Apollo Pact thanks General Jack Bergman (R-MI) and Congressman Lou Correa (D-CA) for their leadership in co-chairing this historic, bipartisan caucus. It was a pleasure and honor working with the Congressmen and their offices on this initiative.
Bipartisan Congressional Caucus Launched
to Explore Psychedelic Research for Mental Health
Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus
Press Release | November 17, 2022
Washington, D.C. - Today, Congressman Lou Correa (D-CA) and Congressman Jack Bergman (R-MI) announce the launch of the Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus. The Caucus will address ways to alleviate the national mental health crisis through psychedelic science and research.
“Having served our Nation as a member of the United States military and in Congress, I’ve seen the destruction post-traumatic stress disorder can cause on my fellow veterans and their families. Our job is to find solutions to these problems, and if psychedelic-assisted therapy can help treat or even fully cure someone of their PTSD, we need to take a closer look at these potential life-saving therapies,” said Congressman Bergman, co-chair of the PACT Caucus.
“Psychedelic-assisted therapies have shown incredible lasting potential to treat depression, substance use disorder, & PTSD. Further clinical research is necessary– we must learn more about what additional diseases and disorders these compounds can successfully treat, but we should also learn what they don’t work for,” said Congressman Correa, co-chair of the PACT Caucus. “If these treatments can save the lives of my constituents and fellow Americans, and are safe to receive in clinical settings, why would we not want to research them?”
The goal and purpose of the PACT Caucus is to promote rigorous and urgent clinical research into the efficacy of psychedelics in treating brain health conditions, in accordance with the law. Therefore, this caucus is not for advancement of psychedelics for other uses, including legalization for recreational use or decriminalization of the compounds.
“Despite the initial promising results, so much more research is needed to determine efficacy and durability of these findings, to better understand the psychotherapy needed to support psychedelic journeys and to identify who can safely benefit. But to date, it has been difficult for investigators to properly vet these treatments because conducting the trials with Schedule I compounds involve so many hurdles,” said Rachel Yehuda, PhD, Director for the Center for Psychedelic Psychotherapy and Trauma Research and the Icahn School of Medicine at Mount Sinai.
"The potential of these therapies is life-saving. But the risks of doing this outside of a clinical setting without medical screening and supervision are dangerous, and that is why I am excited this caucus is focusing on the clinical applications and research of psychedelics, and not decriminalization or legalization for recreational use," said former U.S. Congresswoman and chair of psychedelic patient advocacy Apollo Pact, Mimi Walters.
Background & Need
● According to the National Institute of Mental Health (NIMH), approximately 50 million Americans have any mental illness (AMI) at any given time, of which 13 million Americans have serious mental illness (SMI). These numbers have increased due to the COVID-19 pandemic, lockdowns, and economic hardship that followed
● Most Americans struggling with mental illness, including clinical depression and PTSD, take medication as primary treatment. Unfortunately, the majority of patients with these conditions do not receive adequate benefit from currently available medications.
● Mental health continues to be a relentless challenge for Americans who serve, or have served, in our nation’s armed forces. Every day, 17 veterans take their own lives – a number that has remained stubbornly persistent despite existing pharmacological and psychotherapeutic treatments.
● Research conducted at leading institutions and universities nationwide shows that in a medically controlled setting with expert screening and preparation, psychedelics can relieve anxiety, depression, PTSD, and substance use disorder. These trials show dramatic results. When used with medical screening and support, it could be more effective at treating some psychiatric disorders than existing treatments and without taking daily medication. A single treatment has improved symptoms for months, and even years.
● The U.S. Food and Drug Administration granted breakthrough therapy designation to MDMA and psilocybin in 2017 and 2019, respectively. According to the FDA, "Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on clinically significant endpoints." Additionally, in September 2021, the Acting Director of National Drug Control Policy recommended reducing barriers to research using Schedule I substances.
● Johns Hopkins University and New York University are advancing FDA-approved clinical trials using psychedelics to treat addictions and other mental disorders. The Icahn School of Medicine at Mount Sinai is conducting trials of psilocybin-assisted psychotherapy and MDMA-assisted psychotherapy in PTSD in collaboration with the James J. Peters Department of Veterans Affairs Medical Center. The Dana Farber Cancer Institute of Harvard Medical School is working on a clinical trial using psilocybin for hospice patients. Yale University is performing multiple trials assessing psilocybin for depression, headache disorders, and obsessive compulsive disorder (OCD).
The PACT Caucus will:
● seek to increase awareness among members of Congress, their staff, and the media of evidence-based psychedelic science and research based on FDA-approved clinical trials psychedelic-assisted psychotherapy (PaT)
● hold regular briefings on Capitol Hill to keep members of Congress and their staff informed of the latest psychedelic science and research news
● support increased federal funding for psychedelic science, medicine, and R&D and champion other legislative policies and priorities of importance to the research and science community
● highlight priorities on behalf of interested members of Congress to external stakeholders and the Executive branch
● convene bipartisan thought leaders to educate Congress on the evidence around the research and science
The PACT Caucus will seek more funding for the NIH for clinical trials to accelerate research:
● The Congressional PACT Caucus will advocate for adequate mental health spending by the National Institutes of Health (NIH) for PaT clinical trials to accelerate research. The goal is to generate enough safety and efficacy data from the clinical trials for FDA and DEA to make their decisions regarding PaT therapies.
● NIH's budget increased to $3,911 million in FY 2022, compared to $2,174 million in FY 2013.
● The Advanced Project Research Agency for Health (APRA-H) is embedded in NIH. APRA-H's mission is to "support transformative high-risk, high-reward research to drive biomedical and health breakthroughs—from molecular to societal—that would provide transformative solutions for all patients." Congress allocated APRA-H $1 billion in 2022.
Contacts
Elizabeth Barrie: Elizabeth.Barrie@mail.house.gov
Alec Zender: Alec.Zender@mail.house.gov
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Leading Psychedelic Patient Advocacy Organization Calls on Congress to Make Psychedelic Research A Top Priority
· Newly-founded patient advocacy nonprofit calls on Congress for funding and research prioritization of psilocybin in clinical trials.
· U.S. House Appropriations Committee has indicated support for further research into psychoactive substances that may benefit treatment of PTSD, major depressive disorder, and other serious mental health disorders.
· According to Johns Hopkins University, an estimated 26% of Americans ages 18 and older -- about 1 in 4 adults -- suffers from a diagnosable mental disorder in a given year. Many people suffer from more than one mental disorder at a given time.
NEW YORK, August 10, 2021 – The Apollo Pact, a leading medical psychedelics patient advocacy nonprofit established by psilocybin clinical trial study participants, applauds recent actions taken by the U.S. House of Representatives encouraging the National Institute of Health (NIH) to sponsor psychedelic “research to evaluate the effectiveness of psychedelic therapies in treating PTSD, major depressive disorder, and other serious mental health conditions.”
The reference of support for research into psychoactive substances – particularly as they may apply to veterans’ mental health – was included in report language accompanying the U.S. House of Representatives consolidated appropriations package funding the Department for Health and Human Services (HHS) and moves onto the Senate Appropriations Committee next.
Additionally, a recent U.S. House of Representatives vote to remove a decades old ban prohibiting the federal government from funding some research with Schedule I drugs, including psychedelics, evidences growing support by Congress to loosen restrictions with federal funding into psychedelic research.
A shift in Congressional prioritization could be a breakthrough for patients suffering from diagnosable mental disorders or other serious mental illness. According to Johns Hopkins University, an estimated 26% of Americans ages 18 and older -- about 1 in 4 adults -- suffers from a diagnosable mental disorder in a given year. Many people suffer from more than one mental disorder at a given time. Approximately 9.5% of American adults ages 18 and over, will suffer from a depressive illness (major depression, bipolar disorder, or dysthymia) each year.
Currently, the Food and Drug Administration (FDA) granted psilocybin Breakthrough Therapy designation “to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.”[1]
Apollo Pact is a 501(c)(3) patient advocacy organization with the mission to develop and drive initiatives to overcome the stigma of psychedelic research for mental health disorders and to promote access to medical information and research on psychedelic-assisted therapies. The nonprofit was created by Jon Kostakopoulos, the first study participant in New York University’s clinical trial treating alcohol use disorder with psilocybin-assisted therapy, along with long-time government affairs professional Ali Amirhooshmand, a clinical participant in a Johns Hopkins University study using psilocybin on healthy patients.
“The COVID-19 pandemic has exacerbated the Nation’s already overtaxed mental health crisis, and mental and behavioral health disorders have skyrocketed across the board, including major depressive disorder, substance use disorders, posttraumatic stress disorder, and anxiety disorders,” noted Apollo Pact CEO, Jon Kostakopoulos. “We represent the millions of patients who may benefit from these compounds and research into their use, and on their behalf, we urge Congress and the Administration to build upon the FDA’s findings and make federal research in this space a top priority.”
“Private funding from philanthropists and foundations, along with funding from the private sector, have been underwriting the vast majority of this research. By allowing federal funding for psychedelic research to open the floodgates and expedite the mental health recovery our nation so desperately needs, it is imperative our policymakers and elected officials help lead the way,” said Apollo Pact Chairwoman and former U.S. Congresswoman, Mimi Walters (R-CA).
Kostakopoulos continued, “Establishing an NIH-backed center of excellence to coordinate and contribute to multidisciplinary research of psychedelic sciences and treatment cures, provide funding opportunities for universities and research institutions, and develop best practices would be a bold step forward to prioritizing the potential for these compounds.”
The Heffter Research Institute, a leading national nonprofit advancing studies on psilocybin for cancer distress and addiction, noted its support of Apollo Pact’s call to action. Since founding the Heffter Research Institute in 1993, Heffter-affiliated researchers account for 63% (17 of 27) of top-cited articles on classic psychedelics.
“Heffter Research Institute for over 25 years has had a primary focus on design, review, and funding of research on psychedelic drugs at elite universities and hears often from those grantees that the holy grail for producing world class life science will be unlocking the substantial resources of the federal government through its National Institute of Health budgets. We look forward to seeing Apollo Pact make progress on achieving its goals,” said Carey Turnbull, President of the research institute.
In coming months, Apollo Pact will partner with lawmakers and key stakeholders in bold new ways in order to protect and advance medical research into psychedelic-assisted therapies and to destigmatize mental and behavioral health disorders.
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About the Heffter Research Institute:
The Heffter Research Institute was incorporated in New Mexico in 1993 as a non-profit, 501(c)(3) scientific organization. Since its inception, Heffter has been helping to design, review, and fund the leading studies on psilocybin at prominent research institutions in the U.S. and Europe. The Heffter Research Institute promotes research with psychedelics to contribute to a greater understanding of the mind, leading to the improvement of the human condition, and to alleviate suffering. Heffter scientists believe that the unexplored potential of psychedelics requires careful scientific research to find their best uses in medical treatment.
About Apollo Pact:
Founded in 2020 by psilocybin clinical trial participants, Apollo Pact represents the patient voice in psychedelic research and advocacy. Our mission is to advance psilocybin research for mental health and improve awareness and advocacy on behalf of patients interested in or currently undergoing clinical trials and research involving a range of psychedelic compounds. We are a registered 501(c)(3) nonprofit organization.
We look to develop and drive initiatives to overcome the stigma of psychedelic research for mental health and substance use disorders and promote access to medical information and research on psychedelics in order to achieve person-centered care.
We provide thought leadership and policy support to state and local consumer organizations, policymakers, and foundations working to change the health care system so it serves everyone — particularly vulnerable members of society whose lives may be improved or changed by clinical research into these investigational drugs.
[1] https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy