For our last issue of 2021, The Microdose reached out to several dozen figures in the psychedelic community—researchers, executives, investors, philanthropists, and journalists— for their take on the most significant developments of the past year, and their expectations –hopes as well as fears– for the year to come.
Reading through their responses (all of which appear below; feel free to skim), I’m reminded just how much happened in the world of psychedelics in 2021, and how much the field has grown– in the scale of research, the diversity of people involved, amount of capital invested, and mainstream recognition. The promise of the small early trials that helped launch the “psychedelic renaissance” less than a decade ago has largely been vindicated by the results reported this year for large trials of MDMA in the treatment of PTSD and psilocybin in the treatment of depression; both compounds appear well on their way to FDA approval in the next few years. It’s worth noting, too, that these results appeared in top journals such as Nature Medicine and the New England Journal of Medicine. And in yet another sign of growing mainstream acceptance of psychedelic research, the NIH made grants to psychedelic researchers at Yale and Johns Hopkins.
Entrepreneurs and VCs were, if anything, busier than the scientists: hundreds of psychedelic start-ups were launched in 2021, dozens of others went public with IPOs, and an industry that did not exist five years ago is now valued at more than $10 billion.
Not all the news was good. Charges of sexual abuse by psychedelic therapists roiled the field late in 2021, sparking an overdue conversation about ethics in psychedelic therapy, especially in the underground. As power and influence in the field shifts from the pioneers and scientists to the entrepreneurs and investors, the culture is bound to change, and probably not for the better. Battles over intellectual property broke out in 2021, and will no doubt become important stories in 2022, as a handful of companies seek to control the key compounds. The irrational exuberance driving the new industry, in which tremendous amounts of capital are chasing a limited number of good ideas –most of them based on selling drugs that remain illegal!– is bound to lead to a shake-out sooner or later.
Lastly, 2021 saw the launch of the newsletter you are reading. A tip of the hat to the team that produces The Microdose twice each week: lead writer Jane C. Hu and editor Malia Wollan.
They and I are grateful for your readership and, as ever, welcome your comments and news tips. If 2021 is any indication, 2022 will be an exciting, even momentous year in psychedelics. We look forward to covering it for you, and keeping you up to date.
From all of us at the Berkeley Center for the Science of Psychedelics, here’s to a healthy and happy new year.
— Michael Pollan
Andrea M. Gomez, assistant professor of neurobiology, UC Berkeley
2021: I was most excited about efforts in the psychedelic space that center Indigenous voices. Specifically, actions from my colleagues at the UC Berkeley Center for the Science of Psychedelics and from other organizations such as Chacruna's Indigenous Reciprocity Initiative of the Americas. Indeed there is much work to do - but it is encouraging to see others taking action aligned with Indigenous values.
2022: This year I was fortunate to have met many fellow young, brilliant, and creative Indigenous psychedelic researchers who will innovate psychedelic research as we know it. Contrary to Western psychedelic pharma approaches, Indigenous psychedelic research modalities have the capacity to advance psychedelic medicinal application within the context of concurrent global mental health and climate crises.
Joe Green, co-founder and president of Psychedelic Science Funders Collaborative
2021: MAPS first phase 3 trial results released, demonstrating the effectiveness of MDMA as a treatment for PTSD. Historic and very, very positive.
2022: Oregon. This is the year of getting the implementation of Ballot Measure 109 right or wrong. First regulated psychedelic system in history, and a lot rides on it.
Carey Turnbull, founder and executive director, B.More Inc, founder and president, Ceruvia Lifesciences
2022: Eagerly watching next year for the first clinical trials for human use of LSD in 50+/- years. John Hopkins and NYU both have studies proposed in their research centers. In the 1960’s both the research and recreational scenes were dominated by LSD, not psilocybin, and for similar reasons: a far more potent and interesting probe of mood and cognition. Worries: a repeat of the 1960’s backlash. Self inflicted by overeager promotion by amateurs.
Shayla Love, senior staff writer, VICE
2021: I have been amazed to see the influx of new psychedelic companies, which have increased at a rate that outpaced my already high expectations. Attending the Wonderland conference in Miami last fall reinforced for me that we’ve entered the next “stage” of mainstreaming psychedelics: It’s no longer about convincing others that this research is legitimate or promising, instead people are clamoring to join in. That’s pretty incredible if you consider that nearly all of these substances are still illegal!
It’s also been very interesting to watch the boundaries of applications for psychedelics continue to expand. Eating disorders, cluster headaches, opioid use disorder, smoking cessation, TBI, and much, much more. I’d like to see if we can start to define some of the commonalities underlying how these compounds can be used for such different purposes, while of course, remaining cautious about saying that psychedelics will be effective as a treatment for all of our ills.
Lastly, I’ve really appreciated discussions that ask tough questions about facets of the psychedelic experience previously taken for granted, like the mystical-type experience, what role it plays in outcomes, and what kinds of cultural priming might be at play there. There's also been a great start in investigating the role of therapy, how it interacts with the compound, and a recognition of the urgency to train people who can responsibly guide others through these experiences.
2022: Anyone who has experienced mental distress is familiar with frustrations around access—that services are too expensive, too limited, or too complicated to actually get their hands on them. I constantly worry about this happening with psychedelic therapy, and it’s one reason I’ll be keeping an eye on intellectual property, for-profit companies, and health insurance coverage. Not to say those things will all be bad, but the healthcare model we exist in has many flaws. Psychedelics won’t be operating in a brand new model, but within that flawed system. Whether the therapy that often comes along with psychedelic treatments will be covered by insurance is a huge outstanding question.
I will be eagerly looking out for more cross-cultural work, to understand how extra-pharmacological factors like setting, priming, and expectation influence patient outcomes. On that topic, I would love to see collaboration with anthropologists, philosophers, and social scientists to dig into those contextual pieces of the puzzle.
I’m also very grateful that there has been a movement towards calling out abusive practices in psychedelics, though there needs to be much more. Those who come forward with their stories need to be welcomed to speak out—not turned away or quieted. I think this will be a hugely important step into making psychedelic treatments the safest—along with most accessible and effective— they can be.
Manish Agrawal, MD, Aquilino Cancer Center/Sunstone Therapies
2021: The year saw the broadening of the field beyond the usual suspects in terms of institutions and pharma–the range of voices is getting much more diverse, helping move the field beyond what has been fairly narrowly defined.
2022: Looking forward to seeing the results of the major depressive disorder trial sponsored by Usona and their development plan for that indication. I worry about the correction that is coming and that is needed for the over-hype around psychedelics. I hope it is not as severe as in the past.
Robin Carhart-Harris, Director of Psychedelics Division and Ralph Metzner Distinguished Professor of Neurology and Psychiatry at UC San Francisco.
2021: The Compass Pathways Phase 2B results, trialing psilocybin for treatment resistant depression. I was especially eager to hear these results as this was the largest controlled trial on psychedelics to date.
2022: Eagerly watching changes in policy on psychedelics, e.g., will Oregon begin to roll out and how will this go?
Paul Stamets, mycologist, author, medical researcher, founder of Fungi Perfecti.
2021: For the most interesting thing in 2021, I vote, with admitted self interest, as I’m one of the authors, for the largest microdosing study in history published in Nature Scientific Reports. This observational study was immediately elevated to the top one percent of all articles ever published in the Nature publication ecosystem, a measure of the importance of this research. I suspect microdosing offers a unique platform and delivery system for improving mental health.
2022: I look forward to the publication of our second paper on microdosing covering more than 12,000 participants, whereby we see a very strong association with a decrease in depression in people taking small quantities of psilocybin mushrooms, and an increase, interestingly, in psychomotor skills using a standardized method validated for Parkinson’s, Alzheimer’s and traumatic brain injury.
Shelby Hartman, CEO, DoubleBlind Magazine
2021: This year, I was most excited to see the continued growth of interest around equity and access in psychedelics. From Woven Science's report looking critically at what Indigenous reciprocity might actually look like to Chacruna launching their Indigenous Reciprocity Initiative, psychedelic advocates have begun to turn the idea of giving back to Indigenous stewards of plant medicines into actionable steps.
In 2022, I'm most closely looking at how all the various stakeholders within the psychedelic space—from the decriminalization activists to the drug development companies—either come together, or don't, to overturn psychedelic prohibition. The potential of bridging ideological divides in the spirit of overturning outdated drug policies inspires me, but it also concerns me that the divides may only grow.
Rick Doblin, founder and executive Director of the Multidisciplinary Association for Psychedelic Studies.
2021: From the perspective of FDA approval, the most important development of 2021 was our May 10, 2021 publication in Nature Medicine of our outstanding results from our first Phase 3 study of MDMA-assisted therapy for PTSD. This was recognized by Science as one of the top 10 scientific breakthroughs of 2021. From the perspective of patient access and cost-effectiveness for MDMA and for other psychedelic-assisted therapies, the most important development for MAPS and for the field of psychedelic-assisted therapy was MAPS’ April 16, 2021 triumph in our FDA Formal Dispute Resolution Request (FDRR) in which FDA senior management overruled the Division of Psychiatry by rejecting the requirements that the lead therapist needed to be an MD or PhD, permitting master level therapists to be the lead therapist, and that there needed to be a physician on-site during all MDMA administrations, permitting physician screening and physician on-call but not on-site.
2022: The development I’m most looking forward to in 2022 is the results of our second, confirmatory Phase 3 study of MDMA-assisted therapy for PTSD with our interim analysis in May 2022 and our final analysis in November 2022. What most worries me about 2022 is whether or not MAPS can raise the roughly $100 million we need to fund US commercialization and globalization of research into MDMA-assisted therapy for PTSD, initially for England and the European Medicines Agency (EMA).
Michael Silver, professor of optometry, vision science and neuroscience UC Berkeley, director, Neuroscience PhD Program, faculty director, UC Berkeley Center for the Science of Psychedelics
2021: I am greatly heartened by the US National Institutes of Health's moves to destigmatize psychedelic research. In 2021, the NIH funded the first grant for psychedelics treatment research in human subjects in more than 50 years, and multiple NIH directors spoke publicly about the therapeutic potential of psychedelics. This gives me hope that the NIH is following the data and will be supporting substantially more research in this area.
2022: I am worried about the growing influence of corporations on psychedelic research and translational medicine. A land grab of patents in these areas is underway, and while some of these patent applications have been filed with the intention of promoting more equitable access to psychedelic treatments, others seem to be more about maximizing profits and are not focused on the greater good.
Dacher Keltner, professor of psychology, UC Berkeley, director, Berkeley Social Interaction Laboratory, faculty director, Greater Good Science Center
2021: Two things struck me about 2021. The first is that undergraduate and graduate students are enormously interested in the scholarship surrounding psychedelics; how to map the experience; how psychedelics benefit people struggling; how these substances create certain kinds of community; how they may be relevant to the challenges we are facing today. Young people often signal where scholarly fields are going, and what new things will be discovered soon, and I take their interest to be a very good sign. The second thing that felt significant in the conversations I've been part of is that the study of psychedelics is raising the profile of Indigenous cultures, traditions, and practices, and their present conditions and continuing colonization. There are huge risks here – will this new psychedelic movement simply continue to colonize and commodify Indigenous traditions thousands of years old? – or will it bring those forms of wisdom to the forefront of the movement in ways that honor Indigenous cultures and share new resources with them?
2022: I have my eye on how psychedelics will benefit veterans grappling with PTSD. Our veterans are facing unprecedented struggles of the mind, in rising rates of depression, alcohol use and suicide. Their struggles call for bold new approaches like psychedelics that provide them new insights and perspectives on their trauma. I am also looking forward to progress being made in how the neuroscience of psychedelics reveals the neurophysiological correlates of the ecstatic, selfless and mystical dimensions of the psychedelic experience.
Bia Labate, PhD, executive director, Charuna Institute
2021: Chacruna is proud to have helped champion and advance the topic of Indigenous reciprocity into the mainstream conversation in the field of psychedelics. If we can infuse the emergent “psychedelic ecosystem” with the concept that the roots of the psychedelic movement emerged from Indigenous traditions, and if we support the work of Indigenous people on their own terms, we stand a better chance of achieving a safe and healthy environment for current and future generations and protecting a diverse biosphere. As we attempt to grapple with this dawning realization, we can move away from cynicism and helplessness and embody reciprocity in all that we do.
2022: Chacruna’s Council for the Protection of Sacred Plants hopes to advance religious freedom for the use of psychedelics. The medical model is clearly lacking in terms of accessibility, and decriminalization still leaves margin for illegality. We are aware of hundreds of legitimate and sincere religious communities across the country that could benefit from legal protection. We hope that either the powers-that-be proactively recognize our human and religious rights to seek communion with sacred plants, or some good plaintiff comes forward to help open that door.
Brian T. Anderson, M.D., Zuckerberg San Francisco General Hospital and Trauma Center and UCSF, Department of Psychiatry & Behavioral Sciences
2021: The US DEA produced a Notice of Rulemaking for how the agency will handle Religious Freedom Restoration Act petitions for exemption from the Controlled Substances Act. The DEA Rulemaking stands to clarify what has been an obscure legal process for many years – how sincere religious practitioners who use entheogens (psychedelics) in a sacramental manner can exercise their religious freedom to work with these substances recognized and protected by federal law through an administrative means, rather than have to go through litigation.
2022: Bogenschutz et al (NYU) are expected to publish the results of their large Phase 2 randomized controlled trial of psilocybin therapy for alcohol use disorder. This will be, to date, the largest randomized controlled trial of psilocybin therapy to have its results published. (Compass' Phase 2b trial is larger but likely will not be published before this NYU trial.) It will also be the first published randomized controlled trial of psilocybin therapy for a substance use disorder that is appropriately powered to assess efficacy–ie, it is not a pilot study. That will be a big deal for the field to have these data for a non-mood disorder indication (that is, not a depression study).
Charles S. Grob, M.D., professor of psychiatry and pediatrics, David Geffen School of Medicine at UCLA; director, division of child and adolescent psychiatry, Harbor-UCLA Medical Center
2021: In many respects this has been a very challenging year, with the impact of recent events still waiting to be determined. But, from my perspective, one of the more pleasant surprises has been the growing receptivity at the National Institutes of Health (NIH) to begin to provide support for psychedelic research. To that end, I believe National Institute of Mental Health (NIMH) awarded their first grant in 50 years for a research investigation utilizing the psychedelic treatment model, to a pilot psilocybin treatment of refractory OCD study at Yale. And, the National Institute on Drug Abuse (NIDA) recently announced a grant award to the Johns Hopkins psychedelic research program to extend their very promising studies exploring the use of the psilocybin treatment model for cigarette addiction. I believe this is the first NIDA grant award for a study examining the use of the psychedelic treatment model to treat drug addiction. This degree of support from the federal granting agencies is a very welcome surprise and hopefully heralds an ongoing commitment to support investigations exploring both the underlying science of psychedelics and the potential for treatment applications, particularly with patient populations often refractory to conventional treatments.
2022: I’m glad you added the final part to that question, as there is actually a great deal about the future prospects of psychedelics that do worry me. Specifically, I’ve been quite alarmed by the rapid ascent of the for-profit business model as it might pertain to psychedelic treatment. Particularly in regards to efforts at patent acquisitions, this will provide inordinate control of the evolution of the field to business entities that are first and foremost focused on monetizing the field and extracting profit. I am concerned that inevitably this will impact our capacity to provide quality care. If maximizing the return on investments becomes paramount, as will likely be the case, strategies to reduce the costs associated with the treatment will be pursued, including lowering clinical training and licensure standards for treatment facilitators and reducing the extent and quality of preparative and integrative psychotherapy sessions. In the end, lowering costs for administering psychedelic treatment runs the risk of heightening safety concerns and attenuating therapeutic outcomes. While the infusion of for-profit funding has certainly generated more research activity, it might be prudent to reflect on the strings that are often attached to such largesse.
Bob Jesse
2021: This year saw a big step-up in the U.S. government’s support of psychedelic research. In earlier years, the National Institutes of Health partly supported the Johns Hopkins psilocybin study published in 2006, and an NIH grant in 2017 supported Fred Barrett at Hopkins in investigating biological mechanisms of psilocybin effects. This year, NIH gave a prestigious career development award to Ben Kelmendi at Yale, the first of its kind to a psychedelics researcher, and a grant to Matt Johnson at Hopkins to lead a study of psilocybin-assisted treatment for tobacco addiction in collaboration with NYU and University of Alabama at Birmingham.
2022: Researchers at Johns Hopkins and NYU expect to publish the first findings from a study with religious leaders in which clergy from various traditions and denominations were given supervised and supported high-dose psilocybin sessions.
Erik Davis author of High Weirdness, podcast Expanding Mind
2021: This last year, I have been fascinated and pleased with the variety of serious and substantial Indigenous reciprocity initiatives and commitments from institutions and companies like Riverstyx, Chacruna, Sia, Journey Colab, and Panacea Plant Science.
2022: There are many things that anger and worry me but, sticking to the happier flip side, I am most invested in the rich, fascinating, and sometimes difficult encounter now unfolding between psychedelics and religion, at least in the broadest sense of the term.
Patty Debenham, interim executive director, UC Berkeley Center for the Science of Psychedelics
2021: I was surprised by the mainstream acceptance and interest in psychedelics. I am seeing this reflected in popular media (Nine Perfect Strangers, Fantastic Fungi); in my friend who has two young children and has started microdosing; and in celebrity conversations such as Will Smith talking with Oprah about his ayahuasca journeys to repair his marriage.
2022: I’m looking forward to opportunities for the underground aspects of psychedelics to come out of the shadows and grow as a legitimate, legal field. Established fields of psychology and holistic medicine can share processes and lessons learned from years of thinking through how to best serve healers and patients alike.
Sa'ad Shah, managing partner, Noetic
2021: The science behind taking the hallucinogenic component out of the medicine.
2022: Companies like Onsero, Delix , ASRI, CaaMTech and Gilgamesh. These companies are on the cutting edge of psychedelic drug development, going after mental and inflammatory related ailments, including the addiction market. Also, eager to see education platforms/certifications flourish for psychedelic-assisted therapist training. I continue to be worried about the bad actors in the space - several of them in the public domain with weak IP and weak science.
Anthony P. Bossis, clinical assistant professor of psychiatry, NYU Grossman School of Medicine, NYU Center for Psychedelic Medicine
2021: Reflecting back on last year, it’s heartening to see the widening landscape of clinical and non-clinical projects related to psychedelics – especially amid the pandemic – and the expanding research community; the increase in serious interest by the culture; and especially the growth of a truly multidisciplinary emerging psychedelic profession. Let’s hope a rising tide lifts all boats. The past two years have reminded us of the ubiquitous nature of suffering, and, ideally, psychedelic research seems poised to lead to treatments to alleviate such distress.
2022: Looking forward to next year and beyond, in addition to the promise of psychedelics as clinical medicine or therapeutics, I look forward to the study of these medicine-generated experiences to potentially help explore the nature of human consciousness - the numinous, peak, or mystical experiences that are a natural part of being human. And the many implications that might flow from this, including fostering inter-spiritual dialogue and the enhancement of insight and creativity – all keenly needed in this extraordinary and challenging zeitgeist.
With rapid growth, comes greater responsibility. I worry about the ever-quickening pace of developments - in the culture and business realm, among others – and the risk that this speed could compromise a psychedelic treatment model that has been shown to be safe and effective in clinical research. Given all the good neuroscience, I hope we don’t lose sight of the heart of the matter, particularly with the classic psychedelics such as psilocybin, LSD, and mescaline - of the experience in consciousness and the meaning associated with it, as being vital to therapeutic and transformative change.
Feeling grateful this New Year’s Day for this newsletter and the information. After spending time last night with family who are suffering with depression and addictions I hope this treatment option helps.
I look forward to the support and development of relations with indigenous peoples that respects and protects them while allowing a transfer of knowledge and experience to those outside.
While I do not see psychedelics as a panacea for all that ails the human condition, I do see them as a necessary part of restoring balance between our species and the ecologies of our planet. (This point cannot be overstated: The psychedelics are a necessary part of establishing a visceral awareness of our interrelation with world ecologies which will be part of how we can rebalance our relationship to be sustainable, benign, and meaningful rather than abusive, exploitive, instrumental and dangerously dysfunctional.)
I also hope that the failures of human systems with disinformation susceptibility, selection and confirmation biases which have been on clear display during the pandemic will provide lessons going forward when we grapple with the far more dangerous climate crisis. There will be bad actors who are vested in the status quo who will do what they can to derail efforts that disrupt their profit models.
All in all though, I think the door is open for advances in the field of psychedelic research, decriminalization, and the introduction of them in therapeutic and religious contexts to advance our species past what appears to be a great filter - our dysfunctional and exploitive relationship with planetary ecologies.