Welcome and Introduction of Leith States
Lia Mix: Good morning and good afternoon, everyone. Thanks for being with us. I’m Lia Mix, CEO of Delphi. It’s an honor to welcome Dr. Leith States to our Insight Session.
Dr. States is a physician, executive, and veteran whose career has spanned the battlefield, the boardroom, and senior public health leadership. He is a board-certified preventive medicine physician and formerly served as Acting Assistant Secretary for Health and Chief Medical Officer at the U.S. Department of Health and Human Services (HHS). In those roles, he helped shape national public health strategy across behavioral health and substance use policy, disease prevention, health equity, and cross-agency coordination. He often worked at the intersection of science, ethics, and public trust, including the responsible evaluation of evidence for psychedelic therapies.
On a personal note, I had enough proximity to Dr. States’ work in the federal government to see how he approached high-stakes issues affecting millions of Americans. He consistently brought a cool head and a warm heart. I’m grateful for his service, and I’m especially grateful for his engagement in the evolving conversation around psychedelic therapies and for his advisory role with the Ibogaine Healthcare Policy Institute (IHPI) at Delphi.
Dr. States, thank you for joining us today.
Leith States: Thank you, Lia. It’s a pleasure to be with you. Thank you for the invitation.
A Through Line: Patience, Curiosity, and Service
Lia: Our audience will be very interested in your line of sight on psychedelics and ibogaine. You’ve moved through military service, federal public health leadership, and now emerging therapeutic policy. Looking back, do you see a through line that connects these chapters?
Leith: I struggle with that question for two reasons. First, there’s a serendipitous quality to where I am now compared to where I started. It feels like a Forrest Gump moment: you show up to work, and history happens around you.
Second, this work became personal for me. It connects to experiences that shaped how I see the transformative potential of these medicines.
If I had to name a through line, it’s patience and curiosity. It’s staying open-minded and adaptive, being critical across systems without being beholden to them. That’s what brought me to this work at this stage.
Lia: That resonates. There’s a difference between understanding how systems work and getting trapped inside them. You’ve been able to see the system and still think beyond it. It also makes me think about how your experience as a physician on the front lines shaped your view of public health policy.
Leith: Two early experiences shaped my view of leadership and public service, and also what it means to be a doctor working across individuals and populations.
For context, I served on active duty in the U.S. Navy as a Medical Corps officer and spent a fair amount of my career with the U.S. Marines. One of the most important leadership lessons I learned came from a deployment on a training mission in India.
We were lining up for chow. The Indian Army contingent went first, with the most senior officers at the front of the line and the most junior enlisted eating last. When the Marines lined up, it was the opposite: the youngest Marine went first, followed by noncommissioned officers (NCOs) [enlisted leaders], then senior enlisted, then junior officers, and the most senior officer in that element went last. For us, that was a captain, an O-3 [a company-grade officer rank].
The Marine Corps ethos is “officers eat last.” You take care of your people first. Leaders focus on the people and the mission, not themselves. In public health and public service, that translates to accountability and stewardship, especially for people who are most vulnerable and least likely to have a voice.
The second experience came during a deployment to Afghanistan. As we prepared to redeploy home, I was delivering the standard brief: don’t drink and drive, don’t use drugs, don’t get into fights, make good decisions. It became clear that the greatest good I could do as a physician was keeping the population healthy before small problems became bigger problems. That “ounce of prevention” perspective aligned completely with preventive medicine and public health.
That’s what widened my view of being a doctor beyond the clinic. The greatest good is often doing the greatest good for the greatest number as early as possible.
Lia: That’s a powerful set of lessons: take care of your people and keep them healthy. You’ve carried those insights forward. Public health is often incremental and slow, with occasional watershed moments.
Leith: Exactly. There are watershed moments, but by and large it’s an incremental, slow-moving process.
How Psychedelic-Assisted Therapies Reached Federal Policy
Lia: Let’s shift to psychedelics. Over your career in medicine and public service, the public and professional perspective on psychedelics has shifted radically. When did psychedelics first enter your professional field of view, and what made you take them seriously as a public health topic rather than dismissing them as fringe?
Leith: Another Forrest Gump example. I was at HHS at the right place and time. Congress and the administration were receiving more inquiries about psychedelic-assisted therapies, and there was more signal in the media and public discussion.
My division was tasked with coordinating an intentional approach, not only within HHS but across the federal interagency. As it often goes, I was volunteered to lead it.
Before that, I was naïve. I didn’t understand the pace of progress, the emerging evidence, or how disruptive this could be for psychiatry, mental health, and behavioral health. My learning curve was steep. That was around 2022.
From the outset, I had to engage with the evidence across clinical trials, harm reduction [strategies to reduce health harms without requiring abstinence], implementation science [research on how to deliver interventions effectively in real-world settings], and early real-world data [data from routine clinical practice]. I also had to understand perspectives across the interagency and, importantly, from the outside world: advocacy groups across the spectrum, pharma, and tribal and indigenous perspectives around rights and stewardship. It was clear that society was not ready, and still largely is not prepared, for what broader access could mean.
Lia: So you were immersed in the evidence and in the stakeholder landscape.
Leith: Yes. As public servants, we need a working understanding of topics that will shape population outcomes. But some of the best information comes from proximity to lived experience. That’s where anecdotes matter: you hear a single voice, a family, an experience, and over time you see the themes that repeat across communities. Those patterns informed how I understood the landscape.
Lia: That matches my experience. First, the research, then the relationships, then a deeper understanding of lived experience and the science behind it.
Why Psychedelic-Assisted Therapies Disrupt Behavioral Health
Lia: From what you’ve learned, how are psychedelics different from other emerging therapies?
Leith: They are different in a lot of ways. One way to frame it is to look at the historical approach to behavioral health through the Diagnostic and Statistical Manual of Mental Disorders (DSM) [psychiatry’s standard diagnostic guide]. Behavioral health often relies on subjective assessments and imprecise categories. In that lack of precision, clinicians and systems can become beholden to dogma. Providers tend to avoid uncertainty, and healthcare systems reinforce that tendency.
Psychedelic-assisted therapies are entering a behavioral health system that is already broken: under-resourced, under-staffed, and poorly reimbursed. Payers and health systems often don’t understand the care model, and primary care providers become the default touchpoint without adequate support. The result is uncoordinated care, insufficient use of existing modalities, dropouts, and chronic maintenance on whatever is available.
I don’t see psychedelic-assisted therapies as a replacement. I see them as an adjunct to the current treatment armamentarium [the medicines, equipment, and techniques available to a medical practitioner]. Their differences show up in the care model:
- Preparation and screening
- The length and structure of treatment episodes
- Expectations around outcomes and durability
- Integration and follow-up support
- A shift toward restoration and wellness, not only symptom management
At their best, they can help people see behavioral health and substance use conditions as something you heal from rather than an identity that defines you. That includes shifting away from the idea of moral failure, particularly for substance use disorder (SUD).
That said, there are devils in the details. Drug approval alone won’t make everything work. The sequencing, timing, integration approach, and provider training all matter, and those choices will shape outcomes.
Lia: That’s a clear overview of both promise and complexity. One example is buprenorphine-based treatment, like Suboxone or Subutex, and methadone for opioid use disorder. Many people stay on those long-term. The opportunity with ibogaine is different: people might move from living around a diagnosis to not carrying that diagnosis at all.
It reminds me of oncology. There was a time when cancer was often fatal, and then investment in research created paths to recovery that are now routine. Psychedelics feel like they may be at a similar inflection point for mental health and behavioral health.
Leith: I agree with the analogy. It’s important to look at past examples where sustained resources and evidence development created major shifts. Oncology moved toward precision: you can match therapies to biology and improve survival. That took time, coordination, and persistence.
With psychedelic-assisted therapies, there’s debate about the New Drug Application (NDA) [the U.S. Food and Drug Administration submission requesting approval of a new drug] pathway, but the U.S. Food and Drug Administration (FDA) has flexibilities to adapt to new constructs and still uphold rigorous randomized trials across Phase I, Phase II, and Phase III.
If we do this well, we could get to thoughtful Risk Evaluation and Mitigation Strategies (REMS) [FDA-required safety programs for certain drugs] that are protective without being so restrictive that access collapses into a cash-pay landscape [care paid out-of-pocket rather than covered by insurance]. The goal is to reach the people who need it, not only those who can afford it. The system can adapt, but it takes time.
Ibogaine, Federal Signals, and Responsible Leadership
Lia: Let’s talk about ibogaine specifically. It occupies a different space than most other psychedelics. From your perspective, what makes ibogaine unique from a public health and safety standpoint?
Leith: Ibogaine is a powerful medicine. I wouldn’t say it’s in a class entirely of its own, but it is distinctive. I’m glad evidence is being built to describe that power in a rigorous way.
There are early signals across a range of conditions, including substance use disorder (SUD), alcohol use disorder (AUD), post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), and other neurocognitive and neuroimmune issues. Much of what we have today is still early: case studies, use cases, and small cohorts. We need prospective studies to understand causality, and that will come.
From a safety standpoint, the medical requirements are central. Because of cardiac risk and the intensity and duration of the experience, it lends itself to a medical home [a clinical setting responsible for coordinated, continuous care]. It requires strong telemetry support, provider support, and careful clinical protocols.
It’s also controversial because it can disrupt parts of the current behavioral health incumbency. Methadone, Subutex, and Suboxone can become “liquid handcuffs” for life. Ibogaine is framed more as restoration, as healing, as moving from “I am my disorder” back to “I am me.”
Lia: That gets to incentives. Some parts of the existing system benefit from long-term disease management. Introducing something that can reduce chronic dependence disrupts those incentives. That doesn’t mean we stop; it means we move thoughtfully. It also doesn’t mean we remove other options. Ibogaine won’t be appropriate for everyone. The point is more tools for healing.
Leith: Exactly. The incumbents will need to see themselves in the future landscape. These therapies should augment, not replace, what we already use to help people recover. Ibogaine won’t be right for everybody, but for a significant and growing group, it will be powerful.
Lia: One hope is that if people no longer need ongoing disease management, cost savings could be redirected to better support people who are not appropriate candidates for ibogaine.
Leith: One federal signal I’m watching is the Advanced Research Projects Agency for Health (ARPA-H) EVIDENT program. The aim is to move behavioral health toward precision, with biomarkers [measurable biological signals], imaging, evoked potentials from electroencephalogram (EEG) [a brain-wave test], and even artificial intelligence (AI) tools that help match people to the right suite of interventions in the right sequence.
Another signal: earlier this week, the Drug Enforcement Administration (DEA) issued a rule related to annual quotas for Fiscal Year 2026, including increases for psilocybin and 5-MeO to expand research throughput. I would like to see ibogaine eventually reach that kind of posture as evidence builds, especially as Phase I work begins, and more studies are launched.
Lia: That kind of movement matters. With ibogaine, there’s also a different abuse potential profile than many other psychedelics, which I hope influences how the government evaluates it.
Leith: There’s also a risk area: state and federal discordance. Colorado is developing an approach tied to decriminalization for ibogaine. It’s interesting to compare ibogaine and cannabis. Cannabis has been legal in many states for 20-plus years despite high abuse potential and a complex federal status. In recent years, there have been updated analyses in the federal scheduling context.
A similar pattern could emerge in which states move ahead through ballot measures or legislation before clinical trials are complete. That can create dissonance and a real public health risk. We’ve seen how federal-state misalignment can contribute to problems with opioids and kratom. For public health leaders, this is a persistent governance challenge.
For me, this is why the moment is so important. We have an opportunity to set an intentional agenda: evidence first, policy next, and public health protections and safety built in from the start.
Lia: You’re advising IHPI, and the field is still early. What convinced you to invest your time and energy in this initiative?
Leith: It resonates with what draws me to public service. It focuses on the gap between where we are and the future state we need, and it doesn’t assume someone else will do the work. It asks what we must do now to get where we need to be later.
I also value the people involved. The group you’ve brought together is interdisciplinary, and it’s encouraging to see people stay focused on solutions rather than getting stuck in silos.
Lia: I feel the same. There’s a gap that research institutes, advocates, and private companies cannot fill alone. An entity like IHPI can coordinate and move policy forward in a way that is mindful and operational.
If we got this right, and we looked back five, 10, or 15 years from now, what would success look like for ibogaine? What role do you think IHPI plays?
Leith: This assumes we see approved psychedelic-assisted therapies in the near term, likely psilocybin and MDMA, which would create a more “platform” infrastructure: workforce development, payer considerations, Current Procedural Terminology (CPT) codes [billing codes used to document and pay for medical services], workable REMS, and broad education for the public and providers. It also means building a pipeline from clinical trials to implementation science and real-world evidence, then feeding those learnings back into the next wave.
If that infrastructure develops, ibogaine could come online into a system that is already learning how to deliver these therapies responsibly. In the next few years, I hope we see Phase I studies, and then Phase II studies, and the care model begins to integrate into larger systems.
The system I think about most is the U.S. Department of Veterans Affairs (VA). It’s mission-driven, has strong data, and can operate as a closed-loop system. It also treats complex patients: not “unicorn” cases with one diagnosis, but PTSD plus SUD, plus AUD, plus heart disease, plus diabetes, plus long-term tobacco use. Success would look like durable integration in systems like the VA, with learning that disseminates to broader healthcare.
I also see risks around decriminalization and deprioritization [law enforcement choosing not to prioritize certain offenses], as well as broader personal-use dynamics. Not because people should never have access, but because short-horizon initiatives can add the wrong fuel to the fire and create backlash.
Finally, there’s the international stewardship piece. There are indigenous and traditional communities in Gabon and elsewhere who have stewarded iboga over long periods. The medicine alone is not the cure; it creates an opportunity. Set and setting [the physical and psychological context of a psychedelic session] matters. In many cases, the people who have done this best are those who did it first and have curated the practice carefully. We need to remain mindful of that as the footprint expands.
Lia: That’s a helpful frame: infrastructure, real-world learning in systems like the VA, managing state-federal misalignment, and international stewardship. We’re seeing those conversations happen now, including engagement with traditional leaders in Gabon.
Before we close, many people listening are leaders, decision-makers, and practitioners. What advice would you give about acting responsibly as psychedelics move forward?
Leith: I’ll give my three rules for leadership: transparency, integrity, and competence. My rule under those three is that I am never the person who has all three in the room. Sometimes I have two. Sometimes I have one. The answer is building a team where, collectively, those qualities are present.
If I can lead with integrity, I may need someone else to help deliver with transparency. If I’m not the most competent on a topic, I need subject-matter expertise around me. If I have that cadre, I can move into unfamiliar spaces with confidence and humility.
Transparency, integrity, and competence, practiced relationally and collectively. Seek those qualities in colleagues, share what you have, receive what others bring, and keep evolving your mindset.
Lia: Thank you. That’s a clear call for openness and disciplined leadership in a space that can easily fall into dogma and rigidity.
Dr. States, thank you for your wisdom and your perspectives on psychedelics and ibogaine, and for your role in this work.
Lia: Wishing everyone a wonderful rest of your day. We look forward to seeing you next month at a Delphi Insight Session.
Q&A with Dr Leith States
Note: Due to time constraints, the questions asked during the Insight Session were answered offline.
Q1: Are there any unique opportunities for PAT [psychedelic-assisted therapies] to be more or less affordable than conventional psychiatric care? How can we prevent PAT from being subject to the same barriers to care as other pharmaceutical or non-pharmaceutical therapies?
Leith: Answer will follow within a few days.
Q2: Could you please elaborate on your thoughts, beyond research, for immediate steps that need to be taken within the health system to prepare for the introduction of psychedelic-assisted therapies? Specifically, could you speak to some of the ways you think HHS should be preparing agencies, healthcare providers, and communities — who are increasingly looking to these new tools for healing themselves and their peers?
Leith: Answer will follow within a few days.
Q3: In discussing your evolving understanding of psychedelics, you describe both data/research and relationships/anecdotes. When approaching officials and policymakers, either skeptical or unfamiliar with psychedelics, what have you seen to be effective in blending those components? What comes first? How would you frame that narrative?
Leith: Answer will follow within a few days.
