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Pathways to Healing: Avesta’s Advocacy for the Breakthrough Therapies Act

Written by Dr. Ladan Eshkevari

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On March 13th, 2024, Avesta joined the Veteran Mental Health Leadership Coalition and Reason for Hope alongside Senators Cory Booker and Rand Paul to advocate for the Breakthrough Therapies Act. The event aimed to rally congressional support for the Bill, which could revolutionize access to psychedelic medicine. Avesta’s co-founder, Dr. Ladan Eshkevari, played a vital role in bringing attention to the Act’s transformative potential.

Dr. Eshkevari, along with a diverse group of twenty veterans, scientific and clinical experts, and patient advocates, took to the halls of Congress to educate Senate and Congress members and their staff about the nation’s mental health crisis and offer a solution.

America’s Mental Health Crisis

The United States is in the throes of a deepening mental health crisis that has seen a relentless rise in addiction, suicide, and overdose rates over the past decades. This escalating problem impacts everyone, but veterans disproportionately suffer a heavy burden. 

Data reveals that between 6,000 and 16,000 veterans lose their lives to suicide annually, with veteran rates approximately 57% higher than those of non-veteran adults. This is a harrowing indication of the profound mental health challenges facing those who have served.

Alongside veterans, the nation grapples with an estimated 13 million individuals with PTSD, 21 million battling major depressive disorder, and 2.8 million dealing with treatment-resistant depression. 

Traditional therapeutic avenues, notably SSRIs, have fallen short of adequately addressing these conditions. At best, they mask symptoms. At worst, they exacerbate the situation. For decades, innovation in mental health treatment has been stagnant, leaving countless in dire need of effective alternatives.

Psychedelic Medicine for Mental Health

The emergence of breakthrough therapies, specifically MDMA and psilocybin, offers a beacon of hope amidst rampant despair. Research shows these compounds deliver rapid-acting, robust, and enduring effects, targeting the root causes of trauma rather than mitigating symptoms. 

For example, in clinical trials, 71% of participants receiving MDMA-assisted therapy no longer qualified for a PTSD diagnosis, and 54% of participants receiving psilocybin therapy were in remission following treatment.

Outcomes like this led the FDA to grant both compounds Breakthrough Therapy designations between 2017 and 2019. This status signifies that psilocybin and MDMA may substantially improve upon existing mental health treatments and provide an avenue to fast-track the normal drug review process. 

  • MDMA received a designation for post-traumatic stress disorder (PTSD) in 2017.
  • Psilocybin received two designations. One for treatment-resistant depression (TRD) in 2018 and the second for major depressive disorder (MDD) in 2019.

Despite the designation, clinical trials required for FDA approval can take years to complete and are expensive to undertake. And in the meantime, the path to accessing these therapies is fraught with obstacles due to their Schedule I classification. Psilocybin and MDMA’s illicit status means thousands of veterans and citizens must seek treatment abroad or underground to prevent legal repercussions at home. 

The Breakthrough Therapies Act proposes a pivotal solution to rectify this injustice. 

The Breakthrough Therapies Act

In March 2023, Senators Cory Booker and Rand Paul reintroduced the Breakthrough Therapies Act [H.R. 1393; S. 689] with support on both sides of the aisle. 

The bill proposes redefining “currently accepted medical use with severe restrictions” within the Controlled Substances Act to include drugs or substances designated as Breakthrough Therapies or those authorized for expanded access. This crucial adjustment targets Schedule 1 compounds like MDMA and psilocybin, whose controlled status inaccurately suggests they have no accepted medical use.

Specifically, the Act would enable the DEA to rapidly reclassify Schedule I breakthrough therapies to Schedule II, reducing barriers to research and enabling compassionate use for terminally ill patients under the federal Right to Try Act.

  • Enhanced Research Opportunities: Moving these substances to Schedule II would allow researchers to face fewer obstacles in studying their efficacy and safety, potentially accelerating the development of new treatments.
  • Increased Access to Innovative Treatments: Patients with conditions that have not responded to conventional treatments might gain access to these therapies sooner, as the drugs could be more readily developed and eventually prescribed under Schedule II regulations.
  • Support for State-Level Initiatives: With substances like MDMA and psilocybin rescheduled, states would have more flexibility to advance their own policies regarding the therapeutic use of psychedelics, potentially leading to more progressive and patient-centered approaches to mental health care.
  • Compassionate Use Basis: The Act could make these therapies available to Americans on a compassionate use basis. “Compassionate use basis” refers to a regulatory provision allowing patients with severe or life-threatening conditions to use investigational drugs when all other options have failed. 

Why Advocacy Matters

Despite bipartisan support and endorsement from the Veteran Mental Health Leadership Coalition and Law Enforcement Action Partnership, the Breakthrough Therapies Act has not yet secured a hearing in Congress. That means psychedelic medicine advocates still have to bridge the gap between the scientific community and the policymakers who establish our healthcare frameworks. 

On March 13th, Dr. Eshkevari helped merge these groups by educating legislators on psychedelic advancements and bringing patient voices to the forefront of the conversation. Days on Capitol Hill foster collaborations among government bodies, research institutions, patients, advocates, and healthcare providers like Avesta. They also help ensure equitable access to therapies across all society segments. 

The Bottom Line

The Breakthrough Therapies Act is an essential step in addressing mental healthcare where other medications and modalities have failed. The evidence for psilocybin and MDMA’s incredible efficacy over traditional antidepressants is mounting every day. And with the help of psychedelic researchers, patients who have experienced their effects, and advocates like Dr. Eshkevari knocking on Congress’ door and urging our nation’s leaders, this legislation will gain much-needed traction. 

Advocates are fighting to offer a lifeline to those suffering from severe mental health conditions. This pivotal moment offers a glimpse into a future where transformative care is accessible, and Avesta looks forward to heralding a new era of hope.

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