Remdesivir Under Scrutiny: Clinical Trials and the Involvement of Military Personnel

Ethics and Risks of Military Clinical Trials for Remdesivir

Introduction

The recruitment of military personnel for clinical trials involving Remdesivir, an antiviral treatment for COVID-19, raises urgent ethical questions, particularly given the absence of data on whether these service members have experienced harm during the trials Notably, the U.S. Army Medical Research & Development Command has actively sought military members and Department of Defense (DoD)-affiliated civilians diagnosed with moderate to severe COVID-19 for these trials. Expanded Access Remdesivir (RDV; GS-5734™) This practice brings to light significant concerns about the safety profile of Remdesivir and the implications of using our troops as subjects for a drug with a troubling history.

Recent reports from the World Health Organization (WHO) and the European Medicines Agency (EMA) have raised alarms regarding the adverse effects of Remdesivir. The WHO highlighted a disproportionately high number of liver and kidney problems in patients receiving Remdesivir compared to those on other COVID-19 treatments. Meanwhile, the EMA has initiated a review of reports concerning acute kidney injuries associated with the drug. Despite these alarming concerns, military personnel have been recruited for clinical trials involving Remdesivir, raising serious questions about transparency and accountability in the research process, particularly regarding the lack of publicly available trial results.

The clinical trial identified as NCT04302766, which involves Remdesivir, has raised significant questions regarding its findings and the transparency of data. Despite the ongoing inquiries and a congressional request for clarification, specific results from this trial remain elusive.

Remdesivir has been used in various settings, including military personnel, but evidence of its effectiveness is mixed. Some studies indicate that while Remdesivir may reduce recovery time for hospitalized patients with COVID-19, it has not consistently demonstrated a significant impact on mortality rates Association of Remdesivir Treatment With Mortality Among Hospitalized Adults With COVID-19 in the United States Observational studies, including those within the Veterans Health Administration, suggest that while it can prolong hospital stays without improving survival outcomes, the overall benefits in clinical practice are debated. VA and Remdesivir

JM Phelps - FOIA Requests

Leading the way in investigating the responses and submission of FOIA requests concerning clinical trial NCT04302766 is JM Phelps. JM Phelps

This work is being followed closely in anticipation of his Remdesivir Papers announcement.

JM’s announcement can be found here: The Remdesivir Papers His diligent work has illuminated the significant lack of communication from numerous military treatment facilities regarding this trial, which further complicates the situation. As inquiries persist, Phelps's efforts underscore the urgent need for greater accountability and transparency surrounding the data from this trial. For more on his FOIA questions, follow @JMPhelpsLC. JM Phelps Remdesivir Investigation

Funding and Development Background

Remdesivir's development was initially supported by a grant from the CDC (U.S. Department of Health and Human Services) in 2017, following earlier research on Ebola and coronaviruses. CDC Remdesivir Grant A partnership between the CDC and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) laid the groundwork for the drug’s clinical application within military contexts. Army Partnership This collaboration raises questions about potential conflicts of interest and the ethical ramifications of involving military personnel in trials for a drug with a questionable safety profile.

Clinical Trials and Military Recruitment

The clinical trials for Remdesivir, overseen by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) under Dr. Anthony Fauci, primarily relied on Houston Methodist as the sole participant source. This has led to scrutiny regarding the relationships between key figures, including Dr. Fauci, Dr. Boom (CEO of Houston Methodist), and Judge Hughes, raising questions about vested interests in promoting favorable outcomes for Remdesivir. Houston Methodist - Again!

The U.S. Army Medical Research & Development Command's active recruitment of military personnel includes medical centers globally, Military Recruited Globally such as:

• Naval Medical Center San Diego, CA

• Naval Medical Hospital Jacksonville, FL

• Martin Army Community Hospital

• Eisenhower Army Medical Center

• Tripler Army Medical Center

• Womack Army Medical Center

• Craig Joint Theater Hospital, Afghanistan

• NATO Role 3 Multinational Theater Unit, Kandahar

• US Naval Hospital, Guam

• US Military Hospital, Kuwait

This extensive recruitment effort emphasizes the need to carefully consider the health risks that service members may face due to Remdesivir's side effects, which include kidney and liver damage, cardiovascular complications, and other serious concerns.

Risks to Service Members

The ethical implications of involving military personnel in clinical trials for Remdesivir are profound. The health risks associated with the drug prompt concerns about whether the Department of Veterans Affairs will provide disability compensation for any injuries sustained during these trials. The potential for harm to our troops is an urgent issue that must not be overlooked.

Historical Context

This situation echoes past ethical breaches in military research, particularly the involvement of servicewomen in clinical trials for breast cancer treatments and other medical interventions. For more on this topic, see my previous February 2023 work (by Dr. Crisanna Shackelford ) discussing the use of service members in clinical trials, which examines the ethical implications and oversight concerns surrounding their involvement in medical research. DOD & Active-Duty Service Women Used in Breast Cancer Clinical Trials Historically, female military personnel have participated in studies with limited informed consent, often under the guise of advancing medical knowledge. For example, the deployment of hormone therapies and other treatments has sometimes lacked comprehensive disclosure regarding potential risks, raising questions about the adequacy of consent processes in military settings.

The Role of Women in Military Medical Research. Bioethics.
This article focuses on the participation of women in military medical research, highlighting the historical context and ethical implications of their involvement. It discusses issues of informed consent and the specific challenges faced by female service members in clinical trials, emphasizing the need for enhanced protections and ethical oversight in research involving women.

https://bioethicsjournal.com/

Moreover, the historical trend of prioritizing medical advancement over the rights and well-being of military personnel underscores the pressing need for rigorous ethical standards in the recruitment and treatment of service members in clinical trials. Challenges With Engaging Military Stakeholders for Clinical Research at the Point of Care in the U.S. Military Health System

Interdependent Funding Streams

As detailed in my previous research Key funding trail leads us to the U.S. Army Medical Research and Development Command (USAMRDC): As one examines the web of interconnected, interdependent funding streams and DoD involvement - namely the use of service women being used in clinical trials - a key funding trail leads us to the U.S. Army Medical Research and Development Command (USAMRDC). USARMRDC Here we find that “US Department of Defense (DOD) received an appropriation from Congress, and specifically a part of this appropriation that went to a part of the Army known as the Medical Research Material Command Center Medical Research 

Much of this funding was for vaccine trials targeting breast cancer.

As we reflect on these practices, it is vital to ensure that contemporary research maintains transparency and safeguards the health and autonomy of those who serve .

Conclusion

Ethics

“Is it ethical to allow the first line defenders of our Nation to also be subjected to the ‘first line risk’ of clinical trials “that benefit corporations.”  Dr. David Martin, Personal communication with Dr. Crisanna Shackelford, 2021.

The situation surrounding Remdesivir and its involvement in military clinical trials demands urgent scrutiny. The alarming potential risks associated with the drug, coupled with troubling relationships among key stakeholders, highlight the need for transparency and accountability regarding the health and safety of our service members. JM Phelps's diligent efforts in investigating and submitting FOIA requests concerning clinical trial NCT04302766 shed light on the significant communication gaps from numerous military treatment facilities, further complicating this critical issue. As inquiries persist, we must advocate for the rights and well-being of those who serve, ensuring that ethical standards in medical research are upheld. The implications of this situation extend beyond medical ethics; they touch on the very readiness of our military forces. Only through concerted investigation and public pressure can we ensure that our troops are protected and that their health is prioritized.

Timeline Connection

In a related announcement, the U.S. Army Medical Materiel Development Activity (USAMMDA) recently disclosed its agreement with Gilead Sciences to provide investigational Remdesivir for Department of Defense personnel exposed to COVID-19. This underscores the urgent need to scrutinize the implications of involving military personnel in the clinical trials of a drug already under significant scrutiny. USAMMDA Announces Agreement with Gilead Sciences to Provide Investigational New Drug for Warfighters Exposed to Coronavirus Disease

About the Author

Dr. Crisanna Shackelford is a leading advocate for service members and veterans affected by vaccine-related injuries, with a deep commitment to uncovering the truth about how military personnel have been systematically harmed and disenfranchised. Her investigative research, and collaboration with a VA whistleblower into the lack of accountability and transparency within the Department of Veterans Affairs (VA) has revealed troubling trends in how the VA dismisses vaccine injuries, particularly within the military.

Dr. Shackelford collaborates with notable experts such as Dr. David Martin and engages with leaders in the field, including Dr. Robert Malone, to shed light on the critical intersection of medical ethics and military readiness. As a public speaker, she has been featured on major platforms such as The HighWire with Del Bigtree, along with numerous podcasts where she explores the deeper systemic issues affecting our national defense.

In addition to her advocacy, Dr. Shackelford is the Founder and CEO of Real Reactions, a nonprofit organization that provides financial relief to military personnel and veterans injured by vaccines and injections administered under military authority. Through this work, she aims to ensure that those who have served are given the care and acknowledgment they deserve.

Most of the articles in her Substack explore the complexities of our Armed Forces, veterans' issues, and the ongoing challenges of COVID-19, which often dominate current discussions. She also delves deeply into topics like Nonlinear Warfare, Foresight Development, and threats to our national security. These issues are often interdependent, and understanding their complexity is crucial to shaping our defense posture and ensuring the resilience of our nation moving forward.

References

Here are some resources that provide further insights into the ethical implications of involving military personnel in clinical trials:

1. Chappell, P. (2007). "Informed Consent in Military Research: A Review of Ethical Issues." Bioethics.
   This review discusses the unique ethical challenges surrounding informed consent in military research. It emphasizes the importance of ensuring that service members fully understand the implications of participating in studies, especially given the hierarchical structure of the military, which may influence their decision-making process. The article highlights the need for clear communication and safeguards to protect service members’ rights.

2. Fisher, C. B., et al. (2010). "The Ethics of Research with Military Personnel." American Psychologist.
   This article explores the ethical dilemmas specific to conducting research with military personnel. It addresses issues such as the power dynamics between researchers and service members, the potential for coercion, and the need for institutional review boards (IRBs) to ensure ethical standards are met. The authors call for more comprehensive guidelines tailored to military contexts.

3. Morris, R. (2011). "Ethics in Military Research." Journal of the Royal Society of Medicine.
   This paper examines the ethical considerations in military research, focusing on the balance between scientific advancement and the welfare of service members. It discusses the potential for exploitation, the need for informed consent, and the importance of respecting the autonomy of participants. Morris advocates for rigorous ethical oversight to prevent abuse and protect the rights of military personnel.

4. Davis, M. S. (2014). "Ethical Issues in Research Involving Military Personnel." Journal of Military Ethics.
   Davis highlights various ethical issues in research involving military personnel, including the effects of combat exposure on psychological well-being and the ethical implications of using vulnerable populations. The paper stresses the importance of transparency, informed consent, and the need for researchers to prioritize the safety and welfare of participants.

5. Scherer, L. D., et al. (2017). "Informed Consent in Military Research: A Qualitative Study of the Perspectives of Service Members." Military Medicine.
   This qualitative study investigates service members’ perspectives on informed consent in military research. The findings reveal a lack of understanding among participants about the research process and their rights, often stemming from the military culture. The authors recommend improving communication strategies and emphasizing the importance of informed consent to enhance trust and participation in military research.

We must continue to demand transparency and accountability regarding the results of the clinical trials, particularly concerning any potential harm to service members. Ensuring access to this data is essential for safeguarding their rights and well-being, as it sheds light on the ethical implications of their involvement in research. It is our responsibility to hold the responsible parties accountable and to advocate for the health and safety of those who serve our nation.