[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]


                   EMERGING THERAPIES: BREAKTHROUGHS
                     IN THE BATTLE AGAINST SUICIDE?

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

                                 HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                     COMMITTEE ON VETERANS' AFFAIRS

                     U.S. HOUSE OF REPRESENTATIVES

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             FIRST SESSION

                               __________

                       TUESDAY, NOVEMBER 14, 2023

                               __________

                           Serial No. 118-39

                               __________

       Printed for the use of the Committee on Veterans' Affairs
       
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]       


                    Available via http://govinfo.gov
                    
                                __________

                   U.S. GOVERNMENT PUBLISHING OFFICE                    
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-----------------------------------------------------------------------------------                         
                    
                     COMMITTEE ON VETERANS' AFFAIRS

                     MIKE BOST, Illinois, Chairman

AUMUA AMATA COLEMAN RADEWAGEN,       MARK TAKANO, California, Ranking 
    American Samoa, Vice-Chairwoman      Member
JACK BERGMAN, Michigan               JULIA BROWNLEY, California
NANCY MACE, South Carolina           MIKE LEVIN, California
MATTHEW M. ROSENDALE, SR., Montana   CHRIS PAPPAS, New Hampshire
MARIANNETTE MILLER-MEEKS, Iowa       FRANK J. MRVAN, Indiana
GREGORY F. MURPHY, North Carolina    SHEILA CHERFILUS-MCCORMICK, 
C. SCOTT FRANKLIN, Florida               Florida
DERRICK VAN ORDEN, Wisconsin         CHRISTOPHER R. DELUZIO, 
MORGAN LUTTRELL, Texas                   Pennsylvania
JUAN CISCOMANI, Arizona              MORGAN MCGARVEY, Kentucky
ELIJAH CRANE, Arizona                DELIA C. RAMIREZ, Illinois
KEITH SELF, Texas                    GREG LANDSMAN, Ohio
JENNIFER A. KIGGANS, Virginia        NIKKI BUDZINSKI, Illinois

                       Jon Clark, Staff Director
                  Matt Reel, Democratic Staff Director

                         SUBCOMMITTEE ON HEALTH

               MARIANNETTE MILLER-MEEKS, Iowa, Chairwoman

AUMUA AMATA COLEMAN RADEWAGEN,       JULIA BROWNLEY, California, 
    American Samoa                       Ranking Member
JACK BERGMAN, Michigan               MIKE LEVIN, California
GREGORY F. MURPHY, North Carolina    CHRISTOPHER R. DELUZIO, 
DERRICK VAN ORDEN, Wisconsin             Pennsylvania
MORGAN LUTTRELL, Texas               GREG LANDSMAN, Ohio
JENNIFER A. KIGGANS, Virginia        NIKKI BUDZINSKI, Illinois

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Veterans' Affairs are also 
published in electronic form. The printed hearing record remains the 
official version. Because electronic submissions are used to prepare 
both printed and electronic versions of the hearing record, the process 
of converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.
                         C  O  N  T  E  N  T  S

                              ----------                              

                       TUESDAY, NOVEMBER 14, 2023

                                                                   Page

                           OPENING STATEMENTS

The Honorable Mariannette Miller-Meeks, Chairwoman...............     1
The Honorable Julia Brownley, Ranking Member.....................     2

                               WITNESSES
                                Panel 1

Dr. Carolyn Clancy, M.D., Assistant Under Secretary for Health, 
  Office of Discovery, Education and Affiliate Networks, Veterans 
  Health Administration, Department of Veterans Affairs..........     3

        Accompanied by:

    Dr. Ilse Wiechers, M.D., Deputy Executive Director, Office of 
        Mental Health and Suicide Prevention, Veterans Health 
        Administration, Department of Veterans Affairs

    Dr. Rachel Yehuda, Ph.D., Patient Care Center Director, Bronx 
        Veterans Affairs Medical Center, Veterans Health 
        Administration, Department of Veterans Affairs

                                Panel 2

Sergeant Jonathan Lubecky, USA (Ret.), SGT (Ret.), U.S. Army, 
  Clinical Trial Participant.....................................    19

Dr. Frederick Barrett, Ph.D., Associate Professor of Psychiatry 
  and Behavior Sciences, Johns Hopkins Center for Psychedelic and 
  Consciousness Research.........................................    21

Mr. Mike Mullette, Chief Operating Officer, Multidisciplinary 
  Association for Psychedelic Studies-Public Benefit Corporation 
  (MAPS PBC).....................................................    23

Dr. Rajeev Ramchand, Ph.D., Co-Director, RAND Epstein Family 
  Veterans Policy Research Institute.............................    24

Mr. Brett Waters, Co-Founder, Executive Director, Reason for 
  Hope, Co-Founder, Veteran Mental Health Leadership Coalition...    25

Ms. Juliana Mercer, USMC (Ret.), Director, Veteran Advocacy and 
  Public Policy, Healing Breakthrough............................    26

                                APPENDIX
                    Prepared Statements Of Witnesses

Dr. Carolyn Clancy, M.D. Prepared Statement......................    37
Sergeant Jonathan Lubecky, USA (Ret.) Prepared Statement.........    40
Dr. Frederick Barrett, Ph.D. Prepared Statement..................    41
Mr. Mike Mullette Prepared Statement.............................    44
Dr. Rajeev Ramchand, Ph.D. Prepared Statement....................    47
Mr. Brett Waters Prepared Statement..............................    59
Ms. Juliana Mercer, USMC (Ret.) Prepared Statement...............    92

                          APPENDIX--continued
                        Statement For The Record

American Psychedelic Practitioners Association (APPA)............   135

 
                   EMERGING THERAPIES: BREAKTHROUGHS
                     IN THE BATTLE AGAINST SUICIDE?

                              ----------                              


                       TUESDAY, NOVEMBER 14, 2023

             U.S. House of Representatives,
                            Subcommittee on Health,
                            Committee on Veterans' Affairs,
                                                   Washington, D.C.
    The subcommittee met, pursuant to notice, at 2 p.m., in 
room 360, Cannon House Office Building, Hon. Mariannette 
Miller-Meek [chairwoman of the subcommittee] presiding.
    Present: Representatives Miller-Meek, Bergman, Murphy, 
Luttrell, Kiggans, Brownley, Deluzio, Budzinski, and Landsman.
    Also present: Representative Takano.

   OPENING STATEMENT OF MARIANNETTE MILLER-MEEKS, CHAIRWOMAN

    Ms. Miller-Meeks. Thank you. The Subcommittee on Health 
will now come to order. As a 24-year Army veteran, I have seen 
firsthand the struggles that many servicemembers and veterans 
face in light of their service, which is why I am excited about 
this first House Committee on Veterans' Affairs hearing on the 
potential for psychedelic assisted therapy treatments in the 
emerging battle against suicide, or, as we like to say, 
emerging therapies or breakthrough therapies. I would also like 
to say that as a physician who practices traditional medicine, 
I never thought I would enter Congress to be then advocating 
for emerging breakthrough therapy. I think the science is 
leading the way.
    The VA dedicates a considerable amount of its budget and 
resources in pursuit of evidence-based treatments for veterans 
who suffer from post-traumatic stress disorder and other 
cognitive disorders. For many veterans, this treatment is 
lifesaving, but more work needs to be done. It is a sad reality 
that close to 17 veterans per day will lose their lives to 
suicide. One life lost to suicide is one too many, and our 
fight must continue.
    Psychedelic assisted therapy is a groundbreaking clinical 
procedure that has the potential to transform the way we look 
at mental healthcare. A licensed clinician carefully examines a 
veteran prior to administering a dose of a compound such as 3-
4,Methylenedioxymethamphetamine (MDMA) or psilocybin. A veteran 
must go through two or three sessions, during which intense 
psychotherapy is overseen by a licensed medical professional 
assisting the veteran throughout the experience. These sessions 
last about 8 hours, the full duration of the drug's effects. 
Based on the most recent clinical trials, patients experience 
positive therapeutic responses resulting in reduction of their 
symptoms, if not remission, altogether.
    The fight against suicide and substance abuse goes hand in 
hand, as substance use disorder can lead to higher suicide 
rates among veterans. Therefore, we cannot be afraid to explore 
new treatment methods, especially the ones that we will hear 
about today, that have proven to transform veterans' lives and 
are done in a clinical and a scientific manner. Still, we must 
argue and urge caution when speaking on this topic. We are not 
advocating for the legalization or the casual use of 
psychedelics. What we are discussing is the clinically 
administered dosage of these substances in combination with 
targeted therapy sessions in a clinical setting.
    I look forward to hearing more about the process and 
progress that the VA and our private healthcare partners are 
making in advancing what could be a new way of treating the 
debilitating mental health conditions that affect our veteran 
community. I would like to hear what next steps are 
anticipated, as well as what challenges, including bureaucratic 
barriers, safety concerns, workforce, and others that should be 
addressed in moving forward. I am also looking forward to 
hearing from our second panel on the positive personal impact 
this therapy option has had on their lives and in successfully 
treating their Post-Traumatic Stress Disorder (PTSD).
    I want to reiterate, we are not advocating for the 
legalization or casual use of psychedelics, but rather the 
advancement of science of their medicinal properties in a 
clinical setting with assisted therapy. Thank you all for being 
here, and I look forward to our discussion and hearing the 
multiple perspectives based on the incredible expertise present 
today on both panels to discuss this important topic. With 
that, I yield to Ranking Member Brownley for her opening 
statement.

      OPENING STATEMENT OF JULIA BROWNLEY, RANKING MEMBER

    Ms. Brownley. Thank you, Madam Chair. I look forward to 
hearing more today about the potential therapeutic benefits of 
psychedelic assisted therapies for veterans. The landscape of 
psychedelics has evolved significantly in recent years, and we 
are at the brink of a new era in which these substances, once 
stigmatized and misunderstood, are being examined for their 
potential to address mental health and addiction challenges, 
and we need to make sure that the Department of Veteran Affairs 
is keeping up.
    Veterans are continuing to die by suicide at rates higher 
than the general population. We know that pharmaceuticals and 
certain types of therapy are not enough for many veterans. Many 
post-traumatic stress patients do not respond to traditional 
medication-only treatments because traditional medications are 
only treating symptoms such as insomnia or anxiety. As our RAND 
witness points out in his testimony, up to 30 percent of 
patients drop out of evidence-based psychotherapy treatments, 
and more than half who do complete treatments still retain 
diagnoses of post-traumatic stress.
    We need to look at all available treatment options, and one 
of them is the topic before us today. While the research in 
psychedelics has been limited, it has shown promise. However, 
as the chairwoman said, it is our duty as Members of Congress 
to ensure that treatments offered to veterans are both 
effective and safe. We must weigh the risks and rewards 
carefully, recognizing the need for safeguards while also 
fostering innovation at VA and other Federal agencies and 
expanding treatment options. This is also an exciting topic 
because at a time when much of Congress is polarized and 
partisan, this is one area where many of us on this dais agree 
that more should be done to research psychedelic assisted 
therapy.
    I look forward to the discussion today about what VA is 
already doing and whether Congress needs to take action to 
change existing statues, whether more can be done to bolster 
research, and whether there is opportunity for greater 
involvement by VA in this research. Some in this room today may 
be skeptical about the wider use of psychedelics. I would like 
us to remain committed to the principles of rigorous research, 
thoughtful policy, and patient centered care.
    Veterans have given so much of themselves to our country. 
Our ultimate goal should be to promote the health and well-
being of veterans and make sure that we are providing them with 
the very best care possible. They deserve nothing less. With 
that, Madam Chair, I yield back.
    Ms. Miller-Meeks. Thank you, ranking member. Thank you, 
Ranking Member Brownley. On our first panel, we have Dr. 
Carolyn Clancy, Assistant Under Secretary for Health at the 
Office of Discovery, Education and Affiliate Networks, 
Department of Veterans Affairs, Dr. Ilse Wiechers, Deputy 
Executive Director at the Office of Mental Health and Suicide 
Prevention, Department of Veteran Affairs, Dr. Rachel Yehuda, 
Patient Care Director at the Bronx VA Medical Center, 
Department of Veterans Affairs. Dr. Clancy, you are recognized 
for 5 minutes to deliver your opening statement.

                  STATEMENT OF CAROLYN CLANCY

    Dr. Clancy. Good afternoon, Chairwoman Miller-Meeks, 
Ranking Member Brownley, and distinguished members of the 
subcommittee. Thank you for the opportunity to discuss VA's 
ongoing clinical trials involving emerging therapies and 
specifically, psychedelic assisted therapy. Accompanying me 
today, as you noted, are Dr. Ilse Wiechers and Dr. Rachel 
Yehuda.
    The VA is committed to safely exploring all avenues that 
promote the health of our Nation's veterans. Veterans Health 
Administration (VHA) continues to effectively advance the 
health and well-being of veterans through the exploration of 
innovative, safe, and ethical emerging therapies. Every study 
in VA is conducted under stringent safety protocols. Our focus 
is not just on finding the best innovative treatments for our 
veterans, but on doing so safely. This is especially true for 
studies that test compounds such as MDMA and psilocybin as part 
of an intensive psychotherapy program to treat veterans with 
PTSD, depression, and other mental health conditions.
    We have also been monitoring psychedelic research outside 
of the VA and will continue to evaluate the scientific evidence 
those investigations uncover for possible use in our future 
studies. There is still much to learn about the potential 
benefits of psychedelic assisted therapy. VA researchers are 
conducting several studies on the use of psychedelic assisted 
therapy for the treatment of mental health conditions. To date, 
the studies underway have been funded by outside organizations 
or philanthropic foundations. VA ensures these treatments take 
place in a safe clinical environment and use pharmaceutical 
grade medications under carefully controlled conditions.
    Potential participants undergo comprehensive medical and 
psychiatric screenings to make sure it is safe for them to 
participate. Furthermore, dosing of psychedelic medications is 
performed only by trained staff who know how to monitor for 
adverse events.
    Last month, the VHA held a state-of-the-art conference on 
psychedelic treatments. This conference provided us a better 
understanding of the current state of scientific evidence, 
allowing us to create a strategic framework for future 
psychedelic treatment research. It also identified the 
necessary steps for potential system wide clinical 
implementation of treatments with Food and Drug Administration 
(FDA) approval.
    This conference also determined a need for clinical trials 
that enroll a unique and diverse population of veterans. 
Rigorous studies of VA patients are important because they 
often have mental and physical health challenges that can 
reduce the effectiveness of a treatment. VHA trials would build 
confidence that the results accurately represent an expected 
clinical response in veteran patients.
    Psychedelic treatments are far from the only emerging 
therapy the VA is researching for the battle against suicide. 
We are also leveraging technology to offer nonpharmaceutical 
approaches to help veterans address the day-to-day challenges 
related to anxiety, suicide prevention, and acute and chronic 
pain. For example, in March of this year, our researchers 
reported that transcranial magnetic stimulation is effective as 
a treatment for depression, even in veterans with traumatic 
brain injuries. We also have a study examining the use of a 
stellate ganglion block to reduce PTSD symptoms. This procedure 
could be a method that expands the range of evidence-based PTSD 
treatments available to veterans.
    VHA also developed a 60-site clinical demonstration pilot 
to address suicide as it relates to pain, deploying 300 virtual 
reality headsets to VA providers across the country. That pilot 
will also test the use of positive environments to distract 
from negative stressors and build both coping mechanisms and 
resilience. We are really excited about the potential of these 
treatments. We are combining these innovations with strong 
research to evaluate and assess health outcomes. Even as we 
encourage new and effective interventions, the VA will continue 
to fully implement current evidence-based interventions that 
move mental health treatments forward.
    We appreciate the committee's continued support in this 
shared mission, and my colleagues and I look forward to 
answering any questions you may have.

    [The Prepared Statement Of Carolyn Clancy Appears In The 
Appendix]

    Ms. Miller-Meeks. Thank you, Dr. Clancy. We will now 
proceed to questioning. As has been my directive in the past, I 
will put myself at the end of the questions. I now recognize 
Ranking Member Brownley for any questions she may have.
    Ms. Brownley. Thank you, Madam Chair. My first question is 
to you, Dr. Clancy, good to see you again. It has been a while. 
Is it already possible for the VA to fund research on 
psychedelic assisted therapies, or are there statutory or 
regulatory barriers that Congress would first have to address?
    Dr. Clancy. There are no statutory barriers. This is a 
highly regulated environment. As Dr. Yehuda, my colleague from 
the Bronx, could describe in great detail, this requires that 
investigators invest a considerable amount of time in getting 
approval from the FDA and the Drug Enforcement Administration 
(DEA), down to the precise doses that will be used in the 
treatment. We have not done anything to discourage this, but I 
think the timeframe of getting all these approvals has been a 
bit of a disincentive to some researchers. Do you want to add 
anything to that, Dr. Yehuda?
    Dr. Yehuda. Thank you. The VA research program works on a 
peer review basis, so nothing precludes a VA investigator such 
as myself from writing a grant. Because of all the steps that 
are necessary to conduct this research, it is often difficult 
to get all of that work done in that kind of a framework. I 
think this is something that will become easier in the future.
    Ms. Brownley. Very good. Dr. Clancy, in your testimony, 
too, you talked about funding virtual reality research and 
demonstration projects. I am sort of curious to know how much 
funding has gone into that. Have you given any consideration to 
directing similar levels of funding toward research on 
psychedelics?
    Dr. Clancy. You know, those are the conversations that we 
are having right now. I will take for the record and be happy 
to get back to you about how much we have invested in virtual 
reality. These are not pure research studies. They really come 
out of our innovation portfolio. In some cases, we are buying 
headsets. In other cases, we are working under something called 
a cooperative research and development agreement with various 
companies that make these headsets. They are wildly popular, to 
put it mildly.
    Ms. Brownley. Thank you. Dr. Wiechers, am I pronouncing 
that name correctly? Are providers at VA permitted to discuss 
psychedelic assisted therapy with veterans if they have 
questions about it? I fully understand that we are still in the 
experimental stages here, but as word of the potential benefits 
of some of these therapies, veterans may have questions and 
they would like to discuss with a physician. Are there any 
limitations around discussing this at all?
    Dr. Wiechers. No. In fact, I would hope and I would 
encourage our veterans to actually openly have these 
conversations with their providers. We want to encourage our 
veterans to share any information that they have received or 
that they are considering about potential participation in one 
of the available research studies, or if they were thinking 
about using recreationally, we would hope they would have a 
conversation with their VA provider first so that we could help 
ensure that they have all the information that they need. There 
is nothing in policy that would prevent our providers from 
having those conversations with the veterans when they have 
questions.
    Ms. Brownley. Great. Thank you for that. This is a question 
for really, any of you, but are any of you aware of clinical 
trials focusing on the potential effectiveness of psychedelics 
for women veterans, particularly women veterans with post-
traumatic stress? I am always advocating for, particularly when 
we talk about mental illness and so forth, that different 
therapies are going to work better for women than men, vice 
versa, and that we need to be thinking specifically about both 
genders as we approach this.
    Dr. Clancy. I do not believe that anyone is focusing 
exclusively on women with PTSD, but we totally agree with you 
about the urgency of the need. A much higher proportion of 
women veterans have PTSD than men. They are a smaller number, 
so absolute numbers are different. It is something of very high 
interest to us.
    We have a number of studies ongoing now, not funded by VA, 
but funded by private foundations and so forth. We will get 
back to you about how many women are involved, but I am quite 
confident we are not at the place where we are going to have 
the statistical power to say anything conclusive.
    Ms. Brownley. Dr. Clancy, you talked about creating sort of 
the future framework of research around this area, so do you 
have a timeframe for that?
    Dr. Clancy. Not at this moment, but we will be following up 
with you. I can absolutely guarantee that.
    Ms. Brownley. Thank you. I yield back, Madam Chair.
    Ms. Miller-Meeks. Thank you, Ranking Member Brownley. I am 
just going to add in that 50 percent of NYU or New York 
University trials involve women. The chair now recognizes 
Representative Bergman for 5 minutes.
    Mr. Bergman. Thank you, Madam Chairwoman. First of all, I 
have a personal request for all three of you. That is, you 
know, the VA has the best hearing aids in the world. I have not 
gotten there yet to get mine, so if you would not mind, when 
you speak into the mic, pull it close. It will help me hear a 
little more clearly. I am sure my colleagues can hear just 
fine, except for Dr. Murphy, who keeps saying what? Anyway, Dr. 
Clancy, great to see you again. It has been a while. Dr. 
Yehuda, it is great to see you. Doctor, this is the first time 
we have met, so I am looking forward to hearing, you know, 
hearing more from you.
    Dr. Clancy, in your testimony, you state that more research 
in the MDMA assisted therapy, especially research including 
more veterans, is needed before the VA can take any next steps. 
As you may be aware, Congressman Lou Correa from California, 
Lou and I came in together as freshmen back in 2017. We 
introduced an amendment to the MilCon VA Appropriations Bill 
directing VA to conduct a widescale study into this treatment, 
which was approved unanimously on the floor.
    Now, having said that, just because something gets approved 
on the floor now the next steps falls, you know, into your 
bailiwick. Now that the House of Representatives has shown its 
support for these efforts, will VA commit to advancing large 
scale research into MDMA assisted therapy to treat PTSD in 
veterans?
    Dr. Clancy. There is no question that we are actually 
funding a number of studies, and I will commit right here that 
we will be keeping all of you informed just as soon as those 
decisions are finalized.
    Mr. Bergman. Is there any barriers right now that exist 
that you could foresee that you would be willing to share with 
us so that we can kind of be proactive here?
    Dr. Clancy. No. The barriers Dr. Yehuda and I described 
earlier all have to do with going through the requisite 
regulatory approvals from the FDA and the DEA. There is not a 
shortcut there. I think I know a number of our colleagues are 
excited about the possibility. Not that they think this is the 
answer, but they are inspired by hearing from veterans whose 
own experience has been very, very positive and want to be part 
of learning whether that is a generalizable finding for many 
veterans.
    Mr. Bergman. Okay. Will the publication of phase three 
clinical trial results with that last month all signs point 
toward MDMA assisted therapy receiving FDA approval within the 
next year. What steps will the VA take before then to have 
therapists trained and ready and to prevent bottlenecks to 
ensure that the veterans in need do not have to wait years to 
actually receive the treatment? We know one of the limiting 
factors here is going to be to have those trained therapists 
ready to take that veteran through the experience.
    Dr. Clancy. Yes. For all of the studies that are ongoing 
right now in VA, all of the therapists have gone through that 
intensive kind of training. A few other people have sought this 
training from the organization Multidisciplinary Association 
for Psychedelic Studies (MAPS) on their own because they see 
this as part of the future and a skill set that they would very 
much need. I can assure you that our state-of-the-art 
conference, the whole question of what is the right research 
strategy and how do we plan right now for implementation would 
make sense. I am going to turn to Dr. Wiechers who will explain 
briefly that we have a pretty good track record here.
    Dr. Wiechers. Thank you, Dr. Clancy. I think there are a 
lot of unanswered questions that relate to what will actually 
come out of the FDA approval process and the steps that will 
need to be taken in terms of ensuring we have trained providers 
that we are following what we anticipate will be REMS, risk 
evaluation mitigation strategies, that will be prudent----
    Mr. Bergman. I do not want to cut you short----
    Dr. Wiechers. Yes.
    Mr. Bergman [continuing]. because I know you have got a lot 
of data to share.
    Dr. Wiechers. I see the time is ticking.
    Mr. Bergman. You know, in war fighting, training and 
readiness is everything, and we train in advance knowing the 
fight is coming.
    Dr. Wiechers. Yes.
    Mr. Bergman. You know the fight is coming. In this case, a 
good fight. The more proactive the VA can be we are here to 
help, to, you know, to knock down any barriers. My time is 
short.
    Dr. Yehuda, I understand these patients are administered 
the medication onsite and are at no point given any kind of 
supply to take home. Do you feel there is any potential for 
recreational misuse through these therapies?
    Dr. Yehuda. Thank you, Congressman, for your question. In 
our experience thus far, I do not think that there is going to 
be opportunity for misuse. One of the most common things that 
veterans say after receiving MDMA assisted therapy and working 
hard processing traumatic memories is, I cannot believe they 
call this ecstasy. Most veterans have told us that they would 
not seek out recreational use of MDMA on their own. I think 
that veterans are very happy to have these treatments in the 
safety of a clinical setting that they have come to trust. It 
is not only the provision of the medication it is also the 
psychotherapy that allows them to open up about very difficult 
experiences----
    Mr. Bergman. Okay.
    Dr. Yehuda [continuing]. so that the environment is really 
ripe for this.
    Mr. Bergman. Well, we have seen your operation, and I 
appreciate you allowing me to go over a minute, because we have 
to make sure that the guardrails are up to not only minimize 
but eliminate abuse and misuse of these substances. With that, 
I yield back.
    Ms. Miller-Meeks. Thank you, Representative Bergman. The 
chair now recognizes Representative Deluzio for 5 minutes.
    Mr. Deluzio. Thank you, Madam Chair. Good afternoon, 
everyone. I think one of the things you will hear across the 
dais here is we all want to make sure that my fellow veterans 
can receive the treatment that is safe and effective. I 
encourage that research. I want to see Federal law not be 
standing in the way of pursuing treatment that could be safe or 
that you are finding is safe and effective.
    Dr. Clancy, I will start with you. In your testimony, you 
write that the VA complies with all applicable laws, rules 
around psychedelics and research. I know Ranking Member 
Brownley asked about funding. General Bergman asked a similar 
question. My question is, are there any statutory barriers for 
the VA to conduct research on psychedelics, cannabis, any other 
Schedule 1 substances?
    Dr. Clancy. There are no statutory barriers, no.
    Mr. Deluzio. That being the case, well, let us start with 
cannabis, is VA doing research into cannabis, and if so, what 
does that look like?
    Dr. Clancy. We have about 10 studies ongoing right now, and 
they range from basic science to what we call health services 
research, which is, how does it work in healthcare every day? 
Of the 10, two are clinical trials. One focuses on PTSD, and 
one is focused on reducing pain, or assessing whether it can 
reduce pain in a meaningful way.
    Mr. Deluzio. Ongoing research?
    Dr. Clancy. Yes.
    Mr. Deluzio. Okay. Do you have an expectation of timeline 
when you might see results?
    Dr. Clancy. I do not know that right at the moment. Again, 
happy to take it, for the record.
    Mr. Deluzio. Thank you. Dr. Clancy or Dr. Wiechers, if you 
are more appropriate to respond here, please feel free, 
shifting back to psychedelics. If research, if these studies 
show that any of these treatments will be safe and effective 
for whatever conditions, does the law prevent the VA from 
ultimately pursuing a treatment? What stands in the way beyond 
FDA approval, should that ever come?
    Dr. Clancy. Well, I am just going to take a key from Dr. 
Wiechers a couple of minutes ago. FDA approval will almost 
certainly be accompanied by something called a REMS approach, 
risk evaluation and management strategy, which may be 
straightforward and it may be quite complicated. That will be 
something that we would obviously review very, very carefully. 
That is not a statutory process.
    Mr. Deluzio. Right.
    Dr. Clancy. This is all about effectiveness and safety.
    Mr. Deluzio. I guess then on both psychedelics and 
cannabis, is there anything Congress needs to change should 
your research and what happens at the FDA suggest these should 
be safe and effective treatments for veterans?
    Dr. Clancy. Not that I can see, no. We would be in touch if 
we thought otherwise.
    Mr. Deluzio. Okay. In terms of research and funding, are 
there funding issues? How can this body and the Congress help 
if there are?
    Dr. Clancy. I think you can help, and you are helping by 
having this hearing, the roundtable a few months ago. We have 
appreciated Congress's support, particularly this committee for 
our research budget. Again, I do not see anything else there, 
but thank you.
    Mr. Deluzio. Very good. Okay. Madam Chair, I yield back.
    Ms. Miller-Meeks. Thank you, Representative Deluzio. The 
chair now recognizes Dr. Murphy, for 5 minutes.
    Mr. Murphy. Thank you, Madam Chairman. Thank you, guys. 
This is very, very intriguing. I just met with some folks 
actually a couple of times today and exploring this. Just being 
a scientist myself, I am going to probe this pretty hard. Do 
not take anything personally, but it is just like we were 
pimped in medical school and everything else. Can somebody give 
me a little bit of a historical scenario? Where did this start 
coming out? Were folks coming in and saying they use these 
stuff recreationally and they were helped by it, or how did all 
this--what was the genesis?
    Dr. Clancy. To the best of my knowledge, some of this work 
dates back to the 1960's, if not earlier. Then there was a 
hiatus. I am going to guess the Controlled Substance Act passed 
in the early 70's had something to do with that. I think the 
people from the organization MAPS, unless Dr. Yehuda knows more 
about the history, could actually give us a more recent 
timeline. It is not that there was suddenly a campaign. This 
has been growing for the past few years, witness--Congressman 
Bergman's, you know, insertion into law----
    Mr. Murphy. Sure, sure.
    Dr. Clancy [continuing]. a few years ago.
    Mr. Murphy. Does anybody really definitively know mechanism 
of action? I know it is serotonin, but anybody specifically 
know where that is going to hit or what it does?
    Dr. Yehuda. Thank you very much for that question. We do 
not specifically know the mechanism of action of psychedelic 
assisted therapy. One reason for that is that an active 
ingredient in the treatment, in the clinical efficacy, comes 
from the combination of administering a psychedelic plus the--
--
    Mr. Murphy. The therapy.
    Dr. Yehuda [continuing]. psychotherapy. We know how these 
compounds act in the brain. We know what receptors they target. 
We know that they maybe build avenues for brain plasticity. The 
real task ahead of us is to conduct research that will answer 
that question. Specifically, why taking psychedelic medicines 
in the context of a safe container with trained providers can 
facilitate, and insight, and introspection, and galvanize 
healing. This is very important work in the lifecycle.
    Mr. Murphy. Is this thought to be really therapeutic or 
maintenance? In other words, what is our schedule here? Are we 
thinking that two or three therapies are curative or is this 
something that we think our vet is going to have to take 
lifelong? Is there going to be subset of patients? All of the 
above?
    Dr. Clancy. I would say that is why we are continuing to do 
research. We have certainly met veterans for whom this appears 
to have been curative. The real test obviously will be for how 
long a period of time and so forth. I think it is too early to 
answer a very logical question like that.
    Mr. Murphy. Subsets of patients with preexisting, you know, 
cardiac disease, arrhythmias. There has to be some exclusionary 
criteria for some individuals just because these things are not 
like taking Tylenol and not like taking aspirin. I will just 
say one of these things. We had an occurrence, I guess it was 3 
or 4 weeks ago, where a pilot who was sitting in a jump seat 
took some magic mushrooms recreationally, and he had taken 
those 3 days before. Then he tried to bring down a plane. Then 
he got restrained in the back and then tried to open the back 
of the door.
    You know, these things are not magic bullets. They are not 
without consequence. I applaud your work on trying to help 
this. This is amazing if it can be done. It would be naive to 
think, one, there are not repercussions, and two, there is not 
going to be abuse. People will find a way to abuse these 
medicines because it is a drug and it is one of these things 
that will be abused.
    Putting guardrails up as stringently as possible is going 
to be critical because we are going to get doctors who are not 
the best doctors in the world that will go through a course and 
will become prescribing mills just like anything else. Keeping 
this well within guidelines is going to be absolutely critical 
from day one, not 5 years afterwards when we see people ruining 
the system, but from day one. There is, you know, to General 
Bergman's point, there is going to be an onrush of individuals.
    I personally, and I will make a plug in. I still am a firm 
believer in hyperbaric oxygen. I know the studies are somewhat 
controversial on that one regard. Just in the same vein that 
you are saying you try to touch these individuals who cannot be 
touched, why would we not do anything that can be? One quick 
question. Is there any comparison to scopolamine with any of 
these things that are being done?
    Dr. Clancy. Not that I am aware of.
    Mr. Murphy. Okay. All right. Good luck on your work, be 
stringent, no predetermined outcomes, and let the evidence take 
you where the decision should be. Thank you very much.
    Ms. Miller-Meeks. Thank you, Dr. Murphy. The chair now 
recognizes the Ranking Member of the Full Committee, Mr. 
Takano.
    Mr. Takano. Thank you, Madam Chair. You know, a few months 
ago, Dr. Elnahal, the Under Secretary for Health, and I visited 
Loma Linda VA healthcare system, where we met with Dr. Shannon 
Remick. She is leading a phase two clinical trial examining 
MDMA assisted psychotherapy in veterans with combat related 
PTSD. She was quite likely the first VA researcher since the 
1960's to administer a psychedelic as medicine to a VA patient. 
I am proud to have this groundbreaking research going on at the 
VA medical center that serves my constituents.
    My question is to Dr. Clancy and Dr. Wiechers. I understand 
that there are currently five clinical trials involving 
psychedelic assisted therapy going on at VA medical facilities. 
To what extent is there interest from other VA researchers in 
getting involved in this research, and how is VA supporting it?
    Dr. Clancy. A big reason that we had the state-of-the-art 
conference in September was to actually bring together some of 
the best and brightest within VA, as well as across the Federal 
Government and from some of our affiliates, to really assess 
the answer to that question, because it is an important one. I 
will say that for people in our system who invest a fair amount 
of time in providing care to people with PTSD, they were 
inspired and very hopeful and hoping that more science like you 
have described at Loma Linda could get us to a place where we 
can know if this is a breakthrough for veterans, and which 
veterans, and how do we do that safely, and so forth. It would 
be hard for me to overstate their enthusiasm. As you and your 
colleagues have said, we have got to make sure that it is both 
effective and safe.
    Mr. Takano. Dr. Wiechers.
    Dr. Wiechers. I would simply say, yes. To echo what Dr. 
Clancy said, we have actually a large and robust kind of de 
novo community of researchers and clinicians across VA who have 
interest in this work, who have taken it upon themselves, many 
of them, to seek out education and training in this space, and 
who are enthusiastically looking forward to becoming more 
involved, both in the research and anything beyond that, as the 
opportunities develop.
    Mr. Takano. Well, thank you. Dr. Clancy, in your written 
testimony, you explained that VA and Department of Defense 
(DoD) determined the current evidence regarding MDMA was 
insufficient to include it as a recommended treatment in their 
latest clinical practice guidelines for the management of PTSD. 
I think I came in, as you were saying, maybe it is a little too 
early. Those guidelines were released in June 2023. How many 
clinical trials would you need to have published? Or how many 
veteran clinical trial participants would there need to be for 
DoD and VA to consider including MDMA in their clinical 
practice guideline?
    Dr. Clancy. I do not have a precise answer to the question 
because it depends both on the size and right now, there are 
not enough veterans that we would feel comfortable in terms of 
saying that this works that well for veterans, notwithstanding 
the fact that there are two phase three trials that are showing 
promising results. It is also about the quality of the studies, 
how clearly and safely were they conducted? It is easy to say 
we are going randomize people or enroll people with these 
specific characters and have other exclusion criteria. The real 
question is, did they actually manage to come up with that? 
Ultimately, the FDA is going to decide in terms of whether they 
approve this.
    Mr. Takano. Okay, so we have another agency then.
    Dr. Clancy. Yes.
    Mr. Takano. How far away would you say we are from 
achieving that level of rigorous study and sufficient evidence, 
you know, if we have optimum support from Congress? My sense is 
that there is strong bipartisan interest in supporting VA and 
encouraging VA to move aggressively in this area.
    Dr. Clancy. Well, I have huge, deep respect for the FDA's 
process. I would say that evaluating a treatment that is a 
combination, as Dr. Yehuda so clearly described, of 
psychotherapy plus a drug, will challenge how they have been 
evaluating processes before. I am quite confident that they 
will but I would not be betting on a timeline.
    Mr. Takano. Thank you. What barriers, if any, are there to 
conducting multisite studies of psychedelic assisted therapy, 
where researchers at multiple VA medical centers would partner 
to enroll participants, adhere to the same study protocols, and 
pool their data?
    Dr. Clancy. You know, one of the core strengths of our 
research program is multisite studies. Over the past few years, 
starting, interestingly enough, just a little before COVID came 
on the scene, but it turned out to be hugely helpful, was a way 
to make it easier and far more efficient and quicker for us to 
stand up multisite studies. I am not seeing a problem there at 
all.
    Mr. Takano. All right. Well, thank you. I am over time. I 
yield back.
    Ms. Miller-Meeks. Thank you, Representative Takano. The 
chair now recognizes Representative Lutrell for 5 minutes of 
questions.
    Mr. Luttrell. Thank you, Madam Chairwoman. Dr. Wiechers, 
so, the Deputy Executive Director for Office of Mental Health 
and Suicide Prevention, you arguably carry the heaviest 
rucksack in the VA, and I applaud you for that. I can imagine 
the challenges.
    In the past, we have had hearings where they are breaking 
out the numbers to us out of your department, and it is an 
exponential growth rate in the wrong direction. It is really 
hard to wrangle. My colleagues have stated, and Dr. Clancy, you 
can answer this one as well, but we are, I would say they may 
argue with it, but a united front behind the efforts and the 
well beings of our veterans. This seems like the next level 
proverbial tool you can put in a toolbox to save the lives, to 
increase the quality of life, and decrease the symptomatic 
issues.
    The VA seems to be actively engaging with Congress and 
moving forward in the right direction. My concern is that it 
dies on the vine between the communications between the VA and 
possibly the FDA. In conversations that you are having, please 
be honest, in conversations that you are having--can I even say 
be honest? I can say be honest, right? Please be honest. We 
need to know. The veterans behind you would love this answered, 
too. Does the FDA seem like they are playing ball with us in 
order to get this thing moved accordingly? Dr. Wiechers, you 
can go with that one, or Dr. Clancy. Dr. Clancy, you have kind 
of talked around it a little bit. I am not trying to get on you 
or anything, but I need the answer. It sounds like the FDA is 
not fully engaged on this.
    Dr. Clancy. First of all, I do not actually have a way to 
assess that, but I did----
    Mr. Luttrell. You would not. Okay.
    Dr. Clancy. Yes.
    Mr. Luttrell. Who does?
    Dr. Clancy. Right. Well, they are an independent body, and 
they have very, very serious responsibilities. I have no doubt 
whatsoever, because I have full confidence in the FDA 
Commissioner currently that there is any reason for them to be 
foot dragging here.
    Mr. Luttrell. Yes, ma'am, I----
    Dr. Clancy. I think this is a tough challenge.
    Mr. Luttrell [continuing]. I can appreciate the 
responsibility that the FDA has, but the members sitting on 
this dais right here, when we walk around our districts, we 
have to talk to the families that lost their veterans. There is 
no more serious a situation than that. Again, so if it seems 
like there is a friction point that this may stall, we want to 
engage.
    Dr. Clancy. Okay.
    Mr. Luttrell. Dr. Yehuda, can you please share with the 
committee just some high-level results from your research so we 
can go home? One of the hardest--excuse me--one of the 
challenges, and if anybody in the room has a creative name 
besides the word psychedelics, we are eagerly awaiting that to 
hit. Can you share with us some results that we can share with 
our base and the rest of the Members of Congress that may be a 
little apprehensive on us pushing this forward?
    Dr. Yehuda. Thank you very much for your question, 
Congressman, and thank you for your service. Yes, we are in the 
middle of a study. We have now randomized 17 combat veterans to 
receive MDMA assisted psychotherapy.
    While we have not completed, except for 10 veterans, I can 
say that I am extremely encouraged by what we have seen, and 
there is every reason to be extremely optimistic that this is 
not only a therapy that can help veterans reduce their PTSD, 
but also give them a way to reconnect with their purpose and 
mission and find ways for them to be more integrated with their 
families and societies. We are very, very hopeful. I do not 
want to get ahead of the trial that is in process just to say 
that there is really every reason for optimism and investment.
    Mr. Luttrell. Thank you. The committee, we are basing our 
kind of our right and left flank off of the science. I am a 
scientist by trade, a neuroscientist by trade before I became a 
Congressman, and we are looking for the empirical data. We are. 
I understand this space lives between science and spirituality.
    I have often said, and maybe this committee may not know, 
but I have gone through these treatments, and it is something 
that I would, for me, this is Morgan saying this, I would 
never, ever tell anybody to do it. It was such a challenging 
experience, but life changing.
    I think, as the chairwoman said, given the proper 
guardrails for those who need it, not for those who want it, 
that is where the magic happens. I can use some scientific 
terminology, but I do not have one in my head right now. Mr. 
Murphy, left. There are no rules and regulations, Mr. Deluzio 
asked a great question, that prevents the VA from moving 
forward on this. I would like to see the VA leading this.
    Our veterans are ready. Our veterans want to move away from 
the selective serotonin reuptake inhibitors (SSRIs) and all the 
other tools that seem to may not move the needle as much as 
they can and break this proverbial tool out to go, hey, you 
know what, if we are at this point now, let us make this a 
thing. Okay? My time is up. Thank you so much, chairwoman.
    Ms. Miller-Meeks. Thank you, Representative Lutrell. The 
chair now recognizes Representative Landsman for 5 minutes.
    Mr. Landsman.
    [Inaudible].
    Ms. Miller-Meeks. Thank you very much. That is the most 
rapid set of questions we have had--and relevant. The chair now 
recognizes Representative Kiggans for 5 minutes.
    Ms. Kiggans. Thank you, Madam Chair. Just a couple of 
questions about the criteria. When we are talking about who is 
eligible for some of these clinical trials, are there any 
disqualifying factors, like addiction, criminal charges, or 
when we have to choose who is going to receive the initial 
treatments, what are we looking for?
    Dr. Yehuda. Thank you very much for the question, 
Congresswoman. Yes. Every clinical trial has exclusion 
criteria, but they are designed to protect the patient from 
potential adverse effects if they are vulnerable. For example, 
patients receive a cardiovascular workup, but we do not look at 
things like, if they are in the justice system, because it is 
not a medical reason to exclude someone.
    Yes, the exclusions are designed to be protective. 
Currently, they are quite conservative. One of the reasons that 
we need to do more research is because, as we become 
comfortable with these treatment approaches, we can see who 
else can fit under the tent. This is a very important part of 
the kind of work that has to be ongoing so that we can make 
this really as generalizable as possible and as safe as 
possible.
    Ms. Kiggans. I know that with some other controlled 
substances, the VA does a great job with things like drug 
contracts and making sure that we are doing periodic drug 
screenings and pill countings and just really staying on top of 
people who are prescribed things like opioid medications. Will 
we have that same type of kind of safety tracking mechanisms in 
place with this type of treatment?
    Dr. Yehuda. In our clinical trial, the patient receives the 
medicine from a physician, and we watch the patient take the 
medicine. There is no opportunity for diversion. Again, this is 
as safe as it gets. Nobody is going home with anything. It is 
really happening under controlled conditions.
    Also, the patient is being monitored in terms of 
biometrics. There is every opportunity to look at whether 
something may need an intervention for the patient's safety.
    Ms. Kiggans. Will you be doing randomized drug screenings? 
I wanted to, you know, if we are going to do a clinical trial, 
just making sure it is as pure as possible so they are not 
going home and using or taking maybe other substances. How are 
we ensuring that the results we are seeing are truly the result 
of the treatment that they are receiving in house?
    Dr. Yehuda. A lot of what we do before we administer MDMA 
therapy is we do preparation. We do a lot of talking about what 
to expect in a psychedelic experience, what it is for, what the 
person's intention is, and what are the kind of barriers or 
reactions that might be anticipated. All of these things are 
discussed.
    If a person will then develop a craving for a substance, 
that will be discussed in the therapy. So far, in our 
experience, that is not what happens. I think people are not 
using the psychedelics to alter their state in the sense of 
getting high or avoiding. They are using this medication in the 
context of facilitating an insight, of allowing them to connect 
with traumatic material, to build empathy, to build self-
compassion, and to be able to confront things that they just 
have not been able to confront before.
    The idea is not let me feel good from a drug. It is let me 
put myself in a state that is most conducive to safely 
exploring material that is very difficult. It is a very 
different paradigm than the paradigm of drug seeking behavior 
in order to avoid and forget. This is seeking a medicine that 
helps you engage, and it is sometimes very difficult in the 
room, and that there is an opportunity to do that work with the 
veteran, especially if the workforce, as it is in the VA, is 
very well trained and well versed in what it means to talk 
about very difficult traumatic war related material.
    Ms. Kiggans. I hear you, and I can appreciate those things. 
I just want to make sure that we are, again, conducting a 
clinical trial that is very pure in its sense, and it does not 
have other factors, because I am sure that this is a group of 
people that is fragile. You know, I think of patients with 
mental health issues and there is a lot of sad stories out 
there that they have tried. I just want to make sure that we 
are being protective of this treatment so that we can have the 
most accurate results. That is my only concern.
    Last question. I just want to know what, if any, if we know 
of any long-term side effects from these treatments.
    Dr. Yehuda. We have not encountered long-term effects yet, 
but that is one of the most important things that we have to 
do. It is often the endpoint of clinical trials is maybe a 
month or at the most, 3 months following treatment. Really, 
what is important here, and the VA affords the opportunity to 
do this, is to really look down the road and see if the gains 
are maintained. What else pops up? How the patient engages in 
healthcare and mental healthcare, and what else we can offer in 
a different way to the veteran?
    Dr. Clancy. I just wanted to add one brief point. Every 
clinical trial in VA and many, many other places has a data 
safety monitoring board. They are constantly, this is an 
independent group. For example, if the results were so 
stunningly positive that it would feel almost unethical to 
continue, for example, a placebo group, the trial will be 
stopped. On the other hand, if some adverse effects emerge, 
that would also question whether we should continue this trial. 
This is all independent. That is part and parcel, and we will 
certainly be watching that very, very closely.
    Ms. Kiggans. Thank you. I yield back.
    Ms. Miller-Meeks. Thank you. The chair now recognizes 
herself for 5 minutes. Certainly, whether we are talking about 
emerging breakthrough therapy or we are talking about 
standardized conventional care, does not every clinical trial, 
randomized controlled trial for a drug, go through a process by 
which patients are excluded from the trial, you are trying to 
get as pure results as possible, would that not be true for any 
type of therapy? Yes, no?
    Dr. Clancy. I would say yes. It is just that it is a little 
bit different. You know, there is not one single science like 
pharmacology or pharmacotherapeutics, right, to guide what 
would be inclusion and exclusion criteria. Clearly, studies 
like the one Dr. Yehuda is leading and others, I think, will be 
highly informative to us in the future.
    Ms. Miller-Meeks. Yes, certainly, this is not only a 
chemical that is being administered. There is psychotherapy. 
That is a little bit different and a little more convoluted or 
difficult, I would think, for the FDA to seek approval. Dr. 
Yehuda, so the Bronx VA is not the only VA that is doing these 
types of studies, and there are also similar studies going on 
through other research institutions and medical facilities as 
well, is there not?
    Dr. Yehuda. Yes, I believe so.
    Ms. Miller-Meeks. I think the evidence and the literature 
would confirm what you just said, that, yes, there is. Dr. 
Clancy, at the VA hosted psychedelic state-of-the-art 
conference, one of the key gaps in research identified was the 
need for more trials conducted with veterans. What is the VA's 
plan to address this obvious gap, i.e., are you setting out to 
do more trials or to expand the number of admissions into 
trials?
    Dr. Clancy. That is a topic that we are working through 
right now. Again, we look forward to sharing our conclusions 
when we have made those decisions.
    Ms. Miller-Meeks. Is it not true, if there were, let me 
give an example, a drug for high blood pressure that was 
approved by the FDA, how long would it take for the VA to then 
prescribe that medication for individuals or a statin for 
cholesterol?
    Dr. Clancy. Well, in the case of pharmaceuticals, we have a 
very active pharmacy evaluation group, and I am mangling their 
official bureaucratic name, that meets almost immediately, and 
that has allowed us to do----
    Ms. Miller-Meeks. Would it take 5 years? Would it take more 
clinical trials----
    Dr. Clancy. No, no, no, it would not take----
    Ms. Miller-Meeks [continuing]. to both Representative 
Bergman----
    Dr. Clancy. Yes.
    Ms. Miller-Meeks [continuing]. and Representative Lutrell's 
point, the concern that we have is that even after FDA approval 
of MDMA assisted therapy or breakthrough therapy, that there 
will be a long lag time until the VA starts instituting that. I 
guess what we would like to convey, or some of us would like to 
convey, is that we think the VA should be preparing for that 
ahead of time.
    Dr. Clancy. Yes.
    Ms. Miller-Meeks. We know that there will be workforce 
issues. We know that the types of veterans that will seek this 
therapy, and that utilizing both the research within the VA as 
well as the research outside of the VA that is being conducted 
be brought into that, because certainly the FDA is not looking 
only at the research the VAs are doing, but they are looking at 
the research that is occurring at other research institutions.
    Dr. Clancy. Yes. No, I think we agree with you completely. 
I would just like to ask Dr. Wiechers to, again, stress that we 
have a strong track record here. This was a very important 
theme at our conference.
    Dr. Wiechers. Thank you, Dr. Clancy. As an example, 
previous emerging therapy, intranasal esketamine, or Spravato, 
was FDA approved in March 2019. We treated our first veteran 
inside VA at the Boston VA in July 2019. It took about 4 months 
for our pharmacy benefits Management National Formulary 
Committee to go through its standard operating processes to 
review all of the information from FDA, and to make its own 
determination about the status within VA, and then for us to 
stand up with building upon some expertise at facilities that 
were already providing ketamine treatments, to then utilize the 
intranasal esketamine treatments. Then we expanded thereafter 
and now have 42 sites across VA providing either ketamine or 
esketamine treatment today.
    Ms. Miller-Meeks. Well, we would hope if the FDA approves 
this, there would be the same rapidity of treatment. As we 
know, ketamine has a dosing issue and more addictive potential. 
When I think SSRIs were discussed, so when we are talking about 
medication that we currently utilize in addition to therapy and 
psychotherapy for veterans for depression. Whether it is 
anxiolytics, antidepressants, these medications have a side 
effect profile that is fairly significant. Whether it is foggy 
brain, whether it is multiple medications, alteration of 
medications, there is a side effect profile that so far, and I 
think Dr. Yehuda alluded to this, you have not seen that same 
side effect profile as you have in the studies that you are 
doing.
    Dr. Yehuda. Yes, because the drug is not administered 
continuously. The drug is taken just a few times. There are 
things that happen during the course of the day that are 
monitored very carefully. Then what we are on the lookout for 
is whether there are other kinds of changes in mood or 
physiologic states that occur over time. This is exactly the 
work that we have to do in the future to make sure that this is 
safe for everybody to take.
    Ms. Miller-Meeks. Thank you. I yield. The chair now 
recognizes Representative Budzinski for 5 minutes.
    Ms. Budzinski. Thank you, Chairwoman, and thank you to the 
witnesses for joining us today. Addressing the behavioral 
health needs of our veterans has really been one of my top 
focuses and priorities as I am honored to serve on this 
committee. As we know, veterans face unique traumas while in 
the line of duty, and many face these struggles alone and 
without the care they need. I just hosted a veterans town hall 
when I was home over the Veterans Day holiday, and I heard very 
much firsthand from the veterans in the district about access 
to more behavioral health treatments was critically and is 
critically important. I really want to be a part of the 
solution, but I also really want to ensure we are doing so in a 
way that builds off of a solid base of evidence. Psychedelics 
have shown promise in early clinical trials, especially when 
combined with therapy.
    However, the scope of clinical trials and research into 
these psychedelics for veterans is still limited and in early 
stages, as I understand. For example, dropout rates in trials 
among veterans is relatively high. Co-occurring medical and 
psychiatric disorders need more research, and cultural 
diversity among trial participants has been very low, some of 
the concerns that I have.
    I also want to make sure we are including women veterans in 
these trials. As we know they face very unique experiences in 
the line of duty as well. I have heard from many women 
veterans, including those on my Veterans Council, about 
military sexual assault trauma they have experienced. We need 
to ensure that we include in any clinical trials for 
psychedelic assistance that taking that into account, I think.
    I want to be clear that I do support the use of psychedelic 
assisted therapy for our veterans, but I want to make sure we 
are not rushing the process and potentially putting veterans in 
danger. I support robust government funding at the VA directed 
toward more extensive research to fully examine the potential 
positive effects and consequences these therapies can have on 
our veterans' community.
    With that, I do have a question. My first question, if you 
do not mind, Dr. Clancy, if psychedelic drugs receive FDA 
approval to treat psychiatric disorders and DEA reclassifies 
these drugs, what steps does the VA need to take to help scale 
these therapies and make them more broadly available?
    Dr. Clancy. When it is approved and when we have enough 
evidence with veterans for all the reasons you just so clearly 
described, one of the big steps would be making sure that we 
had appropriate training. There are some other issues that we 
would need to be exploring. For example, one-third of the 
veterans we serve live in rural areas. For those veterans who 
live in rural areas and have broadband, you know, can this be 
done virtually? That is not happening in this country. I 
learned at the conference that in Europe, some studies are 
pursuing this and so forth. It would be a whole process of 
scaling very similar to what Dr. Wiechers just described in 
terms of starting the first treatment for veterans with 
ketamine or inhaled ketamine, and then building out from there. 
We know how to do this, and we take enormous pride and care 
about making sure that it is safe and well done.
    Ms. Budzinski. Yes, I appreciate what you have shared 
specifically about rural communities. That definitely reflects 
concerns I have within my district and those unique challenges, 
especially when you are looking at trials. I do not know if 
anyone would like to add anything beyond that, beyond what Dr. 
Clancy shared.
    Okay, I just had one other quick question with the time I 
have. How can researchers encourage veterans from various 
racial and ethnic backgrounds, and women in particular, as I 
mentioned, to participate in clinical trials to help ensure 
that trials are representative of the veteran population?
    Dr. Clancy. I am really happy you asked this because, 
again, for all the reasons that you stated a few moments ago. 
The population of veterans we serve now is far more diverse, 
gender, racial, and ethnic background and so forth. That is 
very high in our minds. We have got a group in our Office of 
research and development very much focused on both enrolling 
more diverse patient populations, but also, quite honestly, 
identifying and encouraging future scientists from multiple 
backgrounds.
    Ms. Budzinski. Okay.
    Dr. Clancy. That will be a challenge for sure, but 
important.
    Ms. Budzinski. Okay, great. Thank you. I will yield back. 
Thank you, chairwoman.
    Ms. Miller-Meeks. Thank you. On behalf the subcommittee, I 
want to thank you for the testimony and for joining us today. I 
am sure that we could have many more questions, some of which 
we may submit for answers later. You are now excused, and we 
will wait for a moment as the second panel comes to the witness 
table.
    [Recess]
    Ms. Miller-Meeks. Welcome, everyone, and thank you for your 
participation in today's hearing. Joining us today is Sergeant 
Jonathan Lubecky, U.S. Army retired and a psychedelic therapy 
clinical trial participant, Dr. Frederick Barrett, Associate 
Professor of Psychiatry and Behavior Sciences at Johns Hopkins 
Center for Psychedelic and Consciousness Research, Mr. Mike 
Mullette, Chief Operating Officer at the Multidisciplinary 
Association for Psychedelic Studies Public Benefit Corporation 
(MAPS PBC), Dr. Rajeev Ramchand, Co-Director at the RAND 
Epstein Family Veterans Policy Research Institute, Mr. Brett 
Waters, Co-Founder and Executive Director at Reason for Hope 
and Co-Founder of the Veteran Mental Health Leadership 
Coalition, Mrs. Juliana Mercer, Director of Veteran Advocacy 
and Public Policy at Healing Breakthrough. Sergeant Lubecky, 
you are now recognized for 3 minutes to deliver your opening 
statement.

                 STATEMENT OF JONATHAN LUBECKY

    Mr. Lubecky. My name is Jonathan Lubecky, and I am an 
American veteran. I served 4 years in the Marines, and upon 
seeing the towers fall, I joined the North Carolina Army 
National Guard, and I served in Iraq 2005-2006, with 172 
members of Bravo Battery, 5th/113th. I was medically retired in 
2009 after a total of 12 years' service.
    As a veteran, I have the privilege to have my trauma be 
socially acceptable, unlike so many others, because it is 
easily understood why a veteran who deployed, whose base was 
shelled almost daily, would have PTSD. As someone who 
frequently shares their story publicly, I fully understand why 
so many chose not to share such intimately personal details of 
their trauma.
    Most of my story is shared by hundreds of thousands of 
veterans. I am but one voice of many. I grew up in a house 
where my siblings were abused, where one of my siblings 
suffered from addiction. Like so many, I left for boot camp 
because I wanted to help people and to escape.
    After all I saw and experienced in Iraq, it cracked my 
mental health. I returned home to find my house empty, my dog 
gone, and my wife living with someone else. In the early hours 
of Christmas morning, 2006, less than 2 months after returning 
home, after going to Sacred Heart Church in Raleigh and being 
turned away because they were full, going to Womack Army 
Medical Center and being told to come back after the holidays, 
and I was sent home, I did what 136 Americans do, including 
veterans, I tried to end my life. I put a gun to my head and I 
pulled the trigger. I forever remember the peace I felt as a 
hammer fell because it would all be over at last. I heard the 
pop. I thought I was dead, but the pain was still there. It was 
then that I realized that the ammunition malfunctioned.
    That was the first of five suicide attempts that should 
have been successful. That does not include the daily ideation, 
the hundreds of times I stood on a bridge. Following my last 
attempt, I was passed a note from a The Medical University of 
South Carolina (MUSC) intern that said Google MDMA PTSD, and I 
did. I discovered that MAPS PBC was conducting a clinical trial 
in Mount Pleasant, South Carolina, just across the bridge.
    I was the 26th person in a 25-person study of veterans and 
first responders. I went through a clinical trial lasting about 
4 months. I took MDMA and sat with trained therapists for 8 
hours only three times. To be clear, I have only taken MDMA 
three times in my life, 9 years ago.
    The MDMA does not fix anything like anaesthesia, it puts 
the mind, body, and spirit in the place it needs to be so the 
therapy can work. Much like when I was given fentanyl prior to 
my back surgery, the anaesthesia did not fix my back, the 
surgeon did. For the first time, I was able to freely talk 
about my demons without my body betraying me. With the help of 
Michael and Annie Mithoefer, I not only worked through my 
trauma from Iraq, but my whole life, and excised those demons 
for good.
    The VA in their formulary currently has exceptionally 
powerful drugs such as ketamine, fentanyl, and a long list used 
as anaesthesia that the VA has been able to properly handle and 
use in a medical environment. MDMA assisted therapy is the same 
and objectively safer than many of those drugs.
    Through a guiding hand, I have been placed in circumstances 
where, if I was not healed, I would have cracked. For example, 
attempting to rescue a drowning victim in my backyard, 
attempting to save a gunshot victim in Charleston, and most 
recently, providing humanitarian aid on the front lines of the 
Ukraine-Russia war.
    I am not special. My story is the same as every other 
veteran suffering with PTSD. My story changes because I went 
through MDMA assisted therapy. I was blessed by being able to 
participate in a clinical trial. Most veterans face the choice 
of leaving the country that sent them to war. The country they 
love, they have shown they will die for so they can heal, 
because otherwise they will sacrifice their life for this great 
country, far from a battlefield, at home, alone in the dark.
    The only entity that can ensure that all veterans have 
access to the same treatment I went through in a safe and 
effective manner with trained therapists and medical grade 
substances is the VA. I measure my failures by the list of 
people I know who have committed suicide. It hangs on my 
fridge. We, as a Nation, have left these veterans to suffer. We 
have left them behind. It is beyond time for this country to 
mean it when they say we do not leave anyone behind and ensure 
that there are more sons and daughters, mothers and fathers, 
and fewer loved ones left with nothing but a folded flag 
because I know that the sole reason my son has a father instead 
of a folded flag is because I went through MDMA assisted 
therapy.
    Every veteran who is suffering from PTSD and is at risk of 
suicide should have access to the treatment I received by going 
to the VA. I vehemently oppose the idea that you can achieve 
the same results that I did by removing the therapeutic 
component and using untested and potentially lethally tainted 
drugs. Veterans have earned the right to heal by doing what 
this august body asked them to do. It is unconscionable to 
prohibit research, given where the science and evidence 
currently sits.
    Every time I made the choice to end my life, it was because 
I had lost all hope of a better day. Hope of a day like I now 
have every day. Because I share my story publicly, I often have 
veterans reach out, begging for help for access to the 
treatment I went through that saved my life. I am now begging 
the veterans on this committee and for the whole of Congress to 
please give them hope of a better day. We all know it would not 
be tomorrow, but I beg for you to give them the hope of 
someday. I thank you for this opportunity, and I stand ready to 
answer questions.

    [The Prepared Statement Of Jonathan Lubecky Appears In The 
Appendix]

    Ms. Miller-Meeks. Thank you, Sergeant Lubecky. Dr. Barrett, 
you are now recognized for 3 minutes to deliver your opening 
statement.

                 STATEMENT OF FREDERICK BARRETT

    Mr. Barrett. Chairwoman Miller-Meeks, Ranking Member 
Brownley, and members of the subcommittee, I thank you for the 
opportunity to testify today. I am Dr. Frederick Barrett, 
Associate Professor of Psychiatry and Behavioral Sciences at 
Johns Hopkins University School of Medicine, and I am the 
Director of the Center for Psychedelic and Consciousness 
Research at Johns Hopkins. I am providing testimony as an 
individual and not as a representative of any institution. The 
following are my own views and not necessarily those of Johns 
Hopkins University, Johns Hopkins Medicine, or the Psychedelic 
Research Center.
    I have been conducting human research with psychedelic 
drugs in healthy individuals and patients with mood and 
substance use disorders at Johns Hopkins for 10 years. This 
program of research was initiated by my mentor, Dr. Roland 
Griffiths, who published the first psilocybin administration 
study in the modern era in 2006. The study is widely recognized 
as the study that reignited and catalyzed academic and medical 
interest in psilocybin. Since then, dozens of peer reviewed 
empirical reports of clinical trials have been published 
testing the safety and potential efficacy of psilocybin and 
closely related compounds to treat patients with a wide range 
of psychiatric disorders, including mood, substance use, 
anxiety, obsessive compulsive, and other disorders. Notably, 
two FDA regulated multisite phase three registration trials are 
currently underway to determine whether psilocybin can be 
approved as a medicine to treat patients with depression.
    We also come at a time when FDA is also considering whether 
to approve the related compound, MDMA, for the treatment of 
patients with posttraumatic stress disorder.
    Depression, substance use, PTSD, and trauma writ large are 
leading causes of disability that plague our veterans as well 
as citizens at large in this country and around the world. I 
urge the committee to do everything in their power to 
facilitate the careful and thoughtful evaluation and 
implementation of these therapies, and importantly, the 
expansion of access to these therapies to as many veterans as 
possible in the event that they receive FDA approval. Evidence 
to date demonstrates the relative safety of psychedelic drugs 
to appropriately screen individuals in controlled settings, but 
these drugs do have known risks. These risks are well managed 
and mitigated for properly screened individuals when under the 
care of trained therapists. Within these procedures, we have 
safely administered nearly 1,000 doses of psilocybin to well 
over 400 individuals at Johns Hopkins since 1999.
    While incredibly promising, psychedelic science is still 
underfunded, hidden behind some restrictive regulatory 
barriers, and not well understood by clinicians, policymakers, 
and the general public. I am grateful for you all for doing 
your due diligence and hosting these panels. I think there are 
clear next steps that can be taken to address these deficits. I 
urge the representatives of this committee to support programs 
that will allow the education of at least stakeholders, if not 
the general public, about the risks and the potential 
therapeutic benefits of psychedelics. These will be incredibly 
important, especially in the context of local ballot 
initiatives and state legislation that seek to kind of 
circumvent the FDA and the Federal processes.
    I also urge the representatives of this committee to 
consider funding initiatives that will not only foster a 
greater level of investment in psychedelic therapy in the VA 
and research in the VA, but also more broadly within academic 
medicine, law, and public policy. Finally, I would like to urge 
the representatives of this committee and the House to support 
the bipartisan and bicameral Breakthrough Therapies Act, 
introduced by Representatives Mace and Dean, as well as 
Senators Paul and Booker. This act proposes the Schedule 1 
compounds that are granted breakthrough therapy designation by 
the FDA be automatically rescheduled to Schedule 2, which would 
substantially ease the burden of academic research into these 
compounds, while not substantially increasing risk to the 
public, especially in the case of psilocybin and MDMA. Thank 
you for this opportunity to speak on this topic that I believe 
has such great import at this time. Thank you.

    [The Prepared Statement Of Frederick Barrett Appears In The 
Appendix]

    Ms. Miller-Meeks. Thank you, Dr. Barrett. Mr. Mullette, you 
are now recognized for 3 minutes to deliver your opening 
statement.

                   STATEMENT OF MIKE MULLETTE

    Mr. Mullette. Chairwoman, ranking member, and subcommittee 
members, thank you for your leadership in holding this first in 
kind hearing on emerging therapies and their potential for 
treating veterans suffering from PTSD and other mental health 
conditions. On behalf of MAPS Public Benefit Corporation, it is 
a privilege to be here. My name is Mike Mullette, and I am the 
Chief Operating Officer of MAPS Public Benefit Corporation, a 
public benefit company working to change the way mental health 
conditions are treated.
    The mission is personal for me. For the past two decades, I 
have seen my wife, who is a therapist, struggle to find 
effective solutions for her patients with PTSD. I joined this 
company with the goal to help my wife, healthcare providers, 
and patients ultimately have access to new treatment options.
    PTSD is a mental health condition affecting approximately 
13 million Americans each year. However, currently available 
treatments only provide modest efficacy. Disproportionately 
impacting veterans, seven out of every 100 veterans will have 
PTSD at some point in their life. Despite growing mental health 
needs, there has not been significant innovation in decades. At 
MAPS PBC, we have made significant progress at researching a 
new investigational treatment for PTSD known as MDMA assisted 
therapy. It is an acute treatment that entails a unique 
combination of talk therapy and medicine.
    In our clinical studies, the participants received either 
MDMA in therapy or a placebo and therapy three times over a 12-
week period, with three therapy sessions in between each 
medication session. In 2017, the FDA granted MDMA assisted 
therapy breakthrough designation, which is a process designed 
to expedite the development of drugs intended to treat serious 
conditions with preliminary clinical evidence that indicates a 
potential improvement over available therapies.
    Both of our phase three clinical trials, which were 
designed under a special protocol assessment with the FDA, met 
their prespecified primary and secondary endpoints and were 
published in Nature Medicine. In these studies, participants in 
the MDMA assisted therapy group experienced significant 
reduction in PTSD symptoms versus participants receiving 
placebo and therapy. MDMA assisted therapy also offered 
significantly reduced clinician rated functional impairment, 
which is measured by the change in baseline in the Modified 
Sheehan Disability Scale. This scale measures impairment in 
functions in three areas: work, social and family life. No 
serious adverse events were reported in either the MDMA group 
or the control group.
    We are pulling together all of the data and preparing to 
submit our new drug application to the FDA by this year's end. 
If successful, we anticipate MDMA assisted therapy for the 
treatment of PTSD could be approved by the FDA next year, 
making it the first emerging therapy of its kind available to 
patients suffering from PTSD. The Veterans Administration has 
the opportunity to create innovative care models to ensure 
treatment for PTSD are scalable, accessible, and, importantly, 
covered in a timely manner for veterans in need. Thank you 
again for your leadership on this issue and your continued 
commitment to the health and safety of veterans.

    [The Prepared Statement Of Mike Mullette Appears In The 
Appendix]

    Ms. Miller-Meeks. Thank you, Mr. Mullette. Dr. Ramchand, 
you are now recognized for 3 minutes to deliver your opening 
statement.

                  STATEMENT OF RAJEEV RAMCHAND

    Mr. Ramchand. Chairwoman Miller-Meeks, Ranking Member 
Brownley, and members of the subcommittee, thank you for the 
invitation to testify. My name is Dr. Rajeev Ramchand. I am a 
senior policy researcher at the non-profit, nonpartisan RAND 
Corporation, where I co-direct the RAND Epstein Family Veterans 
Policy Research Institute. I will focus on two critical areas 
for policymakers to consider as we learn about the benefits and 
risks associated with psychedelic assisted therapies.
    First, continued investment in research is critical. There 
currently are good treatments available for conditions like 
PTSD, but they do not work for everyone. There is a need to 
invest in research to develop new treatments. This includes 
adequate funding for the National Institutes of Health and 
research programs within VA and DoD. Federal investment is 
necessary because private funding for novel therapies for 
mental health conditions is waning.
    Congress can also make the process for conducting research 
on psychedelic compounds more efficient. Relaxing the 
notoriously time consuming, confusing, and expensive processes 
required to conduct research on Schedule 1 drugs would expedite 
research into psychedelic assisted therapy and help get novel 
treatments to veterans more quickly.
    Second, policy solutions are needed to address potential 
barriers to veterans' ability to access psychedelic treatments 
if and when these treatments become available. The first 
potential barrier is cost. If and when available, MDMA assisted 
therapy will not be cheap, especially in the early years. 
Evidence from Oregon and Australia suggests that the price of 
these therapies will be high enough to be a barrier for many 
veterans, particularly those who want care outside VA. Veterans 
who cannot afford MDMA assisted therapy may try to access it in 
illegal markets where a dose is cheaper but could include 
dangerous adulterants like methamphetamine.
    A second access factor will be whether VA has the workforce 
and resources to provide MDMA assisted therapies within its 
behavioral health infrastructure. VA would need to determine 
who should deliver this treatment and how to accommodate a more 
time and labor-intensive protocol while simultaneously meeting 
expectations to provide care to veterans in a timely manner. If 
VA considers paying for this care through its community care 
network or new partnerships, it will need to consider which 
firms in an emerging market have lasting power, as well as how 
to assess whether veterans are able to access this care in a 
timely manner.
    The final issue related to access is quality. If VA 
providers deliver this care, VA must decide how closely to 
adhere to the FDA approved protocol and how to monitor its own 
providers' adherence to it. VA currently has no process for 
monitoring quality of care veterans receive in the community, 
creating yet another hurdle to outsourcing this care. 
Regardless of whether it provides or pays for it, psychedelic 
assisted therapy is becoming increasingly available. VA should 
prepare its providers to talk to patients about and encourage 
veterans to speak with their providers about their interest in 
these treatments without fear of losing VA benefits.
    In conclusion, psychedelic assisted therapy holds great 
promise, but their full benefits will be realized only with 
continued investments in research, improvements in access to 
these compounds for research purposes, and careful planning for 
how this care can be offered to ensure that all veterans who 
need and want these treatments can benefit from them.

    [The Prepared Statement Of Rajeev Ramchand Appears In The 
Appendix]

    Ms. Miller-Meeks. Thank you, Dr. Ramchand. Mr. Waters, you 
are now recognized for 3 minutes to deliver your opening 
statement.

                   STATEMENT OF BRETT WATERS

    Mr. Waters. Chairwoman Miller-Meeks, Ranking Member 
Brownley, and distinguished members of the subcommittee, thank 
you for the opportunity to testify today on behalf of Reason 
for Hope and the Veteran Mental Health Leadership Coalition. My 
name is Brett Waters, and I am the co-founder and executive 
director of both organizations, which are led by retired Marine 
Lieutenant General Martin Steele. I am also a multi generation 
survivor of suicide loss, having lost my grandfather, a World 
War II veteran, when I was young, and my mom, Sherry Hope 
Waters, 5 years ago. Reason for Hope is named in her memory.
    We are here today because a growing body of evidence 
suggests that psychedelic therapies can provide rapid, robust, 
and durable relief and healing to individuals suffering from a 
variety of mental health conditions, particularly those who 
have not benefited from existing options. Significantly, the 
Food and Drug Administration granted breakthrough therapy 
designations both to MDMA assisted therapy for PTSD and to two 
psilocybin therapies for treatment resistant depression and 
major depressive disorder. This means that the FDA hopes to 
accelerate the approval timeline for these potentially 
lifesaving therapies as they have demonstrated a substantial 
improvement over currently available treatments for these 
conditions.
    However, the Schedule 1 status of MDMA and psilocybin under 
the Controlled Substances Act slows down the necessary clinical 
research and has resulted in a lack of public funding needed 
for such large-scale trials. Schedule 1 also blocks 
compassionate use under the Right to Try Act, including for 
veterans who do not qualify for clinical trials in the United 
States due to their complex conditions. A tragic result of this 
flaw in our regulatory system is that veterans have been forced 
to either leave the country or risk criminal penalties at home 
to access these potentially lifesaving treatments. This is 
morally unacceptable, and we can absolutely do better.
    That is why we urge the committee to support the 
Breakthrough Therapies Act introduced by Senators Booker and 
Paul and Congresswomen Dean and Mace. We are grateful for the 
strong bipartisan coalition that has championed both bills, 
including you, chairwoman, as well as Congressman Lutrell.
    The Breakthrough Therapies Act is simple. It moves Schedule 
1 drugs that the FDA designates as breakthrough therapies or 
approves for expanded access from Schedule 1 to Schedule 2 on 
an expedited timeline. At no cost to taxpayers, this bill 
reduces onerous barriers to innovative research and enables 
compassionate medical use of breakthrough therapies, including 
under the bipartisan Right to Try law. It is an essential step 
to accelerate access to potentially lifesaving treatments, 
particularly for veterans who do not qualify for clinical 
trials in the United States. It seems obvious that our Nation's 
heroes should not be forced to leave the country that they 
selflessly served in an attempt to save their own lives.
    We also urge the committee to ensure sufficient funding for 
large scale VA research programs that better reflect real world 
settings, as well as funding for education and training of 
providers, including veteran peer supporters, in the 
specialized form of care delivery. While our coalition has 
sought to do its part by helping to unlock over $12 million in 
state funding this year for these purposes, it is critical that 
the Federal Government and the VA step up and take a leading 
role to protect the future of our veterans. Thank you for your 
time today and I look forward to answering your questions.

    [The Prepared Statement Of Brett Waters Appears In The 
Appendix]

    Ms. Miller-Meeks. Thank you, Mr. Waters. Ms. Mercer, you 
are now recognized for 3 minutes to deliver your opening 
statement.

                  STATEMENT OF JULIANA MERCER

    Ms. Mercer. Chairwoman Miller-Meeks, Ranking Member 
Brownley, and members of the subcommittee, on behalf of the 
millions of veterans who suffer from PTSD and the organization 
that I represent, Healing Breakthrough, thank you for the 
opportunity to provide remarks on the great hope that MDMA 
assisted therapy holds for those living with chronic complex 
PTSD, a leading cause of veteran suicide. My name is Juliana 
Mercer. I am a 16-year Marine Corps veteran. My military career 
spanned my 20's and 30's and almost two decades of war in which 
I deployed to Iraq and Afghanistan and served on the Marine 
Liaison team at the Wounded Warrior Battalion.
    After active duty, I dedicated my life to seeking solutions 
to the veteran suicide epidemic. Over the years, I have lost 
too many brothers and sisters to the ravages of war. Combat 
deployments, the loss of friends in combat, and the many more 
lost here at home to suicide took a massive toll on my mental 
health. Though immersed in purposeful work, I found myself in a 
place with no purpose. I needed help, and like other veterans, 
I left the country to access a breakthrough therapy not 
available in the United States and was able to reconnect to my 
purpose.
    We lost 5,461 servicemembers in post-911 hostile combat 
operations, and in the last two decades, over 6,000 have 
committed suicide each year. We have lost more veterans here on 
American soil to suicide than we have in the global war on 
terrorism, over 100,000 more. That annual rate has remained 
consistent over the years, implying that nothing currently on 
the market or in practice has meaningfully addressed the root 
cause of PTSD or decreased veteran suicide rates. This is a 
reality worth repeating because it is what motivates me to 
fight for my brothers and sisters every single day.
    Despite billions of taxpayer dollars spent addressing this 
issue, we are still losing over 6,000 veterans per year. That 
is more per year than in 20 years of combined wars. If we 
continue doing what we have been doing, we may be saying the 
same thing 20 years from now.
    Thankfully, there is hope on the horizon. An FDA designated 
breakthrough therapy known as MDMA assisted therapy offers 
scientifically validated hope for veterans who have PTSD. MDMA 
assisted therapy trials concluded that after three sessions, 86 
percent of patients struggling with PTSD reported clinically 
significant reduction in symptoms, while 71 percent of patients 
experienced complete remission of PTSD symptoms.
    The implications of these peer reviewed trial results 
cannot be overstated. MDMA assisted therapy has proven its 
efficacy in treating PTSD and is on the path to FDA approval 
next year. I am here today asking that you lead, as Congress 
must, in such moments of crisis and continue to urge the VA to 
implement a nationwide program for this breakthrough therapy as 
soon as possible. Every day wasted means more lives lost. Thank 
you for letting me share my story and for allowing me to 
advocate on behalf of my fellow veterans. Chairwoman Miller-
Meeks, Ranking Member Brownley, this concludes my testimony. I 
would happily answer any questions you or the subcommittee may 
have.

    [The Prepared Statement Of Juliana Mercer Appears In The 
Appendix]

    Mr. Bergman. [Presiding.] Thank you. Thank you to all of 
you and Chairwoman Miller-Meeks, you know, had to, as we all do 
around here, we are juggling between different hearings and 
meetings. Number one, thank you, all of you, for your honest 
and heartfelt and direct testimony without bias or prejudice in 
any way, because you have, in many cases, lived this. I will 
recognize myself for 5 minutes here.
    By the way, I just got a couple of questions, and anybody 
who wants to provide an answer can. Do not feel you have to if 
you do not, you know, it is not in your wheelhouse. Some 
critics have pushed fear mongering comparisons between 
psychedelic assisted therapy and state medical marijuana 
programs, where individuals can often take home essentially 
limitless amounts of the substance, in this case, some form of 
cannabis, with doctor approval. Given your experience and what 
we have heard from Dr. Yehuda in the previous panel, is this a 
fair comparison? Jonathan.
    Mr. Lubecky. I think a lot of that has to do with the 
context of use. If it is done at a VA or in a medical facility 
under proper supervision, I think it is a very inappropriate 
comparison. For one, I will be honest, I used cannabis for 5 
years to abate suicidal ideation, and it was highly effective. 
When I moved to South Carolina and could no longer do that, 
everything came back. I did MDMA assisted therapy 9 years ago, 
and I have not taken any mental health medication since.
    Mr. Bergman. Okay. Anybody else? Again, we see when this 
topic first came up, there were entities that tried to scare 
our colleagues. Mike.
    Mr. Mullette. Thank you, Congressman. I think it is 
important to note the way in which MDMA assisted therapy would 
be delivered in a clinical practice or within the VA in this 
instance. First of all, as Dr. Yehuda had mentioned earlier, 
medicine is provided on a one-time treatment basis, meaning it 
is delivered one set of medication for one treatment session at 
one time to individuals in a healthcare setting to be taken in 
the presence of a healthcare provider. That would be repeated 
one month later and then one month after that.
    It is really important to understand that the delivery of 
this product will be very well controlled if approved by the 
FDA. We also anticipate that a REMS program, a risk evaluation 
and mitigation strategy, will be implemented by the FDA as 
well, further refining the way in which we can deliver this 
product one at a time in front of a healthcare provider.
    Mr. Bergman. Okay. Anybody else?
    Mr. Ramchand. I would just note that there is a lot of 
activity happening at the state and local levels concerning 
hallucinogenic deprioritization in their criminal justice kind 
of efforts. I do not think the comparison, I think the medical 
purposes, is really well intentioned and guided. This is 
happening at the same time that there is a lot of legislative 
action happening that may make availability of psychedelics 
more or may make psychedelics more accessible just due to what 
is happening at state and local levels.
    Mr. Bergman. Okay.
    Mr. Waters. I think one of the critical components to the 
legislation that I have referenced, as well as Dr. Barrett with 
the Breakthrough Therapies Act, in terms of reducing the 
barriers to research and compassionate use by rescheduling from 
Schedule 1 to Schedule 2, one of the key things that could, you 
know, come about from that is kind of preventing that state-by-
state approach and the kind of ballot initiative or legislative 
legalization, whether for medical use or recreational use that 
we saw with the rollout to cannabis. One of the critical and 
very valid talking points for many people who are suffering is 
that some people just do not have time to wait, and maybe they 
either cannot leave the country or they do not have the 
financial resources to do so. By rescheduling and making it 
easier both to conduct clinical trials, to get funding for 
those trials, and to ensure compassionate use is at least 
available to those who might not qualify for ongoing trials, 
that is a critical way that we can make sure through the 
medical system that this is legally available to people and can 
actually prevent some of that state-by-state approach that we 
have been seeing.
    Mr. Bergman. Okay. Juliana, any thoughts? You do not have 
to.
    Ms. Mercer. I think it is important to note that with the 
cannabis, it is self-medication, and with the MDMA, it is under 
the care of a healthcare provider, and it includes therapy that 
helps you work through your problems.
    Mr. Bergman. Okay. Thank you. Sometimes when we do not 
understand something, we fear it. One of the goals of our 
committee, both sides of the aisle here, is to take the 
temperature down, get rid of the fear mongering, and get right 
into the realistic research and the outcomes that we know are 
potentially available. In fact, when we developed the 
Psychedelics Advancing Therapies (PATH) Caucus, we added GOOD 
to it. You got to have good acronyms here in D.C. GOOD stands 
for Get Off Opioid Dependency. One, two, or three, and done, 
not a continual life of medications.
    I can guess, but I am just going to ask the question. Just 
give me a head nod. Can we give veterans access to these 
promising new treatments without legalizing recreational use of 
psychedelics? Okay. Thank you. With that, Ranking Member 
Brownley, I yield to you.
    Ms. Brownley. Thank you, Mr. Chairman. Thank you to the 
witnesses for being here. I wanted to ask all of you the same 
question I asked on the first panel with regards to if there is 
any awareness of clinical trials having to do looking at 
effectiveness on women veterans versus men veterans with these 
kinds of therapies, if you are aware of any research or trials 
that are going on?
    Mr. Barrett. Thank you very much, Ranking Member Brownley, 
for the question. There is a distinct lack of a clear 
scientific record in human clinical trials comparing the 
effects of MDMA, psilocybin, or other psychedelics between 
those with different biological sex. I can say that I just came 
from the Society for Neuroscience Conference where I chaired a 
press conference demonstrating a number of preclinical animal 
model trials that demonstrate potential sex differences in the 
response to psilocybin and other psychedelic drugs. This has 
not yet made it to the level of human clinical trials, and I 
think it desperately needs to.
    Ms. Brownley. Thank you. I could not agree with you more. 
Thank you very much. Sergeant Lubecky, thank you for being 
here. Thank you for your testimony. I think you have made it 
clear after 9 years of therapy that you are healed, not cured. 
Is that an accurate way to express it?
    Mr. Lubecky. Yes, ma'am. I mean, there is nothing that, if 
I had a traumatic experience, would say I would not get PTSD 
again. I am currently PTSD free, even after all the traumas 
that I outline in my testimony, which have happened in the past 
9 years.
    Ms. Brownley. Does that mean that the triggers before you 
had the treatment, the triggers that would lead you to want to 
take your life and other things, are those triggers, have they 
just disappeared? Or do you know how to deal with them in a 
more effective way? I am kind of curious to know exactly how 
that works.
    Mr. Lubecky. Well, I think the best way to answer that 
question, ma'am, is the 4th of July before I took my first MDMA 
dose, I was in South Carolina. They love their fireworks. I was 
in a closet in my body armor having flashbacks of Iraq with my 
service dog.
    This past May, on my last trip to Ukraine, as with every 
trip, Kyiv came under fire. This is where I learned air raid 
sirens are the same all over the world, unlike police sirens, 
which change from country to country. I was able to, once I 
assessed the situation, made sure my building was not damaged, 
there was nobody hurt around me, I rolled over and went back to 
sleep and did not have any nightmares. I have not had any 
nightmares like that since I have been home either.
    The triggers still exist. There is still people dropping 
bombs in this world. They just do not affect me the way they 
did. I have a proper emotional response, and then it does not 
come up again.
    Ms. Brownley. Thank you for that. Again, thank you for 
being here. Dr. Ramchand, I think we all agree that--I think 
all of us here agree that we need more research. Research is 
obviously very, very critical. I wanted you to speak to why it 
is so important that the VA is funding research for veterans 
and veterans specifically. If you could just speak to that.
    Mr. Ramchand. I mean, the VA has a huge office of research 
that in order to access care, I mean, I think that this was 
described in the first panel, their clinical practice 
guidelines said that there were not enough veterans enrolled in 
trials. They did not have enough evidence for veterans. That 
was one of the reasons that they have not kind of prioritized 
at this point, psychedelic assisted treatments.
    I think that the VA is the natural place to conduct 
research on veterans. If that is going to be held as a criteria 
for making policy decisions about the availability of these 
compounds, then I think, you know, the VA needs to be at the 
forefront doing this research, and that is why we need to 
invest in research within the VA.
    Ms. Brownley. Yes, I agree, and I think that, you know, 
suicide rates are higher in the veteran community. They have 
different health issues that are not necessarily consistent 
throughout the general public. I personally think it is really 
critically important that we focus on the community of 
veterans, both men and women. Women are the fastest growing 
cohort within the veteran community. Thank you for that.
    Last, I will ask Ms. Mercer. You have talked about, again, 
you know, more research. I think the question that I just 
wanted to ask you about is what do you see as the key things 
for the VA and the committee to focus on the very near term?
    Ms. Mercer. The VA needs to be prepared for the logistical 
challenges around implementing a novel treatment. We have 
worked really closely with VA stakeholders to identify some of 
these critical logistical challenges and potential solutions. 
They are going to need to train thousands of clinicians. They 
are going to need to find the right facilities, the room where 
they are going to be able to access for over 8 hours to be able 
to facilitate this treatment.
    There is going to need to be education and outreach to both 
staff and to patients. There are so many things that need to be 
done before they are able to be successful in implementing an 
MDMA program.
    Ms. Brownley. Thank you. I yield back, Mr. Chairman.
    Mr. Luttrell.
    [Presiding.] Thank you, ranking member. There was a very 
good question or statement in quite a few of your opening 
remarks. Mr. Waters, I am going to start with you, and then, 
Dr. Barrett, I am going to shift over to you. The rescheduling 
from Schedule 1 to Schedule 2, and this is not a debate, but 
open for interpretations on your behalf. We are in our infancy, 
though these efforts have been around for a while, Mr. Barrett, 
we are surely in our infancy. My concern in the conversations 
that I have quite often on the direction that we are trying to 
take is the rescheduling and the concern of the expansion away 
from what we are trying to accomplish. Do you think the 
rescheduling from 1 to 2, do you think we are in a place that 
that is necessary to happen right now, Mr. Waters? Or is that 
something that longitudinally we can bring out with the VA's 
help, because I am going to be working in parallel with them, 
is there a timeframe?
    Mr. Waters. I believe it is necessary, and it is logical 
that it should happen now, because the way that the system 
currently works is that after FDA approval, these products 
automatically have to be rescheduled within 90 days. The 
advantage that we get by rescheduling at this point, before 
these are FDA approved for use in interstate marketing, and, 
you know, we will be seeing these on commercials, there is an 
interim step in the process where we will make it easier to do 
research, to fund that research, and to enable compassionate 
use of these treatments that we will be able to help buildup 
the evidence base and give us a better understanding of their 
use in real world settings.
    The move from Schedule 1 to Schedule 2 really is pretty 
small. There is no change in criminal penalties. Other, you 
know, from misuse or diversion.
    Mr. Luttrell. You would be surprised how not small that 
move is on our side.
    Mr. Waters. Well, for the barriers to research, it is 
significant for compassionate use.
    Mr. Luttrell. I understand and appreciate the research 
aspect of it.
    Mr. Waters. Yes.
    Mr. Luttrell. I am just saying on this side, that is a very 
large boulder to shove.
    Mr. Waters. I am sure.
    Mr. Luttrell. I am sorry, go ahead.
    Mr. Waters. There is otherwise, you know, because these are 
not approved treatments yet, they are not going to be available 
to be marketed in widespread use. That is certainly where we 
are hopefully going to be seeing MDMA in very short order, 
hopefully by early 2025.
    Mr. Luttrell. Mr. Barrett.
    Mr. Barrett. Thank you for the really important question, 
Representative Lutrell. I, of course, make no claims to be a 
policymaker or understand the intricacies therein, but I do 
acutely understand the barriers to research. I have to say that 
one of the largest barriers to entry of some of the most 
qualified scientists in the world to be studying these things 
is highly tied up in obtaining approval for using Schedule 1 
substances in research. The barriers for using Schedules 2 
through 5 are far lower.
    My understanding was that it would make this not only far 
more accessible to incredibly qualified researchers who it may 
be very difficult to access otherwise, but this would speed the 
process of answering the multitude of very important questions 
that we still have not answered that have been asked in this 
panel today, in this hearing, including, well, what about 
repeated dosing? How long will the effects last? What is the 
schedule? What is the exact appropriate dose for a given 
individual in a given population? What about all of these other 
compounds? I can go on for days about how many questions we do 
not have answered.
    Frankly, having this move and allowing for greater research 
before approval would make the post approval world safer, 
possibly more effective, and possibly easier to implement. Of 
course, this is speculation, but that is my initial response.
    Mr. Luttrell. I think there are just so many little nuances 
that we need to run in breast with each other. If anything gets 
out in front that should not be, we will lose this like we did 
back in the 60's. That is not somewhere where we need to be and 
where we need to go. Thank you for those answers. I will move 
it over to you for closing statements.
    Ms. Brownley. Well, this has been a very important hearing, 
hopefully the beginning of many more to stay on the trajectory 
of getting to where we would, I think, all like to get to. I 
really thank the witnesses here today for, first of all, being 
here for doing the work that you are all doing to move these 
therapies forward.
    I am a believer but we do need to do more research. We do 
need to make sure that we have got all of our--that everything 
is in place. All the, I think, Ms. Mercer, you talked about all 
of the logistical things that need to get done. I think those 
are really good suggestions in terms of training and everything 
else that we can begin to be doing now in anticipation of.
    I am just, you know, very, very grateful really to all of 
you. Sergeant Lubecky, thank you particularly for being here 
and sharing. It is always, I think, for all of us here, it is 
really important to hear from our veterans, hear what the 
impacts are, and your kind of personal assessment of this. I 
can imagine that as you speak to so many other veterans, how 
desperate many, many are to have the same kind of experience 
that you were able to have. It is our obligation to try to meet 
those needs. Thank you all very much.
    Mr. Luttrell. Thank you, ma'am. I would like to thank 
everyone for their participation in today's hearing and for 
this thoughtful examination of emerging therapies and the 
potential promise in combating veteran suicide. For many, this 
is a new and challenging topic, but I hope that this oversight 
hearing provided the measured discussion vital to ensuring 
policymakers have the needed background and scientific 
information with regards to potentially life-saving therapies.
    My colleagues and I are committed to serving our veterans 
and doing everything possible to move the needle in addressing 
the suicide and substance abuse crisis. This committee will not 
shy away from exploring new avenues and approaches in this 
fight. I appreciate everyone's willingness to come here today 
and for their input. Above all, thank you for your work serving 
our veterans. I look forward to the continued achievement and 
advancements in science and will be watching this space closely 
in the coming months and years.
    The complete written statements of today's witnesses will 
be entered into the hearing record. I ask unanimous consent 
that all members have 5 legislative days to revise and extend 
their remarks and include extraneous material. Hearing no 
objections, so ordered. I thank the members and the witnesses 
for their attendance and the participation today. This hearing 
is adjourned.
    [Whereupon, at 3:48 p.m., the subcommittee was adjourned.]
      
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                         A  P  P  E  N  D  I  X

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                    Prepared Statements of Witnesses

                              ----------                              


                  Prepared Statement of Carolyn Clancy

    Good afternoon, Chairwoman Miller-Meeks, Ranking Member Brownley 
and distinguished Members of the Subcommittee. Thank you for the 
opportunity today to discuss ongoing clinical trials within the 
Department of Veterans Affairs (VA) involving emerging therapies, and 
specifically, psychedelic assisted therapy and immersive technology, 
like virtual reality that supplements treatment Veteran treatment. 
Accompanying me today is Dr. Ilse Wiechers, Deputy Executive Director, 
Office of Mental Health and Suicide Prevention and Dr. Rachel Yehuda, 
Patient Care Center Director.

VA Psychedelic Research for Post-Traumatic Stress Disorder

    VA is committed to studying interventions that promote the health 
of the Nation's Veterans. In line with this goal, VA conducts studies 
under stringent protocols at various facilities Nation-wide to identify 
if compounds such as MDMA (3,4-Methylenedioxy-methamphetamine) and 
psilocybin in combination with intensive psychotherapy are efficacious 
in treating Veterans with post-traumatic stress disorder (PTSD), 
treatment resistant depressive disorder, major depressive disorder and 
potentially other mental health conditions, such as substance use 
disorders. VA also continually monitors ongoing psychedelic research 
outside VA. Based on our assessment of the literature to date, there is 
still much to learn, and much yet to be understood, about the potential 
benefits of psychedelic compounds. Our Department is not only focused 
on finding the best innovative treatments and cures but doing so 
safely.
    While there are several research studies on the use of psychedelic-
assisted therapy for the treatment of mental health conditions being 
conducted at VA facilities, they are funded by outside organizations, 
not by VA. Medical research with these substances takes place legally 
through a specific process that involves review of the study protocol 
by the Food and Drug Administration (FDA) and obtaining a research 
registration from the Drug Enforcement Administration (DEA). VA 
complies with all applicable laws in obtaining and using psychedelics 
in its research studies. While ORD's intramural research program is not 
currently funding research in this area, the office is closely 
following the growing research literature and is working with OMHSP 
determine whether additional studies of psychedelics for Veterans are 
warranted.
    Safety comes first in all of the clinical research conducted within 
VA. Investigational treatments are delivered in a safe clinical 
environment using pharmaceutical grade medications under careful 
quality controls. Potential research participants undergo careful 
medical and psychiatric screening to make sure it is safe for them to 
participate. Finally, dosing of psychedelic medication is supported by 
staff trained in psychedelic-assisted therapy who are knowledgeable to 
monitor for adverse events and follow clear protocols for using 
psychotherapy in combination with psychedelic medication.

Psychedelic State of the Art Conference

    ORD and OMHSP co-hosted a ``State of the Art (SOTA) Conference: 
Psychedelic Treatments for Mental Health Conditions'' in September 
2023, to help address two major objectives. The first objective was to 
better understand the current state of scientific evidence and to 
identify a strategic framework to consider future psychedelic treatment 
research for select mental health conditions. The second objective was 
to determine the necessary next steps for potential VA system-wide 
clinical implementation for psychedelic compounds for potential future 
use.
    The Psychedelic SOTA Conference took place in two parts. The SOTA 
virtual seminar occurred September 6-8, 2023, and included speakers 
from industry, non-VA academia and Veterans' advocacy groups, as well 
as attendance from Congressional stakeholders and Federal agencies 
participating in the SOTA Workshop. These seminars provided a summary 
of the available data on MDMA and psilocybin, information about current 
studies, and stakeholder perspectives, as background for the SOTA 
Workshop discussions. The SOTA Workshop occurred September 27-28, 2023, 
in Denver, Colorado. Seventy-two (72) participants included key 
internal VA stakeholders, clinicians, and psychedelic researchers along 
with representatives from key partner Federal agencies (such as the 
National Institutes of Health, FDA, Department of Defense (DOD), 
Substance Abuse and Mental Health Services Administration, and the U.S. 
Department of Health and Human Services' Office of the Assistant 
Secretary for Health). SOTA Workshop attendees were broken into four 
workgroups for intensive discussion and deliberation on four key areas 
of strategic planning: Pre-Clinical Research, Clinical Research, 
Clinical Practice Logistics and Implementation, and System Wide 
Clinical Decision-Making and Scale. The workgroups provided 
recommendations for future research directions and potential clinical 
implementation considerations.

Research Regarding Therapeutic Potential MDMA for PTSD treatment

    Two phase 3 trials \1\ of MDMA treatment for PTSD have shown 
statistically significant reductions in PTSD symptoms, with the 
publication of the second trial just occurring last month. In that most 
recently published trial, 87 percent of subjects who received MDMA vs. 
69 percent of subjects who received a placebo had a clinically 
meaningful response. The Bronx VA Medical Center was a recruiting site 
for both of these trials. Although each study is different, all current 
psychedelic studies within VA are paired with non-drug treatments (that 
is, psychotherapy). These treatment protocols involve intensive 
psychotherapy with at least one licensed clinician. Two clinicians were 
required for MDMA sessions in the Phase 3 trials cited here: MDMA-
assisted therapy for severe PTSD: a randomized, double-blind, placebo-
controlled phase 3 study Nature Medicine. Based on a recent review of 
the literature, VA and the Department of Defense (DoD) determined the 
current evidence regarding MDMA as a treatment was insufficient to be 
included as a recommended treatment in the updated VA/DoD Clinical 
Practice Guidelines (CPG) for the Management of PTSD and Acute Stress 
Disorder (ASD); released in June 2023). VA/DoD CPGs follow a rigorous 
process of reviewing the quality of evidence, the balance of risks and 
potential benefits, and the feasibility of implementing interventions 
for PTSD and ASD across health care systems. Primary concerns with the 
MDMA-assisted psychotherapy data included the small number of Veterans 
in the trials that had been published (32 Veterans included), and a 
relatively small number of total participants (176 overall), as well as 
the use of inactive placebo as a comparison condition. The use of 
inactive placebo has allowed participants to correctly guess what 
treatment they received, which can bias results significantly and is a 
particular problem for a novel treatment with anecdotal support 
(leading to increased expectation of benefit for the participant). The 
two studies both used inactive placebos.
---------------------------------------------------------------------------
    \1\ MDMA-assisted therapy for severe PTSD: a randomized, double-
blind, placebo-controlled phase 3 study Nature Medicine Mitchell JM et 
al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, 
placebo-controlled phase 3 study. Nat Med. 2021 Jun 27(6):1025-1033.
---------------------------------------------------------------------------
    One of the key gaps in research identified at the SOTA was the need 
for more trials conducted with Veterans, specifically with the unique 
and diverse population of Veterans who receive care through VHA. The 
issue of needing more rigorous study (such as one that uses an active 
comparator rather than placebo) in VA patients is important because 
studies conducted in our population typically show smaller effects than 
studies conducted outside of VA.
    VA Immersive: Virtual Reality for Physical and Mental Well-Being
    VA is leveraging immersive technology to test a non-pharmaceutical 
approach to help Veterans address the day-to-day challenges related to 
physical and mental well-being. VA recognizes that immersive 
technology--like virtual reality (VR) and augmented reality (AR)--has 
the ability to transform care delivery and experience, and VA is 
focused on efforts to expand its application and evidence-based 
implementation. Immersive technology leverages the senses of sight, 
sound and touch to bring a new level of engagement and sense of 
presence to each Veteran's health care experience. Immersive technology 
also expands the footprint of the health care system, increasing access 
by offering Veterans opportunities to receive care at medical care 
facilities and from the comfort of their home. This technology, when 
used to supplement care provides a more immersive, engaging experience 
than traditional telehealth or care by creating more enjoyable 
therapeutic environments, gamifying the approach, or by transporting 
the patient to environments otherwise difficult to access in the 
presence of a clinician. Additionally, it can also provide a means for 
standardized assessment and metric completion in-device to be shared 
with the clinician decreasing interrater variability in some instances 
and allowing VA to better capture Veteran impact. One example of this 
effort is the potential implementation of VR to aid chronic pain 
management. Multiple VR-based programs are being evaluated, which have 
received preliminary approval, and are now being evaluated for higher 
level approval. One of the VR-based programs is being co-developed with 
VA and another FDA-authorized treatment for chronic low back pain. 
Given that experiencing pain is a significant risk factor for suicide 
among Veterans, this is being pursued as part of VA suicide prevention 
efforts.
    Eliminating Veteran suicide is a top VA priority, and we continue 
to work diligently across the Department and with Federal, tribal, 
state and local governments to advance a public health approach to 
suicide prevention. The VA suicide prevention strategy is guided by the 
National Strategy for Preventing Veteran Suicide 2018-2028 and is in 
alignment with the President's 2021 National Strategy for Reducing 
Military and Veteran Suicide. Part of VA's suicide prevention strategy 
is to fund innovation through demonstration and special projects to 
inform promising and best practices with measurable outcomes. Projects 
are prioritized for their ability to reach specific high-risk/
vulnerable Veteran populations. Results from these projects inform 
potential wider dissemination and implementation of interventions. VA 
has a robust process in evaluation of these projects. Proposed 
demonstration project proposals must be time limited (typically 1-2 
fiscal years), provide specific background justification including 
literature review, provide clear and measurable outcomes to evaluate 
return on investment, include an implementation and evaluation plan, 
must be aligned with national internal and external suicide prevention 
strategies and provide a detailed budget for each fiscal year (FY). The 
project must be used to pilot potential long-term solutions to improve 
outcomes for Veteran wellness and suicide prevention.
    Innovative projects are critical to advance suicide prevention with 
regards to complex risks associated with suicide, such as pain. Recent 
data indicates that about 9 percent of Americans who have died by 
suicide had chronic pain. Furthermore, people with moderate or severe 
pain are three times more likely to have suicidal ideation, and two to 
three times more likely to die by suicide than people without pain. 
Emerging research exists regarding the use of VR to treat a variety of 
physical and mental health conditions.\2\ Ongoing study is needed. 
Systematic reviews and meta-analysis studies evaluating the evidence 
for VR-based treatment of acute and chronic pain management and PTSD 
have returned mixed evidence for treatment and indicate the need for 
more research in this area (Langener et al., 2021; Wu et al., 2022; 
Baker et al., 2022; Knaust et al., 2022).
---------------------------------------------------------------------------
    \2\ Baker, N. A., Polhemus, A. H., Ospina, E. H., Feller, H., 
Zenni, M., Deacon, M., DeGrado, G., Basnet, S., & Driscoll, M. (2022). 
The state of science in the use of virtual reality in the treatment of 
acute and chronic pain: A systematic scoping review. Clinical Journal 
of Pain, 38(6), 424-41. https://doi.org/10.1097/AJP.0000000000001029; 
Cieslik, B., Mazurek, J., Rutkowski, S., Kiper, P., Turolla, A., & 
Szczepanska-Gieracha, J. (2020). Virtual reality in psychiatric 
disorders: A systematic review of reviews. Complementary Therapies in 
Medicine, 52, 102480. https://doi.org/10.1016/j.ctim.2020.102480; 
Dellazizzo, L., Potvin, S., Luigi, M., & Dumais, A. (2020). Evidence on 
virtual reality-based therapies for psychiatric disorders: Meta-review 
of meta-analyses. Journal of Medical Internet Research, 22(8), e20889. 
https://doi.org/10.2196/20889;
---------------------------------------------------------------------------
    OMHSP and the Office of Health Care Innovation and Learning 
partnered at the beginning of FY 2023 to develop a pilot program that 
addresses intersections of suicide as it relates to pain. Specifically, 
VA established a 60-site pilot that has deployed 300 VR headsets to 
mental health and non-mental health providers to VAs across the 
country. This pilot leverages software that is being evaluated for use 
as a tool to help clinical care teams address chronic pain and or 
suicidality. This pilot also includes utilization of positive 
environments to distract from negative stressors and to build positive 
coping mechanisms and resilience related to chronic pain and mental 
health diagnoses like development of VR applications to support 
breathing exercises, sequential muscle relaxation, or other evidence-
based complimentary modalities. In addition, it includes co-development 
of multiple in-vivo exposure environments, like a restaurant or grocery 
store, to supplement treatment for trauma-related triggers or phobias 
as Veterans transition into civilian life. This will include data 
collected regarding ease of use and experience in addition to patient 
reported outcomes for pain, anxiety, suicidality, pain interference, 
depression and mood. As of October 2023, over 450 VR sessions have been 
completed with over 200 unique Veterans being served through this 
pilot.

Conclusion

    When it comes to improving veteran mental health, VA will continue 
to fully implement the current evidence-based interventions we know 
works to move forward treatment of mental health concerns, while we 
simultaneously encourage ongoing innovation paired with strong program 
evaluation and research to assess for new effective interventions. Our 
Department is not only focused on finding the best innovative 
treatments and cures but doing so safely. We appreciate the Committee's 
continued support in this shared mission. Nothing is more important to 
VA than supporting the health and well-being of the Nation's Veterans 
and their families. My colleagues and I are prepared to respond to any 
questions you may have.
                                 ______
                                 

                 Prepared Statement of Jonathan Lubecky

    My name is Jonathan Lubecky, and I am an American Veteran. I served 
four years in the Marines, and upon seeing the Towers fall I joined the 
North Carolina Army National Guard. I served in Iraq 2005-2006 with 
Bravo Battery, 5th/113th FA and was medically retired in 2009 after a 
total of 12 years service.
    As a Veteran, I have the privilege to have my trauma be socially 
acceptable, unlike so many others, because it is easily understood why 
a Veteran who deployed, whose base was shelled almost daily would have 
PTSD. As someone who frequently shares their story publicly, I fully 
understand why many chose not to share such intimately personal details 
of their trauma.
    Most of my story is shared by hundreds of thousands of Veterans. I 
am but one voice of many. I grew up in a house where my siblings were 
abused. Where one of my siblings suffered from addiction. Like so many, 
I left for boot camp because I wanted to help people, and to escape.
    After all I saw, and experienced in Iraq had cracked my mental 
health, I returned home to find my house empty, my dog gone, and my 
wife living with someone else. So in the early hours of Christmas 
morning 2006, less than two months after returning home, after going to 
Sacred Heart Church in Raleigh and being turned away because they were 
full. Going to Womack Army Medical Center and being told to ``come back 
after the holidays'' and I was sent home. I did what 136 Americans, 
including Veterans, did. I tried to end my life. I put a gun to my head 
and pulled the trigger. I will forever remember the peace I felt as the 
hammer fell, because it would all be over. At last. I heard the pop, I 
thought I was dead, but the pain was still there. It was then that I 
realized the ammo malfunctioned.
    That was the first of 5 suicide attempts that should have been 
successful. That doesn't include the daily ideation, the hundreds of 
times I stood on a bridge. Following my last attempt, I was passed a 
note from an MUSC Intern that said ``Google MDMA PTSD'', and I did. I 
discovered that MAPS PBC was conducting a clinical trial in Mt 
Pleasant, SC just across the bridge. I was the 26th person in a 25 
person study of Veterans & First Responders. I was able to participate 
because someone else was healed after 1-2 sessions, and declined 
further treatment, so it could be expanded to include me. I went 
through a clinical trial lasting about 4 months. I took MDMA and sat 
with trained therapists for 8 hrs only three times. To be clear, I have 
only taken MDMA three times in my life, 9 years ago.
    The MDMA doesn't fix anything. Like Anesthesia, it puts the mind, 
body and spirit in the place it needs to be so the therapy can work. 
Much like when I was given fentanyl, prior to my back surgery, the 
anesthesia didn't fix my back, the surgeon did. For the first time I 
was able to freely talk about my demons, without my body betraying me. 
And with the help of Michael and Annie Mithoefer I not only worked 
through my trauma from Iraq, but my whole life, and excised those 
demons, for good.
    The VA in their formulary currently has exceptionally powerful 
drugs such as Ketamine, Fentanyl, and long list used as anesthesia that 
the VA has been able to properly handle and use in a medical 
environment. MDMA-Assisted therapy is the same, and likely objectively 
safer than many of those drugs.
    And through a guiding hand, I have been placed in circumstances 
where if I was not healed, I would crack.
    For example, attempting to rescue a drowning victim in my backyard, 
attempting to save a gunshot victim in Charleston, and most recently 
providing humanitarian aid on the front lines of the Ukraine/Russia 
war.
    I am not special. My story is the same as every other Veteran 
suffering with PTSD, my story changes because I went through MDMA 
Assisted Therapy. I was blessed by being able to participate in a 
clinical trial. Most Veterans face the choice of leaving the country 
that sent them to war, the country they love, and have shown they will 
die for, so they can heal, because otherwise they will sacrifice their 
life for this great country far from a battlefield, at home, alone, in 
the dark.
    Veterans Exploring Treatment Solutions (or VETS) provides 
scholarships to do just this. VETS receives thousands of applications 
annually, and can only send 230-250 people per year. They specifically 
focus only on Special Operations Personnel. So far they've helped 
almost 1,000 Special Operators get access to psychedelic treatments, 
and 100 percent of those surveyed say they'd recommend the treatment to 
other veterans. The only entity that can ensure that ALL Veterans have 
access to the same treatment I went through in a safe and effective 
manner, with trained therapists and medicinal grade substances, is the 
VA.
    I measure my failures by a list of people I know who have committed 
suicide. It hangs on my fridge. We as a Nation have left these Veterans 
to suffer, we have left them behind. It is beyond time for this country 
to mean it when they say ``we don't leave anyone behind'' and ensure 
that there are more sons and daughters, mothers and fathers, and fewer 
loved ones left with nothing but a folded flag, because I know that the 
sole reason my son has a father instead of a folded flag is because I 
went through MDMA Assisted therapy. Every Veteran who is suffering from 
PTSD and is at risk of suicide should have access to the treatment I 
received by going to he VA. I vehemently oppose the idea that you can 
achieve the same results that I did by removing the therapeutic 
component, and using untested and potentially lethally tainted drugs. 
Veterans have earned the right to heal, by doing what this august body 
asked them to do, it is unconscionable to prohibit research given where 
the science and evidence currently sits.
    Every time I made the choice to end my life it was because I had 
lost all hope of a better day. Hope of a day like I now have everyday. 
Because I share my story publicly, I often have Veterans reach out 
begging for help, for access to the treatment I went through that saved 
my life. I am now begging the Veterans on this committee, and for the 
whole of Congress to please, give them hope of a better day, we all 
know it won't be tomorrow, but I beg for you to give them hope of some 
day.
    I thank you for this opportunity and stand ready to answer any 
questions.

                               Biography

    Jonathan M. Lubecky, U.S. Army SGT(R) , is the founder of Lubecky 
Strategic Direction, Legislative Director for Veterans Exploring 
Treatment Solutions, and VP Communications at Apollo Pact. He is a 12-
year retiree of the U.S. Armed Forces, serving in both the Marine Corps 
and the Army. He has been a freelance journalist since 2014. Since 2016 
he has been a Strategic Communications & Governmental Affairs 
Consultant advocating for psychedelic medicine and Veterans. Jonathan 
returned from a deployment to Iraq in 2006. Shortly after returning, he 
was diagnosed with posttraumatic stress disorder (PTSD) and a traumatic 
brain injury. While battling PTSD, enduring multiple forms of 
treatment, and taking dozens of pills per day to manage symptoms, he 
attempted to take his life five times. While recovering from that fifth 
attempt in the hospital, he was surreptitiously instructed to ``Google 
MDMA PTSD''. Beginning exactly 8 years after being released from active 
duty from Iraq, Jonathan began MDMA-assisted therapy in a MAPS Phase 2 
study and completed the protocol in early 2015. As of November 22, 2022 
he has been healed of PTSD as long as he had PTSD
    Jon was appointed the National Veterans Director for the Rand Paul 
for President campaign. Realizing the potential of psychedelic medicine 
to heal his fellow veterans and the millions of Americans suffering as 
he once did, he has been involved in media, politics, and government 
affairs, with a focus on the Department of Defense, Department of 
Veterans Affairs, and Media ever since receiving MDMA therapy. Jonathan 
graduated with honors from The Citadel in Charleston, South Carolina, 
as a Veteran Day Student. He has a bachelor's in political science with 
a concentration in international politics and military affairs with a 
minor in intelligence analysis. He is based in Washington D.C.
                                 ______
                                 

                Prepared Statement of Frederick Barrett

    Chairman Miller-Meeks, Ranking Member Brownley, and Members of the 
Subcommittee, thank you for opportunity to testify before you today.
    I am Dr. Frederick Barrett, PhD, Associate Professor of Psychiatry 
and Behavioral Science, Associate Professor of Neuroscience, and 
Associate Professor of Psychological and Brain Sciences at the Johns 
Hopkins University School of Medicine. I am also the Director of the 
Johns Hopkins Center for Psychedelic and Consciousness Research. I am 
also a standing member of the Johns Hopkins Medicine Institutional 
Review Board, co-chair of the Psychedelics Task Group of the National 
Network of Depression Centers, editorial board member of the academic 
journal Psychedelic Medicine, and author of over 40 peer-reviewed 
scientific articles on psychedelic drugs.
    I am providing testimony today as an individual, and not as a 
representative of any institution. The following views are my own, and 
do not necessarily reflect those of Johns Hopkins University or Johns 
Hopkins Medicine.
    I have been conducting human research with psychedelic drugs in 
healthy individuals and patients with mood and substance use disorders 
at Hopkins for over 10 years. This program of research began in 1999, 
with the approval of one of the first human psilocybin studies in the 
modern era, led by my mentor, Dr. Roland Griffiths. This study not only 
demonstrated that psilocybin could be safely administered in a 
laboratory setting, but it demonstrated that carefully screened and 
appropriately supported healthy individuals could benefit from 
ingesting of psilocybin in a controlled setting. This study, published 
in 2006, is widely recognized as the study that reignited academic and 
medical interest in psilocybin. Since then, peer-reviewed empirical 
reports of clinical trials have been published testing the safety and 
potential efficacy of psilocybin and closely related compounds to treat 
patients with tobacco use disorder, alcohol use disorder, headache 
disorders, existential dread associated with a terminal cancer 
diagnosis, obsessive compulsive disorder, complex trauma, anxiety, and 
importantly major depressive disorder and treatment resistant 
depression, and there are many more clinical trials currently under way 
to study the effects of psilocybin in these and many other psychiatric 
disorders. Of note, two FDA-regulated, multi-site, phase 3 registration 
trials are currently under way to determine the effects of psilocybin 
in patients with mood disorders. Successful trials may lead to FDA 
approval of psilocybin to treat depression. We also come at a time when 
the FDA is considering whether to approve a related compound, MDMA, for 
the treatment of patients with post-traumatic stress disorder. 
Depression, substance use disorder, PTSD, and trauma more broadly are 
not only leading causes of disability in the United States and around 
the world, but they are particularly vexing illnesses that are plaguing 
our veterans. I urge the committee to do everything in their power to 
facilitate the careful and thoughtful implementation of these therapies 
and importantly the expansion of access to these therapies to all 
veterans in the event that they receive FDA approval. Such expansion 
and access may also pave the way for greater expansion and access to 
care givers, family members, loved ones, and those in the community who 
are impacted by the suffering of our nation's best, who are willing to 
sacrifice their lives to defend our freedoms.
    Studies of the safety and potential medical efficacy of psychedelic 
drugs have now been spearheaded or sponsored and conducted by Hopkins 
as well as a small number of other academic medical institutions and 
private entities. These studies are building a growing record of 
information demonstrating both the relative safety and potential 
efficacy of psychedelic therapies in a wide range of psychiatric 
indications. These studies have been funded nearly entirely by private 
philanthropy. Our center at Hopkins was founded by a 17-million-dollar 
gift from the Steven and Alexandra Cohen Foundation as well as from Tim 
Ferriss, Matt Mullenweg, Craig Nerenberg, and Blake Mycoskie - 
philanthropists who had the wisdom, vision, and capacity to establish 
our center and provide support to our now more than 40 professionals, 
including faculty, therapists, and staff, who now continue this 
important work. Only recently has the National Institute on Drug Abuse 
and the National Center for Complementary and Integrative Health come 
through with a notable grant for the investigation of clinical use of 
psychedelics.
    Evidence to date demonstrates the relative safety of psychedelic 
drugs for appropriately screened individuals in controlled settings. 
Psilocybin, for instance, is known to evoke a modest but reliable 
increase in heart rate and blood pressure. Risks of increased blood 
pressure and heart rate are mitigated in research by screening out 
those with substantial cardiac abnormalities. The most apparent risks 
of psilocybin are psychological. These risks are mitigated by screening 
out individuals who have a personal or family history of psychosis or 
mania. These risks are further mitigated by careful counseling and 
preparation by trained therapists who then accompany a study 
participant during the 4-6 hours of acute subjective effects of a high 
dose of psilocybin. Participants then undergo debriefing followed by 
aftercare and therapy for the days and weeks following their 
experience. With these procedures in place, we have safely administered 
over 800 doses of psilocybin to well over 400 individuals since 1999.
    To conduct this research, investigators must assemble an expert 
team including physicians, therapists, often pharmacists, regulatory 
specialists, and other scientists to first tackle the substantial 
regulatory burden that precedes any drug administration. We first seek 
the approval of our institution review boards, and we also submit an 
Investigational New Drug application to the FDA. With institutional and 
FDA permissions in hand, we then must apply for DEA approval. This 
regulatory process takes us an average of about 9-12 months from first 
regulatory submission to approval to receive drug product and begin our 
research. This process is onerous and arduous at best, and while 
ultimately surmountable, provides a substantial barrier to entry even 
to seasoned senior scientists with valuable contributions to make who 
have not yet begun conducting psilocybin research. Given the barriers 
to entry, work in this area is currently still limited to large and 
expansive academic medical institutions who can secure private 
philanthropic support that will not only fund the research, but that 
will also provide funding and support for over a year's worth of 
professional effort for a team of investigators to simply file the 
paperwork to attempt to begin. Given the promise and prospect of our 
current findings, as well as the myriad questions that still need to be 
addressed within this field, I believe that greater access should be 
given to qualified investigators who want to contribute with new and 
rigorous research, and that we re-evaluate whether that barriers that 
have been put in place to protect our public from the most dangerous 
compounds really apply appropriately to psychedelic compounds.
    As we anticipate approval of psychedelic drugs as medicine by the 
FDA, we are also faced with numerous questions that have yet to be 
answered. These include whether the current treatment paradigms are 
optimal for all psychiatric or medical indications. Will some disorders 
require higher or lower doses of psilocybin or MDMA for treatment? Will 
some individuals require follow-up or repeated visits? How well can we 
integrate models from group therapy into a paradigm that currently 
relies on one-to-one therapy or a one-to-two relationship between 
patient and a therapist dyad? How can we predict who will respond well 
and who will not respond to treatment, and can we optimize the delivery 
of care to maximize the chances that someone will have a therapeutic 
response? When rolling out MDMA and psilocybin therapies, these 
questions will be present in the minds of the clinicians on the front 
lines who are delivering this care. Answering these questions will only 
serve to further benefit the veterans who will receive access to this 
care.
    One striking question that is imminent upon FDA approval is how 
best to train clinicians to deliver this new therapy. Current FDA 
requirements include that at least one of the therapists be a licensed 
mental health practitioner, but qualifications, background, and 
training are not specified any further. We at the Johns Hopkins Center 
for Psychedelic and Consciousness Research are exploring these and 
other implementation questions now and in the future, but more 
attention must be paid to this critical element of the entire care 
package, and this must specifically be addressed as these therapies are 
offered to veterans.
    While incredibly promising, psychedelic science is still 
underfunded, hidden behind restrictive regulatory barriers, and 
importantly not well understood by clinicians, policymakers, and the 
general public unless those individuals are deeply immersed in the 
field. There are clear next steps that can be taken to address these 
deficits.
    I urge the representatives of this committee to support programs 
that will allow for the education of at least stakeholders, if not the 
general public, about the risks and potential therapeutic benefits of 
psychedelics. This comes in the context of many local ballot 
initiatives and proposed state legislation that seeks to increase 
access to psychedelics despite current federal regulations. Educational 
initiatives will help to ensure that we can move forward not only with 
informed and appropriate policy, but with an informed electorate and 
society.
    I urge the representatives of this committee to consider funding 
initiatives that will not only foster a greater level of investment in 
psychedelic research in the VA, but also more broadly within academic 
medicine, as fundamental questions regarding dose, delivery, training, 
and optimization will help veterans as well as the broader base of 
patients in this country. Funding support will be necessary if we are 
to have any chance of answering these questions.
    Finally, I urge the representatives of this committee and the House 
to support the bicameral Breakthrough Therapies Act, introduced by 
representatives Mace and Dean, as well as senators Paul and Booker. 
This act proposes that Schedule 1 compounds that are granted 
``breakthrough therapy designation'' by the FDA be automatically re-
scheduled to Schedule 2. Schedule 1 compounds are defined as drugs with 
no currently accepted medical use and a high potential for abuse. FDA 
breakthrough designation is granted to drugs that are intended to treat 
a serious condition, where preliminary clinical evidence indicates that 
the drug may demonstrate substantial improvement over available 
therapy. It is inordinately more difficult to study Schedule 1 
compounds than compounds in any other schedule. FDA acknowledgement of 
preliminary evidence of medical benefit should justify movement of a 
drug to Schedule 2, which would substantially ease the burden of 
academic research into these compounds, especially in the case of 
psilocybin and MDMA, while not substantially increasing risk to the 
public.
    Thank you for this opportunity to speak with you on a topic that I 
believe has such great import and relevance to the health and welfare 
of our nation's veterans, as well as our country as a whole.
                                 ______
                                 

                  Prepared Statement of Mike Mullette

    Chairwoman Miller-Meeks, Ranking Member Brownley, and Members of 
the subcommittee, thank you for the opportunity to offer this statement 
for the record. As the Chief Operating Officer of MAPS PBC, I sincerely 
appreciate your leadership in holding this first of its kind hearing on 
emerging therapies and their potential for treating Veterans suffering 
from PTSD and other mental health conditions.
    MAPS Public Benefit Corporation (``MAPS PBC'') is a clinical-stage 
company focused on developing prescription psychedelics to bring new 
options to those living with mental health conditions. Based in San 
Jose, California, MAPS PBC has completed two phase 3 clinical trials 
evaluating investigational 3,4-methylenedioxymethamphetamine-assisted 
therapy (MDMA-assisted therapy) as a potential treatment for post-
traumatic stress disorder (PTSD), both of which met their pre-specified 
primary and secondary endpoints.\1\ Founded in 2014, MAPS PBC is a 
subsidiary of the Multidisciplinary Association for Psychedelic 
Studies, a 501(c)(3) non-profit organization changing the way mental 
health conditions are treated.
---------------------------------------------------------------------------
    \1\ Mitchell JM, Ot'alora MG. et al. MDMA-assisted therapy for 
moderate to severe PTSD: a randomized, placebo-controlled phase 3 
trial. Nat Med. 2023 Sept 14 doi: 10.1038/s41591-023-02565-4. Mitchell 
JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for 
severe PTSD: a randomized, double-blind, placebo-controlled phase 3 
study. Nat Med 609 2021;27:1025-33.

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Background on MDMA-AT

    MDMA (3,4-methylenedioxy-methamphetamine) is an entactogen - a 
class of psychoactive drugs that produce experiences of emotional 
communion, oneness, relatedness, emotional openness and are thought to 
have use for various medical conditions.\2\ In the 1960's and 1970's, 
MDMA was used in conjunction with psychological therapy by mental 
health providers to enhance patients' access, processing, and 
communication of difficult emotions and experiences.\3\ In 1985, the 
U.S. Drug Enforcement Agency (``DEA'') made MDMA a Schedule I drug 
under the Controlled Substances Act preventing it from being used for 
recreational or medical use.\4\ Since then, research has shown the 
unique properties of MDMA allow it to act as a catalyst to support 
psychotherapy by helping attenuate the brain's fear response allowing 
patients to access and process painful memories without being 
overwhelmed.\5\ With a growing body of evidence supporting the 
potential medical use of MDMA, in 2017 the U.S. Food and Drug 
Administration (``FDA'') granted MDMA-assisted therapy Breakthrough 
Therapy designation, a process designed to expedite the development and 
review of drugs intended to treat serious conditions and that 
preliminary clinical evidence indicates that it may demonstrate 
substantial improvement over available therapies. MAPS PBC expects to 
submit a new drug application including data from two Phase 3 studies 
(MAPP1 and MAPP2) that showed clinically significant improvements in 
PTSD symptoms following acute treatment with MDMA-assisted therapy to 
the FDA in 2023. If approved by the FDA, the DEA would reschedule MDMA 
from a Schedule I drug, making it available for prescription medical 
use. MDMA-assisted therapy is also being studied in other 
indications.\6\, \7\, \8\, \9\
---------------------------------------------------------------------------
    \2\ O'Neil, M.J., The Merck Index: An Encyclopedia of chemicals, 
drugs and biologicals. Merck Research Laboratories, Merck and Co. Inc, 
Whitehouse station, New Jersey, 2006. 319
    \3\ Wagner MT, Mithoefer MC, Mithoefer AT, MacAulay RK, Jerome L, 
Yazar-Klosinski B, Doblin R. Therapeutic effect of increased openness: 
Investigating mechanism of action in MDMA-assisted psychotherapy. J 
Psychopharmacol. 2017 Aug;31(8):967-974. doi: 10.1177/0269881117711712. 
Epub 2017 Jun 21. PMID: 28635375; PMCID: PMC5544120.
    \4\ National Institute on Drug Abuse What is the history of MDMA? 
National Institute on Drug Abuse (NIDA) (nih.gov). Accessed, September 
8, 2023. What is the history of MDMA? National Institute on Drug Abuse 
(NIDA) (nih.gov)
    \5\ Yazar-Klosinski B, Mithoefer MC. Potential Psychiatric Uses for 
MDMA. Clinical Pharmacology & Therapeutics, 2016 Nov 9. https://
doi.org/10.1002/cpt.565
    \6\ Danforth AL, et al. Psychopharmacology (Berl). 2018;235:3137-
3148.
    \7\ Wolfson PE, et al. Sci Rep.2020;10:20442.
    \8\ Sessa B, et al. J Psychopharmacol. 2021;35(4):375-383.
    \9\ ClinicalTrials.gov Identifier: NCT05584826

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Background on PTSD

    PTSD is a mental health condition affecting approximately 13 
million Americans each year \10\, yet currently available treatments 
only provide moderate efficacy.\11\ People with PTSD can experience 
debilitating symptoms that impact nearly all areas of a person's 
life.\12\ They also frequently experience comorbidities including 
anxiety, depression, and substance use disorder.\13\ PTSD has an 
enormous economic impact resulting in an annual burden of over $200 
billion.\14\ Currently available treatments for PTSD are inadequate to 
address the full spectrum of patients who need treatment and may not 
provide adequate relief from debilitating symptoms.\15\ These 
limitations combined with high treatment discontinuation rates in 
psychotherapy underscore the urgent need for novel and effective 
therapies.\16\ Moreover, PTSD disproportionately impacts Veterans. 
According to the U.S. Department of Veterans Affairs' National Center 
for PTSD, 7 out of every 100 Veterans (7 percent) will have PTSD at 
some point in their life.\17\
---------------------------------------------------------------------------
    \10\ A National Center for PTSD. US Department of Veterans Affairs. 
Accessed February 14, 2023. https://www.ptsd.va.gov/understand/common/
common--adults.asp
    \11\ Morina N. Remission from post-traumatic stress disorder in 
adults: a systematic review and meta-analysis of long term outcome 
studies. Clin Psychol Rev. (2014) Apr;34(3):249-55. doi: 10.1016/
j.cpr.2014.03.002
    \12\ The Mayo Clinic, PTSD, Symptoms and Causes www.mayoclinic.org/
diseases-conditions/post-traumatic-stress-disorder/symptoms-causes/syc-
20355967c
    \13\ Grinage B.D. Diagnosis and Management of Post-traumatic Stress 
Disorder. Am Fam Physician. (2003);68(12):2401-2409
    \14\ Davis LL. The economic burden of posttraumatic stress disorder 
in the United States from a societal perspective. J Clin Psychiatry. 
(2022) Apr 25;83(3):21m14116. doi: 10.4088/JCP.21m14116.
    \15\ Morina N. Remission from post-traumatic stress disorder in 
adults: a systematic review and meta-analysis of long term outcome 
studies. Clin Psychol Rev. (2014) Apr;34(3):249-55. doi: 10.1016/
j.cpr.2014.03.002.
    \16\ Varker T. Dropout from guideline-recommended psychological 
treatments for posttraumatic stress disorder: A systematic review and 
meta-analysis. Journal of Affective Disorders Reports (2021) Apr 2021, 
100093. doi: 10.1016/j.jadr.2021.100093
    \17\ VA National Center for PTSD. US Department of Veterans 
Affairs. Accessed October 17, 2023. https://www.ptsd.va.gov/understand/
common/common_veterans.asphttps://www.ptsd.va.gov/understand/common/
common_veterans.asp

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Critical Mission Ahead

    MAPS PBC's mission to alter the way mental health conditions are 
treated is personal for me. For the past two decades I have seen my 
wife, who is a therapist, struggle to find effective solutions for her 
patients with PTSD. I joined this company with a goal to help 
healthcare providers like her and their patients have access to new 
treatment options. As you are aware, there has not been significant 
innovation in the treatment of PTSD in decades. Despite growing mental 
health needs, development of new treatments has been slow, and the 
complexities of treating PTSD have grown. People with PTSD frequently 
experience comorbidities including anxiety, depression, and substance 
use disorder.
    At MAPS PBC we have made significant progress researching a new 
investigational treatment for PTSD known as MDMA-assisted therapy. This 
investigational acute treatment entails a unique combination of 
medicine and talk therapy. While MDMA-assisted therapy is novel, the 
components are not new. Both prescription treatments and talk therapy 
are currently used to treat mental health conditions. What is unique is 
using them together. In our clinical studies, the participants received 
either MDMA and therapy or placebo and therapy three times over a 
twelve-week period, with three therapy sessions prior to commencing the 
medication sessions and three therapy sessions after concluding the 
medication sessions (for a total of nine therapy sessions).
    Both of our phase 3 clinical trials evaluating investigational 
MDMA-assisted therapy as a potential treatment for PTSD, met their pre-
specified primary and secondary endpoints. The results of the most 
recent Phase 3 study, MAPP2, were published in the September issue of 
Nature Medicine.\18\ In that study, participants in the MDMA-assisted 
therapy group experienced a significant reduction in PTSD symptoms 
versus participants receiving placebo with therapy. This was measured 
by a change from baseline at 18 weeks in Clinician-Administered PTSD 
Scale for the Diagnostic and Statistical Manual of Mental Disorders, 
Fifth Edition (CAPS-5) score--the gold standard in PTSD 
measurement.\19\ MDMA-assisted therapy also significantly reduced 
clinician-rated functional impairment which was measured by a change 
from baseline in the modified Sheehan Disability Scale (SDS). This 
scale measures impairment in functioning in three areas: work, social 
life, and family life. No serious adverse events were reported in 
either the MDMA group or the placebo control group.
---------------------------------------------------------------------------
    \18\ Mitchell JM, Ot'alora MG. et al. MDMA-assisted therapy for 
moderate to severe PTSD: a randomized, placebo-controlled phase 3 
trial. Nat Med. 2023 Sept 14 doi: 10.1038/s41591-023-02565-4
    \19\ See more information from the VA's National Center for PTSD at 
https://www.ptsd.va.gov/professional/assessment/adult-int/caps.asp.
---------------------------------------------------------------------------
    Just last week I had the honor of spending time with a trial 
participant who is a former Naval Academy graduate. When asked why he 
had been interested in participating in our study he shared that 
despite exceptional success in the military he had struggled with 
suicidal thoughts and what eventually was diagnosed as PTSD for many 
years, not just due to combat trauma but because of many factors 
throughout his life. He said he tried many other things, but he felt 
despondent and hopeless and was desperate for some relief. While the 
safety and efficacy of MDMA-assisted therapy has not been demonstrated 
and it has not been approved by the FDA, this participant shared that 
he hopes other veterans have access to potential treatment options if 
they are approved. He hears from many of them on a regular basis and 
knows they feel desperate for new options to be available in the VA 
medical system rather than having a growing number of Veterans feel 
forced to seek treatment for their PTSD outside the United States.
    At present MAPS-PBC is aggregating all data and preparing our new 
drug application for submission to the FDA by year end. If successful, 
we anticipate MDMA-assisted therapy for the treatment of PTSD could be 
approved by the FDA next year, making it the first emerging therapy of 
its kind available to patients suffering from PTSD.
    The Veterans Administration has the opportunity to create 
innovative care models to ensure treatments for PTSD are scalable, 
accessible and, importantly, covered in a timely manner for veterans in 
need.
    Thank you again for your leadership on this issue, and your 
continued commitment to the health and safety of Veterans. I am happy 
to respond to any questions the Committee may have.

Mike Mullette
                                 ______
                                 

                 Prepared Statement of Rajeev Ramchand

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                   Prepared Statement of Brett Waters

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                  Prepared Statement of Juliana Mercer

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                        Statement for the Record

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 Prepared Statement of American Psychedelic Practitioners Association 
                                 (APPA)

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