End the VA Ketamine Debacles and Pass the Marine Jodi Maroney Act for Psychedelic Medicine
End the VA Ketamine Debacles and Pass the Marine Jodi Maroney Act for Psychedelic Medicine
The Issue
In the near future, Psychedelic Medicine will be widely used to heal patients suffering from chronic pain, mental health conditions, and suicidality. The cost-saving, life-changing, and life-saving potential for these new treatments are immense. These groundbreaking medicines will require a trustworthy healthcare system that follows stringent policy to prevent unnecessary harm. A system that is willing to hold itself accountable for its failures. Unfortunately, the Veterans Health Administration, under the US Department of Veterans Affairs (VA), has repeatedly broken trust with medically complex patients: it has failed to safely and reliably administer Ketamine as a psychedelic treatment. One such failure led to the suicide of a Veteran who served as a helicopter pilot in Iraq and Afghanistan. She is not forgotten.
For treatment-resistant Veterans that suffer everyday with mental health conditions and chronic pain, the use of Ketamine as a "Psychedelic Medicine" has been a major breakthrough. These patients have battled for years, even decades, to improve their health using conventional drugs and therapies offered by the VA, often without success. Psychedelic Medicine will lead the way to profoundly heal mental anguish and chronic pain. It will become our nation’s most powerful tool in the fight to end the epidemic of Veteran suicide. But it must be safely and reliably administered to prevent unnecessary harm and disastrous outcomes.
In the last 5 years, we have become aware of at least 4 different VA Ketamine Debacles. Failures occurred through VA facilities in San Diego, Muskogee, and El Paso. The largest failure was nationwide with Ketamine Wellness Centers (a now defunct independent provider that was approved to treat Veterans by the VA Community Care Network). In each debacle, Veterans were consistently healing with their established Ketamine providers, protocols, and route of administration (Intravenous, Intramuscular, Intranasal, etc.). Then the VA abruptly changed, delayed, stopped, and/or denied reapproval of this breakthrough medicine that was able to help conventional treatment-resistant patients.
The first two debacles were investigated by the VA Office of Inspector General. The answers and guidance from these investigation reports could have prevented the two current failures. Unacceptable policy violations and unethical decision-making continue to have negative outcomes for medically complex and fragile patients. These VA Ketamine Debacles must come to an end.
- The VA must understand that it cannot give hope and ‘transformative healing experiences’ to our most vulnerable Veterans and then rip it all away.
- The VA must become a Safe and Reliable provider of Psychedelic Medicine.
- And the VA must rebuild trust with the Veterans it has left behind.
We call on our public servants, the VA staff members in Positions of Power, to put every affected Veteran of the VA Ketamine Debacles back on their original treatment protocol. Medically, ethically, and legally, these patients deserve “Continuity of Care” that will help relieve their physical pain, mental health conditions, and suicidal ideation. Putting them back on the path of healing is how the VA accounts for its policy violations and unethical decision-making. This is how the VA rebuilds trust. If the VA is ever going to end the epidemic of Veteran suicide, trust is sorely needed.
We call on our Elected Representatives to make an official edit, proposal, and passing of the Marine Jodi Maroney Act for Psychedelic Medicine. This will help transform our nation’s healthcare in the areas of chronic pain, mental health, and suicide prevention. And it will allow the VA’s extensive research capability and operational capacity to lead our country with these profoundly healing treatments.
Leading the way on Psychedelic Medicine will help the VA live up to its mission statement: “To fulfill President Lincoln’s promise to care for those who served in our nation’s military and for their families, caregivers, and survivors.” Veterans have already served. Those "who shall have borne the battle” no longer have to fight. And they should not have to struggle with a healthcare system that is supposed to care for them. With our voices we can help the VA fulfill its promise. With our support we can help Veterans heal and fully come home.
We call on ourselves and each other to sign and share this policy petition. This is how our Elected Representatives, the Department of Veterans Affairs, and all of us honor the legacy of Captain Jodi Maroney. She served our country in a time of war. She came home and volunteered to help those of us in need. She left us too soon. She will always be remembered. Keep flying Marine. Keep flying.
The Marine Jodi Maroney Act for Psychedelic Medicine
On behalf of the Veterans that the VA promises to care for, and in remembrance of Captain Jodi Maroney, we propose the following actions in regards to Psychedelic Medicine:
1 - Our Elected Representatives will continue their bipartisan push to get these treatments medically approved for ALL their constituents. Congress will allocate more funds for research that includes medical trials for Veterans, current military servicemembers, and civilians. Conventional treatment-resistant patients suffer every single day while waiting for the eventual medical availability of these groundbreaking medicines. More research will lead to faster approval.
2 - A retrospective research study/survey will be conducted on Veterans that previously received the IV Ketamine Chronic Pain Protocol through the VA. That treatment was never approved by the Veterans Health Administration. This years-long accidental and unethical experiment on Veterans never should have happened. But, as proven in their medical records, it worked. Now it is vital to study the success of an unapproved protocol that was able to heal treatment-resistant patients. And it is necessary to document the negative effects and disastrous patient outcomes that occurred due to the abrupt discontinuation of a psychedelic treatment that was relieving conventional treatment-resistant chronic pain.
3 - A retrospective research study/survey will be conducted on Veterans that previously received Ketamine for the approved mental health protocol - with specific focus on how this psychedelic medicine healed their other health issues and improved their overall quality of life. Most psychedelic research is currently focused on treatment-resistant mental health conditions. Many patients are medically complex with mental health issues, chronic pain, life-threatening disease, medication problems, and socioeconomic barriers. Studying current results will lead to more diverse clinical trials and the approval of psychedelics for other life-impairing conditions (Arthritis, Cancer Pain, Fibromyalgia, Long Covid, Lyme Disease, Neuropathy, Parkinson’s Disease, Phantom Limb Pain, etc.).
4 - Once a Veteran begins a protocol for Ketamine or any Psychedelic Medicine, no administrative debacle can interrupt, change, or otherwise rip away these transformative healing experiences. As already evidenced by the first two VA Ketamine Debacles (OIG reports #20-03359-220 and #21-01836-66), changing protocols, abruptly canceling future treatments, and lack of care coordination can lead to negative patient outcomes. For medically complex and fragile treatment-resistant Veterans, this unnecessary harm and broken trust can lead to suicide.
5 - If a Psychedelic Medicine protocol is interrupted, changed, or taken away by VA administrators or due to unforeseen circumstances, the VA is medically, ethically, and legally bound to offer the Veteran the exact same protocol that was healing them. This is in line with the law of the VA MISSION Act and 38CFR17.4010 (a(5)) - Community Care Eligibility:
- “The Veteran and the Veteran’s Referring Clinician determine it is in the Best Medical Interest of the Veteran, for the purpose of achieving Improved Clinical Outcomes,” to be reapproved for the exact same Psychedelic Medicine protocol that provided clinically significant healing (as proven in the Veteran’s medical records).
- Among other factors, this reapproval is based on the “nature of the service required by the Veteran; the potential for improved Continuity of Care; and the quality of the care provided.”
6 - In regards to Psychedelic Medicine, the VA Office of Community Care will:
- Respect the legislative intent of the VA MISSION Act, which is to give Veterans greater choice in their own healthcare. It is also designed to give power to front-line VA doctors and other “Referring Clinicians” that know what is in the “Best Medical Interest” of the Veteran.
- Follow its own guidelines to develop and implement a coordinated care plan. In light of the VA Ketamine Debacles, the care plan must prevent policy violations.
- Follow its own guidelines to Facilitate a Collaborative Relationship regarding all aspects of the care coordination process between itself, VA providers, Veterans, and community providers. All parties need to understand the importance of following a psychedelic protocol from start to finish.
7 - In regards to Psychedelic Medicine, the Veterans Health Administration will:
- Safely and reliably approve Ketamine within VA facilities or through a VA Community Care approved provider.
- Create internal policy stating that it is not medically or ethically acceptable to forcibly change a Ketamine protocol or its route of administration (for which efficacy is not established) on a patient already receiving Ketamine through the VA.
- Create internal policy stating that it is not medically or ethically acceptable to discontinue a VA provided psychedelic protocol that has already been proven to work for the individual Veteran.
- Hold employees accountable if it is found that they try to cover up any honest mistake, policy violation, or egregious failure in its administration of Psychedelic Medicine. Mistakes and failures happen. Covering them up and failing to provide “Continuity of Care” is unacceptable, illegal, and directly contradicts the VA mission to care for Veterans.
- Be operationally ready with plans and policies to heal Veterans once new Psychedelic Medicines (Psilocybin, MDMA, etc.) are fully approved.
8 - Congress will continue to support the VA and other Research Institutions as they work with the FDA through its 4 Expedited Programs for Serious Illness. In regards to Psychedelic Medicine:
- These new drugs should receive a Breakthrough Therapy designation as they demonstrate a substantial improvement over what is currently available for conventional treatment resistant patients. This will expedite the development and review of psychedelic medicines. Priority Review can lead to an FDA approval decision within 6 months of a drug application.
- Fast Track and Accelerated Approval for these new drugs will facilitate development and help address the unmet needs of treatment-resistant patients suffering from chronic pain, mental illness, and suicidality. Psychedelic Medicine will also address the unmet needs of Veterans dealing with severe pain and existential distress from life-threatening disease such as cancer from exposure to Agent Orange or Burn Pits.
All of the above falls in line with the VA MISSION Act, the STRONG Veterans Act, the Commander John Scott Hannon Veterans Mental Health Care Improvement Act (HANNON Act), and the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act (PACT Act). This legislation was passed because of the need for more access to quality care, more advanced mental health research, and more alternative breakthrough therapies such as Psychedelic Medicine. These bipartisan initiatives have helped millions of Veterans and their families, caregivers, and survivors. This is a testament to what happens when everyday citizens like us voice our concerns and demand that our elected representatives work together to improve our lives.
We have voices that matter. The politicians that represent us will hear that Psychedelic Medicine can transform our nation’s healthcare. The VA will hear that they must become a safe and reliable provider of Psychedelic Medicine. And everyone that suffers from chronic pain, mental health conditions, and suicidal ideation will hear that we truly care about them.
Thank you for signing and sharing this petition. Thank you for sharing your voice. And thank you for taking the time to remember Marine Jodi Maroney and everyone that left us too soon. They are not forgotten.
#MarineJodiMaroney
#VAKetamineDebacles
https://inewsource.org/2020/06/04/san-diego-veterans-suicide-ketamine/
https://www.statnews.com/2023/03/17/ketamine-clinics-shut-down-patients-scrambling-treatment/
77
The Issue
In the near future, Psychedelic Medicine will be widely used to heal patients suffering from chronic pain, mental health conditions, and suicidality. The cost-saving, life-changing, and life-saving potential for these new treatments are immense. These groundbreaking medicines will require a trustworthy healthcare system that follows stringent policy to prevent unnecessary harm. A system that is willing to hold itself accountable for its failures. Unfortunately, the Veterans Health Administration, under the US Department of Veterans Affairs (VA), has repeatedly broken trust with medically complex patients: it has failed to safely and reliably administer Ketamine as a psychedelic treatment. One such failure led to the suicide of a Veteran who served as a helicopter pilot in Iraq and Afghanistan. She is not forgotten.
For treatment-resistant Veterans that suffer everyday with mental health conditions and chronic pain, the use of Ketamine as a "Psychedelic Medicine" has been a major breakthrough. These patients have battled for years, even decades, to improve their health using conventional drugs and therapies offered by the VA, often without success. Psychedelic Medicine will lead the way to profoundly heal mental anguish and chronic pain. It will become our nation’s most powerful tool in the fight to end the epidemic of Veteran suicide. But it must be safely and reliably administered to prevent unnecessary harm and disastrous outcomes.
In the last 5 years, we have become aware of at least 4 different VA Ketamine Debacles. Failures occurred through VA facilities in San Diego, Muskogee, and El Paso. The largest failure was nationwide with Ketamine Wellness Centers (a now defunct independent provider that was approved to treat Veterans by the VA Community Care Network). In each debacle, Veterans were consistently healing with their established Ketamine providers, protocols, and route of administration (Intravenous, Intramuscular, Intranasal, etc.). Then the VA abruptly changed, delayed, stopped, and/or denied reapproval of this breakthrough medicine that was able to help conventional treatment-resistant patients.
The first two debacles were investigated by the VA Office of Inspector General. The answers and guidance from these investigation reports could have prevented the two current failures. Unacceptable policy violations and unethical decision-making continue to have negative outcomes for medically complex and fragile patients. These VA Ketamine Debacles must come to an end.
- The VA must understand that it cannot give hope and ‘transformative healing experiences’ to our most vulnerable Veterans and then rip it all away.
- The VA must become a Safe and Reliable provider of Psychedelic Medicine.
- And the VA must rebuild trust with the Veterans it has left behind.
We call on our public servants, the VA staff members in Positions of Power, to put every affected Veteran of the VA Ketamine Debacles back on their original treatment protocol. Medically, ethically, and legally, these patients deserve “Continuity of Care” that will help relieve their physical pain, mental health conditions, and suicidal ideation. Putting them back on the path of healing is how the VA accounts for its policy violations and unethical decision-making. This is how the VA rebuilds trust. If the VA is ever going to end the epidemic of Veteran suicide, trust is sorely needed.
We call on our Elected Representatives to make an official edit, proposal, and passing of the Marine Jodi Maroney Act for Psychedelic Medicine. This will help transform our nation’s healthcare in the areas of chronic pain, mental health, and suicide prevention. And it will allow the VA’s extensive research capability and operational capacity to lead our country with these profoundly healing treatments.
Leading the way on Psychedelic Medicine will help the VA live up to its mission statement: “To fulfill President Lincoln’s promise to care for those who served in our nation’s military and for their families, caregivers, and survivors.” Veterans have already served. Those "who shall have borne the battle” no longer have to fight. And they should not have to struggle with a healthcare system that is supposed to care for them. With our voices we can help the VA fulfill its promise. With our support we can help Veterans heal and fully come home.
We call on ourselves and each other to sign and share this policy petition. This is how our Elected Representatives, the Department of Veterans Affairs, and all of us honor the legacy of Captain Jodi Maroney. She served our country in a time of war. She came home and volunteered to help those of us in need. She left us too soon. She will always be remembered. Keep flying Marine. Keep flying.
The Marine Jodi Maroney Act for Psychedelic Medicine
On behalf of the Veterans that the VA promises to care for, and in remembrance of Captain Jodi Maroney, we propose the following actions in regards to Psychedelic Medicine:
1 - Our Elected Representatives will continue their bipartisan push to get these treatments medically approved for ALL their constituents. Congress will allocate more funds for research that includes medical trials for Veterans, current military servicemembers, and civilians. Conventional treatment-resistant patients suffer every single day while waiting for the eventual medical availability of these groundbreaking medicines. More research will lead to faster approval.
2 - A retrospective research study/survey will be conducted on Veterans that previously received the IV Ketamine Chronic Pain Protocol through the VA. That treatment was never approved by the Veterans Health Administration. This years-long accidental and unethical experiment on Veterans never should have happened. But, as proven in their medical records, it worked. Now it is vital to study the success of an unapproved protocol that was able to heal treatment-resistant patients. And it is necessary to document the negative effects and disastrous patient outcomes that occurred due to the abrupt discontinuation of a psychedelic treatment that was relieving conventional treatment-resistant chronic pain.
3 - A retrospective research study/survey will be conducted on Veterans that previously received Ketamine for the approved mental health protocol - with specific focus on how this psychedelic medicine healed their other health issues and improved their overall quality of life. Most psychedelic research is currently focused on treatment-resistant mental health conditions. Many patients are medically complex with mental health issues, chronic pain, life-threatening disease, medication problems, and socioeconomic barriers. Studying current results will lead to more diverse clinical trials and the approval of psychedelics for other life-impairing conditions (Arthritis, Cancer Pain, Fibromyalgia, Long Covid, Lyme Disease, Neuropathy, Parkinson’s Disease, Phantom Limb Pain, etc.).
4 - Once a Veteran begins a protocol for Ketamine or any Psychedelic Medicine, no administrative debacle can interrupt, change, or otherwise rip away these transformative healing experiences. As already evidenced by the first two VA Ketamine Debacles (OIG reports #20-03359-220 and #21-01836-66), changing protocols, abruptly canceling future treatments, and lack of care coordination can lead to negative patient outcomes. For medically complex and fragile treatment-resistant Veterans, this unnecessary harm and broken trust can lead to suicide.
5 - If a Psychedelic Medicine protocol is interrupted, changed, or taken away by VA administrators or due to unforeseen circumstances, the VA is medically, ethically, and legally bound to offer the Veteran the exact same protocol that was healing them. This is in line with the law of the VA MISSION Act and 38CFR17.4010 (a(5)) - Community Care Eligibility:
- “The Veteran and the Veteran’s Referring Clinician determine it is in the Best Medical Interest of the Veteran, for the purpose of achieving Improved Clinical Outcomes,” to be reapproved for the exact same Psychedelic Medicine protocol that provided clinically significant healing (as proven in the Veteran’s medical records).
- Among other factors, this reapproval is based on the “nature of the service required by the Veteran; the potential for improved Continuity of Care; and the quality of the care provided.”
6 - In regards to Psychedelic Medicine, the VA Office of Community Care will:
- Respect the legislative intent of the VA MISSION Act, which is to give Veterans greater choice in their own healthcare. It is also designed to give power to front-line VA doctors and other “Referring Clinicians” that know what is in the “Best Medical Interest” of the Veteran.
- Follow its own guidelines to develop and implement a coordinated care plan. In light of the VA Ketamine Debacles, the care plan must prevent policy violations.
- Follow its own guidelines to Facilitate a Collaborative Relationship regarding all aspects of the care coordination process between itself, VA providers, Veterans, and community providers. All parties need to understand the importance of following a psychedelic protocol from start to finish.
7 - In regards to Psychedelic Medicine, the Veterans Health Administration will:
- Safely and reliably approve Ketamine within VA facilities or through a VA Community Care approved provider.
- Create internal policy stating that it is not medically or ethically acceptable to forcibly change a Ketamine protocol or its route of administration (for which efficacy is not established) on a patient already receiving Ketamine through the VA.
- Create internal policy stating that it is not medically or ethically acceptable to discontinue a VA provided psychedelic protocol that has already been proven to work for the individual Veteran.
- Hold employees accountable if it is found that they try to cover up any honest mistake, policy violation, or egregious failure in its administration of Psychedelic Medicine. Mistakes and failures happen. Covering them up and failing to provide “Continuity of Care” is unacceptable, illegal, and directly contradicts the VA mission to care for Veterans.
- Be operationally ready with plans and policies to heal Veterans once new Psychedelic Medicines (Psilocybin, MDMA, etc.) are fully approved.
8 - Congress will continue to support the VA and other Research Institutions as they work with the FDA through its 4 Expedited Programs for Serious Illness. In regards to Psychedelic Medicine:
- These new drugs should receive a Breakthrough Therapy designation as they demonstrate a substantial improvement over what is currently available for conventional treatment resistant patients. This will expedite the development and review of psychedelic medicines. Priority Review can lead to an FDA approval decision within 6 months of a drug application.
- Fast Track and Accelerated Approval for these new drugs will facilitate development and help address the unmet needs of treatment-resistant patients suffering from chronic pain, mental illness, and suicidality. Psychedelic Medicine will also address the unmet needs of Veterans dealing with severe pain and existential distress from life-threatening disease such as cancer from exposure to Agent Orange or Burn Pits.
All of the above falls in line with the VA MISSION Act, the STRONG Veterans Act, the Commander John Scott Hannon Veterans Mental Health Care Improvement Act (HANNON Act), and the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act (PACT Act). This legislation was passed because of the need for more access to quality care, more advanced mental health research, and more alternative breakthrough therapies such as Psychedelic Medicine. These bipartisan initiatives have helped millions of Veterans and their families, caregivers, and survivors. This is a testament to what happens when everyday citizens like us voice our concerns and demand that our elected representatives work together to improve our lives.
We have voices that matter. The politicians that represent us will hear that Psychedelic Medicine can transform our nation’s healthcare. The VA will hear that they must become a safe and reliable provider of Psychedelic Medicine. And everyone that suffers from chronic pain, mental health conditions, and suicidal ideation will hear that we truly care about them.
Thank you for signing and sharing this petition. Thank you for sharing your voice. And thank you for taking the time to remember Marine Jodi Maroney and everyone that left us too soon. They are not forgotten.
#MarineJodiMaroney
#VAKetamineDebacles
https://inewsource.org/2020/06/04/san-diego-veterans-suicide-ketamine/
https://www.statnews.com/2023/03/17/ketamine-clinics-shut-down-patients-scrambling-treatment/
77
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Petition created on August 19, 2024