Welcome to the Second Edition of The News from Healing Breakthrough!
We look forward to continuing to share important updates about our 501(c)(3) program’s mission to transform Veteran PTSD treatment with MDMA-Assisted Therapy and the most relevant news from the field here.
Highlights in this issue:
Advocacy: Working Towards a More Unified Voice
Healing Breakthrough Hosts D.C. Reception to Honor our Political Champions
Our Annual Report 2023 (just published!)
NASDVA Washington Conference and the VSO Opportunity
A New Era for Mental Health Treatment at the VA
Lykos Awaits FDA Approval of MDMA-AT
Advocacy: Working Towards a More Unified Voice
MDMA-Assisted Therapy (MDMA-AT) may soon be legally available to treat Post-Traumatic Stress Disorder (PTSD) in the United States, so it will set the precedent for any other FDA-approved psychedelic treatments to follow. Our advocacy team continues to prioritize Veteran access to MDMA-AT for PTSD and the U.S. Department of Veteran Affairs (VA) given its potential to scale this treatment nationally, and catalyze adoption globally.
To this end, in 2024, we are aiming for stronger collaboration between the various psychedelic therapy advocacy groups in Washington D.C. so that our messaging to federal policy makers is more coordinated and effective. Several weeks ago, we held a number of very positive 1:1 and group meetings with advocacy allies including Jesse Gould of Heroic Hearts Project, Brett Waters of Reason for Hope, Melissa Lavasani of Psychedelic Medicine Coalition, Charlie Panfil of Daschle Group, and Josh Narrow of The Conafay Group. And, this Fall, Healing Breakthrough plans to convene the community for a short retreat so that we can share goals and objectives and continue to align on a collective strategy that supports the whole.
Jesse Gould of Heroic Hearts (left) and Juliana Mercer of Healing Breakthrough (right). Photo credit: DANIE Photography.
HB Hosts D.C. Reception to Honor our Political Champions
Healing Breakthrough recently hosted a reception to honor our bi-partisan coalition of political champions standing with us in the fight against PTSD and Veteran suicide. On the evening of March 20, in the beautiful halls of Congress (Room 1300 of the Longworth House Office Building), HB’s Director of Veteran Advocacy, Juliana Mercer, and Executive Director, Jason Pyle, presented Veterans Mental Health Leadership Awards awards to General Jack Bergman (R-MI), Judge John Carter (R-TX), and a number of others. We also had the opportunity to thank some of the many friends and partners who have contributed to recent wins.
From left: Jason Pyle of Healing Breakthrough, General Jack Bergman (R-MI), Juliana Mercer of Healing Breakthrough. Photo credit: DANIE Photography.
Juliana Mercer of Healing Breakthrough and Judge John Carter (R-TX). Photo credit: DANIE Photography.
NASDVA Washington Conference and the VSO Opportunity
HB’s Juliana Mercer had a chance to catch up with VA Secretary Denis McDonough briefly at the National Association of State Directors of Veteran Affairs (NASDVA) Washington Midwinter Conference on February 21. Secretary McDonough expressed his excitement about the work Healing Breakthrough and so many others in the space are doing to help heal our Veterans, and noted that he often wonders, “Is this [MDMA and psilocybin] real?,” because these treatments hold such great promise. We applaud his leadership and support.
With the VA, scientific/clinical, and even conservative press community now having joined the public conversation regarding psychedelic therapies, this space is no longer considered “fringe”. It has entered the mainstream. However, an important next step is to garner increased support from the highly influential “Big Six” Veteran Service Organizations (VSOs). Apart from The American Legion (representing 2 million members) and Disabled American Veterans (DAV) (representing over 1 million members), few have spoken or acted publicly in support of Veteran access to MDMA-AT thus far, even though mental health and suicide prevention are legislative priorities for all of them. Our goal is to change that in 2024.
A New Era for Mental Health Treatment at the VA
On January 6, VA announced plans to fund research of MDMA and psilocybin to treat mental health conditions, including PTSD and depression. Since the VA held its State of the Art Conference (SOTA) on psychedelics in September 2023, working groups have been steadily mobilizing a psychedelics task force led by Deputy Executive Director of the VHA Office of Mental Health and Suicide Prevention, Ilse Wiechers, and others. The purpose is to assess the potential of this new class of treatments to treat Veterans within the VA system, and to guide the adoption process. We understand that the task force is comprised of cross-functional talent and expertise from multiple areas within the agency including Office of Research and Development (ORD), VA Office of Healthcare Innovation and Learning (and Innovation Ecosystem (VHA IE)), National Center for PTSD (NCPTSD), Office of Rural Health (ORH), and others.
In March, Healing Breakthrough celebrated the inclusion of Bergman-Correa Amendment language in the FY24 MilConVA bill passed by the House. The bill implies that $20 million in government funding will be directed towards “breakthrough therapies”, including psychedelics, in the coming months.
“We are truly grateful to our Congressional champions, who’ve worked hand-in-hand with us to get federal skin in the game for MDMA-AT research,” said Juliana Mercer.
Juliana Mercer speaks to Fox News about how MDMA can be used to address Veterans’ mental health issues (clip here)
The Healing Breakthrough advocacy team is already hard at work to secure appropriations for MDMA-AT in the FY25 cycle. While the VA has a long history of healthcare innovation and is well-positioned to scale these new treatments, significant funding and resources are needed. Our analysis of the VA’s psychedelics RFA outlines some of the limitations of its current efforts and underscores the continued vital role of private donors in the interim.
Lykos Awaits FDA Approval of MDMA-AT
On February 9, Lykos Therapeutics made an announcement that propelled our mission forward: the US Food and Drug Administration (FDA) accepted its New Drug Application for MDMA-AT, and granted it priority review, underscoring the urgent unmet need for innovation in the treatment of PTSD. The FDA grants priority review for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment of serious conditions compared to current standard treatments.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024, which is when we now expect a final decision on drug approval. The next step would be the rescheduling of Lykos’ MDMA-AT formulation to Schedule II or III (but not necessarily the rescheduling of the Schedule I MDMA substance it is derived from) by the Drug Enforcement Agency (DEA) within 90 days of FDA approval.
2024 is a pivotal year so far. Stay tuned!
Other updates and upcoming events
For your radar
Don’t miss our first Annual Report (2023): find a copy here.
On May 10, HB’s Executive Director, Jason Pyle, and NCPTSD Executive Director, Paula Schnurr, will be featured speakers at Horizons NYC with a talk on ‘Studying MDMA-Assisted Therapy for PTSD within Veteran populations’. Details here.
Juliana Mercer: Recent Podcast Appearances
NPR’s 1A Podcast - The power of psychedelic therapy for members of the military
The American Legion Podcast (Tango Alpha Lima Be The One) - Keeping veterans out of the ‘black hole’
WFAE (Charlotte’s NPR) - Psychedelics, no longer just party drugs — could change the way we treat mental health
Healing Breakthrough: Recent Press Highlights
Task & Purpose - VA has $20 million for MDMA therapies, but that’s not all it needs
Politico - Psychedelic medicine gets a boost
The Hill - Lawmakers, advocates champion MDMA as a ‘game-changer’ in PTSD treatment and MDMA For PTSD, Groundbreaking Therapy And The Push To Help Our Veterans
National Geographic - How psychedelics could help recovering veterans
Military Times - Psychedelic to receive fast-track review as possible PTSD drug
That’s it for the second edition of The News from Healing Breakthrough! Thank you for being here. We hope you will keep following along with us in this journey to bring healing to millions, starting with hundreds of thousands of Veterans through the VA.