[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]
EMERGING THERAPIES: BREAKTHROUGHS
IN THE BATTLE AGAINST SUICIDE?
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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
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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
54-362 WASHINGTON : 2024
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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
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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.
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\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\
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\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\
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\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.
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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
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Prepared Statement of Brett Waters
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Prepared Statement of Juliana Mercer
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Statement for the Record
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Prepared Statement of American Psychedelic Practitioners Association
(APPA)
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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