    [Senate Hearing 119-156]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 119-156

                         SEPARATING FACT FROM FICTION:
                      EXPLORING ALTERNATIVE THERAPIES FOR
                            VETERANS' MENTAL HEALTH

    =======================================================================

                                 FIELD HEARING

                                   BEFORE THE

                         COMMITTEE ON VETERANS' AFFAIRS
                              UNITED STATES SENATE

                        ONE HUNDRED NINETEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                AUGUST 22, 2025

                                   __________

           Printed for the use of the Committee on Veterans' Affairs

    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

            Available via the World Wide Web: http://www.govinfo.gov

                                    __________

                       U.S. GOVERNMENT PUBLISHING OFFICE
    61-533 PDF                  WASHINGTON : 2025

    -----------------------------------------------------------------------------------

                     SENATE COMMITTEE ON VETERANS' AFFAIRS

                         Jerry Moran, Kansas, Chairman
    John Boozman, Arkansas               Richard Blumenthal, Connecticut,
    Bill Cassidy, Louisiana                  Ranking Member
    Thom Tillis, North Carolina          Patty Murray, Washington
    Dan Sullivan, Alaska                 Bernard Sanders, Vermont
    Marsha Blackburn, Tennessee          Mazie K. Hirono, Hawaii
    Kevin Cramer, North Dakota           Margaret Wood Hassan, New
    Tommy Tuberville, Alabama                Hampshire
    Jim Banks, Indiana                   Angus S. King, Jr., Maine
    Tim Sheehy, Montana                  Tammy Duckworth, Illinois
                                         Ruben Gallego, Arizona
                                         Elissa Slotkin, Michigan

                         David Shearman, Staff Director
                    Tony McClain, Democratic Staff Director

                               C O N T E N T S

                                  ----------

                                August 22, 2025

                                                                       Page

                                    SENATOR

    The Honorable Tommy Tuberville, U.S. Senator from Alabama........     1

                                   WITNESSES
                                    Panel I

    Ilse Wiechers, MD, MPP, MHS, Deputy Executive Director, Office of
      Mental Health, Veterans Health Administration, U.S. Department
      of Veterans Affairs accompanied by Miriam J. Smyth, PhD,
      Executive Director, Brain, Behavioral and Mental Health Broad
      Portfolio, Office of Research and Development, U.S. Department
      of Veterans Affairs............................................     4

                                    Panel II

    Steve Levine, MD, Chief Patient Officer, Compass Pathways........    16
    Adam Marr, Director of Operations, Veteran Mental Health
      Leadership Coalition...........................................    18
    James K. Wright, MD, Adjunct Assistant Clinical Professor,
      University of Alabama at Birmingham............................    20
    Brian Schiefer, U.S. Air Force Veteran, Founder, SCI-DI..........    21

                                    APPENDIX
                              Prepared Statements

    Ilse Wiechers, MD, MPP, MHS, Deputy Executive Director, Office of
      Mental Health, Veterans Health Administration, U.S. Department
      of Veterans Affairs............................................    39
    Steve Levine, MD, Chief Patient Officer, Compass Pathways........    46
    Adam Marr, Director of Operations, Veteran Mental Health
      Leadership Coalition...........................................    50
    James K. Wright, MD, Adjunct Assistant Clinical Professor,
      University of Alabama at Birmingham............................    76
    Brian Schiefer, U.S. Air Force Veteran, Founder, SCI-DI..........    78

                           Submissions for the Record

    HBOT4Heroes.org, Edward R. di Girolamo, PE, Executive Director...    83
    American Psychiatric Association.................................    84
    LinkedIn article ``Aquanautics for Spinal Cord Injury: Undersea
      and Hyperbaric Research Project''..............................    86
    Letter of Recommendation by Christopher P. Lucas, MD, MPH,
      Upstate Medical University in Syracuse, NY.....................    92
    Clinicom statement...............................................    93
    Presentation by James K. Wright, MD, Col., USAF (Ret.)...........    94

                         SEPARATING FACT FROM FICTION:
                      EXPLORING ALTERNATIVE THERAPIES FOR
                            VETERANS' MENTAL HEALTH

                                  ----------

                            FRIDAY, AUGUST 22, 2025

                                           U.S. Senate,
                                Committee on Veterans' Affairs,
                                                        Washington, DC.
        This field hearing was held, pursuant to notice, on August
    22, 2025, at 11:02 a.m., in American Village, Liberty Hall,
    3727 Highway 119, Montevallo, AL, Hon. Tommy Tuberville,
    presiding.

        Present: Senator Tommy Tuberville

              OPENING STATEMENT OF HON. TOMMY TUBERVILLE,
                       U.S. SENATOR FROM ALABAMA

        Senator Tuberville. I'd like to call this Committee hearing
    into session. Today, the Senate Veterans' Affairs Committee
    will conduct oversight and receive testimony on the importance
    of access to alternative therapies and treatment for veterans
    struggling with mental health conditions. It is a huge problem.
        Today, we will hear directly from the Department of
    Veterans Affairs researchers in the field and veterans with
    personal experience. Thank you all to the witnesses for coming
    to my home State of Alabama, where more than 400,000 veterans
    call home, and thank you to Chairman Moran for allowing me to
    hold this hearing today. He's the Chairman of the Armed
    Services Committee in Washington, DC.
        The room we are sitting in today may look familiar, but no,
    we're not here in the White House. It is pretty though. It
    looks nice. We're sitting in a replica of the first or the East
    Room of the White House in Montevallo, Alabama, the American
    Village. American Village is leading the way in educating
    generations of Alabamians and Americans on the founding of our
    great nation.
        American Village has also been designated and dedicated as
    a veterans' living legacy, and sits on the same grounds as the
    Alabama National Cemetery. I cannot think of a better location
    for today's hearing.
        Unfortunately, what we're here to discuss is not new. We
    lose an average of 18 veterans a day to suicide. Think about
    that, 18 veterans a day, and our veteran class is growing
    because of all these 20-year wars that we've been fighting over
    the last few years. We cannot sit back while those who put
    their lives on the line for our great nation suffer day in and
    day out.
        We have a lot of suffering. We're on a race against time.
    One life lost is way too many. Our veterans deserve access to
    innovative, critical lifesaving therapies and treatment. Over
    the last two decades, the VA has added many evidence-based
    therapies to better care for the mental health of our veterans.
    And in many of these cases, veterans will see an improvement in
    their mental health within weeks and months after using one of
    these therapies.
        I applaud the work being done by the VA, but there is still
    a lot more that we have to do. That's why earlier this year, I
    introduced HBOT Access Act. This bill would simply require the
    VA to provide Hyperbaric Oxygen Therapy, or HBOT, as a
    treatment option to any veteran who is suffering from PTSD, or
    TBI, who has already tried no less than two evidence-based
    treatment options.
        HBOT is one of many therapies we will hear about here
    today. States across the Nation are also introducing their own
    pieces of legislation to expand access or to fund alternative
    treatment options for our veterans. I'm eager to hear how the
    VA is working to study and provide access to treatments outside
    of medication such as opioids and a depressants traditional
    psychotherapy.
        Last December, for the first time since the 1960s, VA has
    announced that it would fund a study on MDMA-assisted therapy
    for PTSD and alcohol use disorders. The first time. And to
    date, the VA has sponsored 11 clinical trials for evidence-
    based psychedelic-assisted psychotherapies. VA Secretary Doug
    Collins said himself that the VA is continuing to look at new
    alternative treatments.
        As a Member of this Committee, I look forward to working
    with him and get this done. I'm confident that under leadership
    of Secretary Collins, Secretary Kennedy, and President Trump,
    we will see generational change at the VA for our veterans
    struggling with their mental health.
        So, today we will have 5-minute opening statements from our
    witnesses. We have two witness groups. First, I'd like to
    introduce Dr. Ilse Wiechers--is that close enough?
        Dr. Wiechers. It's Wiechers.
        Senator Tuberville. Wiechers?
        Dr. Wiechers. Yes----
        Senator Tuberville. There you go.
        Dr. Wiechers [continuing]. Sir.
        Senator Tuberville. Dr. Wiechers is currently serving as
    the Deputy Executive Director for the Office of Mental Health
    at the Veterans Health Administration at the U.S. Department of
    Veterans Affairs. In this role, Dr. Wiechers oversees the
    timely development and implementation of policies and programs
    to ensure veteran-centered, evidence-based, and high-quality
    mental health services to over two million veterans annually.
        She leads OMH's legislative policy and partnership work,
    engaging regularly with key congressional and veteran service
    organizations stakeholders. Dr. Wiechers is a practicing board
    certified Adult and Geriatric Psychiatrist who completed her
    medical education at Duke, residency at MGH/McLean Hospitals,
    and fellowship at Yale.
        She received a master's degree in Public Policy from Duke,
    and a master's degree in Health Science from Yale University.
    She also serves as faculty at University of California San
    Francisco and Yale. Thanks for traveling here today, Doctor,
    and a Distinguished Fellow of the American Association for
    Geriatric Psychiatry and the American Psychiatric Association,
    and has been elected to the membership of the American College
    of Psychiatrists.
        Then we have Dr. Miriam Smyth--is that right?
        Dr. Smyth. Yes, Senator.
        Senator Tuberville. I want to get as close as possible.
    It's not as bad as Tuberville. I promise you that.
        [Laughter.]
        Senator Tuberville. Doctor is also accompanied by Miriam
    Smyth, Acting Director of Brain, Behavioral and Mental Health
    Broad Portfolio at the Office of Research and Development at
    the U.S. Department of Veterans Affairs. She focuses on
    advancing precision mental healthcare within the VA and
    conducting research into high priority areas such as post-
    traumatic stress disorder and depression.
        Dr. Smyth has also overseen a program of $105 million in
    clinical research funding, and approximately 430 ongoing
    research projects to improve veterans' health and well-being,
    and serving as ORD's Clinical Research and Development Service
    Acting Director since March 2022.
        Dr. Smyth has initiated many high-visibility national
    projects to advance ORD's goals, particularly in the area of
    precision mental health and emerging therapies. She leads the
    PTSD psycopharma--how do you pronounce that?
        Dr. Smyth. Psychopharmacology.
        Senator Tuberville. Okay, good. Alright. We're going to
    have a lot of that today--Initiative, and has worked to advance
    research on the use of psychedelics, cannabis, and transcranial
    magnetic simulation to treat mental health conditions that are
    resistant to today's first-line approaches.
        She recently led ORD efforts to issue VA's first request
    for application in psychedelic research to treat veterans
    mental health conditions, and she has co-authored ``Research
    and Implementation of Psychedelic-Assisted Therapy in the
    Veterans Health Administration,'' published in The American
    Journal of Psychiatry in January 2025.
        So, we are here today to try to find answers. Folks, we
    have a lot of people in trouble. In my five years in the
    Senate, I've never seen a problem like this that continues to
    grow, get bigger, and it's only going to get bigger. And so,
    here today with two experts that can hopefully give us some
    answers and what they've studied and what they've seen.
        So, we'll do 5-minute opening statements with each witness.
    Doctor, please.

                                PANEL I

                                  ----------

      STATEMENT OF ILSE WIECHERS, MD, MPP, MHS, DEPUTY EXECUTIVE
          DIRECTOR, OFFICE OF MENTAL HEALTH, VETERANS HEALTH
    ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS ACCOMPANIED
    BY MIRIAM J. SMYTH, PHD, EXECUTIVE DIRECTOR, BRAIN, BEHAVIORAL
       AND MENTAL HEALTH BROAD PORTFOLIO, OFFICE OF RESEARCH AND
            DEVELOPMENT, U.S. DEPARTMENT OF VETERANS AFFAIRS

        Dr. Wiechers. Thank you, sir. Good morning, Senator
    Tuberville, and to everyone here today. Thank you for allowing
    us to discuss new effective ways to care for our Nation's
    heroes. I'm Dr. Ilse Wiechers, Deputy Executive Director of VA
    Office of Mental Health, and alongside me is Dr. Miriam Smyth,
    Executive Director of the Brain, Behavioral and Mental Health
    Broad Portfolio within Office of Research and Development.
        Today, I will discuss VA's research and clinical efforts in
    emerging therapies, including psychedelic-assisted therapy and
    Hyperbaric Oxygen Therapy, or HBOT, as well as other innovative
    treatments. VA operates the largest integrated health system in
    the United States, providing comprehensive services to over
    nine million enrolled veterans annually.
        Our mission centers on caring for those who have borne the
    battle, their families, and caregivers. Mental health care is
    crucial, which is why we continuously strive to support a
    robust clinical and research program focused on improving
    mental health outcomes for veterans.
        While current evidence-based treatments such as prolonged
    exposure therapy, cognitive processing therapy, eye movement,
    desensitization, and reprocessing, and medications help many,
    approximately one-third of veterans with PTSD or major
    depression do not find relief. This is what has driven our
    commitment to researching and implementing innovative therapies
    that may offer significant benefit to veterans. VA is exploring
    the therapeutic potential of psychedelic compounds like MDMA
    and psilocybin.
        As of July 2025, we have 12 clinical research studies in
    psychedelic treatments for mental health conditions at nine VA
    medical centers studying MDMA, psilocybin, DMT, and LSD,
    focusing on PTSD, major depressive disorder, generalized
    anxiety disorder, and substance use disorders.
        This fiscal year, VA announced funding for a study on MDMA-
    assisted therapy for PTSD and alcohol use disorder among
    veterans. This trial will be taking place at the Providence VA
    Medical Center. All studies comply with Federal guidelines for
    clinical research and use of controlled substances while
    gathering scientific evidence regarding the efficacy and safety
    of these compounds when combined with psychotherapy.
        These therapies remain investigational and it is important
    to not self-medicate with psychedelics outside of a clinical
    research setting, as doing so can carry significant risks.
    Although HBOT is recognized for conditions like decompression
    sickness and wound healing, the FDA has not authorized it for
    use with PTSD or TBI treatment.
        VA and DoD clinical practice guidelines (CPG), found
    insufficient evidence to recommend HBOT for PTSD and strongly
    recommend against its use for mild TBI. Published results of
    scientifically rigorous VA and DoD research on TBI have
    repeatedly shown that HBOT has the same impact as a placebo and
    no clinically relevant long-term effects.
        In addition to the lack of patient improvement, the use of
    HBOT after a mild TBI may have harmful impacts including
    seizures. VA continues to closely monitor the research on HBOT
    and none of the recently published studies have changed our
    recommendations at this time.
        Beyond psychedelics in HBOT, VA evaluates other innovative
    treatments to address difficult to treat mental health
    conditions. For example, I helped lead the national rollout of
    ketamine and esketamine treatments for treatment-resistant
    depression, and I continue to be a practicing psychiatrist
    providing ketamine infusions to veterans each week.
        As scientific evidence evolved, these treatments were
    incorporated into the recommendations in the 2022 VA/DoD
    clinical practice guidelines for major depression. VA has gone
    from eight facilities offering these treatments 10 years ago to
    now offering them in 49 facilities across the country.
        Another example is ganglion block, which involves injecting
    local anesthetic into a cluster of nerve cell bodies in the
    neck. Although promising, there is insufficient evidence from
    current research to recommend SGB as a standard clinical
    treatment for PTSD. However, VA is supporting ongoing studies
    at VA facilities to clarify its potential benefits and
    determine its efficacy in treating PTSD among veterans.
        While VA's research efforts continue, veterans will receive
    the mental health care and support that they need whenever and
    wherever they need it. Our proven evidence-based care options
    for veterans experiencing PTSD or depression include mental
    health care at our VA facilities, assistance with reintegration
    into their communities, counseling at Vet Centers across
    America, 24/7 access to qualified crisis responders at the
    Veterans Crisis Line, emergent suicide care for veterans at any
    VA or non-VA facility at VA expense, and much, much more.
        In conclusion, VA is committed to continuing to research
    and to advance the science behind emerging therapies and
    ensuring they're safe, effective integration into mental
    healthcare, through rigorous scientific evaluation. We will
    ensure new therapies undergo thorough testing and peer review
    for safety and effectiveness tailored to meet our veterans'
    unique needs. By exploring and integrating innovative
    therapies, we aim to leave no veteran behind. We appreciate the
    Committee's support and this shared mission. My colleague and I
    are ready to respond to any questions you may have.

        [The prepared statement of Dr. Wiechers appears on page 39
    of the Appendix.]

        Senator Tuberville. Thank you. And as we do these, I've got
    about 10, 12 questions. We'll start with you, Doctor, if you
    want to add anything to that we'll--if you don't, fine. But
    let's get as much information as we possibly can. I think it
    would be good.
        So, if we're rolling out a new therapy, such as we are
    quite often, what's the process? How do we do that? How does
    that work? How do we roll a process out of doing a new drug or
    a new therapy to help veterans?
        Dr. Wiechers. Sure. Thank you for that question, Senator. I
    think I'll use as an example our rollout of esketamine or
    Spravato, which was FDA-approved March 2019. It required a
    different way to think about the time spent in a clinic because
    there was a requirement for people after the dosing, which is
    an intranasal dosing, to stay for monitoring for 2 hours. And
    that's not what a typical mental health clinic visit looks
    like.
        So, we developed a national protocol. We met with folks who
    were using similar agents like ketamine and learned from them
    by learning about best practices. We created a community of
    practice that was nationwide and everyone learned from one
    another together as we rolled out our national protocols.
        We went to our folks with research experience in that area
    with that type of agent. And they were our first sites to
    implement clinically. And then we learned from them and rolled
    out, to kind of in phases, to the next level. And that is how
    we kind of, in a phased approach, learning each phase kind of
    in an iterative way so that we learn lessons before we roll
    things out more broadly.
        Senator Tuberville. Ms. Smyth, you want to add anything to
    that? Would you like?
        Dr. Smyth. No, thank you, Senator.
        Senator Tuberville. Okay. So, you have to work directly
    with the FDA when bringing out a new drug, or is it a drug
    already tested and they're allowing you to test it on veterans?
    How does that work?
        Dr. Wiechers. So, in terms of studying drugs that are still
    investigational, I will actually defer to Dr. Smyth to say a
    little bit about how our researchers work with investigational
    drugs.
        Dr. Smyth. So, we have quite a bit of experience with this,
    Senator, because we began working with Schedule 1 drugs in
    2017, which involved cannabis. And so, our researchers have to
    get FDA approval and had to get a license from the DEA. And
    then, they have to go through various regulatory steps,
    including institutional review boards. So, the process is very
    well defined and is working for us.
        Senator Tuberville. Good. Thank you. What's the biggest
    challenge that the VA faces in terms of implementing these new
    programs? For VA, what's your biggest challenge? What do you
    have to fight? Because it seems like every time we do something
    for the veterans, it's almost a fistfight to get something
    done. Nobody wants to approve anything. Doctor?
        Dr. Wiechers. Thank you for the question, sir. I think one
    of the biggest challenges is just change. Change is hard
    especially if a change in practice is asking our providers to
    do something they've never done before. So, I think just the
    efforts to educate and ensure everyone has the information they
    need about a new treatment or a new type of service that we're
    delivering. So, I think educating and informing everyone, and
    getting everyone's buy-in to help move things along as we
    innovate and implement new things.
        Senator Tuberville. There has had to be some experience
    though from some of these drugs used not on veterans, but just
    some average citizens. Correct? I mean, do y'all use that
    experience from what they've learned from some of these other
    programs to try to help people with other mental disorders?
        Dr. Wiechers. So, thank you. Sure. We certainly learn a lot
    from the scientific literature studying kind of a community or
    general population. But the veterans using Veterans Health
    Administration services are unique in many ways, and that's one
    of the reasons why we want to ensure that we have studies and
    scientific study of that population specifically to make sure
    that, number one, it's safe in that population. Because a lot
    of our veteran population have significant mental health burden
    as well as substance use disorder and lots of medical
    conditions as well, more so than the general population.
        And so, first, to ensure its safety in our veteran
    population, and second, to ensure that it is as effective in
    the veteran population as it is in the general community
    population. So, that's one of the reasons why we like to see
    scientific evidence that supports its use in the veteran
    population specifically.
        Senator Tuberville. Yes. And if you have people here today,
    and we have veterans that will watch this online, it's a sense
    of urgency. Sometimes we don't feel a sense of urgency because
    people are dying every day. I know we have somebody every month
    that dies of suicide from PTSD that's a veteran. And I know we
    want to do the right things, but we also need to feel that
    sense of urgency, you know. How does the VA track the success?
    When something good happens, how do we assess that across the
    country when it's being used?
        Dr. Wiechers. So, thank you, sir, for that question. We
    actually have a really robust set of--at least in mental health
    that I'll speak to--a robust set of metrics and measurements
    that we're tracking that look at outcome, that look at access,
    that look at utilization of services, that really help us in
    real time, identify how veterans are doing and how individual
    health systems are doing across the Nation.
        And so, we have lots and lots of data at the VA, actually,
    which is one of the benefits of being at the VA is we've got a
    really robust data set that allows us to learn from the health
    system in a robust way in addition to what we learn from the
    scientific studies that we do in the research side of the
    house. So, we can learn things as a clinical system, and we are
    a learning health system that allows us to kind of evolve as we
    go.
        Senator Tuberville. And I think it's so important that we
    pass that information on down. I know in the five years, we've
    spent tens of billions of dollars in the VA and we still hadn't
    been successful of really getting just information from the DoD
    to the VA. I mean, because different servers on each end.
    Communication is the key to anything. I think we all know that.
        And so, if we're going to study drugs and study therapies,
    we need to do it as quickly as we possibly can, but do it the
    right way. What criteria does the VA use to approve these new
    therapies? I mean, what list do you go down to approve these?
        Dr. Wiechers. So, in speaking about pharmaceuticals----
        Senator Tuberville. Anything. You know, is there a grocery
    list that we have to go through to from start to finish to
    approve a drug for a veteran to use?
        Dr. Wiechers. So, there's not a list per se, but there is
    an existing process with our pharmacy benefits management
    national formulary, that whenever a new drug is approved by
    FDA, it kind of starts automatically this standard process of
    review that the national formulary team undertakes.
        And that has a group of experts from across the country
    that review the data that the FDA reviewed, that review data
    about safety and efficacy in the veteran population
    specifically and then make determinations about the
    availability of it. And if there are certain criteria that we
    will utilize inside VA for who is eligible for receiving that
    medication.
        Senator Tuberville. Do veterans get to sign up for these
    experiments? How does that work when you have a new therapy
    that you want to try? How do they find people to try it on? I
    mean, it's got to be used somehow to see if it works. How does
    that work?
        Dr. Wiechers. So, I'll defer to Dr. Smyth to say a little
    bit about recruitment for VA research studies.
        Dr. Smyth. So, Senator, I will say that veterans, as a
    group, have been remarkably generous to each other. It's just
    phenomenal how willing they are to sign up for clinical trials,
    and how willing they have been to join our Million Veteran
    Program, which actually hit the enrollment of a million
    veterans this past fall. So, we offer opportunities for
    veterans to join clinical trials, and again, they sign up.
        Senator Tuberville. Good. Thank you. Doctor, your
    testimony, you mentioned ketamine.
        Dr. Wiechers. Ketamine, yes.
        Senator Tuberville. Ketamine and----
        Dr. Wiechers. And esketamine.
        Senator Tuberville. Yes. That's good--I couldn't pronounce
    nor spell it--as emerging therapies at the VA. How is this
    therapy administered to the veteran, and what does it look
    like?
        Dr. Wiechers. Sure. So, ketamine infusions are very similar
    to any other kind of infusion clinic. So, for example, if
    you've been to an infusion clinic for chemotherapy, it
    oftentimes will look similar to that. The one where I practice
    in San Francisco has four bays with recliner chairs, and IV
    poles, and blood pressure cuffs, and pulse ox machines.
        And so, each veteran will come in and have a seat. They
    talk with you first to check in and see how things are going. A
    nurse will start an IV and then for about 40 to maybe 50
    minutes the medication is infused through that IV. And then,
    they rest afterwards for a little bit. We check in after, and
    then they head home. And that is what a ketamine infusion
    treatment looks like. So, in total, they're probably in the
    clinic for about 90 minutes to 2 hours.
        Intranasal esketamine is kind of like your allergy
    medication that you use. And it's self-administered same way.
    So, you squeeze and inhale. It oftentimes, our clinics look
    similar to our ketamine clinics; our recliners, because you
    need to be in a reclined position when you do the inhalation.
        The veteran comes in, checks in with nursing and the
    doctors. They are given the device to administer. They self-
    administer with the nurse and doctor there watching. And then,
    they rest and are monitored blood pressure and pulse ox for
    about 2 hours afterwards, which is part of the requirement by
    FDA, to monitor people for 2 hours afterwards and rest. And
    then talk with the team after, and then head home. And so,
    again, they are there for about maybe two, two and a half hours
    for an esketamine treatment.
        Senator Tuberville. So, we're still in experimental stage
    with these two?
        Dr. Wiechers. No, this is clinical practice, sir. Both of
    those are FDA-approved medications. Esketamine is specifically
    FDA-approved for the indication and treatment of treatment-
    resistant depression. Ketamine is an anesthetic agent that is
    being used off-label, but it's an FDA-approved medication
    that's been used since the 1950s, I believe.
        Senator Tuberville. Results?
        Dr. Wiechers. Results are good. Results are quite good for
    many people. It doesn't work for everyone. It's not a magic
    bullet, but the data looks good for those for whom it helps. It
    can help quite a bit.
        Senator Tuberville. Side effects?
        Dr. Wiechers. Side effects are feeling drowsy, feeling a
    sense of dissociation, which is sort of a little bit like
    leaving your body or having distorted perceptions for a period
    of time. While the infusion is running for ketamine or while
    shortly after the inhalation of the intranasal treatment with
    esketamine, we can see a short-term increase in blood pressure
    that usually then goes away within 20 to 40 minutes. And for
    the most, sometimes nausea and occasionally vomiting. Those are
    the common side effects.
        Senator Tuberville. Availability?
        Dr. Wiechers. So, we have ketamine and esketamine one or
    both available at about 49, 50 sites around the country right
    now.
        Senator Tuberville. Good. So, you're seeing good results.
        Dr. Wiechers. We're seeing good results.
        Senator Tuberville. Ms. Smyth, you'd like to add anything
    to that?
        Dr. Smyth. No, sir. She covered it quite well.
        Senator Tuberville. She covered it. Good. Alright.
    Transcranial magnetic stimulation therapy.
        Dr. Smyth. Yes.
        Senator Tuberville. Let's talk about that.
        Dr. Wiechers. Yes. So, we have TMS at 62 facilities around
    the country right now. It is also indicated for FDA and
    approved for treatment of depression that has failed at least
    two trials of oral medications. And it is a special TMS machine
    that has a chair and then a device that comes down over the
    head that delivers magnetic stimulation through probes. You
    come and you sit down in the chair and receive your treatment.
    And then, and then go home.
        The treatment course is every day for a period of time
    which is a little bit different and more intensive in terms of
    coming into the clinic than with the ketamine or esketamine
    where we do twice a week for a couple of weeks. And then, we
    aim to do every couple of weeks one or once a month. So, the
    TMS is a course of treatment over a course of daily for a
    couple of weeks.
        Senator Tuberville. So, it's not abrasive?
        Dr. Wiechers. It is not abrasive, no. It sometimes causes
    headaches, but for the most part it's generally very well
    tolerated.
        Senator Tuberville. It's working?
        Dr. Wiechers. And it is working.
        Senator Tuberville. Yes. How many places do we have this?
        Dr. Wiechers. 62, sir.
        Senator Tuberville. 62?
        Dr. Wiechers. Yes.
        Senator Tuberville. I wonder if we have those in Alabama.
    Do you know?
        Dr. Wiechers. I can get you an answer, but I'll have to
    check and get back to you to confirm which of these we have,
    and where nearest by we have them and reach out.
        Senator Tuberville. How new is this?
        Dr. Wiechers. TMS has been around for quite a while. There
    are innovative types of treatment, kind of the protocol that
    is--so there's innovations happening in the protocol that make
    it more rapid. So, kind of condensing the number of treatments
    so that you do a whole lot in one or two days rather than every
    day for weeks. The evidence is still growing on those to see if
    those are more effective or as effective as the standard
    protocol that we use today, but this treatment has been around
    for quite some time.
        Senator Tuberville. That's awesome. All right. I'm sure
    you're monitoring the Compass Pathways COMP360.
        Dr. Wiechers. Yes.
        Senator Tuberville. Again, there's another drug there. What
    is it called? P-S-I-L-O-C--how do you pronounce that?
        Dr. Wiechers. Psilocybin.
        Senator Tuberville. Okay. Assisted therapy as it's going
    through FDA trials. How's that going?
        Dr. Wiechers. I will defer to my colleague, Dr. Levine, to
    speak more about that on Panel 2, specifically about the
    Compass work. But I will say that VA has been partnering with
    Compass and other of the private sector companies who are
    working in the psychedelic space so that we can--and we're
    meeting with them regularly to be updated on how their progress
    is going.
        Senator Tuberville. Good, good. Besides approving new
    therapies, how can we use the programs like the Fox Suicide
    Prevention Grant to help our veterans who are struggling with
    mental health?
        Dr. Wiechers. Thank you for that question, sir. One of the
    great things about the Fox Grants Program is that it's meeting
    veterans in the community where they are in ways that often, we
    don't with VA, properly engage with those folks.
        I think at least from where I'm sitting, I think one of the
    most important missions we have right now is engaging the
    veterans who don't already come through our doors and getting
    them to engage in services that will help them with mental
    health, substance use, or suicidal ideation, and problems that
    they're having.
        So, the Fox Grants helps extend beyond us and beyond our
    walls to access and ensure that veterans are getting help they
    need.
        Senator Tuberville. So, let's talk about something that
    I've been trying to push through the VA for 5 years, is
    hyperbaric chambers. Obviously, it's expensive. A lot of the
    VAs don't have them, don't want to spend the money on them. But
    no matter what it costs, we've got to take care of our
    veterans.
        And, you know, this bill that I presented, you have to go
    through two other therapies before you're able to use the
    hyperbaric. Now you can use them either in the VA or out of the
    VA. We've got to find, you know, some alternative way to help
    some of these people that some drugs don't help or other
    therapies. So, what's your thoughts on HBOT?
        Dr. Wiechers. Thank you, sir, for the question. So, in
    regards to hyperbaric oxygen treatment, it is FDA-approved and
    authorized for use in a variety of different medical
    conditions. It has not been authorized for use as treatment for
    PTSD or TBI. It also is not covered and reimbursed by CMS and
    most private insurance as treatment for PTSD or TBI.
        Our review of the evidence available and as stated in our
    VA/DoD clinical practice guidelines, we don't find there to be
    sufficient evidence to support it as an evidence-based
    treatment. And given, as you mentioned, the expense, but also
    how intensive the HBOT treatment is, and based on some of our
    experiences with the clinical pilot program we ran back in 2018
    to 2021 for the Hannon Act, Section 702, we have determined
    that the feasibility of kind of using this clinically, given
    the lack of evidence at this time, that suggests it is more
    beneficial than other existing treatment options we have
    available. That's the rationale we have for not offering it as
    a clinical service at this time.
        Senator Tuberville. Are we doing studies on HBOT?
        Dr. Wiechers. So, I'll defer to Dr. Smyth to speak to the
    state of research currently.
        Dr. Smyth. So, currently, Senator, we are not doing any
    studies on HBOT. The reason being that none of our principal
    investigators in the field are researchers out there at our 102
    sites. None of them have chosen to submit a proposal to us for
    HBOT research.
        Senator Tuberville. Good. Well, you know, I bring this up
    because of my experience of coaching, over the years, a lot of
    the different schools that I coached at, we had hyperbaric
    chambers that kids with concussions. We felt like it helped, it
    enhanced, it cleared their mind to some point. I think my wife
    caught onto a little bit. She actually bought me one
    [laughter]. I don't know what that says [laughter], but I get
    in one at least twice a week. You know, it's an hour, and it's
    not pressure of going up. It's like pressure going 100 feet
    under the water, and you breathe straight oxygen.
        Now, I can't tell you whether it's helped me or not, but I
    do know that we hear quite a few people that do it on their own
    that it's helped. So, hopefully, in the future, we can bypass
    some of the red tape and at least try. Some therapies that are
    not working on some veterans, hopefully, it can help in that
    area.
        So, earlier this year, Secretary Collins made statements on
    social media that his administration was looking into
    alternative therapies. Do you know if that's an accurate
    statement, or are y'all getting feedback down from the top
    level that we're looking into the different therapies like
    HBOT?
        Dr. Wiechers. We are committed to continuing what we have
    been doing for many years, which is researching and reviewing
    research from outside on all of these innovative treatments for
    mental health.
        Senator Tuberville. Again, anything it would help.
    Anything. So, on our next panel, we'll have Dr. Jim Wright
    testify on the efficiency of HBOT. To date, we've had 12,000
    veterans with TBI or PTSD. They have received HBOT treatments
    with near universal improvement with depression scores being
    reduced by at least 39 percent. So, is that a good number?
    You'd think if you're doing a therapy and you've got 39 percent
    increase in help, your thoughts and your experience.
        Dr. Wiechers. So, I'd be happy to take a look at the
    studies referencing that number to better understand what that
    means. But in context, I'm happy to hear that there are
    veterans that are experiencing improvement in symptoms. And so,
    anything that's helping folks, I agree, is a good thing. But
    before I commit resources, and put a lot of energy and emphasis
    into things at a system-wide level, I need to see more
    convincing and rigorous scientific data.
        Senator Tuberville. So, how often does the VA update its
    evidence-based therapy and complementary and integrity health
    list? And can it keep pace with all the emerging effective
    treatments?
        Dr. Wiechers. So, that's a great question. So, our clinical
    practice guidelines are on average about every five years
    reviewed and updated. But in the intervening period between, we
    can implement change in our system and the care that we
    provide. And the perfect example of that is ketamine and
    esketamine.
        So, it wasn't until the 2022 clinical practice guidelines
    that they became recommended treatments for treatment-resistant
    depression. But we were deploying and implementing that
    starting in 2019 because the FDA-approved esketamine and we had
    the scientific evidence that these were safe and effective
    treatments. So, we actually started deploying it, and then the
    CPG caught up after. So, the CPG doesn't stop us from doing
    something clinically if the evidence has been gathered that
    supports its use clinically.
        Senator Tuberville. Thank you. In your testimony, you
    mentioned that the HALT Fentanyl Act gave private, non-
    governmental entities the ability to expand their control,
    Schedule 1 and Number 2 research protocols. Can you provide
    additional details on what this means to the VA and ongoing
    efforts of research and on controlled substances?
        Dr. Wiechers. So, that more applies to folks outside the VA
    and the research that they do, which of course, we monitor and
    follow. And that helps inform what we know about our veteran
    population. And it is kind of in adjacent to, in addition to,
    the work that we are hoping to do and that we have ongoing at
    our VA facilities currently.
        Senator Tuberville. So, I believe there's a common
    misconception that these substances, if approved for treatments
    for veterans with PTSD or other mental health conditions, will
    be able to self-medicate. Could you please address this
    misconception and provide details about these treatments and
    how they may entail the VA in the future, if approved for
    treatment?
        Dr. Wiechers. So, if any of the psychedelic substances are
    approved in the future, I anticipate that they would be
    approved with what's called a REMS program, Risk Evaluation
    Mitigation System program, that FDA puts in place for high risk
    medications when they approve them. And that REMS, I would
    assume, would want this to be administered in a medical
    setting.
        So, this is not going to be a take-home medication. These
    are going to be medications administered like ketamine and
    esketamine in a clinic at one of our facilities in some future,
    should they be approved.
        Senator Tuberville. So, I have people, veterans, come to my
    office quite often and say, Coach, I've gone to another country
    and a drug at this--a certain drug has helped. What advice
    would you give to that veteran? And can they pass that along?
    And do we look into that? What's the process on that?
        Dr. Wiechers. So, thank you for asking about that. I know,
    and I have heard and spoken with veterans as well who have gone
    elsewhere to take these medications. I caution my own veterans
    that I see in clinic from using psychedelic substances on their
    own, and I would caution any other veterans from----
        Senator Tuberville. Would you suggest that?
        Dr. Wiechers. I would not personally suggest that. I would
    ask them to look for a clinical trial nearby and engage in
    using one of these substances in a way that allows for rigorous
    monitoring and safety insurances.
        Senator Tuberville. So, if they've gone through something
    like this, what would you tell them? Who do they see in our
    country to pass this information along, whether it helped or
    didn't help? Who do they go to?
        Dr. Wiechers. So, I appreciate that many veterans have had
    these experiences and that they have had profound positive
    impacts on them. So, I want to make sure that that is clear.
    So, I appreciate that, and I appreciate that many of those
    veterans are sharing those stories with us so that we can learn
    and hear about it.
        One thing I do want to say is that veterans can feel
    comfortable to speak with their own providers if you're coming
    to the VA about this type of experience because it helps us
    understand, it helps your provider understand where you're at,
    and what you've experienced, and what you've been through.
        So, I would just encourage veterans to make sure that their
    healthcare providers know about things like this so that they
    can help make good shared decisions about next steps with their
    treatment based on what they've tried in the past.
        Senator Tuberville. So, how can you help us back in
    Congress balance innovation and safety? What advice would you
    give to myself and my colleagues on the VA Committee, direction
    we go in terms of balancing all the new innovation that's
    coming in, how we make sure it's safe. What would you tell us
    as a group?
        Dr. Wiechers. I would say that we need to continue to study
    in a safe way so that we can ensure the safety of something
    before we implement using something clinically. So, continued
    support for research of innovative mental health treatments is
    what I would suggest is what we need your help with.
        Senator Tuberville. Yes. We're about done here with this
    group. So, any comment that you'd like to make to this group
    and to our audience that's going to watch on closed circuit?
    How do we help our veterans? What do we do? What new directions
    do we need to take? How do we save these 18 lives that are
    being taken a day in our country?
        Dr. Wiechers. I would say that if there are any veterans
    out there who are in crisis, to reach out to friends, to
    family, to people who you trust. Pick up a phone and call 988
    and press 1 for the Veterans Crisis Line. Go to your local VA.
    Go to someone that you trust, and let them know that you're
    having trouble, and you need help. And the VA is here to help
    you.
        Senator Tuberville. Thank you. And the number one thing
    that I hear is to tell somebody you are close to your problem.
    Don't keep it to yourself. It's really sad the point we've
    gotten to, but I think help is on the way. I think we're
    working on it more. We're putting more money. If money could
    solve this problem, it would have already been solved.
        But money's not going to solve this problem. People are
    going to solve this problem, and we've all got to work on it
    together. So, thanks for both of you for coming from so far
    away, coming here and being part of this. Again, psychedelics,
    HBOTs, anything that we can do to help our veterans, we want to
    do.
        And again, it's not about money, it's about people. And
    we're going to continue to work on. Again, we have 400,000, and
    just in this state alone. You know, the hundreds and hundreds
    of thousands and millions of veterans are looking for answers.
    And we need to get those answers for them.
        So, thanks, both of you. Thanks for coming. Thanks for
    coming this far away, and hopefully, we can continue this
    dialogue in the future. Give them a hand. Thank y'all.
        [Applause.]
        Senator Tuberville. Alright. We'll start. And again, we
    have four instead of two. We've got a little bit longer
    introduction, but again, we're here for a reason, and so we
    want to make sure we do this right.
        In our next panel of witnesses, we will cover a wide
    variety of perspectives on alternative therapies for our
    veterans. We'll hear from Compass Pathways, a biotechnology
    company with a psilocybin therapy going through FDA approval.
    Two veterans who will share their lived experience with
    alternative therapies and their work to get our heroes access
    to them. And lastly, a professor and a former trauma surgeon
    who has conducted cutting edge research on HBOT, and PTSD, TBI
    for our veterans.
        This panel will help set the record straight on what
    alternative therapies look like in practice. We will use this
    time to separate fact from fiction, whether that be on
    psychedelic-assisted therapies, HBOT, or even peer-to-peer
    mentoring.
        Our veterans who are already suffering from mental health
    conditions connected to their time and service should not have
    to risk their lives and well-being overseas just to receive an
    alternative form of treatment. Veterans should also be able to
    safely access these evidence-based alternative treatments here
    in the United States within the guardrails of the law.
        The American people and our veterans deserve to know the
    facts. I look forward to working with each and every one of you
    here to get our veterans access to life-saving and life-
    changing alternative treatments for their mental health. So,
    let's see if we can make some progress here.
        We'll have 5-minute opening statements, but I'd like to
    start and introduce each one before we start those. Dr. Steve
    Levine. Doctor, thanks for being here today. Currently, serves
    as the chief patient officer for Compass Pathways. Dr. Levine
    is a board-certified psychiatrist that has spent his career
    working across the healthcare system to improve people's lives
    through creating access to innovation.
        He completed internship and residency in psychiatry at New
    York Presbyterian Hospital, Weill Cornell Medical Center. He
    then completed fellowship subspecialty training in
    psychosomatic medicine, psycho-oncology at Memorial Sloan
    Kettering Cancer Center in New York Presbyterian Hospital.
        Before coming to Compass, he founded Actify Neurotherapies
    that built new models of care delivery across U.S. for
    interventional psychiatry treatments. Dr. Levine has been
    published extensively in both peer-reviewed journals and lay
    audiences around the world. He has served in leadership roles
    for professional societies and not-for-profit entities and
    received numerous awards for leadership and service. Dr.
    Levine, thanks for being here, and I hope I didn't hack that up
    too bad.
        Dr. Levine. Thank you, sir.
        Senator Tuberville. Adam Marr. I'll introduce one of my
    constituents here. Adam's based in Slocomb, Alabama. Adam is
    the director of operations for the Veteran Mental Health
    Leadership Coalition. The Veteran Mental Health Leadership
    Coalition is a national coalition of individuals and
    organizations united by the mission to prevent suicide, drive
    innovation, and reshape the future of mental health care for
    veterans and their families.
        Adam is a U.S. Army veteran--thanks for your service--where
    he served as an Army captain and an AH-64 Apache pilot with the
    deployment to Iraq. He also co-founded the Warrior Angels
    Foundation with his older brother Andrew, a decorated Green
    Beret who suffered from combat-related brain trauma, to give
    veterans access to innovative treatments for TBI.
        Adam is also the national co-host for the American Legion
    national podcast, Tango Alpha Lima. Today, he is accompanied in
    the audience by his wife of 16 years, Elisa, their children;
    Amelia, Austin, and Aria Marr, his mother, Shirley Marr, and
    in-laws Kenny and Sheila Austin. You got a large group here.
        [Laughter.]
        Senator Tuberville. I'm glad we got a big enough arena.
    Thanks for being here, Adam.
        Dr. Jim Wright, our next witness. Another one of my
    constituents of Vestavia Hills, Alabama. Dr. Wright is an
    adjunct assistant clinical professor at the University of
    Alabama, Birmingham. Dr. Wright held the rank of Colonel and
    served for 28 years in the United States Air Force. Thank you
    for your service. He held several roles in the Air Force,
    including plastic surgeon at Clark Air Force Base in the
    Philippines, chief plastic surgeon at Wilford Hall Medical
    Center, and chief of hyperbaric medicine research at Brooks Air
    Force Base and special tactic surgeon.
        Dr. Wright completed a fellowship in undersea and
    hyperbaric medicine at the United States Air Force School of
    Aerospace Medicine in 2007. Along with Dr. Eddie Zant, Dr.
    Wright initiated HBOT for active-duty military. He was also a
    principal investigator for the National Brain Injury Rescue and
    Rehabilitation Study, which used HBOT for TBI and PTSD. And
    after his years of service, Dr. Wright became a hyperbaric and
    wounded care physician in Washington State before coming to
    Alabama to work as a burn trauma surgeon. Thanks for being
    here, Dr. Wright.
        And then, Brian Schiefer, our fourth and final witness.
    Brian is a United States Air Force veteran--thank you for your
    service--and a founder of SCI-DI. Brian is a former U.S. Air
    Force Tactical Air Control Party (TACP) member and served in
    both Afghanistan and Iraq. In 2008, during his pre-deployment
    training excise in California, Brian's life was forever
    changed.
        After recovering from his injuries and spinal fusion
    surgery, Brian made the commitment to redefine his recovery. He
    has since become an advocate for innovative therapies for
    veterans and others with spinal cord injuries, TBI, and
    neurological conditions by founding his organization SCI-DI.
        I am thrilled to have each one of you here today to share
    your experiences in alternative therapies, and I welcome each
    of you to give your opening statement. Dr. Levine.

                                PANEL II

                                  ----------

     STATEMENT OF STEVE LEVINE, MD, CHIEF PATIENT OFFICER, COMPASS
                                PATHWAYS

        Dr. Levine. Thank you, Senator. Senator Tuberville, all
    present, thank you for the chance to testify at this important
    field hearing today. Improving the mental health of veterans is
    a national imperative, and we appreciate your leadership to
    achieve this goal.
        My name is Dr. Steve Levine. I'm a psychiatrist, and I
    serve as the chief patient officer for Compass Pathways.
    Compass is a biotechnology company dedicated to accelerating
    patient access to evidence-based innovation in mental health.
    Our lead compound COMP360 is a synthetic pharmaceutical grade
    form of psilocybin being studied in robust clinical trials in
    treatment-resistant depression and post-traumatic stress
    disorder or PTSD.
        COMP360 was granted FDA breakthrough therapy designation
    for TRD in 2018 and will potentially be a first-in-class
    treatment. Compass is leading the way in psychedelic clinical
    trial research and is conducting the largest ever FDA regulated
    clinical trials studying the safety and efficacy of psilocybin.
        We have already generated positive primary endpoint data in
    two large well-controlled clinical trials of a single
    administration of psilocybin in a supervised medical setting.
    In May 2022, the positive results of our 233-participant Phase
    2 trial were published in the New England Journal of Medicine,
    and in June 2025, just two months ago, we announced the
    successful achievement of the primary endpoint for 258
    participants in the first of two ongoing Phase 3 trials. Our
    second Phase 3 trial will enroll approximately 568 additional
    participants.
        In addition to TRD, in May 2024, Compass announced positive
    top line results from a Phase 2 study in PTSD, which showed
    COMP360 was well-tolerated with both rapid and durable
    improvement in symptoms from baseline observed following a
    single administration.
        Compass is currently finalizing plans to begin a late-stage
    trial in PTSD. The United States is in a mental health crisis
    with one in five adults experiencing mental illness in any
    given year. Among the most pressing and debilitating conditions
    within this crisis are PTSD, affecting 13 million Americans,
    and TRD in about 3 million. Both conditions are marked by
    severe symptoms, high suicide risk, and limited medication
    treatment options.
        Amid a national mental health emergency where anywhere from
    17 to 44 veterans die by suicide each day, we must urgently
    explore and advance novel treatments to help patients
    struggling with depression, PTSD, and other serious mental
    health conditions.
        Well-controlled clinical studies of the safety and efficacy
    of innovative treatments like psychedelics are currently
    underway. That is why it's essential to set standards like
    those available through the FDA framework to facilitate the
    safe, effective, and efficient delivery of these treatments to
    veterans in need.
        Compass shares the Committee's goals to ensure that our
    Nation's veterans can access appropriate care and treatments.
    We commend the VA for its openness to new treatment options,
    and for the significant research that has performed related to
    psychedelics. While these compounds are still being studied for
    potential review by the FDA, we encourage the VA to prepare for
    the possible entry of psychedelic therapies into the VA health
    system so that it is ready should these treatments be approved.
        We recommend that the VA begin by developing treatment
    protocols, training personnel, and preparing clinical care
    settings. Compass is committed to partnering with the VA to
    ensure that sites have the required infrastructure and training
    in place for successful implementation as we've begun to do in
    regular meetings with the VA's integrated project team. Our
    shared goal must be to ensure that safe, effective medications
    for the treatment of depression and PTSD are accessible to
    veterans as soon as possible.
        In closing, possible FDA approval for certain psychedelic
    compounds is on the horizon as there are several ongoing late-
    stage clinical trials. FDA-approved psychedelics enhance
    patient safety by ensuring that these drugs have been proven to
    be safe and effective for specified conditions and patient
    populations, and that they are prescribed by licensed and
    trained healthcare professionals for the appropriate patient at
    the appropriate dose.
        Again, we thank the Committee and Senator Tuberville for
    holding this important hearing, and I'm happy to answer any
    questions.

        [The prepared statement of Dr. Levine appears on page 46 of
    the Appendix.]

        Senator Tuberville. Thank you. Doctor Adam.

    STATEMENT OF ADAM MARR, DIRECTOR OF OPERATIONS, VETERAN MENTAL
                      HEALTH LEADERSHIP COALITION

        Mr. Marr. Senator Tuberville, thank you for the honor of
    sharing my American veteran story at this field hearing today,
    and for your bold leadership helping to elevate this
    conversation. My full written testimony has been submitted for
    the record. Today, I'll focus on the essentials, but before I
    begin, I do want to recognize my family and friends and
    colleagues here today, and I'm going to dedicate these remarks
    to my late father, Woody Marr. He went home to be with the Lord
    this year. He loved his wife, and his four sons, who all
    served.
        He and mother prayed every day that we would return from
    our deployments and we did. We just didn't know that that's
    when the real battle was going to begin. My older brother,
    Andrew an SF Green Beret came home with TBI and PTSD. The
    system's answer; 13 symptom-masking medications and they told
    him; this is your new normal.
        My younger brother, Austin, an infantry sergeant with two
    combat tours, medically separated, spiraled into depression,
    placed on SSRIs, and one night I found him unresponsive after a
    suicide attempt in the park in our hometown. Me, the Apache
    helicopter pilot, middle brother. Well, sir, I brought all my
    soldiers' home, but I watched my own brothers collapse, all
    while I tried to figure out how to pull out of my own nose low
    dive.
        You see, sir, this isn't just our story, unfortunately,
    it's become an American veteran story. But veterans aren't
    broken, though parts of the system are. For decades, care has
    numbed instead of healed; pills, brief therapy sessions, and
    labels that never address the root cause of trauma.
        In the past 20 years alone, we've lost more veterans to
    suicide and overdose than in Iraq, and Afghanistan, and Vietnam
    combined. Out of desperation, veterans began building something
    different, emerging therapies delivered with rigorous care
    models and veteran-led support.
        Andrew found hope initially through neurohormone
    replacement and anti-inflammatory protocols with Dr. Mark
    Gordon of Millennium Health Centers. Austin and I had different
    injuries. We required different therapies. After Austin's
    suicide attempt, he sought psychedelic-assisted therapy with 5-
    MeO-DMT from Dr. Martin Polanco through The Mission Within. My
    own journey, I became one of the single most transformative
    experiences of my entire life, reconnecting me to my purpose,
    my faith in Jesus Christ, and my call to serve.
        These treatments do, however, carry risks and require
    medical oversight. For us, though, for my brothers, for my
    family, they were lifesaving. But what happens on the other
    side of these therapies when proper integration and community
    support is applied? What happens when veterans begin to become
    whole again? I'll tell you, sir, they stand back up to serve
    and they help those still struggling because that's what we
    were trained to do.
        That's what my brother and I did. We created Warrior Angels
    Foundation in 2015, one of the first Global War on Terrorism
    nonprofits to focus on funding root cause treatments for TBI
    and PTSD. We helped to change the stigma and culture around
    being too tough to ask for help. In the years since, a new wave
    of veteran leaders has stepped forward, creating new nonprofits
    to meet the urgent need for care. Their focus has been on
    therapies like psychedelics, neurorestorative care, TMS, HBOT,
    and whole-health approaches grounded in the strength of peer-
    led community support, coupled with education and advocacy
    efforts.
        Now, since 2022, through the VMHLC, under the leadership of
    Lt. Gen. Martin R. Steele, USMC (Ret.), we've united 50-plus of
    these organizations. 50 plus of these organizations exist, sir,
    each represented by veterans, families, clinicians, and
    researchers on the front lines of these innovative programs and
    care models. All this so we can collectively educate and
    advocate for these approaches.
        Meanwhile, nearly every major psychedelic from MDMA, to
    psilocybin, to ibogaine, to 5-MeO-DMT, is in FDA trials. Six of
    them have earned breakthrough therapy status from the FDA. But
    until last year, the VA with nearly $1 billion research budget
    has only committed $1.5 million to a single trial.
        Acknowledging that that has since changed, but just like
    the representatives set up here before, that's the greatest
    challenge they're facing; change. That must change. We must
    invest in research, expand access, and do so expeditiously. We
    are requesting from Congress, sir, simply put, partnership to
    fund research and pilot programs at scale; to support and fund
    community-based veteran services; to prepare for FDA approval
    by training clinicians in building the infrastructure now.
        Veterans didn't wait for the system to save us, Senator. We
    couldn't. We had to build what was needed because this is about
    moving from suffering to solutions, about healing veterans and
    families, and about those in service being able to return to
    service. Now it's time for the VA and the Federal Government to
    continue to step up and support in a large way to bring these
    solutions home.
        My father's prayers were answered when his sons came back
    from war. However, too many families are still praying for
    their loved ones to come home, physically, mentally,
    emotionally, spiritually, and morally. It's time their prayers
    are answered. It's time for partnerships, sir.
        Thank you, Senator Tuberville. May God bless you. May God
    bless our Nation, and may God bless the veterans and families
    who fought for our freedoms. Thank you.
        [Applause.]

        [The prepared statement of Mr. Marr appears on page 50 of
    the Appendix.]

        Senator Tuberville. Thank you, Adam. Well said. You might
    need to run for politics.
        [Laughter.]
        Senator Tuberville. Dr. Wright.

     STATEMENT OF JAMES K. WRIGHT, MD, ADJUNCT ASSISTANT CLINICAL
             PROFESSOR, UNIVERSITY OF ALABAMA AT BIRMINGHAM

        Dr. Wright. Thank you, Senator, and thank you for allowing
    me to give some information on hyperbaric oxygen treatment for
    neurologic injuries in veterans.
        Hyperbaric oxygen is the delivery of 100 percent oxygen to
    a person in a pressurized chamber and is used as a treatment
    for certain diseases and conditions. Oxygen levels 7 to 14
    times that are achieved by breathing room air are possible. The
    therapy affects more than 8,100 known human genes and thousands
    of cellular processes, and is effective in treating a variety
    of conditions from neurologic injury to chronic wounds.
        Hyperbaric oxygen has been used as a treatment for brain
    and nerve injuries for 89 years since it was first described by
    Dr. Albert Behnke in the U.S. Navy for the treatment of the
    brain and spinal cord injuries in decompression sickness. Since
    then, it has been used for a variety of brain and nerve
    injuries in addition to decompression sickness such as carbon
    monoxide poisoning, stroke, post-concussion syndrome, traumatic
    brain injury, PTSD, depression, chronic pain syndromes, post-
    COVID illness, and narcotic addiction recovery.
        It is useful to think of the actions of hyperbaric oxygen
    as occurring in four ways in brain and nerve injury. One, it
    provides oxygen to the damaged areas of the brain and spinal
    cord, which don't have enough oxygen to function or heal. Two,
    it promotes the synthesis of growth factors, which cause the
    in-growth of new blood vessels and allow nerve axons to
    reconnect and damage tissue to heal. Three, it's a potent
    suppressor of inflammation, which is a component of TBI, PTSD,
    depression, anxiety, chronic pain, and other neurologic
    disorders. And four, it acts directly on nerve cells in the
    brain and spinal cord to enhance function and suppress pain.
        In treating TBI and PTSD, hyperbaric oxygen has had
    remarkable results over the past 20 years. It is universally
    effective. Few, if any recipients fail to improve and many are
    made completely well from debilitating injuries. Brain function
    and cognition is improved even after decades of TBI or PTSD.
    Depression scores are reduced by 39 percent, and suicidal
    ideation is usually abolished.
        Quality of life and everyday function is improved.
    Medication requirements are reduced and chronic pain is also
    reduced. These results are long lasting or permanent after a
    single series of 40 treatments, though, some veterans require
    more treatment depending on the severity and length of illness.
        To date, more than 30,000 individuals with TBI and PTSD
    have received hyperbaric oxygen treatment in the United States,
    40,000 in Israel, and with nearly universal improvement. More
    than 12,000 of these individuals were veterans. Nearly all--of
    these treatments have been provided free to veterans through
    the generosity of our citizens. Of all these people, we are
    aware of only two suicides in the last 15 years. That is a
    remarkable achievement.
        The use of hyperbaric oxygen treatment for spinal cord
    injuries is in its infancy in the United States, but results so
    far have shown similar benefits as in TBI, or PTSD, as well as
    the halting of functional deterioration and the improvement in
    function in a few cases, especially early after injury.
        As a solution, I propose that hyperbaric oxygen treatment
    be made immediately available to our veterans with TBI, PTSD,
    and spinal cord injuries. The huge quantity of case reports, as
    well as numerous randomized controlled studies, speak to the
    utility and safety of the treatment, as well as providing more
    than enough evidence of efficacy for approval as part of the
    standard of care.
        It would be well to ensure the established safety protocols
    are strictly adhered to, and that all treatments are directed
    by properly trained physicians in approved chambers.
    Additionally, good recordkeeping would validate the utility of
    these treatments. Finally, I recommend that a working group be
    established to design the implementation of this effort.

        [The prepared statement of Dr. Wright appears on page 76 of
    the Appendix.]

        Senator Tuberville. Thank you, Dr. Wright. Thank you for
    your research. Very important. Brian, saved the best for last
    down on the end.

     STATEMENT OF BRIAN SCHIEFER, U.S. AIR FORCE VETERAN, FOUNDER,
                                 SCI-DI

        Mr. Schiefer. Thank you, Senator. Thank you for inviting me
    to this panel. I'm Brian Schiefer, a former Air Force TACP who
    served in Afghanistan, 2003, Iraq '05-'06, again, '06-'07. In
    2008, during a pre-deployment training exercise in California,
    my life was forever changed after a Humvee rollover accident
    left me with severe injuries, including fractures in my spine
    at four different levels, multiple broken vertebrae, broken
    ribs, broken clavicle, broken sternum, bilateral
    hemopneumothorax, torn shoulder ligaments, a skull fracture,
    and severed the number six nerve in my left eye.
        Stabilized with chest tubes and airlifted to Loma Linda
    University's polytrauma center. I then underwent a spinal
    fusion surgery that took 14 hours, followed by 6 weeks in the
    ICU where I was informed that I had less than a 1-percent
    chance of ever walking again. While it was not possible to
    distill in 5 minutes my lived experience during the last 17
    years since the accident, I'm able to present those aspects
    that directly inform why I'm here today.
        Despite the VA's various strengths and good intentions, the
    severity of my injuries equally revealed its limitations for
    veterans with complex injuries. It is my testimony that, had I
    relied only on the standards of care within the VA, I would not
    be here today. Refusing to accept defeat, I instead became my
    own advocate, making it my mission to learn everything about my
    injuries and their impact on my new life.
        What ensued was a process of trying and in many ways,
    unambiguously benefiting from a range of underutilized
    therapies and activities that were unavailable, unknown or
    actively discouraged within the VA. Through redefining my own
    recovery, I became committed to advocating for innovative
    therapies leading to my founding of SCI-DI, an organization
    empowering veterans and others with spinal cord injuries, TBI,
    and other neurological conditions.
        Despite having only one working eye and one working arm,
    during my initial hospital-based postsurgical recovery was
    marked by continued work on my Bachelors in International
    Relations, as well as my relentless research on how to improve
    my condition. My recovery continued with 5 months at the La
    Jolla VA SCI inpatient unit followed by grueling therapy at the
    Detroit Medical Center's Center for Spinal Cord Injury
    Recovery.
        Measurable progress to my lowers was limited and TBI
    symptoms--cognitive fatigue, vision issues, and emotional
    strain from my skull fracture and nerve damage complicated
    rehabilitation. In a 2009 ceremony, I was medically retired
    from active service by PACAF Commander, Lt. Gen. Utterback. I
    then relocated to the Florida Panhandle to adapt to paraplegia,
    tackling challenges like thermoregulation, hand-controlled
    driving, and daily tasks like grocery shopping and cleaning--
    without the proprioceptive feedback, a constant struggle
    learning to deal with my paralyzed body.
        In addition, cognitive struggles were persistent. Despite
    my medical history of a skull fracture and severely compromised
    lung function in the immediate aftermath of my accident, my
    cognitive struggles were attributed to my adjustment of
    paralysis. Then, in 2010, prompted by TACP colleagues receiving
    PTSD and TBI care under an Air Force Special Operations Command
    protocol in Destin, Florida, I secured a formal TBI diagnosis
    from the VA. That was nearly two years post-accident.
        With this new diagnosis, I enrolled in a Hyperbaric Oxygen
    Therapy, HBOT, study under Dr. Eddie Zant at his private clinic
    in Destin, Florida. I experienced immediate improvements in
    cognition, sleep, memory, and relationships, and no longer
    waking up in a fog. With over 300 HBOT dives to date,
    therapeutic benefits include enhanced TBI recovery, tissue
    healing, and post-surgical outcomes.
        For years, I traveled to UCLA for surgeries, including
    shoulder reconstructions and spine procedures. My former TACP
    teammates, who served under me, flew in for weeks to carry me
    post-op, a humbling experience of brotherhood addressing the
    gaps the VA overlooked during my inpatient stay. My experience
    with UCLA Operation Mend exemplified comprehensive care, as
    specialists collaborated to address my complex symptoms,
    setting the gold standard care and for veteran healthcare.
        The VA's care, even for basic needs like wheelchairs,
    seating cushions, catheters and hand controls, has been
    problematic at best. Procurement often required me to navigate,
    essentially alone, bureaucratic hurdles for essential
    prosthetic devices and general medical care. Over the years,
    there have been situations that required my persistent
    attention for weeks, months and sometimes even years to resolve
    the issue.
        I continue to advocate and push for innovative approaches
    to ensure no one has to endure the hardships and misery I've
    faced, pressing for systemic changes to make VA care more
    responsive and effective for veterans with complex injuries.
    Such advocacy includes over a decade of service as a Consumer
    Reviewer for the Congressionally Directed Medical Research
    Programs (CDMRP), evaluating grants for SCI, TBI, orthopedic
    outcomes, and neurological conditions.
        This role exposed the critical research gaps, particularly
    in the underfunded fields of SCI and TBI, with veterans three
    times more likely to suffer a SCI than their civilian
    counterparts. In 2018, I discovered adaptive scuba diving and
    working with a small team, pioneered techniques tailored to my
    needs. Underwater is in a barrier-free 3D environment, I found
    liberation--reduced pain, better sleep, and relief from TBI-
    related cognitive fog, much like HBOT but with the freedom of
    floating and movement. I now have nearly 100 scuba dives to
    date.
        A final example of how I benefited from an unorthodox
    therapy is my personal experience with psychedelics. Among the
    many benefits was an unexpected and remarkable restoration of
    my sense of connection to my body and the lost sensation areas
    and the proprioception areas that I can no longer feel. I
    noticed less inflammation in my body, improved cognition and
    sleep and a deeper sense of connection and well-being with
    those around me.
        This further inspired me to found SCI-DI in 2022, and we
    filed for nonprofit status in 2025, to make adaptive diving and
    innovative therapies like HBOT, psychedelics, noninvasive
    neuromodulation, and ketones accessible to others. SCI-DI
    bridges medical science, adaptive sports, and cutting-edge
    technology to empower the 294,000 Americans with SCI, including
    42,000 veterans, and 17,730 new cases annually.
        Our team of medical, academic, and military experts
    collaborates in ``skull sessions'' to explore bold ideas, from
    standardizing HBOT protocols to researching psychedelics for
    inflammation reduction using objective measures like cytokines.
    Driven by a ``don't talk about it, be about it'' ethos, SCI-DI
    partners with institutions like the Lakeshore Foundation and
    Alabama Brain Lab, leveraging novel neuromodulation devices
    like BRAIN Buds and ELVis as new, scalable healing modalities.
        We continue to pursue grants through CDMRP, ARPA-H, and the
    DoD that align with our team's interests and skill sets. We've
    recently spoken at the 2024 and 2025 Aerospace Medicine
    Association meetings, hosting workshops and talks on
    neuromodulation, vagus nerve and photic stimulation, and
    psychedelics. Sparking vital conversations with pilots, divers,
    and aerospace and hyperbaric medicine technicians and thought
    leaders, and other consumers at the concurrent Undersea and
    Hyperbaric Conference.
        Although the VA is not currently structured to provide
    therapies like HBOT or psychedelics, veterans should not have
    to wait for historically slow systemic changes. A way forward
    is partnering with nonprofits like SCI-DI, which have the
    experience and agility to offer these treatments. For example,
    voucher systems or VA reimbursement to such organizations would
    ensure veterans gain timely access to life-changing therapies,
    bypassing bureaucratic delays.
        My journey from a near-fatal accident to championing for
    alternative therapies was only possible by accessing these very
    novel therapies that, not only promoted my recovery, but
    allowed me to flourish. My experience underscores the urgent
    need for these innovative, accessible solutions for
    inadequately served veterans with complex injuries.
        I'm here today to share how HBOT, adaptive sports,
    psychedelics, and non-invasive neuromodulation can transform
    lives and urging this Committee to support research funding the
    policies to bridge these gaps for our Nation's heroes. Thank
    you for your time.
        [Applause.]

        [The prepared statement of Mr. Schiefer appears on page 78
    of the Appendix.]

        Senator Tuberville. Thank you, Brian. Thank you for your
    service. And God bless you, what you're going through. Okay.
    We're here today, and again, we've got video on this, not just
    for the people here, but hundreds of thousands of veterans will
    watch this. So, I've got a couple dozen questions.
        Make it short and sweet, but give these veterans something
    that you know that can help them. Give them advice. Give them
    an understanding of there's people here to help. And you, as
    Brian just said, what he's been through, the tough times. So,
    everybody will have questions, but if you've got something that
    you want to add to somebody, just break in. This is a
    conversation.
        Steve, thanks for coming. Thanks for the update on Compass
    Pathways. I hear a lot of misinformation about psychedelic-
    assisted therapies. I think we all do. Can you walk us through
    and from start to finish on how these therapies work?
        Dr. Levine. Thank you, Senator. I think the first thing
    that may come to mind for many people would be the baggage of
    psychedelics from 1960s. Counterculture. What they----
        Senator Tuberville. Back during my day.
        [Laughter.]
        Dr. Levine. Yours are the 1980s and 1990s, right?
        Senator Tuberville. Yes, yes, 2000s.
        Dr. Levine. What they may be less informed about is the
    therapeutic potential of psychedelics. And they may not be
    aware that there are many trials undergoing late-stage trials
    that are moving rapidly toward FDA approval that may create new
    options on a range of conditions that include PTSD, depression,
    treatment-resistant depression, which is a difficult to treat
    depression.
        And what these treatments tend to look like is as described
    a bit by Dr. Wiechers earlier; these happen in supervised
    medical settings. This isn't like an SSRI, a traditional
    antidepressant where somebody picks up a prescription at a
    pharmacy and takes this every day at home and has side effects
    typically on a daily basis because of it.
        This is typically one or maybe a few administrations over a
    longer period of time with the support of a healthcare
    professional in a supervised setting, having some preparation
    ahead of time for it, having follow-up afterwards.
        But what we are seeing so far in conditions like PTSD and
    depression is that people can have almost immediate reduction
    in their symptoms, almost immediate relief and a return to life
    that can have very lasting effects even after just a single
    administration.
        Senator Tuberville. Thank you. So, to be clear, all this
    should be done in a VA, right? Don't be doing it on your own?
        Dr. Levine. Correct. And that is a misunderstanding. People
    may think that because they've done this on their own at some
    point, that they may know what the effect that this treatment
    could have on them. But the setting is really important, and
    being adequately prepared and the safety setting around you
    being there is critically important. And that is how these
    medicines are being studied. That's how they will likely be
    approved, and that's where we see the best outcomes.
        Senator Tuberville. So, today's title of this hearing is
    separating fact from fiction. What's the most misunderstood
    thing about psychedelics? The most misunderstood.
        Dr. Levine. Yes, I think it's largely where I started here
    about there's a lot of excitement about psychedelics right now.
    There's the baggage that's attached historically, but I think
    people don't recognize that the way that they're being studied
    right now in rigorously designed clinical trials is very
    different than someone just taking a psychedelic on their own.
        This is for somebody who's been shown in research to be
    able to benefit from this treatment, supported by somebody who
    knows about their condition, who can safely support them. And
    people may not realize how close we are getting actually to
    potentially having FDA approvals here. As I mentioned in my
    opening remarks, we are currently running our Phase 3 studies.
    We've already had the results from the first of those Phase 3
    studies, so things are progressing rapidly. And you said it
    best earlier, Senator, that we need to move with a sense of
    urgency here.
        Senator Tuberville. This is for the whole panel, and we'll
    start with Adam here. What are the one or two actions that we
    in Congress could take to address the mental health crisis of
    veterans or all Americans?
        Mr. Marr. Well, sir, I think it goes back to what I was
    originally saying, and I think that's partnership. With
    Congress, partnership with the VA, partnership with the Federal
    Government. Because my whole story is about finding these
    things out of desperation and being able to still be here to
    talk about it. Then a nonprofit was started to be able to help
    get more people access, and then after that happened, then
    we're coming together to be able to share those stories. That's
    leading to the recommendations and the policy roadmap that we
    have and submitted in our public record.
        So, I think Pathways is like right to try, which is
    currently available. And then I also believe that being able to
    partner with these veteran organizations, the VSOs from 2015
    on, the new Global War on Terrorism VSOs, that have these
    programs, that are conducting the research, that are submitting
    it, that are writing the policy reforms and legislation. And
    sir, we've been developing infrastructure outside of the VA for
    the last 10 years.
        So, it's a change management problem and being able to come
    together maybe in a joint task force where those veteran
    experts that have been doing this, were consulted on that, and
    we can help move this along a lot quicker.
        Senator Tuberville. Dr. Wright, anything? Any advice to
    Congress?
        Dr. Wright. I'll try to phrase it nicely, but I think the
    VA needs to take immediate action. We have suicides occurring
    every day, 6,500 a year. To delay action on these potential
    therapies because they need more study or we don't want to set
    up a research program, is ineffective in treating the suffering
    veterans. We need immediate action, not platitudes, words, or
    more studies on some of these conditions. Some treatments are
    ready to go, like hyperbaric oxygen, probably some of the other
    treatments, they're ready to go. Let's demand that the VA take
    immediate action.
        [Applause.]
        Senator Tuberville. Thank you. And before we go to Brian on
    this, Dr. Wright, I'd like to ask you this; can you explain the
    difference between treatment-resistant depression, TRD, and
    PTSD, and are they often coexisting?
        Dr. Wright. They are often coexisting. I'm not a
    psychiatrist, but I do know that one component of PTSD and TBI
    is depression. And these are caused in part by inflammation in
    the brain, and the structural damage that is caused by the
    concussive events. And there are alterations in brain structure
    in PTSD also, so I understand, so that they're all mixed
    together. And it's no wonder that certain single therapies
    don't work for everybody and people fail and they try another
    therapy. We need all the tools in the toolbox, not one or two.
    And it isn't always drug-related, but maybe there are some new
    drugs which are very helpful, but sometimes we need other
    therapies in addition to drugs.
        Senator Tuberville. Brian, you got anything to add to that?
        Mr. Schiefer. Yes, I will try to be nice as well. I guess
    the main thing would be there are individuals and groups in the
    community already doing this. I think the fastest way to get it
    to veterans would be to partner with those--waiting for the
    bureaucratic red tape of the VA to finally get on board with
    this is going to take months, probably years. And these
    treatments are available currently to the public and the
    civilians, so why can't we get access to the veterans for that?
        [Applause.]
        Senator Tuberville. Good, good.
        Dr. Levine. And Senator, if I can weigh in as well.
        Senator Tuberville. Yes, go ahead.
        Dr. Levine. Yes, and if you're asking about the
    similarities between TRD and PTSD. First, just for the veterans
    who are watching who may not be familiar with some of these
    terms and some of the audience, TRD stands for treatment-
    resistant depression. And what that means is that somebody has
    a major depressive disorder, and they've been failed by at
    least two treatments.
        So, this is a difficult to treat depression and TRD
    treatment-resistant depression and PTSD are like thunder and
    lightning. They're two different things, but they often travel
    together. So, the majority of veterans who have treatment-
    resistant depression, also with PTSD, they do have a lot of
    overlap in terms of the difficulties that arise with having
    these conditions, like difficulties with mood, or sleep, or
    concentration, irritability, risk of suicide. And in fact,
    veterans who have both TRD and PTSD are twice as likely to
    attempt suicide.
        Senator Tuberville. If one of you can answer this, because
    we got quite a few questions go through here, what's the
    biggest misconception about therapies that you'd like to
    correct today? Anybody?
        Mr. Marr. I would just say with respect to psychedelics,
    there's a misconception out there sometimes that these are the
    cure all, the panacea, that it's kind of one and done. And I
    just don't think that that that's a good way to approach these
    really multiple, structured settings. What I mean by that is
    I've experienced a powerful psychedelic called ibogaine, only
    twice, 7 years apart. One time was at the worst time in my
    life, another time I had done a lot of work, a lot of
    processing of that information, peer support, and community to
    be able to integrate that in. So, I needed all that time for
    the next one to be able to have the effects that it did.
        So, I think looking at these as one and done isn't a great
    way to do it. But these therapies are producing better and
    lasting outcomes because they're able to go to the root cause
    as opposed to masking the symptom.
        Senator Tuberville. Dr. Wright, you want to add to that?
        Dr. Wright. Yes. I have some comments about what the VA
    thinks about hyperbaric oxygen. Their thinking is flawed. The
    studies that the DoD and the VA did were all flawed. They used
    hyperbaric air as a sham treatment. Well, we've known since the
    '70s that air delivered under pressure is a treatment for
    lingering neurologic conditions. And guess what? Everybody got
    better in these studies. In fact, the Air Force later retracted
    its opinion on its paper, saying, the sham treatment got
    better, and hyperbaric treatment got better, it must not be
    effective. And they're both effective and they retracted what
    they said.
        So, that study has been retracted by the Air Force. The
    only outlying study was done by the Navy, and they reported no
    objective findings in 24 Marines, who if they said they got
    better, this is all subjective. They would lose their VA
    benefits and nobody does a hyperbaric study with just
    subjective TBI findings. That's an inappropriate study.
        And then, they also did some eye movement reports. So,
    these are elite athletes and they are elite Marines with
    marksmanship skills that are beyond the public's ability. And
    so, their eye movement scores are going to be in the 95th, 96th
    percentile to start with. So, to ask them to improve that with
    hyperbarics is very difficult. So, they're outlying; they
    picked the wrong measurement. So, those studies are flawed.
        Since then, we've had 13 other studies which show that it
    works. Everybody gets it to work except the VA and DoD. It
    doesn't matter what country; Israel, China, and the United
    States, and thousands of people have improved. There have been
    no seizures, by the way. It's a safe and effective treatment.
        Senator Tuberville. Thank you. Brian, let's talk about
    regulatory real quick. As founder of the SCI-DI, you're working
    daily to get veterans access to therapies like HBOT or scuba,
    and alongside other alternative treatments. What's some of the
    biggest regulatory hurdles that you face helping get veterans
    across the finish line?
        Mr. Schiefer. A lot of it, from what I've found over the
    years is education. People only know what they know, and I've
    spent probably 90 percent of my time just educating folks on
    what these therapies are, what they can do. And really from
    that, it comes into the community involvement. We've got a
    great community partner down in Destin for diving. Dr. Zant has
    been a great, great help for HBOT and treating so many veterans
    over the years, pretty much off his own dime.
        I think the big thing is, once again, regulatory hurdles in
    dealing with the VA, and how do we get through the red tape and
    get folks these treatments. I've had folks that have gone down
    to Mexico to receive the ibogaine treatment, and were told from
    their VA provider they were going to lose their benefits if
    they went. And these were folks that were taking two shoe boxes
    full of medications, came back and they're taking nothing.
        Senator Tuberville. What advice do you give them on that?
        Mr. Schiefer. What's that?
        Senator Tuberville. When they go South of the border?
        Mr. Schiefer. I think everybody has a need. And if the
    needs aren't being addressed here in the states, I would
    encourage them to go find what can work best for them.
    Everybody's physiological makeup is completely different, and
    everybody's going to react differently to these therapies based
    on their environment, past histories, traumas, things like
    that. So, I think the big thing right now is just access.
    Giving access to veterans to allow them to go where they want
    to go, where they don't have to fall into the VA catchment is
    going to be huge. Having community resources available to them
    locally.
        And I think that's going to be the biggest hurdle right
    now, is just education. Like Adam said, is not only are
    psychedelics great, but there's a misconception that it's the
    one and done. No. That's just the beginning of the work, and
    it's the integration afterwards and that longitudinal study
    that we really need to keep a track on to really make sure that
    we're helping these guys and girls.
        Mr. Marr. Sir, I'd just like to add on to that with what we
    recommend when folks go down to Mexico to experience these,
    because last November I had the opportunity to advise setting
    up a veterans' program in Mexico at one of these clinics. The
    program's called Beond Service. It's a 9-week best-in-class
    program. This is what we've learned along the way because of
    what we've had to tell people to go down and prepare.
        So, it's 4 weeks of preparation calls in a group of five
    because we train together in groups. So, it's very familiar to
    us. When we do that, you're down there for 8 days onsite at
    this clinic. You're there with medical support and intake, 9 ER
    doctors, emergency care nurses, therapeutic staff, and then a
    culinary that's making sure that you're eating the right things
    to put into your body.
        And then there's an environment where you can have this
    experience where you're prepared, where you're there with your
    peers. And then on the other side of that, we don't rush you
    back into your environment at home. So, you have time to be
    able to start to come back into your body from the effects of
    this medicine.
        And then on the other side, we don't abandon you. It's 4
    weeks of integration, coaching calls, and then when you say
    peer support and community, that's ongoing for a lifetime. But
    that's familiar to somebody that was in the military, to
    somebody that was on a sports team. And it's not familiar if
    you've just been on your own your whole life. And so, being
    able to design programs like this. But we got to design them
    outside of the United States, sir, unacceptable.
        But we've done 10 cohorts in this year alone, 50 veterans,
    female cohorts, because female veterans experience military
    sexual trauma, and we've learned to not put males in their
    cohorts so that they can be able to heal from their wounds. We
    also have two cohorts of veteran spouses because it's not just
    about the veteran, it's about the whole family, and it's about
    being able to support them on the other side.
        [Applause.]
        Senator Tuberville. Good. Steve, what can the VA do to
    increase the number of available alternative therapy
    treatments? What can we do?
        Dr. Levine. You know, I think the VA it's less about how
    the VA makes new treatments available than I think making them
    available as quickly as possible once they are. Right? The FDA
    primarily has the responsibility in protecting the public good
    to evaluate the risk-benefit profile of potential new
    treatments. Once that has been proven, then I think there can
    be no delay in the VA rolling these treatments out and actually
    getting them to veterans.
        It's why I applaud the work that the integrated project
    team is doing at the VA now to start preparations. I think that
    one action that could be taken is increased support for that
    work so that there are the resources available and necessary to
    make sure that personnel are trained, that the space is set up,
    that that the healthcare providers are trained in these
    protocols and they're ready.
        Because the reality is, that if right now, we know that
    veterans are not well served for these conditions. If we look
    at what's in development to the pipeline is what it's called,
    other than psychedelics and perhaps some of the other
    treatments we're talking about today, there isn't much.
        But there are many, many psychedelics in development right
    now. And even if Compass Pathways isn't successful, I hope we
    are, but we may not be, the likelihood is that in the near
    future, there will be one or more new psychedelic treatments
    that are FDA-approved. And if the VA waits until an approval to
    start to get ready, they'll be behind the eight ball and
    there'll be undue delays for veterans.
        [Applause.]
        Senator Tuberville. Thank you. Dr. Wright, you've talked
    about challenges with HBOT. Why's the VA so stubborn about
    this? Is it cost?
        Dr. Wright. I think that might be part of it. Part of it
    could be ignorance. We first met with the VA and their chief
    scientists in 2011, and they brought an FDA staffer, and we
    were appalled by their ignorance. The FDA staffer said, oh,
    hyperbarics are dangerous. There could be a fire. You know,
    hyperbaric therapy's been around since 1936, so I don't know
    why they are ignorant.
        Same problem with the DoD of which I was part, and they
    were just totally against it. And they wanted incontrovertible
    proof. Well, now we have that proof. They wanted level 1 proof.
    We have that proof. We have 70,000 people who have been treated
    successfully, no seizures, no serious side effects, and
    everybody that we know of got better, and very few if--and the
    two suicides, that's all we know about. That's remarkable.
        I think that's enough evidence to proceed. I don't know why
    they're so resistant. Maybe they're afraid they don't have
    enough evidence. They do. I don't know. It's hard for me to
    figure out. I don't know the answer, Senator.
        Senator Tuberville. Thank you. Maybe we can figure it out.
    Brian, I'll start with you. Adam, I want you to answer this one
    too. You two veterans, if you've started your own organizations
    to get veterans alternative treatments, you have a unique
    perspective and you face your own unique set of challenges.
    What challenges have your organization faced in working with
    the VA or community care providers in getting veterans access
    to all these therapies? Brian?
        Mr. Schiefer. We haven't worked with the VA for that
    reason.
        Senator Tuberville. At all?
        Mr. Schiefer. It's just been difficult, and just being a
    new organization, we haven't really found the need to work with
    the VA, per se. Dealing with veterans is a very unique
    population of individuals; very driven, very motivated to get
    things done.
        So, what we found is people are going to look for their own
    alternative therapies outside of the VA, even if the VA is
    telling them no. And so, how can I, as an individual who's gone
    through my own experiences, tell somebody they don't have a
    right to treatment or don't have a right to try these different
    things?
        And so, currently, no, we're not working with the VA for
    that reason. We're just using veteran outreach, different VSOs,
    relationships that we have, and things like that, and kind of
    bypassing the VA system.
        Senator Tuberville. Adam?
        Mr. Marr. It's a similar response, although there's been a
    little bit more time working in the space. So, initially, what
    were the pathways to be able to do it, especially if you're
    starting a new VSO, I would compare it to like being an
    established corporation. If you want to bring a new innovation
    in, you go out and you acquire the startup or you have an R&D.
        I don't know where or how that exists within the VA, but
    now as the director of operations for the Veteran Mental Health
    Leadership Coalition, I can say at the higher levels, like
    we're having these type of conversations, but it still comes
    down to systems reform, systems change, and being able to, like
    you so eloquently said, sir, what is the balance between
    innovation and safety? Right now?
        I don't think there's a good balance. I think it's overly
    focused on safety for all the reasons that we know. Medically,
    there has to be greater emphasis on accelerated innovation.
        Senator Tuberville. Steve, you want to add anything to
    that?
        Dr. Levine. Nothing to add.
        Senator Tuberville. Okay. Alright, Dr. Wright, for those
    listening in the room, we might have jumped over this a little
    bit, but if they're not familiar with HBOT, if veterans
    watching this today are not familiar with that, can you walk
    kind of, shortly, through a process of what they go through,
    how they would do it? You know, the procedure, and how many
    therapies they might need to show some kind of progress?
        Dr. Wright. Sure. So, hyperbaric oxygen is provided in a
    hard-sided chamber run by trained personnel directed by a
    physician. So, if you see one of these blow-up spa-type
    chambers, don't go there. And they'll usually, with those blow-
    up things, put an oxygen concentrator in it. That's not safe,
    and it's violating the FDA certification of those chambers.
    They're only good for air, and they don't go deep enough to
    provide the type of treatment we want.
        So, you have to find a certified hyperbaric facility that
    would treat you, and many of these are outside of hospitals.
    Most hospital chambers won't do it because they won't get paid
    right now by anybody. But you can find certain private ones.
    The TreatNOW Coalition, if you just get on the web, you can
    find them and they can direct you to one that might treat you.
        Several (13) states have approved treatment with hyperbaric
    therapy, and especially North Carolina and Kentucky have
    allotted money for the treatment of their veterans. That should
    say something to the FDA when the states are stepping forward
    and providing the treatment the VA is not providing. And if
    you're in Alabama, unfortunately we don't have that yet, but
    we're hoping to do that in the future, but you got to find a
    certified chamber. You can always call me or another member of
    this group that works with veterans and we can direct you to
    one in your area.
        And many people like Dr. Zant, we started the treatment. We
    treated the military people for free. We didn't tell the
    surgeon general, we just did it. It worked. And he's still
    treating some people for free. His accountant told him, you
    can't do this forever. But God bless him. And there are many
    people who do this on their own nickel. So, it's a little
    difficult trying to hook up with a chamber, but it can be done.
        The other thing I should add is that many of our veterans
    with PTSD actually also have TBI, but nobody asks them about
    that. And so, they go together. So, sometimes they'll tell you,
    ``I was okay, and then I got concussed and then things started
    to go downhill.'' So, getting a proper diagnosis would be
    helpful. So, that's why the physician comes in.
        Senator Tuberville. I think that's why my wife bought me
    one [laughter]--I ran into a lot of trees at one time with a
    football helmet [laughter], but a lot bigger than me. Very
    informative.
        But we're going to take 2 minutes each, 2 minutes and tell
    what--just look in the camera and tell the veteran what do they
    need to do? I mean, they're in trouble. Take two short minutes
    each, give them your spiel, tell them what you believe in, and
    we'll end this up. Steve, let's start with you.
        Dr. Levine. Thank you, Senator. You know, because as you
    say speaking directly to the veterans who are watching this
    right now, I think the most important thing for them to hear is
    that you can hear from this panel, from this room, from the
    attention being paid here, that there's a recognition that
    there are tremendous unmet needs in the treatment of PTSD and
    the treatment of depression that we are currently not meeting
    the moment right now in caring for our veterans.
        However, that there are many promising treatments in
    development, and I hope that that creates some hope because the
    most dangerous thing is the loss of hope. And so, I think that
    veterans can look forward to a time, hopefully in the near
    future, where they don't have to leave the country they served
    in order to receive these treatments. That they continue to
    move through the FDA pathway, through regulatory pathways.
        And we are firmly committed to partnering with the VA, to
    working with our government, to everyone who is united in this
    mission, to ensure that we do create new options for our
    veterans, whether that's psilocybin, and other psychedelic
    treatments, or other innovation that is so sorely needed.
        Senator Tuberville. Thank you. Adam?
        Mr. Marr. Sir, I would say that these are not alternative
    therapies. These are emerging therapies. These are breakthrough
    therapies. These are the innovations of our time. So, if you're
    a veteran and you're considering one of these, and you're
    worried about the stigma or things that you've heard in the
    past, look to your left and right to a brother. Come to the
    VMHLC, because we're out front advocating for these things.
        But we're advocating because we help expand access, because
    we help document and make sure that we're producing the
    research outcomes that we're helping to draft the policy based
    off what we've learned through going through the hardships year
    after year. We're not starting from scratch. We have 10 years
    of infrastructure to be able to ensure that training the
    processes, the technologies, and the inter-agency coordination
    all the way up to the highest councils in the land to make
    these things happen.
        So, it is happening. And if you want to come there, then
    we're not going to be able to get you one of those treatments,
    but one of our 50 partner organizations are. And, Senator, that
    list is continuing to grow, and grow, and grow. And so, that's
    what I would recommend.
        And lastly, I would just thank you for this opportunity,
    for elevating this beyond alternative into the conventional.
    And we are ready to partner on this to be able to move forward
    together because that's the way it needs to be done, in unity,
    in ways that we haven't been able to before. Thank you.
        [Applause.]
        Senator Tuberville. Thank you. Dr. Wright?
        Dr. Wright. I would say if you're a veteran and you're not
    at the VA getting treated for some reason, maybe if you can
    find it in your heart to go back there and try, do that. If you
    don't get satisfaction, write your Senator and your Congressman
    and tell them about it.
        And now, if you want hyperbaric oxygen, my best suggestion
    is contact the TreatNOW Coalition--just like two words struck
    together--they're on the internet, or one of these other
    agencies, and they'll put you in contact with a facility that
    offers treatment to veterans.
        Senator Tuberville. Thank you, Dr. Wright. Brian?
        Mr. Schiefer. I would say you have to be your own best
    advocate. Nobody knows you, and your body, and your physical
    condition, mental state better than you. So, understanding
    that, there are organizations out there that can help and are
    willing to help, but you have to do your own research and kind
    of sort that out, and kind of sort your way through it.
        Just because the VA tells you no, doesn't mean it's a hard
    no. There are a lot of alternative therapies that are coming
    online right now. Everybody has to find what works best for
    them. What works for me may not work for Dr. Wright and vice
    versa.
        So, be willing to try new things with your own risk factor.
    And there is hope out there. And I think these alternative
    therapies are going to provide hope for thousands of veterans
    and the civilian population.
        Senator Tuberville. Thank you. So, I don't think people
    really understand. Hopefully, they got this from today, that
    this is a national emergency, this is bad. You know, we got a
    lot of problems in this country. This is really bad, and it's
    getting worse. It's not going to get any better. We're having
    more and more veterans that we're adding into the VA.
        I don't think people realize that the VA is the largest
    healthcare system in the world, but sometimes we think that the
    VA is for the employees. It is not. It is for the veterans. We
    need to help our veterans. And again, we're in tough times, but
    tough times are handled by tough people. And so, hopefully,
    today's hearing opened some eyes.
        Again, a lot of people are going to watch this. And we got
    have two great panels, the one at the beginning and the one
    here. But we're just anxious to see the VA improve, and
    hopefully, that these alternative therapies will help. Just
    talking about them, visiting about them, understand a little
    bit more about them. The Committee to consider legislation that
    authorized the use of alternative therapies like HBOT. I hope
    they listen. I really do.
        New treatments are being studied every day, not just to
    help veterans, but everybody in this country. But we need to
    stop the red tape. The red tape is what gets in the way of the
    greatest country ever. And for some reason, we continue to add
    red tape instead of getting things out of the way so we can
    help people.
        Our veterans, they put their life on the line and they
    deserve a fighting chance. We need to give that to them. Money
    is not the problem, folks. We spent a lot of money at the VA, a
    lot of money. These guys can tell you that. But a lot of money
    is not spent the right way, and we need to put our foot down.
        So, I'd like to include the following items for the record;
    a statement from HBOT4Heroes. I'd like to put that in for the
    record, and three documents from Clinicom. And those will be
    added to the record. An article by Dr. William Jamie Tyler. I
    think it would be very, very important. So, that will be
    included for the record.

        [The items referred to begin on page 83 of the Appendix.]

        Senator Tuberville. So, I'd like to thank both groups today
    for being here, all of you, for being here, showing your
    interest. Again, folks, our veterans are in trouble. Anything
    can happen at any time, and hopefully, today, we can start a
    process for some of these therapies that we talked about.
        We educated some people. Not enough people know what's
    going on. They're living. Everybody's busy. Their lives are
    very busy. We're all busy every day, but there's nothing more
    important than saving people's lives that have saved the
    greatest country on the face of the earth; United States of
    America.
        So, God bless y'all, what you're doing. God bless our first
    panel. God bless those of you that came here today. God bless
    our military people today that are in active duty and our
    veterans, and God bless our country. This hearing is adjourned.
        [Applause.]
        [Whereupon, at 12:48 p.m., the hearing was adjourned.]

                                A P P E N D I X

                              Prepared Statements

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                           Submissions for the Record

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