted to creating psychedelic substances that produce many of the
same biological changes as psychedelics, but without their characteristic subjective effects. In this article, we
consider ethical issues arising from the prospect of such potential “nonsubjective” psychedelics. We are
broadly supportive of efforts to produce such substances for both scientific and clinical reasons. However, we
argue that such nonsubjective psychedelics should be reserved for those special cases in which the subjective
effects of psychedelics are specifically contraindicated, whereas classic psychedelics that affect subjective
experience should be considered the default and standard of care. After reviewing evidence regarding the
subjective effects of psychedelics, we raise a number of ethical concerns around the prospect of withholding
such typically positive, meaningful, and therapeutic experiences from most patients.
https://doi.org/10.1017/S096318012200007X Published online by Cambridge University Press
Keywords: psychedelics; hallucinogens; bioethics; psychiatry
Introduction
Psychedelics reliably produce substantially altered states of consciousness—but how do these subjectively experienced effects relate to the therapeutic effects of psychedelics demonstrated in recent
research? Could a psychedelic be created that has no subjective effects (i.e., a “nonsubjective” psychedelic) but identical therapeutic impacts? The prospect of such nonsubjective psychedelics is scientifically
and clinically interesting but raises several bioethical considerations.
Two distinct views have emerged regarding the question of whether it is possible for a nonsubjective
psychedelic to have the same therapeutic impact as currently available psychedelic substances, with their
characteristic effects on subjective experience (i.e., altered states of consciousness). On the one hand,
David Olson1 has suggested that the subjective effects of psychedelics are likely “unnecessary for their
therapeutic effects.” According to this view, currently measurable biological processes which have no
subjective correlates (e.g., neurogenesis and neuroplasticity) can entirely account for the benefits of
psychedelics and are all that are needed to achieve their therapeutic impact (e.g., reducing depression or
treating substance use disorders as well as increasing well-being—described below).
© The Author(s), 2022. Published by Cambridge University Press. This is an Open Access article, distributed under the terms of the Creative
Commons Attribution licence (http://creativecommons.org/licenses/by/4.0), which permits unrestricted re-use, distribution and reproduction,
provided the original article is properly cited.
https://doi.org/10.1017/S096318012200007X Published online by Cambridge University Press
Ethical Issues Regarding Nonsubjective Psychedelics
465
On the other hand, some researchers have suggested that the subjective effects of psychedelics may be
“necessary for their full and enduring therapeutic effects.”2 According to this contrary view, certain
cognitive and affective shifts from the subjective effects of psychedelics account for a large degree of the
size and longevity of their beneficial effects. Such changes may involve, for example, explicit adoption of
alternative conceptual frameworks through which to view and interpret one’s experiences, motivations,
and social relationships.3 While we can imagine nonsubjective psychedelics having some (kinds of)
therapeutic impact, we believe it is highly likely that such impact will be less strong and less enduring
than what can be achieved through the experience of, and conscious engagement with, the subjective
effects of psychedelics.
Data from ongoing preclinical and clinical studies may help adjudicate between these two views. For
example, studies using experimental methods such as the controlled manipulation of exposure to
anesthesia could provide relevant evidence. In what David B. Yaden and Roland R. Griffiths (see note
2) describe as a “critical test,” psychedelics would be introduced during deep anesthesia (expected to
eliminate any subjective effects of the psychedelics due to the anesthesia-induced suppression of
conscious awareness) in one experimental condition and during ordinary waking consciousness in
another condition. If the former (anesthetized) mode of administration resulted in equivalent and
equally enduring therapeutic effects as psychedelics administered without anesthesia, then this would
provide evidence in favor of Olson’s4 view. Another way to test the relative strength of the competing
views would be to create psychedelics that act in a nearly identical biological manner but which do not
produce subjective effects, as is currently being actively explored.
Psychedelics that produce therapeutic benefits, but which do not produce a substantially altered state of
consciousness, have not yet been created. However, a large amount of funding from military and industry
sources has been allocated in order to pursue the possibility of psychedelics or psychedelic-like substances
of this kind effects.5 The rationale for such efforts has been,6 broadly: (1) the subjective effects may not have
any causal role in the therapeutic effects (as mentioned, this issue has not been scientifically settled), (2) the
subjective effects of psychedelics could be harmful to some people (e.g., those with a personal or family
history of psychotic disorders), for who experiencing the subjective effects of psychedelics is indeed
contraindicated,7 and (3) the cost of treatment could be reduced as there might be less of a need for active
clinical support during the experience of acute subjective effects (as these may not need to occur). There is
no doubt that the discovery of such substances would be valuable scientifically (e.g., to address the first
point) and in some cases clinically (e.g., to address the second and third points).
The issue at stake in the present article is not whether such substances should be created, as we agree
they would have considerable value. Instead, the ethical issues we are concerned with arising when
considering whether such possible nonsubjective psychedelics should be the default treatment option.
That is, granting the possibility that nonsubjective psychedelics can be created, what should be the
standard of care for most patients?
Psychedelics and Treatment Potential
Substances considered classic psychedelics include psilocybin (derived from the psilocybe mushroom),
lysergic acid diethylamide (LSD), N,N-dimethyltryptamine (DMT), and mescaline (3,4,5-trimethoxyphenethylamine).8 With the exception of LSD, which was produced synthetically in 1938 in Switzerland,
the naturally occurring psychedelic substances have been used in communal spiritual settings and
religious rituals across a number of cultures for generations.9 In the 20th century, psychedelics have also
been referred to as “hallucinogens,” “entheogens,” and “psychomimetics” due to the nature of the
substantially altered states of consciousness they elicit.10
In the past two decades, clinical trials on psilocybin have demonstrated a significant potential to
increase well-being,11,12,13 as well as decrease anxiety,14,15 decrease depression,16,17,18 and treat substance
use disorders such as alcohol use disorder and tobacco use disorder.19,20 Psilocybin has been granted the
“breakthrough therapy” designation by the United States Food and Drug Administration (FDA) and is
currently in Phase 2b trials for the treatment of Major Depressive Disorder and is being explored for its
treatment potential across a range of other mental disorders.
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David B. Yaden et al.
The Possibility and Scientific Usefulness of Psychedelics with No Subjective Effects
As Olson21 argues, it may be possible to develop substances that produce equivalent therapeutic
benefits to psychedelics without their subjective effects. If so, this would likely be due to several basic
neurobiological processes associated with psychedelics that have been elucidated. Psychedelics, in
both in vivo and in vitro studies, have been measured and shown to produce neurogenesis22,23; they are
also known to foster neural plasticity.24 The prospect of creating chemical substances that are capable
of promoting processes such as neurogenesis and neural plasticity without triggering subjectively
experienced altered states of consciousness is actively being pursued, as noted, through many millions
of dollars of funding from the Defense Advanced Research Projects Agency (DARPA) and industry
sources.
The motivation behind efforts to produce nonsubjective psychedelics appears, as mentioned, to be
two-fold—scientific and clinical. In addition to the aforementioned scientific question regarding
whether the altered state of consciousness associated with psychedelics is causally necessary to produce
the therapeutic effects of these substances (but there is a need to carefully qualify issues related to
studying “consciousness” with psychedelics),25 there are also questions around basic neuropsychopharmacology at stake that could be better understood through this process. Clinically, the subjective effects
of psychedelics may prevent certain groups of people from receiving them—such as those with a history
(including family history) of psychotic disorders. Currently, this is considered a risk factor for negative
outcomes and is generally an exclusion criterion for both research and therapy,26 although it is not yet
established whether potential nonsubjective psychedelics would be safe for these patient populations. In
any case, we want to reiterate our support efforts to create such substances.
There are, however, important downsides to consider regarding using these potential substances as
the default option or the standard of care.
https://doi.org/10.1017/S096318012200007X Published online by Cambridge University Press
The Subjective Effects of Psychedelics
The nature of the subjective effects of psychedelics—which so many resources are currently being
devoted to removing—has been variously characterized, but the field is working toward a convergence. The effects of psychedelics involve perceptual changes such as seeing patterns and vivid
inner imagery, intense positive and negative emotions, as well as feelings of connection and egodissolution.27,28
The acute subjective effects of psychedelics can be psychologically challenging (colloquially described
as “bad trips”). The unusual and sometimes confusing nature of the subjective effects can cause anxiety
and even panic in some people. A survey of recreational psychedelic users who had “challenging”
experiences on psilocybin (i.e., not a representative sample) found that 39% of the respondents rated it
among the most challenging experiences in their life (note: this is not always interpreted as negative or
regrettable; “challenging” experiences are often those from which a person learns the most), but, more
ominously, 11% reported putting themselves or others at some risk, 2.7% required medical attention, and
7.6% subsequently sought treatment for enduring psychological symptoms that they attributed to the
experience.29 In two psychedelic administration studies in psychedelic naïve participants, strong or
extreme ratings of fear occurred in 31%30 and fear and other related states were reported in 39% of
participants31 at some time during sessions, with sustained anxiety or unpleasant psychological struggle
during sessions occurring in 11% of participants.32 Again, these participants did not uniformly consider
the experiences of fear or anxiety as rendering the whole experience undesirable; rather, such negative
emotions were often interpreted as meaningful in themselves and/or accompanied by positive emotions
or feelings of growth.33
In terms of lasting negative impacts of psychedelics, postsession negative symptoms occurred in 0.9%
of 110 participants in drug administration studies at the Vollenweider laboratory in Switzerland (see note
26) and, likewise in 0.9% of 250 participants in studies at Johns Hopkins.34
Despite these challenging experiences during sessions and some risk of lingering negative effects in
terms of psychological stress, psilocybin has been rated as among the safest of all so-called “recreational”
Ethical Issues Regarding Nonsubjective Psychedelics
467
drugs in terms of risk of harm to oneself or others.35 Moreover, classic psychedelics show a positive safety
profile (including with respect to neurotoxicity or potential for addiction) when compared with many
commonly prescribed drugs used for medication.36
Crucially for our discussion here, in addition to the fact that many temporally limited negative
emotions (e.g., fear and anxiety) are subsequently interpreted as meaningful or instrumental for
achieving personal insights or growth, the acute subjective effects of psychedelics when administered
under supportive conditions are rated as producing substantial increases in a deeply felt positive mood
(e.g., feelings of peace, tranquility, and joy).37,38,39,40
In terms of persisting positive effects, there are a number of well-being related outcomes that are may
be orthogonal to therapeutic effects. In a randomized cross-over trial comparing psilocybin to methylphenidate, participants reported much larger increases in positive attitudes about life and/or self, positive
mood changes, altruistic/positive social effects, positive behavior change, and well-being 2 months after a
psilocybin session than after a methylphenidate session.41 Another study involving low and high doses of
psilocybin42 found that 1 month after high dose psilocybin sessions, 94% of participants endorsed an
increased sense of well-being and 89% endorsed positive behavior change. One finding is worth special
mention in this context—the well-replicated finding in at least four clinical trials that most participants
(mean 76%, range 58–94%) rate their psychedelic experiences among the most meaningful experiences of
their entire lives 6–14 months after their last session.43,44,45,46
Despite these promising findings, we caution that more research is needed, especially better
controlled and larger trials before firm conclusions can be drawn regarding these seemingly highly
positive effects.47 With these caveats in place, we believe that the current evidence suggests that the
subjective effects of psychedelics pose some risk of inducing a challenging and stress-inducing experience
that may in some cases have lingering negative psychological consequences, but that the vast majority
of participants report highly beneficial effects that are in many cases considered extraordinarily
meaningful.
https://doi.org/10.1017/S096318012200007X Published online by Cambridge University Press
Risks and Benefits of the Subjective Effects of Psychedelics
If we grant the hypothetical case that nonsubjective psychedelics were created that were shown to be
equally effective at reducing identified mental disorders, then should subjective or nonsubjective
psychedelics be the default treatment?
Olson48 has argued that nonsubjective psychedelics should be the default treatment for several
reasons. He emphasizes the risks associated with subjective effects of psychedelics, particularly for some
patient populations—but also for people in general. As we have acknowledged, there are indeed risks
from psychedelic experiences to some individuals, particularly those who have a personal or family
history with psychotic disorders. There is no question that psychedelic experiences can be challenging or
negative, especially in some patient populations. We have no disagreement here and would indeed
welcome nonsubjective psychedelics for this clinical application.
Another reason raised by Olson49 is the clinical costs associated with administering psychedelics in
clinical settings. Typically, clinicians must spend several hours with patients. Instead, Olson argues,
participants under the influence of the postulated nonsubjective psychedelics would need no supervision. This would cut healthcare costs, or so the argument goes. We agree that it is possible that
nonsubjective psychedelics could reduce economic costs—but at what human costs?
Already, there is a broad movement in medical ethics critiquing bioreductive approaches to treatment, where mental health is conceived of in terms of brain states or chemical processes alone rather than
(also) in terms of a person’s lived experiences in sociorelational context, and the meanings they give to
those experiences as part of a life narrative.50 To be a person, much less a person in good mental health, is
to experience and interpret the world in a certain way (or range of ways); it is not simply to be a bearer of
nonpathological brain states. Accordingly, clinician-supported, psychedelic-assisted therapy involving
an interpersonal process of interpretation, meaning-making, and integration, is considered the gold
standard for treatments involving psychedelics.51 Thus, even if it is possible that nonsubjective
468
David B. Yaden et al.
psychedelics could bring about equivalent treatment effects in terms of measurable decrements in clinical
symptoms, it is highly unlikely that they would also replicate the less-tangible, but perhaps no less
important, effects on well-being derived from the human-to-human therapeutic encounter and associated sense-making of the narrative content of drug-induced subjective experiences or altered states of
consciousness.
Ethical Considerations
https://doi.org/10.1017/S096318012200007X Published online by Cambridge University Press
In the domain of morality, there is a helpful distinction between negative morality and positive morality.
Negative morality describes moral rules or laws that are widely socially recognized and interpreted as
binding, which prevent us from taking certain actions, or tell us what we ought not to do. Positive
morality, on the other hand, asks what we ought to do. This distinction is instructive when applied to the
questions of subjective or nonsubjective psychedelics. If, throughout the course of effective treatments,
we can help foster one of the most positive and meaningful experiences of a patient’s life without undue
risk, then, from the perspective of positive morality, we may be under some obligation to provide such an
experience.
Such an approach is consistent with long-standing operationalizations of health, such as that adopted
by the World Health Organization in 1948. According to the WHO,52 “Health is a state of complete
physical, mental and social well-being and not merely the absence of disease or infirmity.” It is
uncontroversial that a major purpose of medicine is to improve the health of the population. In this
regard, a negative approach to morality might instruct us to avoid taking actions that are likely to cause
disease or infirmity. At best, it requires us to apply the tools of medicine to treat existing problems (since
available treatments ought not to be withheld). However, a positive approach to morality might also
include a duty to promote, in a more holistic fashion, the physical, mental, and social well-being of
patients within our care. Stated differently, as bioethicists have long argued, the moral aims of medicine
encompass more than simply “do no harm” (i.e., the principle of nonmaleficence); rather, clinicians and
other healthcare providers have a positive ethical duty of beneficence (i.e., to do good).53
Consider the hypothetical availability of two otherwise equivalent chemical substances:
1) One substance with the desired treatment effect vis-à-vis a circumscribed mental disorder and no
adverse side-effects stemming from taking the drug
2) Another substance with the same desired treatment effects, a small risk of adverse side-effects
stemming from the subjective experience of taking the drug, but also a high probability of a
profoundly positive subjective experience as well as other persisting positive effects
It may be difficult to assign precise weights to the benefits and risks of each intervention; however, a
broad analysis can still be given. The expected value or disvalue of an intervention is a product of both the
likelihood of good or bad outcomes and the magnitude or degree of each. Given the available data
regarding relatively low likelihood of adverse experiences (especially lasting negative experiences of any
great magnitude) as well as a very high likelihood of positive experiences that are weighted as being of
exceptional magnitude, we believe that consequentialist calculations would pick the second intervention
as by far the more beneficent. To illustrate, less than 1% of participants report lingering negative effects
(and of those, only a minority require therapeutic support), whereas about three-quarters of participants
report the experience to be, as noted, among the most meaningful of their entire lives.
Another major principle of bioethics is the need to ground healthcare decisions in a stance of respect
for persons, often operationalized in terms of valuing the autonomy of the individual. Autonomy means
allowing individuals to choose those ends which they themselves value, so long as others are not unduly
harmed (or disrespected) in the pursuit of those ends. Almost everyone values well-being (which is
typically enhanced by the subjective experience of psychedelics taken under the right conditions), but
this is not the only valuable end that people may pursue. Rather, having a meaningful life is also highly
valued by most people, and it is notable that the typical subjective effects of psychedelics are often
Ethical Issues Regarding Nonsubjective Psychedelics
469
characterized in terms of meaningfulness, not simply increased positive mood or even general wellbeing.54 Such outcomes would presumably not be associated with nonsubjective psychedelics.
Conclusion
Given the choice, many individuals would likely autonomously choose to undergo a treatment with a
high likelihood of being beneficial as well as capturing other valuable ends, such as the meaningfulness of
the experience. In addition to beneficence, therefore, there are reasons rooted in autonomy and respect
for persons at least to offer classic psychedelics, with their attendant subjective effects, as the default
treatment option and standard of care for those who do not have specific contraindications, while also
allowing patients to choose the nonsubjective route if that is what would make them more comfortable.
Overall, we support scientific efforts to create nonsubjective psychedelics, but we hope to ensure that the
subjective effects of classic psychedelics remain an option for those who are willing and able, as many
clinical trial participants report that this experience ranks among the most positive and meaningful of
their lives.
Conflict of Interest. Roland R. Griffiths reports grants from the Steven and Alexandra Cohen Foundation and from Tim
Ferris, Matt Mullenweg, Blake Mycoskie, and Craig Nerenberg for funding the Johns Hopkins Center for Psychedelic and
Consciousness Research (CPCR) during the conduct of the study; grants from the Riverstyx Foundation, a crowdsourced
funding campaign organized by Tim Ferriss, and National Institute on Drug Abuse (grant R01DA03889) for research support
outside the submitted work; personal fees from the Heffter Research Institute (HRI) to cover travel costs as member of the board
of directors of HRI outside the submitted work; and is site principal investigator for a multisite trial of psilocybin-facilitated
treatment of major depressive disorder, which is sponsored by the Usona Institute.
Funding Statement. Support for Drs. David B.Yaden and Roland R. Griffiths through the Johns Hopkins Center for Psychedelic
and Consciousness Research was provided by Tim Ferriss, Matt Mullenweg, Blake Mycoskie, Craig Nerenberg, and the Steven and
Alexandra Cohen Foundation.
Notes
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Cite this article: Yaden D. B, Earp B. D and Griffiths R. R (2022). Ethical Issues Regarding Nonsubjective Psychedelics as
Standard of Care. Cambridge Quarterly of Healthcare Ethics 31: 464–471, doi:10.1017/S096318012200007X