Comité Defense & Veterans Affairs de la Cámara de Representantes
Comité Defense & Veterans Affairs de la Cámara de Representantes, 24 de febrero de 2026
2025-2026 Regular Session · 506 CLOB · 42 min
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Resumen
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El comité escuchó la presentación de HB 1296, que su promotor describió como un programa piloto de investigación y tratamiento de tres años para veteranos y personal de primera respuesta jubilado con afecciones graves de salud mental. Una persona que testificó en representación de Veterans Exploring Treatment Solutions apoyó la propuesta y explicó los tratamientos asistidos con sustancias psicodélicas. Los miembros preguntaron sobre los costos, la selección de pacientes, las alianzas con universidades y qué tratamientos cumplirían los requisitos. El presidente solicitó una estimación más específica del financiamiento. El comité adoptó una enmienda para agregar a los comités de asuntos de veteranos de la Cámara de Representantes de Georgia y del Senado de Georgia como destinatarios de los informes del programa y luego aprobó el proyecto de ley en su versión enmendada mediante votación a viva voz. No se indicó el recuento de votos.
Proyectos de ley tratados (1)
Cada relato abarca el tramo de la reunión que indica. El número del proyecto de ley se dice en ese tramo, salvo cuando era el único proyecto en la agenda de un comité.
HB 1296. Mental health; pilot program to support clinical research of certain veterans and first responders suffering from certain conditions; provide
Desde 0:10:16 · turnos 3 a 135
El promotor dijo que HB 1296 establecería un programa piloto bajo supervisión médica dentro del Department of Behavioral Health and Developmental Disabilities para veteranos y personal de primera respuesta jubilado con trastorno de estrés postraumático (TEPT), depresión, lesión cerebral traumática y afecciones relacionadas. El promotor dijo que comenzaría en 2027 solo si recibiera financiamiento, terminaría en 2030, apoyaría la investigación y el acceso al tratamiento, y exigiría informes anuales.
Una persona que testificó en representación de Veterans Exploring Treatment Solutions describió el tratamiento asistido con sustancias psicodélicas y la terapia de seguimiento. Citó investigaciones que mostraban que alrededor del 66% de los pacientes con TEPT tratados con MDMA ya no cumplían los criterios de diagnóstico, en comparación con una tasa de éxito del 34% al 40% para los medicamentos aprobados. Un miembro apoyó el proyecto de ley basándose en las experiencias de tratamiento de sus amigos.
Al responder a una pregunta sobre los costos, el equipo de presentación del promotor estimó entre $1 millón y $5 millones. La persona que testificó estimó aproximadamente 12 pacientes por cada $1 millón y dijo que el tratamiento con ibogaína dura entre 16 y 22 horas. El presidente solicitó una estimación más precisa del financiamiento. Ante una pregunta sobre los requisitos de participación, la persona que testificó describió el proceso de evaluación de la organización sin fines de lucro, reconoció los riesgos y explicó la preparación y el seguimiento, pero no estableció las reglas de selección del programa piloto. El promotor dijo que las universidades serían socias de investigación.
Aunque el presidente inicialmente presentó la propuesta como específica para la ibogaína, otro miembro cuestionó su redacción más amplia. La persona que testificó dijo que los investigadores podrían seleccionar otros tratamientos que cumplieran los requisitos, y el promotor apoyó esa flexibilidad.
El comité adoptó una enmienda para agregar a los comités de asuntos de veteranos de la Cámara de Representantes de Georgia y del Senado de Georgia como destinatarios de los informes y luego aprobó el proyecto de ley enmendado mediante votación a viva voz, sin que se indicara el recuento de votos.
Transcripción
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- 0:05:55
Hey, for everybody,
- 0:05:59
for everybody out there, we're gonna have just another few minutes to get a few more members here so we can get a quorum.
- 0:09:43
All right, good afternoon, everybody. It's six after 4:00. We hopefully will get a few more members. We do have a quorum, so we're gonna go ahead and get the meeting started. Uh, if you would, I'll offer our invocation, then we'll get started. So if you would pray with me. Lord, thanks so much for today. Thank you for the, the good work we were able to do today. We pray that, uh, even now as we hear the, about this important topic, you would give us wisdom and discernment, uh, to determine the best course of action for Georgia. In your name we pray, amen. All right, thank you so much.
- 0:10:14
Uh, today we're gonna be hearing House Bill 1296. So Representative Momtahan, if you wanna come forward with any of the folks that are gonna sit with you. Uh, we do have a sign-up sheet out there, uh, for anyone that wants to provide any, w- wants to provide any public testimony. We'll do that after the bill is presented and we get questions.
- 0:10:42
And Representative, we are working off of LC461427. Is that the bill that you've got there?
- 0:10:52
Uh, let me turn your... Is this thing working here? Yep. Hello. There you go. All right. All right, whenever you're ready, go ahead. Thank you, Mr. Chairman, and, uh, members of the committee. I have House Bill 1296. That's LC461427.
- 0:11:13
Mr. Chairman and members of the committee, this legislation that you have before you creates a three-year pilot program within the Department of Behavioral Health and, and Developmental Disabilities to support clinical research and provide access to eligible breakthrough treatments for veterans and retired first responders suffering from post-traumatic stress disorder, treatment-resistant depression, major depressive disorder, traumatic brain injury, and related conditions.
- 0:11:48
The bill defines eligible breakthrough treatment very carefully. It includes medical devices granted breakthrough designation by the United States Food and Drug Administration, investigational or approved drugs granted breakthrough therapy designation by the FDA, transcranial magnetic stimulation protocols, including accelerated protocols and other investigational or approved treatments deemed substantially similar by the department. Committee, this is a pilot program, to be clear.
- 0:12:21
It begins in 2027 only if such funds are appropriated. It sunsets automatically in 2030, and it requires annual reporting to the governor and to the General Assembly. The department is authorized to promulgate rules and regulations and to partner with accredited research institutions in Georgia. Funds may be used to establish approved program sites with standardized data collection, conduct clinical trials and real-world studies, subsidize treatment costs at approved sites, invest in clinical infrastructure in underserved areas, provide workforce education and training, and develop treatment guidelines.
- 0:13:04
In short, this bill builds a structured, medically supervised research and treatment framework.
- 0:13:14
Why is that necessary? Because we continue to face a suicide crisis among veterans and first responders. Many of these individuals have pursued traditional therapies. Many have used conventional medications. Many have followed every recommended protocol, and yet some still suffer from debilitating symptoms.
- 0:13:38
I'm sorry. Across the country, states have begun studying breakthrough therapies under controlled, research-based models. Georgia has the opportunity to do the same, responsibly, cautiously, and with oversight. This bill does not declare any treatment a total cure. It allows for research. It allows supervised access. It allows for data collection. It allows Georgia to evaluate outcomes within our own system rather than relying on anecdote or sending our veterans elsewhere.
- 0:14:17
And now let me be very clear. We are not talking about recreational use. We are not talking about unsupervised access. We are not talking about opening the door to casual drug culture. We are not talking about bypassing the Food and Drug Administration. We are talking about medical treatment. We're talking about licensed physicians. We're talking about regulated facilities. We are talking about structured clinical protocols.
- 0:14:51
We are talking about veterans and f- retired first responders who have exhausted conventional options. This is medical. This is supervised. This is accountable. This is temporary. And this is about bringing treatment options home to Georgia for the men and women who have put everything on the line for us. They didn't hesitate when they were called to serve. We shouldn't hesitate to responsibly study every medically supervised option that might help them heal.
- 0:15:26
Members, this is a pilot program with guardrails. It is limited, it is oversight driven, and it focuses on Georgia heroes, and I respectfully ask for your consideration for LC 46-14-27. Thank you, Mr. Chairman, and I'll stand for questions. I know we have folks who want to speak to the bill, and, uh, would be happy to utilize them as part of this, uh, presentation and testimony.
- 0:15:52
Uh, um, well, for members of the committee, if we could, can I recommend that we, um, and, and hear from someone who can actually talk to us about this treatment, about the, the, the drug itself, the treatment, and the model so that we have a better understanding of, of what will entail in the, in the trial program?
- 0:16:16
Thank you.
- 0:16:17
Um, and if you could just introduce yourself and tell us who you, who you represent, who you work for, that'd be great.
- 0:16:25
Yes, sir. Uh, good afternoon, Chairman and members of the committee. My name is Logan Davidson, and I'm here on behalf of Veterans Exploring Treatment Solutions, uh, to support HB 1296. Uh, VETS is our acronym. It's a 501[c][3] nonprofit organization with a mission to end the disproportionate incidence of suicide among American veterans by underwriting treatment grants for special operations veterans seeking psychido- psychedelic-assisted therapies for PTSD, traumatic brain injury, and other mental health conditions to cover the cost for them to leave the United States, go to countries where the treatment is available, and access it there.
- 0:16:57
We also support research and have partnered with Stanford University and Ohio State University in clinical research, um, and advocacy, where we've worked in a number of states, uh, including Texas, uh, in Georgia with Representative Momtahan and Senator Chuck Payne last year, um, and in Washington, DC with Congressman McCaul and Congressman Crenshaw. I had a prepared testimony, but you specifically said that you wanted to learn a little bit more about the treatment and the model, so I'll just speak to that kind of immediately. Um, uh, for the compounds that have breakthrough therapy designation in the United States that we support, um, psilocybin and MDMA are the two that are the most common and furthest along in the drug development process.
- 0:17:34
Um, research using these compounds is happening all across the United States at Emory University, the University of Texas at Austin, Johns Hopkins, UNC Chapel Hill. And traditionally, the way the, uh, medicine is administered, there is, uh, usually a two provider to one patient ratio. Usually, it's a licensed physician, an advanced practice registered nurse, mid-level, something like that, then a licensed mental health care provider. Um, the drug is administered. Um, MDMA is a four to six-hour experience. Psilocybin is about six to eight hours. Um, there's a variety of ways that different people react to it, but primarily, the mental health professional is there to provide support as needed.
- 0:18:09
Some people, uh, have the experience, and they kind of keep it entirely within themselves. Um, Johns Hopkins, for example, when you are dosed with psilocybin, you're given an eye mask and a playlist, and they have worked through the science to understand the exact BPM and what the nature of that playlist should be to help modulate the experience for that patient. Um, traditionally, uh, I'll speak to the veteran experience. They are processing trauma, sometimes combat-related trauma. I will say very often for our special operations veterans, it's trauma that happened before they joined the service that might have led them into pursuing a combat role.
- 0:18:43
Um, this can come in a variety of ways. Um, certain treatments, treatments act differently. One of the ways that it was explained to me by a former member of SEAL Team Six is that any time prior to this that he had tried a traditional trauma therapy, his body went into fight or flight whenever he tried to pro- process his combat experiences. The MDMA that he took as part of MDMA-assisted therapy put him in a place where he was able to engage with those ex- experiences without reliving that experience, and he was able to process the trauma through what would otherwise be traditional therapy.
- 0:19:14
After the treatment is completed, um, at least for folks in our program, there is an integration period. This can last weeks to months, depending on what the patient needs and their provider recommends, and this is traditional therapy as you understand it, sometimes one-on-one with a provider and other times in a group, often the group you go with. Um, while, uh, in American FDA-approved clinical research, it is usually one patient receiving the treatment on their own. In the international, uh, setting where we send folks in countries where it is legal, you're often in a group. Six to eight is what is normal, and then you have four providers to, to meet their needs.
- 0:19:48
And so if you went in a group, you might do integration with your group, where you're all able to process the experience that you had individually, but with a few other people around the area, folks who can understand what you've been with. All of our cohorts are also special operations veterans or veterans connected to the special operations community, so there is a shared culture and understanding of the experiences that you went through prior to the treatment. Then you went through the treatment together, and you're able to process those experiences. Um, psilocybin is in phase three, uh, of drug development with the FDA and has received breakthrough therapy designation, as has MDMA.
- 0:20:20
Psilocybin has shown, uh, incredible efficacy for the treatment of treatment-resistant depression and major depressive disorder. MDMA has shown incredible efficacy in treating post-traumatic stress disorder. When I say incredible efficacy, the statistics on MDMA are that about 66% of patients with PTSD no longer meet the, the standards for a PTSD diagnosis. We would consider them in remission. Um, this is in contrast to traditional PTSD treatments. There are two approved pharmaceuticals. They are both SSRIs. They have a success rate in the 34 to 40% range.
- 0:20:52
Something else that's notable about psychedelic-assisted therapy compared to traditional therapies is that they are fast-acting. So if you were pr- potentially prescribed an SSRI for your post-traumatic stress disorder, it may take six to eight weeks before you start to realize the benefits of that treatment. With psychedelic-assisted therapy, it's a matter of days. So if it is effective, you know immediately, and if it is not, you know immediately, and you're able to proceed to that next, uh, treatment.
- 0:21:20
All right. Any questions from the committee? All right. Representative Clark.
- 0:21:26
I just want to say thank you for carrying this, uh, bill and totally supportive o- of it. And I know a number of buddies who have gone through this type of treatment over in Mexico, 'cause it's not allowed here to-
- 0:21:36
Mm-hmm.
- 0:21:37
And I mean, the results of my buddies, I mean, it's life-changing. Um, absolutely amazing. And then even now I'm talking about the special operations and all that, um, there was this man, um, he was addicted. He was like 15 years dr- uh, addicted to all these hardcore drugs, all this. Went over there, did this treatment, and it's been over 10 years.
- 0:21:58
Mm-hmm.
- 0:21:58
Changed his life. So I mean, I, I mean, I say always keep an open mind to these type of treatments, all that. I mean, if it works and saving lives, which I've seen di- directly, 'cause I mean, I know at the VA and other stuff and there's a lot of treatments, but we see the suicide rate and all that, and I've lost buddies who've killed themselves, shot themselves and all that.
- 0:22:16
Mm-hmm.
- 0:22:16
Uh, but then those who go and get these treatments, um, it's life-changing. So I love what y'all bringing forward and thank you.
- 0:22:24
Representative, if we may, I want to share with you a pretty staggering statistic, if you will, of, uh, with the group, with the group about the suicide rates and the daily, um-
- 0:22:35
Yeah.
- 0:22:35
So the, the statistics on suicide are, um, uh, staggering and terrifying. So since 2001, we've lost over 125,000 veterans to suicide. Um, 2001 is the beginning of 20 years of sustained combat. In that 20 years of sustained combat, we lost fewer than 10,000 soldiers. So we are talking about a magnitude of 10x, 15x of the loss to suicide versus the loss to combat. And those suicide statistics do not include folks who die of drug overdose, of alcoholism, of other deaths of despair. If you start to include things that, of that nature, you're getting into the 250,000, 300,000, 500,000 range.
- 0:23:10
Estimates previously at the VA were 17 to 22 veterans die by suicide every day. Three years ago, they revised those estimates to 17 to 44 veterans die by suicide every day. We got a repor- a VA report for 2026 two weeks ago, and the 17 to 44 estimate is still there. So while there are treatments and they are effective for some people, they are not effective for everyone, and the cost of not bringing new treatments to bear continues at 17 to 44 veterans dying by suicide every single day. Um, I have...
- 0:23:40
I pulled the VA statistics on Georgia in advance of this hearing, and I want to make sure that I, uh, get it right. The Georgia veteran suicide rate is 33 per 100,000. So for every 100,000 Georgians, there are 33 veterans who will die by suicide. Um, the national rate is 18 per 100,000. And so we attribute that traditionally. Texas is another state where you have a higher than normal rate. A higher than normal veteran population, a higher than normal active duty service population generally correlates to those higher rates. And you, you mentioned your friend who'd struggled with addiction.
- 0:24:11
There's a Army Ranger who went through our program. He was in the 75th Ranger Regiment stationed here in Georgia, who was in a training jump preparing to deploy for a second deployment. His chute did not deploy. He was brutally injured, and he was prescribed Percocets by the VA, which started him on a 13-year odyssey of opiate addiction, and this treatment finally interrupted that, and he is now two years sober, um, and has his life back.
- 0:24:35
And I, I think we're talk- talking about one and the same, one of my good friends.
- 0:24:39
Mm-hmm.
- 0:24:40
Amazing story.
- 0:24:40
Yeah. Absolutely. Yes, sir.
- 0:24:43
So, uh, I've got a, a few questions. What, uh, are there any s- are there any states that are doing this now?
- 0:24:50
There are a variety of states that have, that are, that are funding and approving FDA-approved clinical trials. None that have done it through this specific model. This would be kind of, we like to think of it as the next leap. So the state of Texas was the very first one to fund psychedelic-assisted therapy research. This was in 2021, a single clinical trial for veteran, PT- veterans with PTSD at Baylor College of Medicine. And it was a, approximately a $2 million appropriation. That clinical trial is ongoing as we speak. Um, as of February of this year, six veterans had been dosed with psilocybin in the city of Houston, Texas.
- 0:25:23
Um, last year, Texas doubled down and maybe more than doubled down with a $50 million appropriation for clinical research and drug development into another psychedelic compound known as ibogaine, which is just at the very beginning of its clinical drug development and research phase. Uh, New Jersey appropriated $6 million for psilocybin research. Arizona appropriated 5 million for psilocybin, and then last year, 5 million for ibogaine. Um, and Georgia, actually, if I'm not mistaken, made a small, um, but significant $1 million appropriation to support activities happening in the state with this research as well last year.
- 0:25:54
Well, to, to be clear, the, the bill specifically designates ibogaine as what's gonna be researched.
- 0:26:02
Yes, sir.
- 0:26:02
Okay. So again, so in everything we're talking about, we are specifically topping, talking about ibogaine, right?
- 0:26:09
Yes, sir.
- 0:26:10
Okay. All right. And so in, in these other, and so Texas, are there other states that have, that are currently doing trials that you're aware of?
- 0:26:20
On ibogaine, uh, the only other state that has appropriated funds is Arizona. They both did that last year, and so they are in the process of standing up those research trials. So I can give a small progress update on Texas. They completed their RFP, uh, in Q4 of last year, awarded it to a consortium led by University of Texas Health Houston and the UT Medical Branch in Galveston. Um, Arizona, I think, is still in the process of their RFP of selecting who will get this clinical research. There are a variety of other states right now considering legislation on ibogaine research. Uh, Mississippi has legislation that has passed the House and is expected to be heard in Senate committee next week.
- 0:26:54
Oklahoma, West Virginia, Kentucky, and Tennessee all have active ibogaine research legislation.
- 0:27:00
And how much do we expect that this, uh, trial will cost, since it does, it do- it is subject to appropriations? What, what do you anticipate the ask will be for next year? Well, I, uh, uh, to go back a little bit. So what, what the bill contemplates is starting in 2027, correct?
- 0:27:21
That's right.
- 0:27:21
Which would, which would require an appropriation this year.
- 0:27:26
I don't have a firm number. I think we are, uh, requesting an appropriation for this bill. I don't have a firm number right now. Uh, I, I'm, we can
- 0:27:40
It's gonna be in the range of 1 to 5 million, Mr. Chairman.
- 0:27:43
Say again?
- 0:27:43
1 to 5 million.
- 0:27:45
1 to 5 million. And how many, how many people will that accommodate in a trial?
- 0:27:54
It varies, um, but a good rule of thumb is $1 million can get you approximately 12 patients, um, through the treatment. And one of the limitations is that the treatment lasts such a long time that you are paying for the provider's time for that. So Ibogaine is about a 16 to 22-hour experience, so you're paying for 16 to 22 hours of that licensed treatment provider's time, and that is the major, major cost limiter as for how many patients can go through at that cost rate.
- 0:28:18
So y- you said for every million, that could accommodate 12 individuals.
- 0:28:23
Approximately. That's what we've seen in Texas. That might, you know, we might learn some things and become a little bit more efficient, um, in the next 12 months.
- 0:28:29
And then, and how long is a treatment cycle?
- 0:28:32
Um, so the actual active treatment for Ibogaine is about 16 to 22 hours. Um, so for, we've, we've covered the cost of over 1,000 special operations veterans to go to Mexico and receive this treatment. The way it works there is you'll fly in, say, get there on Monday afternoon. Um, you will not have the treatment that day. The next morning, you'll have breakfast, take the treatment. By the end of the night, you have completed the treatment. Usually, you rest and sleep. The next day, you have that first integration therapy session, um, and then you're released to leave. So it's about a two-day inpatient process for Ibogaine specifically.
- 0:29:04
Um, you can stay longer according to, you know, what the provider recommends, what sp- specific dosage you're getting, but that's the, the pretty standard rate.
- 0:29:11
And how many times would, would... How many times would somebody receive that, go through that cycle during the course of a trial?
- 0:29:19
Uh, one time.
- 0:29:20
Okay.
- 0:29:20
Um, and we found while not everyone only goes for one treatment, the vast majority of our grant recipients, after a single treatment, have resolved their PTSD symptoms and improved traumatic brain injury symptoms.
- 0:29:31
All right. And so just to be clear again, what we're talking about in this bill, are, are we, uh, we're, we're talking about treating folks here in Georgia, not sending them out of state for treatment or out of the country for treatment, correct?
- 0:29:45
Yes, sir. Yes, sir.
- 0:29:46
Or relying on, um, out-of-state or out-of-country data, correct? I mean, we're-
- 0:29:53
Yes, sir.
- 0:29:54
The intent of the bill, as I understand it, is that Georgia would develop its own, um, um, its own research essentially.
- 0:30:03
Yes.
- 0:30:03
Correct? Okay.
- 0:30:03
That's correct.
- 0:30:04
Okay. Um, is that, is that you? Who's that? Is that you, Representative Cannon? All right. Go ahead.
- 0:30:10
Thank you, Mr. Chairman. Um, can you walk me through the selection process for kinda who would get chosen? Is it just for SOF guys, or would it be for regular Army guys? I mean, most, I was in years of combat versus SOF guys are just back and forth, you know, mon- on a monthly basis. But, uh, what's your, what is your kinda selection process for how you choose folks who would be eligible for the program?
- 0:30:35
I'll, I'll speak to how our nonprofit works, and then, Representative, if you wanna speak to your intent with the bill. Uh, for vets, traditionally special operations veterans only. Um, part of that stems from the way that we were founded. So our founder is a veteran of SEAL Team Six. We initially only offered grants to SEALs, and then expanded to the entire special operations community. Um, the scale of need is, is staggering, and there is no single entity that can meet it. We have pure organizations that do non-special operations veterans as well. Um, you submit an application, uh, in order to receive the, the treatment.
- 0:31:06
We are then connected to program staff, which for us, our program staff are licensed, uh, master social workers. Um, traditionally, folks have a clinical diagnosis for post-traumatic stress disorder, and traditionally is treatment-resistant. They have gone through the existing-
- 0:31:19
Is it VA or private insurance?
- 0:31:21
Uh, for, for most of our grant recipients, it is by the VA. Um, I'm, I'm, I'm sure there are exceptions to that within the 1,000, but I'm not aware of any o- offhand. Um, also regularly, there's a traumatic brain injury diagnosis, major depressive disorder treatment, uh, resistant depression. Those are really the ones we regularly see coming through our program. Um, besides those, there's also substance use disorders, so everything from alcoholism to opioid use disorder. Those are less common in our grant recipients. Um, there are other organizations that provide grants for those, those patients and veterans.
- 0:31:51
Um, but for us, that's where they are. Uh, you then complete a medical screening, so assuming your grant application is accepted, you will complete a medical screening to ensure that you are healthy enough to go through the treatment. Um, you know, we're certainly not going to submit that there are no risks. It is an intense experience. It is a 16 to 22-hour experience that can be hard on the body. Um, assuming you clear that medical screening, you begin preparation. So you'll spend about six weeks in a group therapy-type setting with the cohort you're going to go with, in addition to one-on-one therapy to make sure that you're prepared.
- 0:32:23
You have to come off of all of your pharmaceutical medications and potentially any, you know, any other substances that you're using that could alter your brain chemistry or anything else in the body. Um, and then you'll go complete the treatment, get back, and then we have six months of that integrative therapy. Um, that's how we screen and select grant recipients. Um, and then while it is mostly special operations veterans, there are exceptions made for, for other veterans, special circumstances, things like that.
- 0:32:59
Chairman Prince.
- 0:33:00
Oh, thank you, Chairman Bonner. Uh, thank you for, uh, bringing this bill and, uh, what we're looking to try to do. Have we, um, and I know we in the early stages of trying to g- you know, push this thing through, but are we looking at some of our, uh, universities, uh, research universities here to sort of collaborate with to probably do some of these tests and as, as well as the research? I know this...
- 0:33:22
Thank you, Representative, uh, Prince. Let me give you a, just a quick section here that shows, um, so on lines 39 through 57, you'll see that we start to, um-
- 0:33:45
On line 41, you'll see where it's establishing network approved program sites. Um,
- 0:33:52
and that's gonna be in conjunction with our research partners. Who would be? Universities. Yeah. The large part, universities. I, I think, um, Logan will tell you that, uh, in Texas these have been led by the schools there, by the research universities. So that's, that's the model we, we'd like to stay with. Yes, sir. Thank you.
- 0:34:15
Representative Gisler.
- 0:34:17
Uh, thank you, Mr. Chairman. Um, so le- number one, thanks for the bill. I, I think there's a lot of promising research around this, and it's, it's amazing. Um, I'd like to see it be successful. Um, to the chairman's point earlier, ibogaine is listed specifically on line 22, but it looks like lines 19 through 21 open that up to anything that the FDA might approve. And then lines 25 through 27, that Section E kinda opens it up to anything that is determined by the department, um, that is approved.
- 0:34:49
So, uh, so it's not really just listed to ibogaine, right? 'Cause you, you've mentioned, um, the psilocybin and MDMA. Um, uh, I don't know. Are those not approved by the FDA right now? Like, uh, does it open the door to use those?
- 0:35:04
Will you repeat those last lines for me? Which lines were you looking at? I, I heard the, uh, 19 through 21.
- 0:35:09
19 through 21, and then Section E right there, 25 through 27.
- 0:35:13
25 through 27.
- 0:35:13
Looks like it, it opens up to any other drug as determined by the department.
- 0:35:19
I can speak to the, at least the first two parts. So ibogaine is specifically identified.
- 0:35:23
Mm-hmm.
- 0:35:23
Um, it's, it's an incredibly promising therapeutic. It's what we send special operations veterans to access in Mexico. It is at the very beginning of its drug development process, which is why it's called out individually.
- 0:35:33
Okay.
- 0:35:33
Um, breakthrough therapy designation... So the o- the other compounds I mentioned are not yet approved by the FDA. They are in an FDA-approved clinical drug development and research. They've received breakthrough therapy designation, which is an official designation by the FDA that essentially you are, you can receive it if you are significantly more effective than existing treatments and have been proven to be safe.
- 0:35:54
Okay.
- 0:35:54
Um, so psilocybin has breakthrough therapy designation for treatment-resistant depression and major depressive disorder. MDMA has breakthrough therapy designation for post-traumatic stress disorder. Um, another, uh, fact that may be useful here is in Texas the legislation supporting ibogaine research actually requires that whoever the drug developer supplying ibogaine is submit their plan to the state to receive breakthrough therapy designation, uh, both for PTSD, depression, as well as traumatic brain injury, opioid use disorder, and other neurological conditions.
- 0:36:23
Okay. So like could, could other substances, psilocybin, MDMA, be used in this trial? And if not, do we need those act- that extra language in there? 'Cause it seems like it opens the door to it.
- 0:36:36
I may be mistaken. Um, and I don't... You know, I'll, I'll give my answer. Um, it is permissive, and so it allows for whatever the, the researchers and the institutions doing the research to select what they feel is best.
- 0:36:48
Okay.
- 0:36:48
Um, that flexibility I think is, is good, and it sort of reflects the next step. Many states have chosen a single compound and focused there. Um, many of us in the advocacy space view the next step as opening it up to allow researchers and the experts actually doing the science and bringing patients through to identify and select what's best for their patient populations, what's best for their state, and what's most efficient, um, with the appropriation they're able to receive.
- 0:37:11
Okay. Thank you. I, I actually like the flexibility, just wanna make sure everyone's clear.
- 0:37:15
Yes, sir.
- 0:37:15
Thank you.
- 0:37:16
Thank you.
- 0:37:16
And I think, mm, if I may, thank you, Representative Chairman, to say that as these become approved by, you know, the, um, FDA, the, our researchers can start using them. I mean, we know the efficacy's there. There are studies that have been done in Texas and otherwise. We wanna make sure that these, these veterans, these heroes have the types of medicines that they need, and that they're not waiting an additional seven months for us to come back into session
- 0:37:50
to pass something to give them the treatment they need. Guys 17 to 44 are dying every day. If we can give them
- 0:38:04
even a shred of hope, of which I believe that this bill does more, I gives it, I think it gives them more than a shred of hope, but if we can give them just a shred, it's worth it. These guys are worth it. They've given it all, and we owe it to them to give them our all to make sure they get the treatment they need. Thank you, Mr. Chairman.
- 0:38:32
Thank you. Uh, I'm not seeing any more questions from the committee. Something that, uh, just a couple of comments from, from me is I, I think we need to nail down that appropriations amount. I think that needs to be tightened up. One to five is a pretty big range, so it needs to be a little more specific than that. Um, secondly, on, um, on line 67, um, I, I don't know the, the will of the committee, but I, I would like to have our committee and our, um, committee in the Senate to receive this report as well.
- 0:39:08
Um, so I would certainly be open to a friendly amendment from a committee member that included, uh, our committee and the Senate committee, if someone's willing to make that as an add.
- 0:39:24
So moved. Second.
- 0:39:25
We have to have the motion on the bill. O- okay. At the appropriate time then. Um, is there any more, any other questions? I'm seeing...
- 0:39:35
Move to pass.
- 0:39:35
Do you have a question? I was gonna second. Okay. So all right, so we've got a move do you pass. Do we have a second?
- 0:39:39
Second.
- 0:39:40
We have a second. All right, now we can consider an amendment. Um, Representative Ballard, would you like to offer that amendment? Do you have language for- Yes. We do. So we would, we would, uh, add, uh, on line 67, uh, after Human Services Committee, a comma, and then the House Defense and Veteran Affairs Committee.
- 0:40:12
Strike and- Okay ... strike comma, then- Okay. Uh, s- back up to say on line 66 we would scratch the word and after representatives, and then on line 67, we would add a comma after Human Services Committee and add House... well, uh, we would add the appropriate committee names for the House and Senate Veterans. Okay. That's... That work?
- 0:40:42
Yes. All right. All right, we got a second?
- 0:40:45
Second.
- 0:40:46
All right. All those in favor say aye.
- 0:40:48
Aye.
- 0:40:49
All right, now the, to... Any opposed? Nope. All right, now to the underlying, the bill as amended. We have a, um, we have a motion and a second. Any other discussion? All those in favor say aye.
- 0:41:05
Aye.
- 0:41:06
All those opposed say no. All right. Bill passes as amended. Thank you.
- 0:41:12
Thank you, Mr. Chairman. Thank you, members, uh, for this critical piece of legislation for our veterans.
- 0:41:16
Thank you. U-
- 0:41:16
Thank you
- 0:41:16
... no other business, we are adjourned.
- 0:41:22
Whoa, you didn't call on me.
- 0:41:24
Well, we didn't- Very much ... we didn't need you.
- 0:41:26
Well.
- 0:41:27
Oh. That's for you, sir. Thank you, brother. Yes, sir. Appreciate you.