Those who support cleaving off $42 million in opioid settlement funds to support ibogaine research and drug development have lost a key champion this week as the Kentucky Opioid Abatement Advisory Commission (KYOAAC) sees a changing of the guard. Now, it looks very likely that the project will be shelved.
Over $50 billion in opioid settlement funds are to be dispersed across the United States in the coming years, with states responsible for their utilisation.
Given the large pot of money, it’s perhaps unsurprising that states have reportedly received pitches from industry for some curious uses of funds. KFF Health News reports that1 one such pitch featured “a lasso-like device to help police detain people without Tasers or pepper spray”, as well as electrical stimulation devices and locking pill bottles2.
But a small coterie of elected officials and bureaucrats buoyed by ranks of psychedelics advocates forwarded perhaps the most surprising suggestion: allocating over $40m of Kentucky’s settlement funds to research and develop ibogaine—a psychoactive alkaloid commonly derived from the iboga plant found in West and Central Africa—as a treatment for opioid use disorder.
The Genesis of ‘Kentucky’s Manhattan Project’
For its part, Kentucky has secured around $900 million in settlements from companies involved in the perpetuation of the opioid crisis, half of which falls under the remit of the KYOAAC.
At the helm of the Commission is Bryan Hubbard, appointed as Executive Director in June 2022, who is responsible for overseeing and administering it on behalf of the Attorney General’s office. Hubbard had previously worked in the state’s Cabinet for Health and Family Services as Commissioner for the Department for Income Support, where he led research on Social Security Disability and Child Support Enforcement programs.
It was Hubbard, in his role as Chair and Executive Director of the KYOAAC, who appears to have unilaterally introduced the idea of carving out settlement funds for ibogaine research—the state’s Manhattan Project, in Hubbard’s and ibogaine researcher-cum-drug-developer Deborah Mash’s words—in the state.
But how did Hubbard become so inspired?
In a ten-page letter seen by Psychedelic Alpha, Hubbard charts his journey of discovery with regards to ibogaine which took him from being “completely ignorant” to a point where he “would stake [his] professional reputation and career on its pursuit”.
The seed was planted when Hubbard stumbled upon a Substack column by Julia Christina in 2021. The newsletter, called The Journey, has just over a few thousand subscribers, according to the platform, and charts Christina’s personal struggles with anxiety, depression and an eating disorder; and the role that she believes psychedelics played in addressing these ailments.
Aside from chronicling the apparent therapeutic effects of psychedelics, Hubbard notes that Christina “also explains how her plant medicine experiences created and affirmed her concrete knowledge of the existence of a Higher Power whose essence is pure, unconditional love”, adding, “I was moved by her life’s story.”
Following his appointment to the KYOAAC, Hubbard says he reached out to Christina to schedule a phone call, which took place on July 29, 2022. It was here, according to Hubbard, that he heard the word “ibogaine” for the first time.
From there, Hubbard says Christina connected him with others who had interest and/or experience in ibogaine.
When asked by Adriana Kertzer—a lawyer who practices in the psychedelic space—who he might wish to be put in touch with, Hubbard “advised her that I was completely ignorant of the subject matter and couldn’t begin to name any specific individuals.”
Hubbard agreed to visit Kertzer’s home in New York City to attend a gathering of individuals and discuss ibogaine’s “potential relevance to Kentucky’s opioid epidemic.” (In the letter seen by Psychedelic Alpha, Hubbard is keen to note that he committed to attending the meeting “on my personal time and dime, even though it presented substantial risks.”)
And so, in December 2022, Hubbard and his wife travelled to Kertzer’s home in New York where he met “researchers, philanthropists, and the leaders of U.S. military veteran organizations whose collective mission is to make plant medicines legally available and accessible to everyone who wishes to benefit”, he said in his letter.
Hubbard recalls receiving “commitments from all attendees to supply whatever informational resources and contacts I may need to decide whether to present ibogaine as Kentucky’s ‘Manhattan Project Opportunity’.” Those attendees, he says, came through; supplying him with “an immense trove of research and informational resources to make an informed judgement as to ibogaine’s legitimacy as a potential breakthrough treatment for opioid dependence.”
“For over a month, I worked a second, off-the-books, after-hours, full-time job-consuming academic research and knowledge from dozens of individual sources to make a measured and informed determination”, he says.
This, Hubbard writes, led him to four conclusions, or “consistent realities” as he calls them.
The first is that opioid dependence is a “neurochemical brain injury that shuts down dopamine and serotonin production”. Those two neurotransmitters, according to Hubbard, “drive all baseline human survival behaviors which encompass the hardwired instincts to eat, drink, and procreate.”
His second conclusion is that “ibogaine clears the brain’s opioid receptors and restores its natural production of dopamine and serotonin”, and his third is that individuals who receive ibogaine treatment “report the acquisition of individual autonomy”.
His fourth “consistent reality” is that “[p]eople who receive ibogaine treatment report receiving absolute affirmation of their individual divinity as spiritual beings who are connected to and loved by a Higher Power”. “The transformative power of this affirmation”, which he describes as “Divinely Engineered power” later in the letter, “is perhaps the most potent and compelling ibogaine attribute.”
All of this leads Hubbard to believe that ibogaine “may be the most advanced neurotherapeutic medication ever discovered.”
Hubbard Goes Public
Having come away from these closed-door discussions convinced of the “Divinely Engineered power” and potential of ibogaine, Hubbard sought to appropriate opioid settlement funds to support the research and development of what he believes to be a breakthrough treatment option for opioid use disorder.
Accordingly, he briefed the Republican Attorney General, Daniel Cameron, advocating for $42m of funding over six years (2024-2030) to establish a public-private partnership to fund clinical trials with ibogaine in Kentucky. Hubbard felt so strongly about ibogaine’s potential that he told Cameron he would stake his professional reputation and career on this pursuit.
Cameron gave Hubbard the green light, allowing him to continue investigating the use of funds. A Press Conference was held on May 31st, 2023, where Cameron kicked things off by teasing “the next big breakthrough”.
Hubbard then took to the podium, cutting right to the chase: “we are here to announce the arrival of Kentucky’s breakthrough opportunity”: ibogaine.
After speakers including Lieutenant General Martin R. Steele of Reason for Hope expressed their optimism for the initiative, Hubbard took to the podium once more to offer some next steps. “Over the coming months,” he said, “the commission will explore the possibility of devoting no less than $42 million over the next six years to the creation of public-private partnerships which can incubate, support and drive the development of ibogaine all the way through the FDA approval process.”3
“Kentucky will also seek to develop the platinum standard model for an ibogaine recovery protocol by hosting multi-site clinical trials right here at home”, he added.
But Governor Andy Beshear immediately questioned the Cameron-Hubbard proposal and expressed frustration that it was announced without consulting his two appointees on the KYOAAC.
The ibogaine initiative “came out of the blue” and “caught everybody off-guard”, according to a source in a Daily Beast exclusive that alleged conflicts of interest. Just as psychedelic advocates were questioning California Governor Gavin Newsom’s motives for vetoing a psychedelic decriminalization bill (SB 58), the Beast’s reporting questioned the motives behind the potential ibogaine funding. Opposition researchers requested ibogaine program-related records from Cameron’s office, the Beast also reported.
It’s difficult to know what motivated this decision to blind-side members of the Commission and the broader Kentucky political leadership. Some may view it as a form of political game theory, whereby opponents of the ibogaine initiative would risk publicly opposing the purported interests of veterans and associated advocacy groups. Others might simply point to factionalism or a breakdown of communication.
Nonetheless, in an 8-1 vote the Commission committed to conducting several public hearings to generate a record of its due diligence.
Three hearings took place: the first (in July) focused on science, the second (in September) heard from those with lived experience of ibogaine use, and the third focused on appraising the FDA’s willingness to approve trials of ibogaine given its known cardiac risks.
Alongside this KYOAAC calendar, unaffiliated events such as The Kentucky Summit (which saw drug developer atai Life Sciences as the presenting sponsor) and new nonprofits like The Kentucky Ibogaine Initiative, Inc. appeared.
Other proponents emerged, too. A Newsweek Opinion piece by former Texas governor Rick Perry, Marcus Luttrell, Morgan Luttrell and Dakota Meyer published the day after the November elections appealed to the Commission to allocate the $42m to ibogaine, arguing that Kentucky possessed “a unique chance to pioneer a revolutionary approach to combat opioid addiction and pave the way for the entire country.”
The $42m in funding for ibogaine, it was said, would be decided in a vote by KYOAAC. The Commission was waiting to see one further piece of evidence or testimony, Psychedelic Alpha understands, prior to voting—a highly-anticipated study from a Stanford researcher that’s still forthcoming. The vote was most recently expected to happen this winter.
A Changing of the Guard
In November, incumbent Andy Beshear defeated the state’s Attorney General Daniel Cameron in the Governor race. Kentuckians also elected Republican Russell Coleman, who describes himself as an “America First Conservative”, to serve as the state’s next attorney general, succeeding Cameron.
At the time, we pondered out loud:
Might the fall-out from yesterday’s elections change the odds of success for this effort? If the changing of the guard reaches the ranks of the KYOAAC, such as Bryan Hubbard, the ambitious $42m appropriation could be dead in the water.
Indeed, it has now become apparent that Attorney General-elect, Coleman, has chosen former DEA Chief Operating Officer and acting administrator Chris Evans to replace Bryan Hubbard as Executive Director.
When asked directly about the future of ibogaine in Kentucky, Herald Leader reports that Coleman expressed concerns that the state is not focusing enough on addiction prevention. “There’s been a lot of ink spilled on ibogaine”, he said.
And so, Hubbard is out of a job. “I find myself at a juncture where a change in leadership has been requested”, Hubbard wrote in a resignation letter dated December 26th.
“Throughout this endeavor, my greatest concern lay in the future viability of the Ibogaine Project”, he continued, adding that “[a]fter a stark discussion with the incoming Attorney General Russell Coleman, I am stepping down to allow for a new direction”.
In the longer letter seen by Psychedelic Alpha, Hubbard says that Coleman “expressed great displeasure with my public advocacy for ibogaine in Kentucky and declared his intent to move the commission in a different direction.”4 The December 15th meeting ended, according to Hubbard, “with a request that I submit my resignation no later than December 31st, 2023.”
“[V]ocal opposition to our endeavor was confined to two contrary voices that occupy significant centers of power” within the state, in Hubbard’s opinion. Those two voices were Andy Beshear5 and researchers affiliated with the University of Kentucky’s Center for Drug and Alcohol Research and HEALing Communities Study Team.
At this point, Hubbard’s ten-page letter turns polemic.
“There is a sordid financial relationship between Big Pharma manufacturers of existing ‘evidence-based best practices’ and university researchers who are paid to conduct and develop research used to secure the commercial availability of their products”, Hubbard went on, accusing the aforementioned groups of “fealty” to ‘Big Pharma’.
Ibogaine, then, “presents a mortal threat” to an “established order” that “monetize[s] sustained human illness”, Hubbard supposes. “The motivation driving much of its opposition is as plain as the dollar bill”, he quips6.
But non-voting member Danny Bentley (Republican)7, had earlier cautioned the Commission on incentive misalignment in the present ibogaine initiative, arguing that “[i]f the people paying for the research own the company and the drug, it was invalid from the get-go.”
Bentley, a pharmacist, also said the initiative was “false hope”, adding that it would take “$2 billion and 10 years” to get an ibogaine product to market. He added that any approved product would bear a black box warning.
The Director of the Center on Drug and Alcohol Research at the University of Kentucky, Sharon Walsh, also expressed concerns about the funding, including by pointing out that the Commission is supposed to allocate funds to ‘evidence-based’ measures.
Anyhow, given that Hubbard—the key architect of this attempt at carving out $42m in funding for ibogaine from the state’s opioid settlement funds—is leaving his post, it appears very likely that the plan will be nixed.
“While skeptics may question why such a promising treatment remains obscure, the answer lies in politics, not science”, Rick Perry and co. wrote in the aforementioned Newsweek Opinions piece.
The difference between Beshear and Coleman’s apparent attitude to KYOAAC’s future (which aims to focus much more on prevention going forward) and Hubbard’s moonshot to develop a “Divinely Engineered” or “Higher Power” is certainly stark.
This effort to appropriate opioid settlement funds in pursuit of a risky endeavour to develop a psychedelic therapy revealed several fault lines.
One such tension is that between in-state interests and national interests. Given that Hubbard et al.’s purported goal was to achieve FDA approval of an ibogaine treatment for opioid use disorder, the reward (FDA approval) would be recognised at the national level, as opposed to benefitting Kentuckians per se.
In his letter, Hubbard notes that there would somehow be “recognition of Kentucky’s proprietary interest in any data, final product, or other intellectual property that may be created by the project.” He added that “Kentucky stood to receive an exponential return on investment”, providing “a perpetual stream of revenue with which to build out the long-term recovery infrastructure.”
But still, the benefit to Kentuckians of spending a significant amount of funds earmarked for state-level abatement efforts might have been too tenuous or risky to make sense for politicians and locals alike; especially given the fact that $42m is unlikely to progress such development to the point of approval.
And, we know that voters in other—more liberal—states are concerned about the appropriation of state funds for psychedelic research; especially where the direct benefit to locals is unclear. As we reported in November, the TREAT California initiative that would have established a $5 billion psychedelic R&D agency in the state was withdrawn after polling suggested Californians did not support the creation of a state agency to fund the program.
Another area of tension is using public funds to support the development of proprietary treatments, whether they be patented compounds, formulations, or protocols; or simply drug products that might ultimately benefit from data or market exclusivity and thus reap outsized financial rewards. As aforementioned, Hubbard sought to address these concerns in the letter seen by Psychedelic Alpha, but questions remain about the extent to which for-profit actors should benefit from opioid settlement funds.
Ultimately, if any party is going to foot the bill—which will likely be measured in hundreds, not tens, of millions of dollars—to bring ibogaine to market as an FDA-approved treatment, it’s most likely going to be industry.
Advocates will hope that the hearings and momentum generated—including the formation of a loose coalition—will provide the basis for further developments in the near term. A number of individuals and groups close to the matter told Psychedelic Alpha that the initiative might be taken to another state in the new year.
Pα Take: This funding would have undoubtedly been a significant milestone for psychedelic research, so its apparent downfall will be disheartening to many advocates. Nonetheless, these events may offer perspective on, and instruction regarding, where psychedelic research sits in terms of state political and funding priorities; especially when viewed in light of other psychedelic policy reforms (and failures) of late. ∎
Stay Informed in 2024 with Pα+
This free article is made possible by our paid subscribers, who gain access to our Pα+ exclusive content.
Subscribe to Pα+ to receive all of our Bulletins, deep dives and analysis, as well as access to the Pα+ Library and other subscriber-only content.
- See KFF Health News’ Payback: Tracking the Opioid Settlement Cash: https://kffhealthnews.org/opioid-settlements/
- The story also notes that North Carolina earmarked nearly $2m in settlement funds for a pilot project of Pear Therapeutics’ digital therapeutic for opioid use disorder. Fortunately, the state hadn’t disbursed funds to Pear at the time of its bankruptcy in spring 2023.
- The cost to develop a drug to the point of FDA approval is often measured in hundreds-of-millions, or billions.
- Hubbard also claims to have received communications from individuals that wish to remain anonymous that Coleman “has been engaged in a months-long whisper campaign against the ibogaine project.”
- Hubbard was keen to point out that Beshear “received his law partner draw while his firm actively represented Purdue Pharma against the people of Kentucky”.
- In the letter itself, Hubbard speaks at length. “The dynastic aristocracy of insider interest which controls Kentucky has developed and operated a dehumanizing system of socioeconomic extraction since the end of the Civil War. It has left a legacy of pathological subjugation which has produced common afflictions among diverse populations…”
- Bentley has since announced his resignation from the house following anti-semitic comments.