When the Democrats won the White House in the early days of the Psychedelic Renaissance, advocates in the field hoped for a loosening of federal restrictions on psychedelic substances after 50 years of criminalization. But in the time since, many of those advocates have come to suspect that the Biden administration is ambivalent, if not outright hostile, to the prospect of legal psychedelic medicines.
Then in July it was revealed that the White House is considering “a Federal Task Force to monitor and address the numerous complex issues associated with emerging substances,” specifically psilocybin and MDMA. The announcement came in a letter from Miriam Delphin-Rittmon, the Assistant Secretary for Mental Health and Substance Use, to Rep. Madeleine Dean (D-Pa), in which she pointed out that the impending FDA approval of these substances for medical use introduces many policy challenges, particularly around “risks to public health [that] may require harm reduction, risk mitigation, and safety monitoring.”
The proposed task force, according to the letter, would take “a broad-spectrum interdisciplinary stakeholder approach” and “may establish and oversee the functions of a public-private partnership” to “ensure we are thoughtfully coordinating work on emerging substances such as MDMA and psilocybin.”
Dating back to his days as a Senator, when he sponsored the Rave Act which had a chilling effect on drug checking services that test for the presence of potentially deadly adulterants, President Biden has not shown himself to be an ally of the psychedelics movement. More recently, however, some observers have noted shifts in some of his positions. Still, the prospect of a federal task force coming from this White House might well give advocates for psychedelic therapies reasons to be concerned about a new intrusive, and possibly repressive, enforcement regime.
But some of the people who have been instrumental in the development of the proposed task force say that now is the right moment for the federal government to support a thoughtful and coordinated introduction of psychedelic medicine services. They agreed to speak with Lucid News about efforts leading to the task force’s development, following the release of the letter when the proposed task force became public knowledge.
These efforts show support from a coalition of influential military leaders, policy makers and scientific researchers for an engaged federal government initiative to integrate the medical and religious use of psychedelics into American society. These advocates point toward the growing body of evidence in the scientific literature showing the effectiveness of psychedelic substances as medicines, when used in a safe and appropriate manner, as well as their potential to promote spiritual connection and general wellbeing.
Avoiding the Mistakes of Cannabis Decriminalization
Brett Waters, a lawyer and psychedelics advocate in New York, points to the confusion generated by the piecemeal, state-by-state legalization of cannabis, a plant that remains illegal at the federal level even as many states collect significant sums in taxes from cannabis sales. These challenges, Waters says, are “quadrupled when you add the therapeutic component. There are a lot of professional licenses at risk, and insurance problems.” These challenges, he says, run “from the training side to the facility side. There are all sorts of issues.”
With Oregon well on its way toward launching the first statewide program to legalize the use of psilocybin, the psychoactive component in magic mushrooms, Waters notes that “more and more psychedelic churches will pop up, more decriminalization and legalization efforts, which will create this really complex legal system. If you want to do it as safely and equitably as possible, they’re going to have to get involved, do more research, and provide more funding and education.”
For the past two years, Waters has worked to pass legislation in Connecticut and Pennsylvania that supports psychedelic-assisted therapy programs and research. He is currently involved in new initiatives in New York, Florida , Illinois and Texas, among other states.
In early 2021, Waters brought together a small group of allies with policy experience under the banner of Reason for Hope (R4H) and established the group as a nonprofit advocacy organization. His co-founders include two retired generals and a clinical psychologist who leads psychedelic research at Baylor College of Medicine and maintains a faculty appointment at Yale University. Together they have played a leading role in the emerging new wave of psychedelics policy development, including at the federal level.
The group shares the view that psychedelics are “a game changing, paradigm shifting form of treatment that is going to be difficult to integrate into the healthcare system,” says Waters. “Our focus is: what policies can we help advance that will safely and affordably make this accessible to people?”
“I don’t have a practice in this space,” says Waters, who is an antitrust attorney at Winston & Strawn in New York. “We view ourselves as an independent, non-financially conflicted public interest policy group, almost a watchdog organization, that can advance policy without conflicts of interest.”
On its website, the group says that it has “operated thus far on a purely volunteer basis.” In August, Reason for Hope received a grant of $500,000 from the Steve and Alexandra Cohen Foundation to support an expansion of their activities. This month the organization received an additional grant of $150,000 from the Joe and Sandy Samberg Foundation.
A Federal Task Force on Psychedelic Therapies
The idea of the federal task force to examine the therapeutic use of psychedelics was introduced to the Biden administration by R4H co-founder Stephen Xenakis, a retired U.S. Army Brigadier General and clinical psychiatrist who has advised the Chairman of the Joint Chiefs of Staff on the psychological health of military personnel. He has long been interested in innovative treatments for combat veterans suffering from post-traumatic stress disorder.
“These can be profound therapies,” says Xenakis about the research into the use of MDMA and psilocybin-assisted therapy to treat PTSD, referring to these treatments as “transformational in the way that there will be a paradigm shift.” He is particularly encouraged by how MAPS PBC and Usona, two of the organizations furthest along in FDA clinical trials, are following protocols that emphasize therapist sessions before and after the drug sessions.
“It’s not just the drug. It’s the therapy that goes with the compound. They are doing what we did in the Seventies,” Xenakis says, referring to his experience as a medical student at the Spring Grove Clinic in Maryland, where he was involved in research into LSD therapies during the first wave of psychedelic research. Before ending in the late Seventies, the program was home base for some of the field’s leading innovators, including Walter Pahnke, Stanislav Grof and William Richards.
Xenakis had been unaware of the revival in psychedelic research that began in the aughts, until a conversation in 2020 with the philanthropist Alexandra Cohen, who has an interest in the field. In 2019, the foundation Cohen started with her husband, New York Mets owner Steven Cohen, made a major donation to the founding of the Johns Hopkins Center for Psychedelic and Consciousness Research.
Xenakis recalled that Cohen felt research and trial programs were going too slowly and asked if he had thoughts about how federal engagement could move the field forward more quickly. “I said, this is what I most enjoy doing. Let me think about it. So I started in July 2020 to figure out what we already know about these therapeutic modalities and how they can be fast tracked.”
Cutting through federal bureaucracy is a proven area of Xenakis’ expertise. In 1992, he was asked to lead a task force that would overhaul the Army’s approach to medicine at a time when the military was transitioning after the end of the Cold War. A paper he wrote on the topic with some War College classmates had attracted the attention of Secretary of State Colin Powell. It argued that military medicine was at an “inflection point.” Then the Berlin Wall fell. A task force was established, Xenakis was put in charge, and he answered directly to the Surgeon General and the Chief of Staff of the Army.
“I realized you need to have a core team to do something transformational,” says Xenakis. “I had worked with then-Vice President Biden on gun violence and suicide, so I knew people that were senior government officials. I approached them about putting together a coordinated initiative from the government side, knowing that there was a lot going on on the private side and in the academic world.”
At a meeting with Admiral Rachel Levine, Assistant Secretary for Health at the Department of Health and Human Services, in August of last year, Xenakis proposed the idea of a federal interagency task force focusing on psychedelic medicine. “I said, this is transformational. This is going to make a lot of people feel we’re in their rice bowls. It’s going to force a lot of changes in operations. We need to have this organized with a core team that’s on the same sheet of music, that’s got a sense of direction, authority, and is moving forward.”
Levine and others at HHS expressed interest.
In the spring of 2022, Xenakis was contracted to consult with the leadership of the Substance Abuse and Mental Health Services Administration inside HHS, to review the status of empirical evidence and explore policy considerations surrounding, as he puts it, “emerging therapeutic healing modalities.”
A Briefing at the White House
As the task force idea began to circulate, Xenakis was introduced to Brett Waters and the Reason for Hope group, which had brought its own proposal to the Biden administration.
Reason for Hope crafted a plan that was far more ambitious than Xenakis’ task force proposal. They suggested that the administration make it their policy to “support and fund research of novel potential treatments… including psychedelic-assisted therapy (PAT),” and that the Office of Management and Budget receive direction “that this work is to be funded and prioritized for approval of studies.”
The plan called for a “Commission on Novel Therapies to Combat the Mental Health Crisis, including PAT,” that would be required to issue a report with recommendations within 6 months. It encouraged the DEA to simplify the process of applying for licenses to research Schedule I substances and “reduce the time for approval by 75%.” It also proposed an inter-agency working group.
As R4H co-founder Lynnette Averill put it, they thought, “Let’s put all our chips on this. Let’s just go for it.”
Members of the Waters group reached out to contacts in the White House. “We got a meeting very quickly. They were clearly already interested in learning more,” about policy options for psychedelic medicines, Waters says.
Around the same time that Xenakis met with HHS last August, the Waters group gave a presentation to the White House Domestic Policy Council. Alongside Waters was Averill, an Associate Professor at Baylor College of Medicine and a Research Psychologist at the Veterans Administration, and Martin Steele, a retired three-star Lieutenant General in the Marine Corps.
Steele is also a co-founder of R4H and serves as CEO. Steele once served as the Deputy Chief of Staff for Plans, Policies, and Operations at Headquarters for the Marine Corps. In 2015, Senator Mitch McConnell assigned him to the Commission on Care that proposed plans for the future of healthcare provided by the Veterans Administration.
They entered the meeting, in the words of Averill, “tentatively hopeful.” She noted that participants had been exposed to many different perspectives about psychedelics. “We knew, of course, that there is a lot of stigma, misunderstanding, misinformation in this field. There’s also a great deal of hype, some earned and some not earned, some appropriate and some not appropriate.”
For the first part of the virtual briefing, the three talked through their policy recommendations. Much of the information they presented was new to the administration representatives, who did their best to keep up. But the most powerful part of the meeting came next. They were joined by Andrew Marr, a retired Green Beret, who spoke movingly of how psychedelic therapy led to his own recovery from brain trauma. He was followed by Ethan Abend, a retired NYPD detective, who suffered both PTSD and a traumatic brain injury and told his story of seeking out and finding psilocybin therapies through the underground.
While the policy proposals were not embraced, the personal testimonies left a strong impression. According to Averill, administration officials also seemed to understand the critical importance of bringing a wide range of diverse viewpoints from the public into this emerging conversation. “For psychedelic medicine, the key stakeholders may be a little bit different,” she explains.
Finding Support on Capitol Hill
Soon after these meetings, Xenakis formally joined R4H as the fourth co-founder and the group came to focus on the inter-agency task force.To build support for the proposal, they began to look for allies on Capitol Hill.
An early meeting was arranged with Representative Madeleine Dean of Pennsylvania, who became aware of the promise of psychedelic medications, specifically psilocybin, through Susan Ousterman, an advocate who had played important roles in legislative efforts in Pennsylvania and Connecticut, the later of which passed.
Ousterman, the president of the Vilomah Memorial Foundation and a player in Pennsylvania politics, had lost a son to opioid addiction. She had learned from a trusted doctor friend about the high success rate of ibogaine therapy for substance abuse. Covid lockdowns, however, prevented her son from receiving legal ibogaine treatment outside of the country. After his tragic overdose, she became a committed activist on behalf of others who suffered as her son had.
In the course of Ousterman’s efforts, she met Waters and arranged for him and his group to meet with Dean. The initial meeting was with one of Representative Dean’s aides. Waters, Averill and the two generals were there, presenting the research, making the case for the task force.
“We had this group of very prominent people listening to my story,” Ousterman recalls, “getting choked up and saying, we have to fix this. I remember someone made the comment, this is why we’re doing it, for people like you and your son. I was in shock for about two days after that meeting. I thought I was going to hit all kinds of roadblocks, fighting the pharmaceutical industry and all kinds of corruption. But these guys, they’re left and right. Retired military generals were in this room saying we have a mental health crisis in this country.
“It was very moving. Right then I actually called Dean on her cell phone and said, I need you to listen to this. This is incredible. She took the meeting and was blown away.”
Ousterman then arranged for a briefing with another Pennsylvania Representative, Republican Brian Fitzpatrick. This meeting had a different tenor, according to Ousterman, who describes Fitzpatrick and his aides as more skeptical. But bringing two generals to the meeting had an impact.
“They were impressed that we had the involvement of the military leaders,” she says. “That’s what sold them.”
In state and local initiatives across the country, psychedelic medicine has attracted bipartisan support. Former Texas Governor Rick Perry, well known for his conservative positions, has become a prominent advocate for psychedelic therapies. A similar dynamic is now emerging in Washington, D.C.
Having generals lead the effort is turning heads. As Waters explains, “Their involvement will always help get us into rooms we otherwise would not get in. For Republican support, just like the veteran angle, it has a big impact. General Steele has a lot of clout on both sides, a lot of connections. He has been in this game for a long time.”
It also seems that personal experience with psychedelics is not limited to left leaning Democrats. Averill noted that aides on the Hill from both sides of the aisle hinted at their own familiarity with mind expanding substances. Did it happen often? “Yes, massively. There was definitely a level of understanding and very much a level of interest,” she says.
A Bipartisan Effort
The task force concept gathered momentum in February when it was proposed in a letter to Xavier Becerra, the Secretary of Health and Human Services, from a bipartisan group of Representatives led by Dean that included Fitzpatrick, Michael Waltz (R-FL), Earl Blumenauer (D-OR), and Dean Phillips (D-MN). Representative Waltz represents Florida’s 6th district, a seat formerly held by Governor Ron DeSantis.
The letter requested the establishment of “an inter-agency taskforce on the proper use and deployment of psychedelic medicine and therapy – and that the taskforce be situated in the Office of the Assistant Secretary of Health.”
Acknowledging that many people will be using psychedelic substances other than those sanctioned by the FDA, the letter points out that “psilocybin and other psychedelic compounds can be cultivated at home relatively easily, and several states have already passed or proposed measures for decriminalization or the creation of intrastate regulatory systems authorizing cultivation, production, distribution, research, and supervised or therapeutic use of non-FDA approved formulations of psilocybin or psilocybin mushrooms.”
The purpose of the proposed task force would be to establish national guidelines that states could choose to follow as they put in place frameworks to regulate the legal use of psychedelics. The letter says that “published national guidelines would be the most effective mechanism in establishing good standards of practice, including provider training, credentialing, state licensure, dispensing, safe and ethical use monitoring, etc.” It would also support the establishment of these frameworks through federal funding.
Earlier this year, Senator Cory Booker and Representative Dean requested $3.45 million in funding for the federal task force from the House and Senate Appropriations Committees. The funding has yet to be approved.
Biden’s Psychedelic Timeline?
In May, Representative Dean received the letter from Delphin-Rittmon that acknowledged HHS is exploring the creation of a federal task force. But the reply got headlines for a different reason. One phrase in particular led some to believe that the Biden Administration was committed to a two-year timetable for psychedelic legalization.
But Waters cautions against interpreting the letter in that way. “The ‘approximately 24 months’ language in the letter was just a boilerplate response directly quoting back the language we used in our letters to HHS.” Waters pointed to the letter from Representative Dean, which Reason for Hope was involved in drafting, as well as one from state legislators in New York, Pennsylvania, Connecticut and Texas. Both letters spoke of the anticipated approval of psychedelic medicines by the FDA in that timeframe.
“These estimates were based on widely reported information (i.e. from MAPS and Compass Pathways on timing of their FDA clinical trials), but unfortunately, do not represent any sort of belief or confirmation on the timing from the Biden Administration,” says Waters.
“No, this was not the Biden administration announcing anything,” he says, adding that the anticipated announcement of a federal task force would not amount to a change in that position.
In response to a request from Lucid News regarding the task force’s status, a statement by SAMHSA said only that the department “is exploring the prospect of establishing a federal task force to monitor and address the numerous complex issues associated with emerging substances.”
A Public-Private Partnership
There has long been interest within HHS in the therapeutic potential of psychedelics. Last year, for instance, the National Institute of Health, a department inside HHS, convened a series of academic presentations about the current state of psilocybin research. These papers are being gathered into a special issue of the peer reviewed journal Neuropharmacology.
The issue includes an article that makes the case for a coordinated federal initiative to develop a national framework, titled “Policy considerations that support equitable access to responsible, accountable, safe, and ethical uses of psychedelic medicines.” Xenakis and Averill are co-authors. The lead author is Captain Sean Belouin of SAMHSA. The paper began as a presentation by Belouin as part of the series, and underwent revision by a team of influential academic co-authors whose affiliations include Johns Hopkins, the David Geffen School of Medicine at UCLA, the UCSF Department of Psychiatry and Behavioral Sciences, and the World Health Organization.
The authors make the case for a “public-private partnership that engages a community of stakeholders from various disciplines” in the development of a coordinated federal framework. The paper reflects an increased receptivity from federal policy makers to recommendations by academic experts about practical approaches to creating a national program.
Waters also believes that a federal effort should include a public-private partnership that is structured to invite input from a “broad tent” of stakeholders.
“This is meant to involve everybody from the religious use side of things, the indigenous communities who have been doing this work for a long time, the harm reduction communities, and mental health communities. Stakeholders who will be impacted by this should have a seat at the table to share their perspective and influence how this is going to move forward,” says Waters.
Xenakis highlighted the importance of including indigenous and religious voices in the process, noting that “these compounds are used very much in the sacramental, religious community. As we saw in the Army, some people don’t want to go see their shrink. They want to see their chaplain. So if they’re going to get healing, they’re going to get it through their religious experience. That’s legitimate.”
General Steele also makes the case for an inclusive approach to the task force.
“Well-intentioned research was there on the civil side” until it was shut down in the 1970s, Steele says. “The sacramental nature of everything from peyote to ayahuasca to you name it, it all had value. If properly handled it really could have been a game changer. But we kicked it into the grandstand.”
According to Steele, one of the task force initiative’s ultimate outcomes could be the rescheduling of psychedelic compounds, beginning with psilocybin. “We’ve got to get [psychedelics] as medicine, get it into Schedule 2, and make this happen to change lives for the better.”