Steven Levine, MD

Medical Ethics Unpacked: Unique Ethical Challenges of Psychedelics

As regulatory agencies weigh the approval of psychedelic therapies, the field of 

 stands on the brink of a paradigm shift—one that offers patients a new treatment option that has a direct impact on brain activity.

recent rejection of Lykos Therapeutics’ MDMA-assisted therapy for PTSD

 has reignited debates over the ethical concerns surrounding psychedelic treatments.

, psychiatrist Steve Levine, MD, and bioethicist Dominic Sisti, PhD, are joined by special guest Amy McGuire, JD, PhD, from Baylor College of Medicine, to discuss unique ethical challenges of psychedelic therapies—consent, access, setting intentions, and integration of traditional practices into mainstream medicine.

“It means there’s values and traditions that are embedded in these treatments that may not be compatible with mainstream medicine,” Sisti said.

Other ethical topics discussed included dosing sessions, therapeutic models, differences between psychedelics and empathogens like MDMA, and the focus on veterans in psychedelic clinical trials.

“To me, it's the combination of the altered state of consciousness that it brings you into and …they can be used in exceptional ways,” McGuire said. “Ceremonial use of these substances…is quite different. Now, whether we think they're different or not, I think it's a separate question of whether they should be treated [differently] as we go through the FDA pipeline, as we go through standard clinical practice. If they're adopted into Western medicine… I'm not so sure that there should be exceptional rules related to them, but I think that…to [not] acknowledge their distinctive features, and their potential to be used in really different types of ways…would be a mistake.”

 Chief patient officer at Compass Pathways

 Associate professor in the Department of Medical Ethics & Health Policy and the director of the Scattergood Program for the Applied Ethics of Behavioral Health Care at the University of Pennsylvania

 Leon Jaworski professor of biomedical ethics and director at Baylor College of Medicine

Relevant disclosures included Lykos Therapeutics and Tactogen for Sisti and Compass Pathways for Levine. McGuire has no reported disclosures.

The Lancet Regional Health-Europe. Psychedelic-assisted psychotherapy: hope and dilemma. Lancet Reg Health Eur. 2023 Sep 4;32:100727. doi: 10.1016/j.lanepe.2023.100727. PMID: 38222970; PMCID: PMC10784116.

Derman, C. The Rise, Fall (and Future?) of MDMA-Assisted Therapy. HCPLive. December 23, 2024. 

https://www.hcplive.com/view/the-rise-fall-and-future-of-mdma-assisted-therapy

Videos

This episode unpacks ethical challenges of psychedelic therapies, such as consent and integrating traditional practices into mainstream medicine.

Medical Ethics Unpacked: Unique Ethical Challenges of Psychedelic Therapies

Medical Ethics Unpacked: Ethical Considerations for Euthanasia & Medically-Assisted Suicide

00:00 - The Parity Between Mental and Physical Illness

05:09 - Requiring Treatment Before Considering Euthanasia 

08:19 - The Complexity of Egosyntonic Psychiatric Conditions 

11:21 - The Potential for "Terminal Addiction" 

16:30 - The Societal Impact and Implications of Psychiatric Euthanasia

, hosts Dominic Sisti, PhD, and Steve Levine, MD, continue their deep dive into the controversial topic of medical aid in dying (MAID) and euthanasia for individuals with severe psychiatric conditions. Part 2 of a 2-part series, this episode shifts from foundational concepts to the intricate ethical considerations surrounding these practices, touching on autonomy, capacity, treatment equity, and societal implications.

Sisti, an associate professor in the Department of Medical Ethics & Health Policy and the director of the Scattergood Program for the Applied Ethics of Behavioral Health Care at the University of Pennsylvania, begins by discussing the notion of parity between psychiatric and physical illnesses in evaluating eligibility for MAID, calling attention to recent research from Kious et al—who argues that mental illnesses should be given equal ethical consideration as physical conditions, though he acknowledges the challenges in assessing long-term trajectories for psychiatric disorders. For instance, conditions like borderline personality disorder may remit over time, but requiring patients to endure suffering for years in anticipation of potential improvement raises moral concerns.

Levine, a psychiatrist and the senior vice president of Patient Access at Compass Pathways, builds on this by exploring how psychiatric illnesses often blur the line between mental and physical health, emphasizing that mental health conditions, like depression or anorexia nervosa, can have physical manifestations that further complicate prognosis and decision-making.

The discussion highlights critical issues with capacity evaluations. Levine outlines the nuanced frameworks used to assess a patient’s ability to make decisions about MAID and stresses the dynamic nature of capacity, which can fluctuate with psychiatric symptoms. Both agree that insufficient or inconsistent evaluations, as seen in some jurisdictions permitting psychiatric euthanasia, risk undermining the ethical integrity of these practices.

Sisti cites evidence from Belgium and the Netherlands, where "assertions" of capacity rather than thorough assessments have led to controversial cases, particularly among patients with mood or personality disorders. The gender disparity in psychiatric euthanasia, with women disproportionately represented, adds another layer of ethical complexity, raising questions about justice and societal biases.

The conversation also examines whether patients should be required to attempt all available treatments, including experimental options, before pursuing MAID. While Sisti suggests this could prevent premature decisions, Levine cautions against infringing on autonomy, noting that some patients may validly reject certain treatments. They grapple with cases like anorexia nervosa, a psychiatric condition with high mortality rates, and whether its ego-syntonic nature—where patients often do not view their condition as a problem—impedes true capacity for MAID decisions.

Finally, the hosts address societal implications. Sisti warns that expanding access to psychiatric euthanasia without addressing underlying structural issues, such as inadequate mental health care and social determinants like poverty and isolation, risks normalizing preventable suffering. Levine reflects on how offering MAID as an option might paradoxically provide hope for some patients but could also undermine their optimism for recovery.

As they conclude, both Levine and Sisti emphasize the need for robust ethical frameworks, thorough capacity evaluations, and thoughtful policymaking to navigate this morally complex issue. They encourage listeners to engage with the growing body of bioethics literature and reflect on how these debates shape our understanding of autonomy, human suffering, and the value of life.

Relevant studies and documentation mentioned in this episode:

Doernberg, Samuel N., John R. Peteet, and Scott YH Kim. "Capacity evaluations of psychiatric patients requesting assisted death in the Netherlands." Psychosomatics 57, no. 6 (2016): 556-565.

Kim, Scott YH, Raymond G. De Vries, and John R. Peteet. "Euthanasia and assisted suicide of patients with psychiatric disorders in the Netherlands 2011 to 2014." JAMA psychiatry73, no. 4 (2016): 362-368.

Kious, Brent M., and Margaret Battin. "Physician aid-in-dying and suicide prevention in psychiatry: A moral crisis?." The American Journal of Bioethics 19, no. 10 (2019): 29-39.

Nicolini, Marie E., Scott YH Kim, Madison E. Churchill, and Chris Gastmans. "Should euthanasia and assisted suicide for psychiatric disorders be permitted? A systematic review of reasons." Psychological medicine 50, no. 8 (2020): 1241-1256.

Nicolini, Marie E., Chris Gastmans, and Scott YH Kim. "Psychiatric euthanasia, suicide and the role of gender." The British Journal of Psychiatry 220, no. 1 (2022): 10-13.

Sisti, Dominic, J. John Mann, and Maria A. Oquendo. "Suicidal behaviour is pathological: implications for psychiatric euthanasia." Journal of Medical Ethics (2024).

Relevant disclosures for Sisti include Lykos Therapeutics and Tactogen. Relevant disclosures for include Levine include Compass Pathways.

This podcast explores complex and sensitive topics, including medically assisted suicide and the ethics of euthanasia. The views and opinions expressed by the hosts and guests are their own and do not necessarily reflect those of HCPLive or MJH Life Sciences. This content is intended to encourage thoughtful discussion and does not constitute medical advice or endorsement of any particular position. Listeners are encouraged to approach these subjects with care and consult appropriate resources for further information.

Podcasts

In part 2 of this 2-part discussion, hosts discuss ethical considerations and the growing evidence base around euthanasia and medical assistance in dying.

Medical Ethics Unpacked: Ethical Considerations for Euthanasia & Medical Assistance in Dying

Medical Ethics Unpacked: Ethical Foundations and Background of Euthanasia & Medically-Assisted Suicide

00:00 Introduction to Medical Ethics Unpacked

00:45 Key Issues in the Debate on Euthanasia and Mental Illness

07:25 Clinical Perspective on Capacity and Competence

12:45 Challenges in Evaluating Capacity in Mental Illness

19:32 Treatment Options and the Role of Social Structures

In their inaugural episode of Medical Ethics Unpacked, hosts Steve Levine, MD, a psychiatrist, and Dominic Sisti, PhD, a bioethicist, begin a 2-part discussion examining medically-assisted suicide, often referred to as medical assistance in dying (MAID), and euthanasia, particularly in the context of severe 

. Part 1 of the discussion featured above focuses on foundational concepts and the broader context of MAID, laying the groundwork for an in-depth ethical discussion in part 2.

Sisti, an associate professor in the Department of Medical Ethics & Health Policy and the director of the Scattergood Program for the Applied Ethics of Behavioral Health Care at the University of Pennsylvania, introduces 2 critical questions at the heart of the debate: determining whether individuals with severe psychiatric illnesses have the capacity to make autonomous decisions about euthanasia and whether psychiatric conditions can be considered terminal. As Sisti notes, these questions are particularly challenging given the complexities of suicidality, which is both a symptom of certain psychiatric illnesses and a factor influencing the desire for euthanasia.

Sisti also examines data from jurisdictions where psychiatric euthanasia is legal, such as Belgium and the Netherlands, noting trends like gender disparities and inconsistent capacity evaluations that raise concerns about equity and justice. He emphasizes the need for robust societal safeguards to ensure that MAID is not prematurely offered to individuals whose suffering might be mitigated through other means.

Later, Levine provides a clinical perspective, delving into the distinction between capacity and competence, explaining how capacity evaluations are conducted by physicians, and discussing the nuances of suicidality as a dynamic and context-dependent phenomenon. He highlights the episodic nature of conditions like major depressive disorder and the potential for recovery through treatments, such as ketamine or psychedelics. However, he acknowledges the limitations of psychiatric care, including gaps in treatment effectiveness and accessibility, which complicate decisions regarding MAID.

Levine also raises the philosophical question of whether a wish to die is always pathological or whether it can sometimes be an expression of autonomy, further blurring the lines in this debate.

The episode sets the stage for part 2, which will explore the ethical considerations surrounding MAID and euthanasia in greater depth. Levine and Sisti aim to address the broader implications of permitting euthanasia in psychiatric populations, touching on justice, societal values, and the role of clinicians in these life-and-death decisions. Stay tuned for the continuation of this complex and thought-provoking discussion.


The inaugural episode of "Medical Ethics Unpacked" delves into the ethical complexities of medically-assisted suicide (MAID) and euthanasia, particularly for individuals with severe psychiatric conditions. Hosts Steve Levine, MD, and Dominic Sisti, PhD, explore foundational concepts, focusing on the capacity for autonomous decision-making and whether psychiatric conditions can be deemed terminal. They discuss data from jurisdictions where psychiatric euthanasia is legal, highlighting concerns about equity and justice. The episode also examines the philosophical and clinical nuances of suicidality, setting the stage for a deeper ethical exploration in the next episode.

In part 1 of this 2-part discussion, hosts explore the ethical foundation and background of euthanasia and medically-assisted suicide. 

 Before we conclude, I’d like to get some final thoughts from each of you, if you have any. Let’s start with you, Dr Nordberg.

 From my perspective, treatment-resistant depression and other complex mental health challenges are systems challenges as much as they are clinical challenges. We haven’t moved the needle in treatment effectiveness in about 50 years, and in no small respect that may be because we haven’t changed our systems that provide care. I’m a big fan of looking at developing systems where we’re doing a lot more precision referral work, and to Martin’s earlier point, identifying different providers, clinics, and centers of strength, and referring to strengths. The only way to do that is to collect the data.

There are challenges around collecting the data. It creates vulnerability and a lot of visibility where there hasn’t been historically. One of the things that we’re working on at Reliant Medical Group is trying to be more precise about how and who we refer. A lot of that involves understanding the patient that we’re being presented with, and also understanding how that person matches up with what we believe is the most likely treatment to be effective for them based on data.

I’m pretty confident that if we can do that work in naturalistic settings, we’ll get past the archaic requirement of failing 2 bonafide medication interventions and get more rapidly to something that’s going to allow a care delivery organization to say, “This is a patient with treatment-resistant depression,” and a payer to say “No problem,” and then allows that care delivery organization to connect that patient with a reimbursed intervention that has a likely shot of helping them. That’s a lot of work to be done, but it starts with measurement and having the confidence to integrate that measurement into your clinical routine.

 Well said. To your original point, we haven’t moved the needle much in these past 50 years. You’re calling for improved systems, better measurement, and moving toward precision care. Hopefully that will be supported by the validation of some biomarkers that can lead to more precise and predictive treatments. Would you also agree that part of this as well is that we haven’t had very many new tools in the past 50 years, and potentially having some effective new tools in the toolbox may also help move that needle?

 It may. We also know that there’s a lot of variability between different providers and that there are different kinds of treatments that appeal more to different kinds of patients. The biomarker research is sexy and exciting because of that possibility of carving nature at its joints and being precise. It’s also a long way off. RDoC [Research Domain Criteria] didn’t deliver the promise of precision opportunities for understanding and deep learning about what drives mental health on a physiological level.

We still have a lot of opportunities with the systems and treatments that are already out there. This system still has a lot of room for optimization. It starts with having the courage to collect more data and letting those data start to tell us what kind of a patient this is and the best place for the patient to go based on what we’ve already learned about similar patients. That’s where my focus is, less so on developing novel interventions. It’s important to figure out where the patients that we’ve been discussing fit in that overall model, but we’re not going to be able to figure that out if we’re not collecting the right data.

 For those of us who deal with the fun stuff, the insurance and billing portion of things, like I’ve been saying this whole time, it’s important to make sure that you understand your payers and their guidelines and policies. You have to play that middleman role between the insurance carriers, providers, and patients. We need to make sure that we’re educating our providers so that they know if there are any changes to these policies so that they can find the right fit for patients.

It’s also important to educate the patients in regard to what qualifies them as having treatment-resistant depression and what’s available out there. Be an advocate for the patient with the payer and keep them involved in the process so that they’re not at home wondering, “What’s going on with my prior authorization? When is my treatment going to start?” Let them know everything along the way and be there for them.

 The theme that I’d leave with is the idea of “better together.” If you think about it, there are 3 participants in the goal here. Front and foremost is the patient because they want to get better. They’re suffering. There’s the provider who’s trying their best to figure out the appropriate care. There’s also the payer who wants to make sure that the patient gets access to the benefit that they deserve and that they’re able to go on and live a healthier and happier life. You have to see that triad.

There’s a likelihood that you can blame the insurer or blame someone else, but at the end of the day, it’s about figuring out how to work better together, that triad, because we have a common interest in improving the life of that patient. That’s the part that I like to focus on. What are we doing this for? Who matters the most? The other stuff can be worked out.

 Thank you. Last but not least, Dr Ares-Romero.

 I love that. I love how you ended with that. Because as somebody who treats treatment-resistant depression regularly, I’m very passionate about having my patients improve their lives. Their quality of life is what’s important, and that they get passion and fulfillment from their lives. It’s beautiful to hear that, that we can work together. That’s key, getting the payer together with a provider. It’s not about you or me. It’s about the patient and how can we come together to work together. I love that.

Despite the hurdles and challenges and everything we’ve talked about, it’s an exciting time in psychiatry. This is a time when we have new modalities, new things, all the data collection, all the systems, and the artificial intelligence that we have now that we haven’t explored. There are so many wonderful things coming that I’m excited. I’m excited for our patients. I’m excited for everything that we’re doing.

 Thank you all again. To our viewing audience, we hope you found this 

® panel discussion to be useful and informative.

An expert panel shares insight on the future treatment landscape for treatment-resistant depression. 

Steven Levine, MD

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