[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
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FIELD HEARING
BEFORE THE
COMMITTEE ON VETERANS' AFFAIRS
UNITED STATES SENATE
ONE HUNDRED NINETEENTH CONGRESS
FIRST SESSION
__________
AUGUST 22, 2025
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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
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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
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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
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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
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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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