Transcription
Okay, there is a lot to say in this introduction, and it is 3:48 a.m., and I'm trying to get this out before the end of the month. It is technically the end of the month, but maybe you can get a little taste of it. This is a really amazing interview with a lawyer named Brian Hubard, who was the major figure in a high-profile project in Kentucky to try to introduce a program to develop ibogaine as a treatment for opioid use disorder. As you might imagine, I think this is a fantastic thing, but as has been the case with many developments in recent years with psychedelics, there has been a surprising amount of opposition, including opposition from Dimitri Mugan, who has been arguably the face of ibogaine in the United States.
I see this as a sort of two-part interview. Part one is this discussion with Brian Hubard, which is an amazing overview of the politics surrounding the Kentucky ibogaine program. This man is a fucking incredible orator. I saw him speak, and the intensity had everyone in the room totally captivated. And then meeting him afterwards, I thought, wow, this is a guy that is good to have on your side. If there were ever a lawyer who I would want to defend something that I cared about, it would be Brian Hubard. And you'll see the way that he answers my questions; it is remarkable. I would not want to be in a debate with this guy.
I actually sent Dimitri a recording of this conversation before I interviewed him, and I think he kind of felt the same way, which is it's hard to argue with the case that he makes. The arguments that have been bandied about, many of which were published in the Kentucky Career Journal, the majority of which were not written by people from Kentucky, and the majority of which were written by people associated with symposia, fall into a variety of familiar categories. What if the treatment is too expensive? What if pharmaceutical companies profit off of it? What if it's dangerous? And aren't we neglecting to address holistic dimensions of addiction that go beyond pure pharmacology? All of these objections are valid, but like anything in life, you have to do a sort of cost-benefit analysis and figure out what will help the most people.
If the issue is that pharmaceutical companies might profit off of ibogaine, this interview makes it abundantly clear that they are currently profiting enormously off of opioid maintenance therapies. So if your concern is capitalism and pharmaceutical profit, I don't think attacking an ibogaine program is a particularly efficacious route. If your concern is that the treatment will be expensive, well, it will be covered by Medicaid if it is approved by the FDA. If the concern is that it's dangerous, well, once again, you have to do a very serious cost-benefit analysis in the situation. One thing that is unquestionably dangerous is opioid use disorder. This is one of the most dangerous disorders you could possibly have. Anyone listening to this would have to agree with me that there is a problem with people who use opioids dying of overdoses. And that even if a therapy is slightly dangerous, if the disorder it's treating is extremely dangerous, it may be worth the risk.
I've seen all kinds of bad arguments. There was a physician named Ryan Marino who tweeted, "Ibogaine was studied in earnest, large-scale, global trials in the 90s, which were all shut down because so many participants died. Ibogaine is incredibly cardiotoxic and unsafe to use." What if we put that money toward treatments that we already know work that are still severely underfunded? Well, they're not that underfunded; hundreds of millions of dollars are being spent on them, and this is a small fraction of that money. This physician's claim that earnest, large-scale, global trials were conducted in the 90s is half true. There were studies that were of varying quality; few of them were done under conditions that would be rigorous enough to meet FDA criteria. People undergoing ibogaine treatment for opioid use disorder have died; it's a real risk. But dying from opioid overdose is also a real risk, and with appropriate medical care, those risks can be dramatically reduced.
Deborah Mash, who did a lot of the early research with ibogaine, currently is working with a pharmaceutical company called DeMeX. They finished phase one clinical trials with ibogaine; nobody died; there were no severe adverse events. It's a kind of Catch-22: you have low-quality studies that are done in a lot of these clinics where people die, and there's all kinds of confounding issues, even evaluating these deaths. You have to do a baseline risk assessment in a patient population that has this very dangerous drug use disorder; often they're poly-drug users; often they have untreated medical problems. There's a lot of complexity at play, and well, there have been these deaths—I even interviewed someone on my show who was associated with one of these deaths, but I didn't know about it at the time—Can't Yosh Paul, I think was his name. The reality is that when you have underground use or pseudo-medical use in unregulated clinics, there is a lot of potential for harm to occur. Personally, I think that those clinics should be allowed to function as well, but I really think that people should have an alternative that is more regulated.
I've met a couple of people actually involved in ibogaine therapy that frightened me because I thought, these people are so unstable; these are the last people that I would want to be in charge of my life under the influence of this powerful psychedelic. But this is also a typical pattern in drug treatment, where you have people who are previously drug addicts themselves who then become employed at treatment facilities. I don't think there's anything necessarily wrong with that; in fact, I think there are actually major advantages in terms of the empathy that somebody who's gone through the same struggles themselves might have for patients. But I think that a regulated framework is extremely likely to mitigate many of these harms. I think that the basic calculus that needs to be done is, is this more dangerous than it not existing? And I can't think of any way that this could be more dangerous than what currently exists. So I'm very much in favor of the program that Brian Hubard was trying to create.
I think this is an amazing conversation, and I'm going to save more analysis of the deaths and the underground therapy for the upcoming conversation with Dimitri Mugan, which has been recorded. I'm just editing it, and we'll have it out very soon. Enjoy this conversation with the lawyer and one of the architects of the Kentucky ibogaine project, Brian Hubard. [Music]
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Thank you so much for joining me. I've been trying to review this interesting historical moment and how all of this came to be, but for people that are unaware of these settlements about the potential ibogaine program in Kentucky, could you tell me a little bit about yourself and background on this project?
I grew up in the coal fields of Virginia and ended up going to undergrad outside the DC area. Following undergrad, I went to the University of Kentucky law school. I come from a blue-collar family in which I received a very idealized notion of what America is all about in terms of her civics and her history. And when I went to law school, I thought that I was going to learn how to defend truth, justice, and the American way, and to make wrong right and to assure justice for all. And I learned very quickly that the practice of law has almost nothing to do with any of those things. And at the end of my first semester in law school, I had taken on a pretty significant amount of debt to be there, and I saw no real viable choice other than to soldier on to the end and get a job that would allow me to pay those bills.
I accidented into what was the beginning of a 16-year legal career representing three of the state's most significant employers in their workers' compensation cases. For a period of time that began with the onset of the opioid epidemic in Central and Southern Appalachia, and then it spread throughout the rest of the country. This was a dynamic that I saw play out at a very granular level within my workload. I saw it play out within Appalachian society when I would travel into Eastern Kentucky, and when I would return home. It's also something that I saw play out within my family.
There was one deposition that I took a hundred times, and it was of the same type of individual. This person was usually a 35- to 60-year-old white female, usually from the Appalachian region of Kentucky, who would have spent a significant amount of her adulthood working consistently in very hard, low-skill, low-wage jobs and other vocations. At some point in time, this person would experience a relatively minor work accident—a slipping, falling, or a lifting injury of some kind—that usually a person would recover from within six months to a year at the outside. And this person would make their way to a lawyer or a doctor, and lawyers and doctors that would yield these results within the individual were fairly consistent. This person would go to a family physician; they would claim that they were experiencing all these diffuse and debilitating pain symptoms throughout their body. The family physician would proceed to write prescriptions for a combination of opioids and psychotropic medications that were habituating—things like Xanax, Lexapro, Paxil, and others. And then the individual would make their way to a lawyer; sometimes the person would go to the lawyer, and they would send them to the prescribing physician. In all cases, the individual would receive a significant amount of pharmacology; they would undergo every diagnostic study known to exist to ascertain the source of their pain. Sometimes they would make their way to a very inventive surgeon who would develop a diagnostic rationale to perform a very invasive surgery that usually involved the fusion of this individual's spine.
By the time I got to their deposition, if the person was not truly disabled by their work accident, they were disabled by the sort of medical treatment they received, primarily pharmacological treatment. By the time I got to them for a deposition, I would patiently cross-examine this individual; I would have her speak in great detail about her pain symptoms and her inability, and then I would take out medical records related to a variety of diagnostic studies, which demonstrated that there was no objective pathology within the person's anatomy that would explain the nature and extent of her pain complaints. I would go through these records very patiently and methodically, and at the end of the process, the woman would almost inevitably begin to cry, and she would say, "Mr. Hubard, I don't know what's wrong with me. The only thing that I can tell you is from the time I wake up in the morning until the time I go to bed at night, I hurt from the top of my head to the bottom of my feet, and it's all I can do to make myself get out of bed and make breakfast in the morning."
The first 20 or 30 times I saw this, I thought I was being played by a performance orchestrated between the client and her attorney. But as I saw it again and again and again, and I saw it within the context of an individual who had a very solid work history, what I came to conclude was that the individuals were genuine. These women were experiencing true pain, but the source of their pain was coming from a place of tremendous emotional and spiritual despair in the face of their recognition that their life was not going to be one in which they enjoyed any sense of dignified autonomy over their fate. They were going to be living face down in the dirt, hand to mouth, a purely survivalist existence from beginning to end, and that work accident was the precipitating event which broke the life straw of hope that this individual had. The spiritual and emotional pain that they were experiencing was so profound that it manifested itself physically. And instead of recognizing the root cause of despair, which was the true genesis of the individual's pain, they received a combination of pharmacology which essentially anesthetized their soul and ultimately euthanized their body. And I had probably a half-dozen to a dozen individuals who died of overdose within my own caseload.
I came to work in state government by happenstance. I was not in any way politically connected, but I worked with an evaluator who I would speak with about philosophical issues related to the Kentucky judicial system, the way in which there appeared to be a symbiotic relationship between personal injury lawyers and medical providers who essentially commodified human beings and trafficked in their misery to collect, on one hand, legal fees, and then, on the other hand, capture a perpetual revenue stream with a lifetime patient who would be medicated from the time they walked into the doctor's office until the time they went to the graveyard. And I was asked to consider coming in to lead the state's Social Security Disability system by virtue of this individual's connection to the staff of then-Kentucky Governor Matt Bevin. And they wanted to know why Kentucky was second only to West Virginia in terms of the percentage of our population that receives Social Security Disability Benefits.
I agreed to take the job, and I came in, and we did a 35-year retrospective study on the disability program, and the results were just unbelievable. For instance, between 1980 and 2015, KY's population grew 20%; enrollment in the Social Security Disability program grew 249%; the enrollment of children in the disability program grew 449%. And with that, you had an explosion in the issuance of habituating prescription medication to the poorest within those categories, and that was your Title XVI Social Security Disability population. These were individuals who didn't have a substantial work history; they were usually generationally poor, and Social Security Disability was essentially their subsistence income. Within that Medicaid/SSI population, we saw that between 2001 and 2015, there was a 168% increase in the issuance of opioid medications per capita to every adult on SSI and Medicaid, and the dosages essentially climbed from about approximately 47-48 pills per person to 168 pills per person over that 15-year time frame. Some of these percentages may be a little off because I'm a lawyer, which makes me a math cripple. The more alarming statistic, candidly, was the issuance of habituating psychotropic medications to children on Medicaid. And these are kids who range from, you know, the ages of three to 17. And in the year 2000, there were approximately, for every Medicaid child, 400 doses of habituating psychotropics taken per child per year. By the time we got to the year 2015, that number had climbed to about 640—just eye-popping acceleration of opioid prescriptions and habituating psychotropic medications to these populations.
So after Governor Bevin lost, I was picked up by then the new Kentucky Attorney General, Daniel Cameron, who hired me to first run the Attorney General's office of Medicaid Fraud and Abuse Control. And this is a long law enforcement division that essentially investigates and prosecutes medical providers for committing fraud on the Medicaid system. And one of the largest components of that office's caseload was medically assisted treatment clinics. These are treatment clinics that provide addiction recovery services, and they provide medication for opioid use disorder. Those medications are generically referred to as buprenorphine, which is an opioid that goes by the brand names of Suboxone, Subutex, and others, and then methadone, which has been around for a long time. And what we saw in our Medicaid caseload was that essentially we had a variety of these medically assisted treatment clinics whereby there were no-show physicians who would pre-fill and pre-sign prescriptions, hand them to their nurse; they would prescribe the maximum milligram dosages over the maximum period of time, and every day the nurse would just cycle through a cattle call of individuals lined up out the door to give the prescriptions. And the individuals would go out in the parking lot and barter and sell and trade their Suboxone prescriptions for cash in order to go out and buy the more hardcore substances that were out there. The cash market for Suboxone exists among those who want the safe high without any potential possibility of the pollution that comes with fentanyl. The other thing that I came to learn about Suboxone is that it comes with a withdrawal symptom complex that often times, for the person who has received it, is far harsher than even what heroin is.
So recognizing that a lot of these clinics were essentially glorified drug-dealing operations, the issue of buprenorphine diversion became a significant focus of investigative and prosecutorial activity within the office. When the opioid settlements were achieved as part of a multi-state litigation process, KY's share of that $50 billion nationwide settlement was almost $1 billion, and the legislature set up a commission which would receive one half of the money to spend on behalf of the state, with the cities, counties, and towns receiving the other half of that money. The exact figure was to be $842 million. The office came to me and asked if I would be interested in essentially standing up and running the commission and getting it going and getting it functioning. My first response was, you know, this is a very treacherous opportunity. Kentucky and Louisiana kind of compete with each other for which state has the most corrupted political systems all the way from the top of state-level executive branches all the way through their local government structures, and that's been the case here since the end of the Civil War. And my ask of the office was whether they had the spine to ensure that this money would not be plundered, pilfered, or wasted by the usual vultures who are accustomed to feasting on these dollars when they come through the door, or whether they would allow me to run the commission with the degree of accountability, transparency, and accessibility that it called for. And they assured me that they had the spine, so I took the job.
Within the course of my interviews, the question was asked as to what our strategic objective needed to be. I acknowledged the fact that this was one-time money that the state would be receiving, and while $842 million sounds like a lot of money to the regular ear, and indeed it is, when we compare it to the immense scale of the problem, the resource is exceedingly small. And to put that in perspective, Purdue Pharma essentially cleared $1 billion a year on OxyContin sales and did so for over a decade. So what we're talking about that's going to be received by the state of Kentucky over 16 years is essentially just a little shy of eight and a half months of OxyContin sales. So these are meager resources that have to be maximized in terms of their impact. And I said, you know, when you look at our existing treatment models, they deliver unacceptably mediocre results. That is not an outlier opinion; that's an opinion shared by any objective individual who looks at outcome data. It's an opinion that is shared by the leadership of NIDA, by the leadership of the FDA, and by other government regulatory agencies, which see that the measurable impact of what we're doing is not nearly enough to make a material long-term difference over the upward trends of overdose and overdose death, particularly with opioids. And I said that Kentucky needed to look for its Manhattan Project opportunity to take a small percentage of its settlement money to devote toward the creation of a public-private partnership which could essentially facilitate clinical trials with a breakthrough treatment for purposes of improving upon treatment outcomes. And at the time, which was August of 2022, I told the office that I didn't know what that Manhattan Project opportunity looked like, but I would start researching and find out and to get to the bottom of this story by virtue of just some independent exploration and reaching out and discovering, I came across the word ibogaine for the very first time in July of 2022. And from there began a very intensive process of putting together a proposal which would have seen Kentucky devote $42 million, which would have been matched by a drug developer on the front end, to secure FDA approval for clinical trials with ibogaine as a breakthrough therapeutic for opioid use disorder, and then for KY's $42 million to pay for clinical
Trials within the state to get it across the FDA's finish line. And that was a very long, but yet distilled explanation of how I've come to be on your podcast these days.
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Thank you so much. That was a wonderful explanation that I think did justice to a lot of the complexity. So I've seen different numbers. You said 842 million; I read elsewhere 478 million. What is the disparity between these numbers?
Some of it is coming from opioid settlements, and some is coming from the state. The settlements were achieved in stages. So you had the first round of settlements, which were going to bring in a total of about 420 million. Then that figure, toward the end of the summer, beginning of fall of '22, went up to about 480. By the time we got to early spring of 2023, the figure had gone up to $842 million. So the total amount of the settlement, as it stands for Kentucky, is $842 million. Half of that goes to the counties, cities, and towns, and then half of that goes to the commission that I ran, which yields it $421 million with which to work.
Got it. Okay. And of that, you were hoping to spend 42 million on this IAME project, correct?
That's correct. That would have been 10% of the commission share and 5% of the state's total settlement.
Take me through what this would entail, because you're talking about clinical trials and the assessment of IAME, because I've been trying to reconcile what I see as a very good thing with some of these criticisms, and I'm trying to figure out whether there's any validity to some of the backlash. Of course, my impulse is to think no, but one of the criticisms that I saw is that this opioid settlement money would be used to pay for clinical evaluation of a substance that would then be sold, and so it would be as if the money was paying for drug development that would then benefit a future pharmaceutical manufacturer. Is there any validity to that criticism?
Well, let's begin with the observation that that is exactly what's happening now. The chief criticism lobbied at this by the folks whose position you have articulated is exactly the system that we currently have in place right now, where opioid settlement dollars are being used to fund treatments with an exceedingly modest success rate that are provided by the very same companies which produced the problem. So, for instance, and then I'll get to the heart of this criticism in terms of the response specifically related to IAME. Opioid commissions right now are busy building out access to Suboxone treatment and other forms of buprenorphine treatment. Those treatments are provided, manufactured, and sold and marketed by the very companies that created this problem. So when the pharmaceutical industry that has had to participate in these settlements look at the way in which the settlements are structured and the services that academia and the existing public health bureaucracy aim to provide, they know good and well that they are going to recapture eight out of $10 that they have provided by way of settlement by virtue of them getting money on the treatment side for the therapeutics that they manufacture. So let's just start right there.
Secondly, in terms of Kentucky, there was never, nor would there be for any other state, any intent to use public money to create intellectual property which would then be the exclusive commodity purview to the monopoly of a pharmaceutical company or drug developer. Within the Kentucky model, or within the model of any state that may do this, the public-private partnership would have as an integral component a recognition of the state's commercialization interest in whatever intellectual property is generated as a result of this project; a commercialization interest which should see the perpetual return of royalty investment, at at a at a bar minimum, to the state that gives it recompense for the initial investment. Any public dollar has got to be connected to the public's ownership of any completed intellectual property product that goes through this process, which distinguishes IAME from, again, buprenorphine. In the case of buprenorphine, the National Institute of Health spent, I believe, 62.5 million dollars developing the baseline formulation. Once the baseline formulation was created, it was given as a gift to the manufacturers who then proceeded to produce their own synthesized versions with their own unique formulaic twist, then patented it, and then charged big money for it without any return of investment to the taxpayer. So in terms of the specific criticism of the Kentucky project, what has been asserted by way of the model is inaccurate, and the model that has been asserted is one that in fact currently exists and is being employed within the promulgation of what's called the evidence-based best practice treatments, namely buprenorphine method.
Okay, so that's good for establishing that there's nothing unusual in this model, but just to emphasize what you were saying: so if this were to progress through phase three clinical trials, the FDA were to approve IAME for treatment of opioid use disorder, then some of the profit from the pharmaceutical IAME would go back to Kentucky, is that correct?
Absolutely. Whether it is anything that is patentable, whether it is the finalized therapeutic, whether it is a patented method of administration, whether it is a patented treatment model, anything from which money could be made must see the capture of a commercialization interest by the state or states which help fund its creation; an interest that should see a perpetual return on revenue to those states that are participatory in the project.
Right, that seems like a good plan. And in terms of the specifics of who would be providing the IAME, did you have a manufacturer in mind? Were you already collaborating with a company that would have been supplying the IAME?
The universe of drug development around IAME is not large, but it's large enough to be competitive. And had the project been allowed to proceed, what we would have done would have been to have issued a notice of funding opportunity, and that notice of funding opportunity would have listed a series of queries that a drug developer would have to answer. For instance, you know, what is your plan to obtain the FDA's approval of an Investigational New Drug application? What's your proposal by way of the design of the clinical trial? What is your plan for the recruitment of clinical trial participants? How do you propose to recognize the state's commercialization interest in any final patentable intellectual property generated through this project? How do you propose to secure third-party payor approval through insurance of IAME treatment for anyone who needs it? And for those who fall through the cracks of the insurance system, what sort of pharmacy benefit plan will you develop so as to assure access to IAME treatment treatment for all who need it? These are just examples of some of the criteria and queries that the drug developer would have to answer. We would essentially then solicit proposals, which would be reviewed through a competitive review and selection process, and the drug developer who had the best proposal, who appeared to be most credible, and who had the demonstrated resources to match the state's commitment would then be selected, and it would be the one to receive, or to essentially have the clinical trials paid for, for as they execute them within the state. The drug developer at all times assumes all of the financial and logistical risks associated with developing everything that is necessary to secure the FDA's approval for clinical trials. Public funds are used only to pay for the clinical trials once the drug developer secures the FDA's approval to conduct them.
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I see. Okay. And in terms of the different treatment strategies, historically there have been many, many things that have been tried, but agonist replacement therapy with buprenorphine or methadone seems to be the only thing that anyone has really seriously pursued. And I understand your criticism that the very same pharmaceutical companies that profited enormously off of the sale of opioids are now selling treatments for addiction to the substances that they made their fortune on. Actually, I won't even go so far as to say that I think it's ironic. I am aware of it as a criticism, but I feel sort of conflicted because I've known many people who have taken buprenorphine who have been able to stabilize their lives. Are they still dependent on an opioid? Absolutely. Is that ideal? I don't think anybody would say that it is, but the fact remains that these people are not accidentally exposing themselves to an overdose of fentanyl. This does seem to have the ability to stabilize people's lives. So as a treatment, it's certainly not ideal, but I don't fault the manufacturers for selling it because, in many instances, it's the only thing that is available. And I appreciate that you were trying to at least evaluate the possibility of something else. And let me back up and say this to you, Hamilton, because I don't want to be misunderstood by your audience: what you have heard come through from me is my response to criticisms of IAME, which have been primarily directed at it from, at least within Kentucky, the promulgators of the Suboxone/methadone opioid maintenance model. Individuals specifically within the addiction research community at the University of Kentucky who insist that recovery is an individualized journey, that we should not stigmatize an individual based on how they select to pursue recovery, and that that we should have the utmost respect for individual autonomy and not stigmatize based on choice of treatment, were the first to be the most vocal stigmatizers, exclusive insistence on monopolistic models, advocates, and people who were just generally very disingenuous with their criticism and with regard to the manufacturers and your observation about the efficacy of treatment. Something is better than nothing. I am not here to say or to suggest that medically assisted treatment, whether it's buprenorphine or methadone, be scrapped, be abolished, be disallowed as available treatments. They absolutely should be, for all the reasons you've said: they save lives; they have a roughly 25% efficacy rate, and that is better than nothing. Every life saved is significant. The opioid epidemic is a problem that has to be fought by all humanitarian means necessary, and throughout the execution of the Kentucky project, my point was: we should always be looking to diversify, expand, and improve upon our existing options for the purposes of making progress. The response to that position from within Kentucky advocates for opioid maintenance treatment was: everything we have is plenty adequate, and we don't need anything now. That's not born out by reality, however it is measured.
I will mention that Indivior is the parent company which holds patent ownership of brand-named Suboxone. Before these multi-state opioid settlements were achieved, the largest single opioid settlement ever was in 2019, and it was negotiated pursuant to a U.S. Department of Justice criminal indictment and guilty plea that came with a $2 billion fine, with $600 million of that going to the Massachusetts Department of Medicaid. That guilty plea was tendered by Indivior, and it was tendered pursuant to a federal indictment for having engaged in illicit schemes to increase the issuance of Suboxone prescriptions nationwide. And Indivior paid the federal government $2 billion in connection with that guilty plea, and they paid the $600 million to the Massachusetts Department of Medicaid for making material misrepresentations which understated the risk of Suboxone exposure to children. On May 7th, there's a gentleman by the name of Dr. Matt Bivens, who is an emergency room physician and is on faculty at Harvard Medical School, who has written extensively about the opioid epidemic, and he wrote a column that talked about the opening of the opioid industry record archives at the University of California in San Francisco, which contains millions of pages of corporate documentation related to all aspects of corporate activity around the opioid epidemic. Within these documents are corporate communications that Dr. Bivens points out contain celebratory glee over what is seen as the market margins associated with the promulgation of buprenorphine. Now, should we have it? Does it have efficacy? Absolutely. We should, absolutely it does. Should we recognize that it comes with a cost? Yes, we should. Should we recognize that that cost is the enrichment of the very companies that produce this problem? Yes, we should. Should we continue to make it available? Yes, we should. Should we continue to look for opportunities to diversify, expand, and improve upon the results we're getting from buprenorphine because they are currently unacceptably mediocre? Yes, we should.
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Then we're in complete agreement on this. Yeah. And so it's clear that the history of opioids in the United States has been marked by various interest groups manipulating public opinion in various ways. The obvious examples are with opioid manufacturers, the infiltration of medical education to create ideas about pseudoaddiction or to change the culture of prescribing in such a way that liberal prescription of opioids was considered compassionate and medically justifiable, if not ideal. I probably have an unusually liberal attitude toward most of these things. My grandfather was denied morphine when he was dying of cancer because they, I don't know, they thought it was somehow dangerous for him. And so from a young age, I kind of saw how horrible it is when people who need these medications are denied them. And so I've always been probably unusually sympathetic to a lot of these pharmaceutical ideas that opioids should be prescribed liberally. The other reason that I have that perspective is that I think the sort of reductionist idea that all the problems associated with opioid use are a product of the opioids themselves doesn't acknowledge that there are all sorts of complicated issues, which you touched on at the beginning of the conversation, ranging from lack of appropriate medical intervention, what Medicaid pays for, psychological problems, despair, lack of job opportunity, on and on and on and on and on. And I'm sort of curious because you mentioned how these interest groups have promoted the idea of using buprenorphine. Have you seen evidence that there have been interest groups promoting or interfering with IAME in any way?
Well, I would use the Kentucky project as a microcosm of what we will see play out nationally. And we'll set the stage a little bit. And your point on the stigmatization of substance is very well taken. I think I heard Dr. Rick Doblin make the remark that the problem is not a substance, it's an individual's relationship with the substance, and I agree with that 100%. You know, Kentucky has been historically one of the poorest states in the country, in particular the eastern third, which is coal mining country, where generational poverty has been in place again since the end of the Civil War, and where Lyndon Johnson kicked off his war on poverty almost 60 years ago. When OxyContin was introduced there in 1996, that was analogous to a lightning bolt hitting a drought-desiccated forest. All of the conditions which were ripe for the development and explosion of the opioid epidemic had been there generationally. So you are absolutely right: the issue is not the substance per se, it is the relationship people have with that substance and the reasons why that relationship exists. In terms of interference with IAME, the remarkable thing about the Kentucky process was how successful it was, and I measure success by way of how regular, everyday Kentuckians who are very politically conservative and in many cases are very religiously fundamentalist responded to what was a six-month public introduction and education campaign around IAME that began with a very high-profile press conference and then was complemented with three congressional-level-quality five-hour public hearings on the subject. The first hearing focused on the science; the second hearing focused on the lived experiences of people who had received IAME treatment; and the third hearing focused on whether the FDA would even consider giving an approval for an IAME trial given its cardiac risk factors. We had a media specialist who was retained by a philanthropist who followed organic social media responses across the platforms of Facebook, Instagram, Twitter, and LinkedIn as this process played out, just to see what the public sentiment was among those who engaged the story. And the remarkable result was: we had a support-to-opposition ratio of 60 to 40%, based on measured organic social media response. When I would speak to the most hardcore skeptic, whether they were a religious fundamentalist, whether they were the operator of an existing recovery facility, or whether they were somebody who had a reactionary attitude toward the word "psychedelic" because of all the connotations that come with it, when we would explain the attributes of IAME in terms of its physiology, the result produced by way of the individual's change of psychology, and the way in which a person would experience a spiritual awakening at the end of the experience, almost universally when the attributes were explained, the response that I would receive was: what do we have to do to make this available, and how quickly can we do it? The opposition centers were very confined, and they were confined to the University of Kentucky's Center for Drug and Alcohol Research and current Governor Andy Beshear. The current governor and his father were partners at the law firm that represented Purdue Pharma against Kentucky while they were partners there and settled that case for a pittance of its value. The University of Kentucky has established and documented financial relationships with the manufacturers of the existing treatments. And to get back to that original point about Indivior and its status as a convicted federal felon which engaged in an illicit scheme to promulgate its substance, the Kentucky Medicaid population is 1.6 million out of a state that has a population of 4.8 million. Between January 1 of 2017 and October 31 of 2023, Kentucky Medicaid paid for over 110 million doses of buprenorphine to a Medicaid population, not all of whom are on opioid maintenance medication, of 1.6 million people. We have a model that monetizes sustained human misery and depends upon the delivery of chronic treatment models to daily repeat customers. When a therapeutic is introduced that has the potential to cause significant financial disruption to that industry, in light of that industry's recognition that they have high commodity value in the promulgation of buprenorphine models, you're going to get what we had here, which was institutional opposition from those that have made themselves the paid functionaries of the pharmaceutical industry that resist the development of curative treatments for what is the most intractable problem of opioid dependence, and that is the resolution of withdrawal.
And when I hear you say this, it makes perfect sense to me. What you're saying from a logical perspective makes complete sense. There is demonstrably money to be made; money is being made from keeping people on maintenance therapy; it's immensely profitable; and the possibility of a therapeutic intervention that would disrupt those profits can and should be threatening to the financial interests of anybody who's making money off of maintenance therapy. All of that makes perfect sense to me. And I've been part of the psychedelic research world for my entire adult life, so I've had enough perspective on these developments to see how they've evolved over time. And you may or may not be aware that a very similar argument was being made about psychedelics and antidepressants, the idea being that the big Pharma powers that be would never want LSD or psilocybin to be approved as treatments for depression because it would disrupt an analogous maintenance therapy type treatment modality of taking SSRIs daily. It would be a financial threat to the establishment. It makes perfect sense. But what I find interesting is that I have not observed any evidence of that in the realm of depression. There has been enormous amounts of opposition, but the opposition has not come from Pfizer or some major manufacturer of daily oral antidepressants. The opposition has come from within the psychedelic community and the…
Pivot has gone from nobody wants to commercially develop psychedelics because they're unpatentable, or because they represent a threat to the dominant models of treatment, to we can't support psychedelics because somebody might make money off of them and somebody might patent them. It's been this really bizarre reversal that I don't know that I could have predicted.
And from what I have seen with opposition to the Ibogaine program in Kentucky, it didn't appear that it was coming from NIDA or any of these manufacturers of maintenance therapies. It seemed to bizarrely be coming from the Psychedelic Community, from people who had actually tried Ibogaine and benefited from it, but felt that there was something unethical about anybody profiting off of a pharmaceutical psychedelic product.
There was only one individual that I'm aware of who wrote an op-ed that was published in the Louisville Courier Journal who had received Ibogaine to resolve their heroin use and who objected to the use of settlement funds to develop it as a therapeutic. That was the only point of opposition that I encountered from within the Psychedelic community, and if you saw more, I certainly would be interested in reading and taking in the information of opposition. The vocal opponents of this were not the manufacturers, but those who are on the payroll of the manufacturers, who occupy positions of academic research authority combined with the authority of the executive functions of government.
So, for instance, you know, in the case of the University of Kentucky, their researchers sit on the boards of the companies who develop the therapeutics that are sold to treat addiction. When you have the industry supporting the academic researchers whose research is then parlayed into drug approvals through the FDA, which is then parlayed into academic research to support the promulgation of those approved therapeutics to the public health system, which is then used to effectuate the design of regulations and statutory frameworks which elevates the promulgation of these therapeutics, is what is called the evidence-based best practice. You have a circular, self-reinforcing community of financial interest that originates within the pharmaceutical industry, but is amplified and articulated by academic researchers who operate within the guise of the objective scientific evaluator, but who are in fact a function and subsidiary of the pharmaceutical industry.
So in June, after we had our press conference in May of '22, in June one of the lead researchers for the University of Kentucky expressed—you know, this individual expressed her—us to vote for the commission's public hearings and the expiration of Ibogaine's efficacy within the same breath. This individual said, "We don't need any further medications to treat opioid withdrawal syndrome; all the medications that we currently have are more than adequate to the task." Well, that certainly does seem to fly in the face of a reality in which longitudinal studies demonstrate that Suboxone treatment has a 20% patient retention rate at the end of six months, and we see ever-escalating rates of opioid overdose and death despite the fact that these therapeutics are essentially so effective. And the answer that is made to that observation is, "Well, we just need more of it; more of it." I just told you that they paid for 110 million doses of Suboxone for a Medicaid population of 1.8 million. What's lacking, you know, there's something missing from that equation, and I would assert that what's missing is an objective acknowledgement of reality, and that's missing because you have academic researchers who are financial partners with the pharmaceutical industry in terms of promulgating what they call the evidence-based best practices. And I'm happy to send you some fabulous research that has been done pro bono by a group that has taken great pains to establish, through publicly available information that you kind of have to track down, the existence of these relationships, and they're there; they're real, and they exercise influence.
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The two people that I'm aware of—one is Dimitri Mugis, who is a friend of mine, and the other is a guy named Russell Haefele—and their reasons are kind of bizarre from what I can tell. Dimitri Mugis's objection is that it doesn't have a sufficiently holistic intervention where you're not addressing the despair dimensions of opioid dependence, homelessness, lack of job opportunity, or financial stability, nutritional problems—everything that puts someone in a social and psychological position where they become vulnerable to abuse of opioids. The other objection, I think, from Russell Haefele—let me see if I'm pronouncing his name right—Russell Haefele, was maybe more of an anti-capitalist: "How dare they test an experimental treatment on the poor in Kentucky and then commercialize it; isn't this somehow unethical?" Now, I don't think that either of these arguments are particularly persuasive, but as far as I can tell, it also doesn't fall into the category of them being paid by opioid manufacturers. I think that this is, for better or worse, an organic opposition that has little or nothing to do with competing financial interests. And the Dimitri piece appeared, I believe, in December of '23, so we were six months into this, and so far as I know, you know, he is not a gentleman who was on the ground here; he was offering it from an outsider's perspective, which he certainly is free to do, and I just want to answer both of these criticisms substantively.
Dimitri is absolutely right about the necessity of addressing root causes of addiction, and they have everything to do with the circumstances of despair. The reality is we're spending billions of dollars a year on a 75% treatment failure rate, the expense of which prevents governmental systems from addressing those root causes. And Kentucky is a perfect case study of that; this state cannot afford to build out long-term recovery infrastructure; they can't afford to provide housing; it cannot afford to provide job training and basic education services that equip someone to be self-sufficient; it cannot afford to provide all of those things that are necessary for the reconstruction and rehabilitation of an individual's life. And the reason that it can't afford to pay for that is because the acute treatments that we offer fail 80% of the time; they cost roughly $100,000 per person per try, and the average number of attempts someone will go through this treatment system is five—we're spending $500,000 per person on a 75% failure rate. Now imagine if you could just cut the acute treatment expense in half by resolving the core problem of opioid dependence, which is withdrawal syndrome, with Ibogaine, and then you take your savings from a more effective acute treatment and you build out that recovery infrastructure so that you can see someone have an actual chance to build a viable life that ameliorates and overcomes the root causes which produce their addiction to begin with. We are in a vicious cycle where the amount of money we're burning on ineffectual acute treatment prevents the development of infrastructure that allows somebody to have a viable chance to make it. The only way that you can change that paradigm is to develop a more effective acute treatment, and by all estimations, the more effective acute treatment is Ibogaine. Again, when you resolve opioid withdrawal syndrome, when you reverse the neurochemical injury to the brain that is produced by opioid dependence, you give that person the very best physiological opportunity that can be given to pursue long-term, linear recovery that can be clear and coherent and free of the impacts of withdrawal. That is the opportunity that is presented with a different cost model that allows you to provide those long-term recovery supports. And I was very clear throughout: Ibogaine is not an end; it is the very best beginning we can give someone to get to an end, which is long-term, durable recovery.
Second point: When I hear about the use of an experimental drug on poor people in Kentucky, I want to ask this gentleman, "Are you paying attention to the Healing Communities studies? Are you paying attention to the promulgation of drive-by Suboxone clinics in Appalachia, where just about everyone who is involved in local leadership out in the Appalachian Mountains recognizes that wherever there's a Suboxone clinic, there's a 50-50 chance that they're going to produce as much addiction as they treat by virtue of the diversion that they facilitate within their communities? Are they watching the infiltration of these treatment clinics into the inner-city areas of Kentucky, whether they are in Louisville and Lexington or elsewhere? Has this individual bothered to reach out to the gentleman who I know as a colleague who runs the District of Columbia's Office of Medicaid Fraud and Abuse Control, who recognizes that the predatory operation of Suboxone clinics that put themselves in the poorest areas of the district and that function as drug dealers are creating as much addiction as they are treating among poor, disserved, and underserved communities, along a lot of them communities of color?" So when I hear an objection to the development of a therapeutic that would be used to produce a curative result for the people who need it most in the name of experimentation on poor people—objections to it—what the hell does he think's going on right now? You have glorified opioid drug dealing that is occurring in the name of treatment on these very people he claims to care about. He needs to study the issue; he also needs to go back and look at a way that the Biden administration executed in December of '21, at Indivior and its colleagues' request, which essentially relaxed the prescribing requirements for buprenorphine in terms of the credentials of the individuals who get to prescribe it. So no longer do you have to be an addiction physician to prescribe; you can be a physician assistant; you can be a nurse practitioner. And with the stroke of a pen in December of '21, there were 133,000 prescribers of buprenorphine; today, by virtue of that regulatory waiver, there are two million. Indivior accomplished through regulatory modification what it was federally convicted of doing by way of illicit activity in 2019. With all due respect to the latter gentleman, he needs to go and do his homework, and he needs to take a look at the opioid industry record archive at the University of California, San Francisco, so he can recognize that the very business model that produced this problem is being replicated in the name of producing its ostensible evidence-based best practices treatment. And the fact that he would leave poor people in the hands of the opioid industry to receive their treatment is an indictment of his knowledge of the dynamics of this problem and the way in which failure is what is being produced by way of how it is being treated.
Now pardon me, Hamilton, that last exception makes me fighting mad, especially given where I come from.
Yes, and I think that your anger is completely justified. This exact tactic has become immensely prevalent in the Psychedelic community, and that is the use of moralism to say you can't do this, not because it's dangerous, not because it's lacking efficacy, but because you're doing an experimental treatment on poor people. You see, actually, a version of this in other aspects of the Psychedelic world where people will at first say, "Well, we can't have a pharmaceutical psychedelic product because it will be expensive and therefore it won't be available to impoverished people," not realizing that an FDA-approved, insurance-reimbursable psychedelic therapy is exactly how these medications will be made most accessible to those people. And it's a kind of nonsense moralistic hall of mirrors.
And I guess my big question is: You speak about this so persuasively and so authoritatively, and I've now seen you talk about it in person; you make such a compelling and strong case—why do you think it was that you were not able to push this forward, given how strong the points that you're making are?
Well, you know, I go back to how we define success. I had a nine-member commission; I needed five yes votes to get approval in November of '23. Kentucky had a general election among its statewide office holders; my boss, Daniel Cameron, who appointed me to this job, who blessed the Ibogaine project, ran for governor, and he was not going to be able to continue as attorney general because that is a statewide elected office. There was another person who ran for attorney general by the name of Russell Coleman. When the general election occurred, Daniel Cameron lost the governorship; Russell Coleman became the new attorney general. And one of the things that illustrates the dynamic around this issue within the microcosm of Kentucky was the support for this proposal was bipartisan, as was its opposition. We had the support of Republican Attorney General Daniel Cameron; we had the support of a former Democrat governor, a candidate here, a guy who had held a two-term in office as the Kentucky attorney general; he was a five-term congressman, a legacy Kentucky Democrat, fully, fully in support of this project, is the head of the state's largest philanthropy called the Foundation for a Healthy Kentucky; his name is Ben Chandler, and he was heroic in the middle of a general election campaign, as a prominent legacy Democrat, to come out in support of this. The opposition was bipartisan, and that opposition consisted of Democrat Kentucky Governor Andy Beshear and what came to be the newly elected Republican Attorney General Russell Coleman. Our last piece of due diligence from the commission's perspective before we took a vote was to recall Dr. Nolan Williams and to have him come and personally appear for testimony about his study with veterans in Mexico, which was published in Nature Medicine, and to testify about the profound effects on individuals affected by TBI and PTSD, as well as what is recognized as just an unbelievably dramatic neuroregenerative effect that Ibogaine has on the human brain. We were going to have Nolan come in and testify once the Nature Medicine study was published, and following that testimony, we were going to take a vote, and that vote was going to be successful because I serve at the pleasure of the Attorney General at all times. Whether this project was going to go forward was going to be dependent on the newly elected guy, Russell Coleman. Well, on December the 8th, I received a letter from him on his transition team's letterhead asking that I not take any further action on the project until such time as he and his administration could be briefed. I replied within the day and said I was happy to not take any further action; I wanted to make sure that they could be fully briefed and recognize the significant opportunity this was presented to Kentucky because at this point, not only did we have a successful commission vote lined up and on the table, but we had significant philanthropic commitments from what I would consider very convicted philanthropists who have had the opioid epidemic impact their families, who can see and who know that what we're doing is not good enough and that we've got to look to break the cycle that we see playing out in America at a generationally compounding scale. Instead of giving me that opportunity to provide that briefing, one week later, on December the 15th, I was summoned to a meeting that I can only describe as an ambush that was orchestrated by Russell Coleman and members of his transition team, in which he flatly stated his total objection to the way in which I had been an advocate for Ibogaine, his objection to the notion that any sort of project such as that I had been proposing belonged in the Attorney General's office, along with the demand that I give my resignation before he take office on January 2nd. So there was no conversation; there was no briefing; there was no effort to learn and to understand everything that had come around this project, nor the substance of the 15 hours of the testimony that was taken. And that unwillingness to even have a conversation, as well as the ambush nature of the meeting to me, revealed the malice with which this project had been terminated by virtue of the demand for my resignation. I came to learn shortly thereafter that, contrary to public assertions by Russell Coleman that he was open to this project in the fall of '23, that in fact he had been engaged in a very strategic and consistent whispering campaign against it going back as early as July of '23. So everything that he talked about in public during the election campaign in terms of his open-mindedness was fictitious; he was never open-minded about it; he was hostile throughout. And unfortunately, because of the duplicitous nature of his communication with me, I was among the last to find out in that December 15th meeting.
I'll make a couple of other observations about Russell Coleman: This is a guy who came into the power structure within Kentucky through the Mitch McConnell system of matriculation; this guy has been a mollit for as long as he has had lust for power in his heart. Throughout the campaign, when he would give speeches, he would say, without irony or any sense of humor, that his boyhood hero is J. Edgar Hoover. When you combine the fact that this guy has sniffed around the throne of Mitch McConnell for years and has as his boyhood hero J. Edgar Hoover, the fact that this project was terminated with animus, in retrospect, comes as no big surprise. Then when we pair that with what we can understand to be at least some of his benefactors within the opioid maintenance industry and the fact that he counted as a significant part of his campaign contributions companies represented by the law firm of which he was a part that stand to lose from an Ibogaine treatment, an explanation for the project extermination becomes clear. It didn't have anything to do with the lack of public support because it was there; it was there to the tune of 60 to 40; it didn't—it didn't fail because of a lack of support within the commission; that was there, and that vote was going to be successful, and I had told Russell Coleman before he took office that that vote was going to be successful. It happened because you had a political actor with a malevolent attitude toward a competitor to those interests that he came to represent that stand in opposition to the well-being of his people taking an axe to it, and that's the bottom line.
So that sounds like a really strong piece of evidence for what you're describing, in that there are opioid interests coloring this debate; this is not a debate purely about efficacy. But not knowing too much about Russell Coleman, I am aware that he sued Kroger for their involvement in the opioid crisis; it does seem as if he has an anti-opioid stance. So could you tell me a little bit more about what sorts of conflicts of interest he might have or why he, in particular, might not want Ibogaine therapy to move forward?
Well, let's begin with the fact that there are multiple companies, whether they're manufacturers or distributors, that are the target of multi-state litigation, and you know, in so far as there are opportunities within the offices of various attorney generals across the country to continue to proceed with legal action to recover financial compensation for their states, he's duty-bound to pursue that. When I was in the office, the Kroger case was under active evaluation, and it was one that was part of one of those multi-state efforts. So as attorney general, this guy is not just going to sit on his hands and let money flow under the bridge while other states go and pursue collection while he's representing the state of Kentucky against Kroger. He represented Walmart against the state of Kentucky while he was a partner at Frost Brown Todd, representing clients in litigation matters related to the office of Attorney General, and I believe Kentucky settled with Walmart for $52 million sometime in May of '23. And at that point, Russell Coleman was the presumptive nominee of the Republican party for the office of Attorney General because he faced no opposition in the primary; he subsequently, I believe, he withdrew from the case right before the settlement was finalized. But based on actuarial assessments of Walmart's liability, that settlement was for roughly one half of what its value should have been. So you know, just as this guy talked about his open-mindedness to Ibogaine while also orchestrating a whispering campaign against it, he's demonstrated himself as a very duplicitous actor who will take both sides of a singular issue and push that side that is to his greatest immediate strategic advantage. Based on my personal, individualized interactions with him, you know, this guy is a thoroughly disingenuous opportunist, and whatever it is he's doing is in response to what he perceives as the most immediately beneficial strategic advantage.
Okay, that makes sense. And so with this settlement money still existing substantially, I imagine, right—I don't know how much of the $842 million remains unspent—is there hope to come back and try again with Ibogaine? Is there something that can be done? What is your next step?
In March, he made very clear; he declared Ibogaine to be a Schedule One substance; talked about its danger;
Will never be a viable ibogaine research and development project in Kentucky. He set aside what's called a $5 million Innovation fund. That's not a fund that is meaningful enough to bring any therapeutic market that would compete with the existing model. It is window dressing; it's a performative, symbolic exercise designed to deflect what he recognized as significant backlash among the community of interest that followed this, in response to an outright termination. So there's a token, symbolic response to deflect criticism, but there is no meaningful prospect for the sort of ibogaine research and development project that would have yielded an FDA-approved therapeutic in Kentucky. There is elsewhere, and those—those are opportunities that I continue to speak with state leaders about in both Ohio and a handful of other states that are interested in doing this, and I am hopeful that over the coming year one or more will step out to take what the Kentucky framework was and and make it reality.
I think a lot of people listening to this—because this is a podcast, where a lot of people who are interested in psychedelic science and drug policy reform—I think a lot of people are in a position where they recognize the value of these substances, but they don't know how they can help; they don't know what they can do. Is there anything that the community could have done while you were in the midst of this battle that could have made things easier? Is there a way that people can help your efforts?
Well, there's three ways to win a political conflict: one is with money, and the other side has that; the other is with the masses; but in order for the masses to be activated, they have to be introduced and educated as to the possibilities before them for progress, and those actors which aim to stand in the way of and to thwart progress. And then you have a combination of the two, where you use money to introduce and to educate, motivate, and galvanize the masses. If I were going to make a request of the community, it's that they just be consistently involved, through their venues of influence, to make their faces and voices heard to elected leadership that needs to be properly motivated to do the right thing. This effort is going to require a mass movement of organized individuals who are diligent and consistent about demanding that we improve a system—a system that produces a 75% failure rate and that has seen overdose deaths climb from approximately 20,000 15 or so years ago to what is now an annualized death rate of 100,000, despite an exponential deployment of public resources to promulgate therapeutics that fail 75% of the time. There has got to be a broad-based, consistent public demand that our elected leaders and our governmental systems do better and deliver better than what we have and to get out of the way of progress when the opportunity for progress makes itself apparent.
I believe if there had been, you know, a consistent, vocalized mass of individuals who were making their presence known throughout the Kentucky project in a way that would get the attention of opportunistic politicians—if the consequences of those masses and their votes were deemed to outweigh the influence of contributors—we would have been successful. Now that's a tall climb, and that requires a lot of effort, and we executed that project over what was essentially a six-month time frame, so that probably was expecting a little much. You know, Daniel Cameron is an individual of tremendous authenticity and sincerity, and I came to learn that his successor did not quite measure up on either one of those attributes, by virtue of how he conducted himself with this project. And the only way that you can check bad leadership is to hold it accountable with proper information and an engaged citizenry that is willing to put intentions into action.
Yes, I agree, and my concern in all of this is that people are so easily manipulated, and their energy is so easily wasted or directed toward the wrong goals. I mean, I've followed coverage of the opioid epidemic very closely since it began, and the amount of bloodlust oriented at the Sacklers has been really alarming to me. And I, of course, understand why somebody might hate Richard Sackler, but hatred of the Sackler family doesn't bring back the dead; it doesn't save the people who are struggling with addiction currently. And even after the media was completely saturated with coverage and documentaries and books about the terrible crimes of the Sackler family, the number of opioid overdoses continued to rise, and the traditional argument that everyone had been manipulated—that nobody knew that oxycodone was addictive—simply couldn't hold anymore. It was a sort of absurd idea that I don't think was ever true to begin with—this idea that nobody knew. I think people knew very well. I think patients knew; I think physicians knew; and I definitely think the manufacturers knew. So the issue isn't that nobody knew that opioids are addictive; the issue is that people weren't taking the appropriate measures to ensure that people weren't hurt—whether it was providing psychological resources for people struggling with substance abuse, or safe injection sites, or widespread access to naloxone, or ibogaine, or changing the prohibition of opioids so that the black market didn't dominate and introduce fentanyl, which made things far more dangerous than they had to be. But instead, I saw more enthusiasm oriented toward attacking art museums that had received philanthropic contributions from the Sackler family—something that is, as far as I'm concerned, utterly meaningless.
Well, unfortunately, we live in a society which is enthralled with the opportunities to pursue performative symbolism that has no real consequence or effect on real life. It's the easy exercise, as opposed to having to engage in the daily process of applying consistent, follow-up pressure on elected representatives and the systems of government that they oversee to deliver results. You know, when you have a society that is captured by a framework of survivalism and and a hand-to-mouth existence, you don't have much time to do anything other than to vent and to be reactionary in a way that allows you to release all of that pent-up negative emotion and also indulge the escapism that comes into it. You know, when people are just trying to get by, it's a whole lot easier to raise your head and to give out a primal scream and go on down the road thinking you've done something than it is to engage in the hard work that comes with having the responsibilities of an engaged citizen. And to your point on the Sacklers, they couldn't have done what they did without the willingness of officialdom to be complicit. Officialdom is as responsible as the Sacklers. And you also make a point about the fact that people did know. I can't tell you how many depositions I took of physicians who were prescribing oxycodone for soft tissue, low back strains, who I would confront with research literature which said these medications are to be prescribed for these categories of conditions, which do not include lumbar musculoskeletal strains with non-verifiable radiculopathy. These medications would be specifically challenged within a litigated case; we would perfect what was called a medical legal dispute, where we would specifically and explicitly challenge a physician's prescribing behavior for a particular individual because it was far in excess of what the condition called for and was detrimental to the person based on its propensity for habituation. Those were—those were rarely, if ever, successful. We had a workers' comp judiciary here in Kentucky that was appointed by the governor, and the governor took their appointment advice from the plaintiff's lawyers. When I could go in and look at a docket, see who the lawyer was and who the judge was, and know what the outcome is going to be on the cases, regardless of what the evidence was. You're not dealing with a legal system; you're dealing with a system of patronage and graft and corruption. And these systems existed in Kentucky, and they existed throughout the country, and they helped facilitate every bit of this that happened. The Sacklers may have invented a chemical formulation that was tremendously addictive, but it depended on a multifaceted distribution system that included government, that included the judicial system, that included the medical system, which ensured that it got pumped into everywhere there was a human being in this country, and their success would not have been possible without the participation of those actors.
Yes, yes, I agree completely. The other criticism that I have with Dimitri's perspective—that using ibogaine as a treatment doesn't address the holistic dimensions of opioid dependence—is that I kind of think that, as far as pharmacotherapies go, it's pretty damn good for that. I mean, this is not a drug that simply interferes with opioid withdrawal and that's it. The psychedelic dimensions of the ibogaine experience are widely reported to exert a far-reaching benefit for users in terms of helping them assess their own motivations for using substances, helping them assess the circumstances of their life that led them to be in this particular position. I mean, I've used iboga in a traditional ceremony in Gabon. I am not dependent on opioids, nor have I ever been, but it was incredibly clear to me that this experience exerts a far-reaching therapeutic effect in terms of helping people reconceptualize their own life and how they're living it. The preliminary evidence for efficacy is pretty strong, but what's really important not to ignore is that this does change people beyond just their relationship with opioids, and that's one reason that it has this long tradition in Gabon. Traditionally, no one in Gabon was using iboga as a treatment for opioids; that actually has emerged in recent years because tramadol has been introduced to Central West Africa. But traditionally, that was never a motivation. And I'm under the impression that you've tried ibogaine yourself, and I'm curious in your experience, as well as the experience of people that you've spoken with, how you feel about these psychedelic dimensions of the experience and how that could have specific applicability to the people you've encountered in Kentucky who struggled with opioid use.
When—when I was growing up, and I'm of the age at which my grandparents were within that Great Depression, World War II, Greatest Generation cohort—my grandfathers were grade-school-educated coal miners. These men had lives of deprivation and difficulty that I cannot begin to imagine. I remember taking an oral history from one of my grandpas—about the Great Depression—and it was a college assignment out of English class to—to get an oral history from somebody. And I said, "Hey, won't you tell me about what you experienced in the Great Depression?" He said, "Well, we didn't notice; we didn't notice anything; we were already dirt poor." You know, he was one of 16 children; they had dirt floors in their house, and it was a hand-to-mouth subsistence farming living until he was old enough to go work in the coal mines at the age of 16. These guys lived incredibly hard lives, and they were representatives of their generation at the time. I can remember being a young boy and going to the grocery store with my grandparents, or going to their church, or just going out into the community. Neither one of my grandpas had a full set of fingers. You could hear my dad breathe 50 feet across the room from the way in which he had developed black lung and from the lingering effects of tuberculosis that he had contracted in a cold camp, which sent him to a sanatorium for seven years; almost died. These men, though broken in body, had tremendously beautiful, hopeful souls within those bodies, and they were not alone. Appalachian society at the time I was a boy was filled with people who had lived lives of tremendous material and physical deprivation and hardship, and they might have been stooped over pushing a shopping cart down the aisle in their back, but they held their head high; their eyes were clear, and they exuded a spirit of thankfulness and optimism just by virtue of being alive. When I go back home today, I see people who have had—though relatively speaking—are still in a poor existence, an existence that has been far better and far easier from both a material and physical perspective than that which was experienced by their grandparents, despite that their heads are bowed and their eyes are glazed, and they have all the countenance of a defeated and hopeless people.
When I think about ibogaine's properties, I think about the physiology which reverses the neurochemical brain injury caused by opioid dependence, which shuts down the brain's ability to create dopamine and serotonin—an ability that it does not begin to recover until 18 months of complete abstinence from opioid consumption. Abstinence-based treatments have a 7% success rate because a person cannot experience life without dopamine and serotonin presence in that brain. The fact that ibogaine can restore the brain to its pre-opioid exposure condition within 36 to 48 hours, mercifully cutting off a year and a half of suffering, is miraculous. When we combine that with the psychology which is endorsed by individuals who have been captive to compulsion—whether it's the compulsion of opioids, meth, or or any other um behaviors that have been damaging to them and those around them—they come away endorsing a restoration of personal autonomy, freedom, and choice over their decisions that they had never experienced before, whereby they get to have a life where they own their destiny as opposed to being captive to compulsive behaviors which drive them toward destruction. And then we finally get into the spiritual realm, which to me is the most significant part of what ibogaine has to offer. Humans are spiritual creatures. I personally don't happen to believe that the human species is the result of an astrophysical, chemical accident that just happened to us into existence. The human experience is singular and precious, and according to a lot of folks who have used ibogaine, they come away with an affirmation that they are the child of an eternal Creator whose essence is pure, unconditional, almighty love for them as a person, and that they, as an individual, have a special and unique purpose for their life. I cannot imagine a greater gift that we as a society can offer a human being who is caught in the suffering of compulsion—whatever that compulsion may be—than to provide physiological restoration, psychological restoration, and spiritual awakening that comes from an ibogaine experience. The fact that it is criminal is criminal, and whatever my experiences may have been, whatever my assets may be, whatever abilities I may possess, I will apply as best I can to advance this cause for the purposes of human emancipation so long as I've got the ability to do so, and it is a privilege.
I think your observation that your grandparents who lived substantially more difficult lives still had a dignity and a gratitude and a strength that is absent from many people is a really important one, and I think that we have to ask why that is the case. Is it the dissolution of traditions, of religious communities, of traditional values? And I'm not even talking about this from a—because I'm—I'm, for what it's worth, I'm an atheist, but I at the same time recognize that there is a social cohesion that comes from a collective purpose, from a de-emphasis on the individual, and our atomized, hyper-individualistic, electronically-oriented lives have clearly set people up for extreme forms of despair. There's no question that—whether it's the influence of looking at people who are wealthier or more beautiful on social media, or the lack of human connection that comes from this sort of continuous electronic involvement that we have with one another—all these factors are working in concert to make people very unhappy, and the social dimensions required to undo a lot of this are—I won't say impossible—but it's a tall order. It requires major social organization, social cohesion, and a sort of collectivist value system that doesn't come easily, especially once it's been undone to some extent. I don't think that we'll ever be able to return to the way things were in your grandparents' generation without a complete destruction of electronic infrastructure. I think that this is, unfortunately, part of the price that we pay for the many substantial and amazing benefits of our electronic world, but my hope is that as psychedelics are first introduced into our culture medically, that that will then also help promote religious use and other types of use that will help bring people together and lessen some of these other dimensions that contribute to susceptibility to opioid dependence—the sorts of things that Dimitri was recognizing. I think that even if acutely ibogaine does not address all those issues, broadly speaking, what it represents and could represent for a culture in terms of the religious and community values that can come from an appreciation of the iboga experience could have very far-reaching and very real benefits. There is not a formally organized system—whether it be a corporate, nonprofit, or governmental system—that can create the necessary spiritual awakening which can restore an individual's perspective on the incredible privilege it is to be a human being and how precious and rare the experience of life is within the expanse of the known universe. Psychedelics seem to have the unique ability to generate a profound spiritual recognition within an individual which causes them, first and foremost, to value who they are and the worth of the time that they have on this Earth in a way which, when broadly applied, can help recreate a degree of connectedness and cohesion that we currently lack because of how we have been despiritualized by technology and other rationalist systems of Western society which fail to recognize the spiritual dimensions of life. Until we have that spiritual awakening, we are doomed to see the despair dynamics play out in multifaceted ways, as we're witnessing right now in an American society that has, for all of its material wealth and technological advancement, evolved into an incredibly dehumanizing entity that does not seem to connect individuals to their spiritual essence.
Yeah, I mean, you make such strong points that I think that you will succeed, and I really appreciate your conviction because I do think that, at the absolute least, this is worth trying. At the very least, the alternative is to take all the money and resources we have and continue to dump them on what we know doesn't work. There is no—I saw a quote—it's—it's within one of the PowerPoint presentations I used internally within the office, and I saw it again this week. I'm gonna paraphrase it, and it's an Einstein quote that I'm sure many of your listeners have heard before, and it is: We cannot solve problems with the same mindset that we use when they were created. That's it—paraphrase; that's not it exactly, but that's the truth. To insist that we don't make an effort to take a small risk to create innovation to improve a system that is a demonstrable failure—that is a demonstrable failure despite its consumption of an unbelievable degree of public resources—while its failures sow the seeds of additional generational despair that will play out at a compounding scale over time is the very definition of insanity. We cannot continue to simply be satisfied with what we have, double down on the appropriation of resources to expand it, and watch it continue to fail while its failures have significant, destructive repercussions for everyone affected by those individual failures. We have an obligation to do everything that we can to make progress toward the alleviation of human suffering, and there has been more than adequate observational, open-label studies and research to demonstrate that ibogaine holds significant therapeutic promise which is worthy of taking a small percentage of resources to explore and, if validated, fully develop so that its potential may be applied to immense problems that are not getting better.
Agreed. Yes. Yeah. And for the people listening to this who want to follow your work and the progress of these initiatives, where is the best place for them to learn more about you, follow your work? Do you have social media? Is there some—some reading you can direct them to? What should they look for?
Well, I will confess that I have been a Luddite when it comes to all forms of social media. I have never been on it; been proud to have never been on it. But with the transition out of the Attorney General's office and what I believe to be the need to maintain awareness around the work that's being done to advance ibogaine, I—on the advice of a good friend—bit the bullet and had a very rudimentary, very basic, bare-bones website constructed that is a repository of information that has gone into the Kentucky project as well as some of the news stories around it. And that website is simply my name, which is www.wbrianhubard.com—Brian with a Y. So www.wbrianhub.com—Brian with a Y. And when people pull it up, don't laugh at me; I was working on a low budget. I… okay, I will direct listeners to that. And just as one—sort of final, unrelated question—you're such a great public speaker, and you speak so emphatically and enthusiastically. Do you have any secrets? Were you always this good? Well, you—if you could see my face right now, you could see me blush from the compliment. I'm gonna be honest with you; when I hear you and others say that to me, it's always a surprise, no matter how many times I might deliver remarks and receive an enthusiastic reception. I'm always shocked because I look at me in the mirror every day and…
Live with me every second of the day, and I don't see or perceive anything special. What I do feel is tremendous conviction and a tremendous degree of intensity around those convictions. So, when I see a set of circumstances or reality which needs to be addressed, I address it with the full force of the conviction that I carry inside of me. And if that happens to come out as effective communication, I show you that it is purely by accident.
And I appreciate you characterizing what you perceive as that ability in such complimentary fashion, and you honor me with that observation, and thank you. Well, thank you so much for your time; this was profoundly educational for me, and I think a lot of people will appreciate this discussion. And I look forward to bringing up a lot of the points you made with Dimitri, because I think that if he hears what you have to say, it's very hard to disagree with it.
Well, currently, you know, I would assume that he is an egalitarian humanitarian, and the only way people can get ibigan treatment right now is if they have the means, and that means is considerable and expensive. You know, for people who want to level the playing field and democratize access to those things that currently only the people can get a hold of, there is no better opportunity to engage in that endeavor than this one. And, and given his background and knowledge, he's somebody I would love to meet, talk with, and and find common ground so we could work in concert, if that's possible. I'm always down for making friends and allies.
Well, thank you so much for your time, and I will be following the progress as you work on this in other states very closely. And thank you for all of your work, Hamilton. Thank you for all your work, for who you are, and the way in which you have advanced knowledge of psychedelics through all the wonderful productions that you have made on it. It's been a privilege to be your guest, and thank you for letting me be on your platform. All right, have a good day. You too. Okay, bye-bye.