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Speaker 1: On this episode of Newtsworld. According to the Centers for

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Speaker 1: Disease Control, one hundred and seven thousand, three hundred and

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Speaker 1: seventy five people in the United States died of drug

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Speaker 1: overdoses and drug poisonings in the twelve month period ending

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Speaker 1: in January twenty twenty two. A staggering sixty seven percent

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Speaker 1: of those drug deaths involved synthetic opioids like fentanyl. Some

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Speaker 1: of these deaths were attributed to fentanyl mixed with other

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Speaker 1: drugs by cocaine, methamphetamine, and heroine, with many users unaware

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Speaker 1: that they were actually taking fentyl. According to the DA quote,

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Speaker 1: only two melligrams of fentanyl is considered a potentially lethal dose.

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Speaker 1: Close quote. As we watched the death toll arise from

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Speaker 1: fentyl overdoses and understand the personal loss and impact it

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Speaker 1: has a many families. There are researchers on the cutting

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Speaker 1: edge of science king to find a solution, and I'm

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Speaker 1: really pleased to welcome a guest doctor Colin Hale. He

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Speaker 1: is a research associate professor in psychology at the University

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Speaker 1: of Houston's Drug Discovery Institute and author of the news

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Speaker 1: study published in the journal Pharmaceutics entitled quote and immuno

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Speaker 1: conjugate vaccine alters distribution and reduces the anti no susceptive,

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Speaker 1: behavioral and physiological effects of fentanyl and male and female rats.

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Speaker 1: He's developed a potential fentanyl vaccine which could be a

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Speaker 1: game changer for the opioid epidemic. Colin, welcome and thank

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Speaker 1: you for joining me in news World. It's a pleasure,

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Speaker 1: mister speaker, absolute pleasure. I'm curious to start with, how

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Speaker 1: long have you been working to discover this Well, our

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Speaker 1: group has been working on vaccines like this for at

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Speaker 1: least fifteen years, but this particular vaccine we've been working

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Speaker 1: on for about five to six years, so clearly it's

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Speaker 1: a desperately needed vaccine. Tell me, just remembered what was

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Speaker 1: the key to discovering this one. Is it primarily looking

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Speaker 1: at the genetics or how do you go about in

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Speaker 1: this modern era developing these kinds of vaccines. Good question.

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Speaker 1: As I mentioned, we've been working on vaccines like this

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Speaker 1: in the past against methamphetamine, against cocaine, and about five

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Speaker 1: or six years ago the opioid epidemic started and it

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Speaker 1: became quite obvious that this was going to be a

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Speaker 1: huge problem. So the technology that we had developed in

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Speaker 1: previous vaccines, we applied to this one against fentanyl, and

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Speaker 1: fortunately we have gotten significant funding from the Department of

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Speaker 1: Defense to get us to this point and we are

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Speaker 1: excited to move forward. So the way this develops you

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Speaker 1: come up with a theory, you develop an initial chest drug,

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Speaker 1: and then in the current system, as I understand, you

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Speaker 1: try it out either on mice or rats in order

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Speaker 1: to see if it works correct. And these are called

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Speaker 1: preclinical studies, and we've conducted numerous studies in mice and

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Speaker 1: also rats. The journal article that you mentioned was conducted

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Speaker 1: in male and female rats with complete blockade of antifinnyl's

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Speaker 1: effects in vaccinated animals compared to unvaccinated animals. And in

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Speaker 1: that study we looked at quite a few measures, importantly

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Speaker 1: the effects of finnyl on physiology overdose. So we gave

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Speaker 1: a high dose of fentinel to vaccinated and unvaccinated rats,

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Speaker 1: and then we measure your oxygen, blood levels, respiration, heart rates,

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Speaker 1: and activity which are all associated with overdose, and we

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Speaker 1: showed that in our vaccinated animals we completely blocked these

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Speaker 1: ventyl induced effects. Is there any significant difference between using

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Speaker 1: rats and mice? There is a species difference. For me,

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Speaker 1: I'm rat biased. I like rats very easier to work

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Speaker 1: with and you can measure complex behaviors, where for me,

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Speaker 1: mice are not so complex and frankly stupid. Ask and

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Speaker 1: our rats actually technically smarter than mice, I would say, so, yes,

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Speaker 1: that's interesting. I had not had a chance to ask

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Speaker 1: anybody that. So if I understand it, what you've developed

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Speaker 1: in principle, which now we believe works in rats, and

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Speaker 1: you're about to test it on humans, if somebody has

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Speaker 1: a ventyl dose but recovers, you would then apply this

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Speaker 1: vaccine and in the future they would be non responsive

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Speaker 1: to that particular drug, so they wouldn't have a great

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Speaker 1: urge to go take it again. So so sort of

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Speaker 1: an anti relapse medication, would that be a fair way

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Speaker 1: to say it. Yes, so you're right on. I present

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Speaker 1: this as exactly what you said, an anti relapse, a

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Speaker 1: medication that is going to be used in conjunction with

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Speaker 1: maintenance therapies, which your method of upen orphine al trek zone.

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Speaker 1: And we know, however, that a high percentage of this

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Speaker 1: patient populations relapse, nearly eighty to nine percent. We know

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Speaker 1: they will relapse also we know that we have a

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Speaker 1: high rate of non compliance of these medications because of

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Speaker 1: their side effects. I was strengthly startled to realize that

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Speaker 1: if you have opioid use disorder, even with maintenance therapy,

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Speaker 1: the relapse rates approach. That's correct. I mean, that's sort

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Speaker 1: of staggering. It is, and it points towards the need

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Speaker 1: for a novel treatment strategy. And that's what this vaccine is,

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Speaker 1: assuming that it works when the FDA approves it. If

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Speaker 1: I then took the vaccine, would I need the other

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Speaker 1: maintenance drugs? Well, we would prefer that the patient did

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Speaker 1: have maintenance therapy on board because that would be an

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Speaker 1: added protection. However, if they did not and the individuals

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Speaker 1: had been vaccinated, they develop antifentnyl antibodies that are generated

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Speaker 1: from the immune system. T sales communicate with B cells.

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Speaker 1: B cells make antibodies that reside in the blood. If

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Speaker 1: the vaccinated individual consumes fentanyl, those antibodies will bind to

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Speaker 1: fentyl and prevent it getting into the brain, where it

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Speaker 1: stimulates centers that control euphoria and reinforcement, and also control

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Speaker 1: the deadly effects of fentanyl, such as overdose and death.

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Speaker 1: Is the impact of fentanyl that causes death primarily on

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Speaker 1: brain function. It's function. It targets mechanisms in the brain

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Speaker 1: stem that control respiration. It also induces what's called the

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Speaker 1: wooden chest syndrome, where intracostal muscles become rigid and you

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Speaker 1: can't move your diaphragm to inhale or exhale. But at

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Speaker 1: the bottom line is it depresses respiration. Okay, so both

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Speaker 1: through your nervous system in your brain and through your

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Speaker 1: nervous system in your chest, primarily the brain. Is there

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Speaker 1: a plausibility, but at some point we would actually use

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Speaker 1: this as a preventive vaccine for young people in an

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Speaker 1: effort to totally block off the fentanyl addiction. As you

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Speaker 1: can imagine, the response to this study has been enormous,

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Speaker 1: and I have been contacted by numerous parents that are

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Speaker 1: concerned about their kids. Their fear is that their kids

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Speaker 1: are going to experiment with substances, and these substances, as

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Speaker 1: you noted on the intro, have been adulterated with fentyl.

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Speaker 1: So these kids are taking these drugs and unknowingly being

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Speaker 1: exposed to fentyl and unfortunately overdosing and die. So one

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Speaker 1: strategy would be to use the vaccine as a prophylaxis

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Speaker 1: for those individuals that feel that they will be exposed

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Speaker 1: to fentyl in some way. Once you've taken the vaccine,

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Speaker 1: does it have a lifetime effector would you need to

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Speaker 1: renew it? Good question. Our vaccine strategy or protocol is

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Speaker 1: similar to hepatitis B vaccine, where you get an initial

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Speaker 1: vaccination and then a little while later you get a

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Speaker 1: first boost, and then a few months later a second boost.

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Speaker 1: It's the same way for our vaccine, but you don't

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Speaker 1: have to go back and retake it every four or

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Speaker 1: five years. We don't know, okay, well, now, well with

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Speaker 1: hepatitis B, once you've done the two boosters that in

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Speaker 1: It depends on the individual. For myself, when I got

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Speaker 1: hepatitis B, it took and I haven't needed a booster

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Speaker 1: in a long time. Now with this vaccine, we've only

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Speaker 1: gone out twenty weeks after the initial vaccination in rats,

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Speaker 1: and twenty weeks is a long time for a rodent.

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Speaker 1: But at twenty weeks we got complete blockade of fentyl's effects. Now,

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Speaker 1: to determine the enduring effects of the vaccine, we'll have

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Speaker 1: to look at that in the phase one or phase

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Speaker 1: two clinical trials, but we're very confident based on our

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Speaker 1: data that we'll have an enduring response and the antibodies

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Speaker 1: will be there and we'll be able to neutralize fentnyl

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Speaker 1: take it out of the body. So, given the way

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Speaker 1: the FDA operation, how long do you think the process

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Speaker 1: will be to get to a potentially marketable vaccine. You're

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Speaker 1: asking very good questions, and we cannot predict how long

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Speaker 1: this is going to take. However, I do believe and

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Speaker 1: I am confident that the FDA will look upon our

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Speaker 1: application in a different way. In a different way means

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Speaker 1: that part of our vaccine is already in two vaccines

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Speaker 1: on the market and have been for many years and

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Speaker 1: has proven safe and effective. The other part of our

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Speaker 1: vaccine has also been in human clinical trials and also

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Speaker 1: in infants and has also proven safe and effective. So

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Speaker 1: we have two out of the three parts of our

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Speaker 1: vaccine that already been in humans and have proven safe

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Speaker 1: and effective, and so were confident that these data will

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Speaker 1: help us. We hope, it's not for sure that the

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Speaker 1: FDA will look positively on our application. Now, the research

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Speaker 1: you're doing is at the University of Houghton's Drug Discovery Institute.

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Speaker 1: Do you imagine then forming some kind of private public

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Speaker 1: partnership to go through the next phase because of dems

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Speaker 1: dramatically more expensive the further you go down the human trial. Yeah,

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Speaker 1: so you're right. I'm at the University of Houston. I

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Speaker 1: am a founding member of the Drug Discovery Institute, but

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Speaker 1: all of our work here at you have h is

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Speaker 1: in our laboratories and also through the Animal Behavior Core Facility,

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Speaker 1: which I'm also a founding a member of the Core Facility,

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Speaker 1: and through the Department of Psychology and Times, which is

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Speaker 1: an institute here that has been very supportive as far

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Speaker 1: as how to move forward. There are a number of ways.

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Speaker 1: University of Houston has overwhelmingly supported us with protecting intellectual property,

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Speaker 1: getting the patent secure, and also they are very supportive

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Speaker 1: of entrepreneurship and moving this thing forward. I think after

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Speaker 1: what has happened recently, with all the publicity, I think

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Speaker 1: they're going to be even more supportive. In fact, I

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Speaker 1: was contacted just today that Governor Abbott will be visiting

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Speaker 1: our lab next week. I can tell you, as somebody

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Speaker 1: who looks at the whole country, this crisis of drug

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Speaker 1: addiction and drug overdose is so enormous. I have several

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Speaker 1: friends personally who have lost children to drug overdoses, and

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Speaker 1: it is truly a national crisis. We had one of

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Speaker 1: our interns do a comparative study. If you look at

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Speaker 1: the wall for the people who were killed in Vietnam

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Speaker 1: and you build a comparable wall, extending it down to

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Speaker 1: cover everybody who's been killed in the last ten years

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Speaker 1: from drug overdoses, the wall would be one point one miles.

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Speaker 1: We have quietly accepted a level of assault on our

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Speaker 1: children that is just staggering. And so what you've done,

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Speaker 1: I mean you're going to have everybody and their brother

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Speaker 1: and sister coming to visit because people are so desperate

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Speaker 1: for hope. And as you could tell when we called you,

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Speaker 1: we wanted to share this in a podcast with people

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Speaker 1: because I know there will be so many people instead

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Speaker 1: in what you're doing. So let's go back in your life,

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Speaker 1: because after all, these things get done by people who

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Speaker 1: have unique passions and put in time. How did you

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Speaker 1: decide to get into biological research. Well, I originally biopsychology,

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Speaker 1: and I didn't feel like that was enough. I went

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Speaker 1: to graduate school. I didn't feel like that area was enough,

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Speaker 1: so I ended up joining a lab at the University

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Speaker 1: of Texas Medical Branch in the Department of Pathology and

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Speaker 1: worked on heart issues heart things, and then eventually got

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Speaker 1: into surgery. I worked for a veterinary surgeon for a

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Speaker 1: while and then I left Austin at the time and

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Speaker 1: took a position at Yale School of Medicine Department Psychiatry.

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Speaker 1: From then on, it has always been research how does

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Speaker 1: the brain respond to certain substances that are misused by

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Speaker 1: humans and anything that has to do with psychiatry cognitive impairments.

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Speaker 1: I was a faculty at Thomas Jefferson Medical School and

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Speaker 1: Department Neurosurgery, where I developed with my colleagues a peptide

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Speaker 1: that enhanced memory and learning, and then I made my

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Speaker 1: way back to Yale Department Psychiatry again. This time I

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Speaker 1: was developing radio ligands or things that helped us look

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Speaker 1: at things in the brain, such as brain scans and things.

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Speaker 1: And then had the opportunity to come back to taxes

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Speaker 1: and so I was recruited along with my colleagues doctor

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Speaker 1: Trees Costin and doctor Thomas Costin. We were recruited by

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Speaker 1: Baylor College of Medicine and Department of psychiatry, and there

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Speaker 1: I also did some human research in addition to animal research.

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Speaker 1: And then doctor Costin requested I joined his group more

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Speaker 1: to focus on the vaccines because he was the first

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Speaker 1: one to bring a anti addiction vaccine into humans. It

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Speaker 1: was anti cocaine vaccine. He was the first one to

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Speaker 1: do that. And so it got to phase two and

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Speaker 1: I think phase three clinical trials, and there was some

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Speaker 1: issues that prevented it from getting onto the market. We

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Speaker 1: know what those issues are and we have much better technology.

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Speaker 1: We have plans to apply this technology to an anti

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Speaker 1: cocaine vaccine. But then eventually University of Houston recruited terras

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Speaker 1: Constant to partment psychology and then they acquired quite a

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Speaker 1: bit of money, built new labs, new buildings, incredible animal facility,

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Speaker 1: and then Terry goes, well, why don't you think about

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Speaker 1: coming over here, and then said, well, it looks fantastic.

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Speaker 1: The facilities are incredible, and then he did somebody to

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Speaker 1: establish the Animal Behavior Core facility. So that was one

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Speaker 1: of the main reasons I came over here. But all

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Speaker 1: during that time we had been developing the anti methodphetamine vaccine.

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Speaker 1: We got a grant in coordination with Baylor. We formed

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Speaker 1: a small company and this was a small business Initiative

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Speaker 1: grant to test the vaccine. At the time, there were

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Speaker 1: some milests that NAIDA National Institutes on Drug Abuse did

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Speaker 1: not feel that we achieved, and then pulled the funding.

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Speaker 1: And eventually we found out where the funding went, and

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Speaker 1: at the time, the opioid epidemic was starting to ramp up,

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Speaker 1: and so those funds went to individuals looking at potential

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Speaker 1: treatments for opioid use disorder. So we of course had

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Speaker 1: our technology. We lost the funding and then gained funding

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Speaker 1: to produce the anti finthal vaccine and that's what we've

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Speaker 1: been focused on since now, and fortunately we've made tremendous progress.

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Speaker 1: Some people argue that harm reduction strategies are another form

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Speaker 1: of treatment. Can you talk about the whole notion of

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Speaker 1: harm reduction strategies and whether they are in fact effective.

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Speaker 1: You point out that some ninety percent of people in

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Speaker 1: fentinal addiction tend to relapse even if they're on a

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Speaker 1: harm reduction strategy, But well, what should the average citizen

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Speaker 1: know about the concept of harm reduction strategies. I've written

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Speaker 1: about this A doctor David nutt Over in England was

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Speaker 1: one of the first to really push harm reduction strategies

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Speaker 1: into mainstream psychiatry. It's been around for quite a while,

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Speaker 1: such as needle exchange programs to reduce disease transmission, providing

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Speaker 1: safe spaces to take drug in Switzerland, I believe they

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Speaker 1: were the first ones to do that. Canada, up in Vancouver,

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Speaker 1: I believe they were some of the first to start

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Speaker 1: the needle exchange programs. And the idea is to provide

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Speaker 1: for example, clean needles to reduce HIV transmission hepatize. That's

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Speaker 1: the overall strategy. Balancing that strategy, it needs to be

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Speaker 1: combined with techniques that decrease drug use. Where I see

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Speaker 1: that it's going wrong is that you know, you're providing

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Speaker 1: even clean drug, clean needles, clean safe space, and you're

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Speaker 1: facilitating the drug intake and not really offering strategies and

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Speaker 1: treatments to decrease drug intake. That's where I see that

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Speaker 1: kind of faulty in my view. But the overall strategy

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Speaker 1: of harm reduction innately is positive, but apparently with fentanyl

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Speaker 1: at least, it has remarkably limited impact. Yes, fentanyl is

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Speaker 1: a very highly reinforcing or highly addictive opioid, and it

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Speaker 1: is cheap, it's everywhere, and it only takes very very

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Speaker 1: small amounts to achieve euphoria with our vaccine. For people

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Speaker 1: that want to quit, this is an added tool to

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Speaker 1: help those achieve sobriety. Once they relapse, they can get

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Speaker 1: back on the wagon to sobriety. For those that don't

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Speaker 1: want to quit, this probably will not work for them.

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Speaker 1: You know, often you'll see if an individual can't find fentanyl,

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Speaker 1: they'll switch to heroin. If they can't find heroin, they'll

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Speaker 1: switch to oxycodone or hydrocodone or another opioid. What does

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Speaker 1: make fentanyl different from either the prescription drugs leconso cotton

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Speaker 1: or heroin? Why is fentanyl so much more impactful? So,

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Speaker 1: the key to the addictive properties of any drug is

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Speaker 1: how fast does it get into the brain to trigger

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Speaker 1: these euphoric centers or the circuitry that produces euphoria. And

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Speaker 1: Ventanyl is highly lipophilic. That means that it loves fat.

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Speaker 1: It goes into fat very very quickly, so therefore it

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Speaker 1: gets into the central nervous system extremely quickly. Drugs that

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Speaker 1: get into the central nervous system quickly are the most

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Speaker 1: addictive so people get to a point where from addiction

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Speaker 1: they just find it extraordinarily hard to quit because as

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Speaker 1: the drug starts to dissipate, they have a deep physical

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Speaker 1: pain urging them to replenyship man, Is that a fair summary, Yes, sir,

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Speaker 1: that's part of the addictive process with opioids, and very

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Speaker 1: specifically two opioids. If you've been taking these drugs for

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Speaker 1: a long period of time, you develop tolerance, so you

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Speaker 1: need more of the drug to get that high. If

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Speaker 1: you have to developed tolerance, stopping these drugs will eventually

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Speaker 1: produce a withdrawal syndrome, and so the individual then gets

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Speaker 1: into this endless cycle of having to take the drug

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Speaker 1: to not experience a bad effect, and that bad effect

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Speaker 1: is withdraw and it's a terrible cycle. I find it

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Speaker 1: horrifying that we have slid into this culture where you

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Speaker 1: lose one hundred thousand people a year and we really

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Speaker 1: haven't done anything effective. And one of the reasons you're

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Speaker 1: going to be visited by so many people is for

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Speaker 1: the first time there's a breakthrough that sort of fits

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Speaker 1: the American model, which is technology defeats problems. And I

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Speaker 1: think that that's a remarkable part of this I hope

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Speaker 1: we'll be able to stay in touch with you, and

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Speaker 1: I want to thank you for joining me. You know, Colin,

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Speaker 1: we've just had Thanksgiving and we have a lot to

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Speaker 1: be grateful for, and frankly, your hard work and that

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Speaker 1: of your team, the commitment you've shown, the years you've

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Speaker 1: put in may produce a lot of Thanksgivings over the

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Speaker 1: next few years for thousands of Americans who are saved

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Speaker 1: from dying of fentanyl because of the hard work you're doing.

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Speaker 1: So I hope that this is the beginning of many

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Speaker 1: happy Thanksgivings for families that otherwise might lose a loved one.

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Speaker 1: I'm impressed and honored to have a chance to talk

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Speaker 1: with you, and I want to thank you for joining

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Speaker 1: me on Newtsworld and sharing your research. Well. I appreciate

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Speaker 1: you having me on your platform and it was an honor.

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Speaker 1: Thank you to my guest doctor Colin Hale. You can

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Speaker 1: read his study about the new fentanyl vaccine being developed

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Speaker 1: on our show page at newtsworld dot com. Newts World

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Speaker 1: is produced by Gingwish three sixty and iHeartMedia. Our executive

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Speaker 1: producer is Guarnsey Sloan. Our producer is Rebecca Howe and

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Speaker 1: our researcher is Rachel Peterson. You art work for the

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Speaker 1: show was created by Steve Penley. Special thanks the team

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Speaker 1: at Gingwish three sixty. If you've been enjoying Newtsworld, I

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Speaker 1: hope you'll go to Apple Podcast and both rate us

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Speaker 1: with five stars and give us a review so others

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Speaker 1: can learn what it's all about. Right now, listeners of

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Speaker 1: newts World can sign up for my three free weekly

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Speaker 1: columns at gingwist sixty dot com slash newsletter. I'm newt Gingwig.

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Speaker 1: This is news World