Concerns Over Informed Consent in Remdesivir Clinical Trials for Service Members and Veterans

Concerns Over Informed Consent in Remdesivir Clinical Trials for Service Members and Veterans

Concerns are escalating regarding the informed consent forms that service members and veterans might have signed to take part in a clinical trial assessing the efficacy of remdesivir as a treatment for COVID-19.

“Are you a service member or veteran who participated in the U.S. Army Medical Research and Development Command’s (USAMRDC) clinical trial NCT04302766 for the treatment of COVID-19 with remdesivir (GS-5734™)? Are you a spouse or family member of a service member or veteran who participated in the trial? Are you in possession of the Informed Consent Form?”

Individuals who qualify as service members, veterans, or their family members are strongly urged to come forward if they were impacted by the administration of remdesivir as part of a COVID-19 treatment trial conducted between 2020 and 2021. Click here to share your experience.

Published for the first time by Gateway Pundit on October 4, 2024, an investigative report titled The Remdesivir Papers has surfaced alarming data indicating that a staggering 64 percent of service members and veterans, whose fatalities were reportedly linked to COVID-19, had received remdesivir during their treatments.

Amidst growing scrutiny, the author of the report has expressed serious concerns regarding the Informed Consent Form that was provided to participants at the initiation of the USAMRDC clinical trial NCT04302766. The Gateway reached out to attorney R. Davis Younts to discuss these troubling issues in detail.

The retired Air Force lieutenant colonel and former judge advocate general officer described the informed consent form as fundamentally a contract, stating, “I would certainly argue that from a legal standpoint, all the same principles [of a contract] are going to apply.”

“According to the principles of contract law,” Younts elaborated, “it’s basically an agreement between two parties coming together to reach a mutual understanding on something.” He underscored that honesty is crucial to ensuring “the benefit of the bargain.” In simpler terms, both parties involved are entitled to receive what they agreed upon without any form of deception.

Commenting specifically on the contents of the informed consent form issued by USAMRDC, Younts pointed out the following alarming statement found in Section 6.1:

“Remdesivir has also been given to Ebola survivors in West Africa and to people with Ebola virus disease. Some of these people had side effects.”

Taking into account that The New England Journal of Medicine (NEJM) reported in May 2019 that the use of remdesivir resulted in the highest mortality rate compared to other investigational therapies in a trial concerning Ebola in the Democratic Republic of Congo, Younts asserted that “this informed consent is very misleading.” The data showed that 93 out of 175 participants (53.1 percent) in that specific remdesivir group died during the trial.

Younts stressed, “the essence of informed consent is that individuals should possess the freedom and capacity to make knowledgeable decisions concerning their healthcare.” He emphasized that “one cannot genuinely consent to something if they are not provided with accurate and comprehensive information.”

For Younts, given the significant number of deaths reported by NEJM in 2019, the claim that “some people had side effects” raises serious ethical concerns, as he believes it represents a considerable level of deception.

Furthermore, Section 7 of USAMRDC’s Informed Consent Form for clinical trial NCT04302766 stated that “at best, the website will include a summary of the results.” However, contrary to this promise, no results have yet been posted to the designated site. “They failed to honor the contract,” Younts contended. “For any medical provider, pharmaceutical company, or other entities to claim they would disclose the results and then not deliver is a blatant breach of the contract.”

In light of these serious allegations, multiple inquiries via email were dispatched to the military treatment facilities implicated in the trial. Additionally, a FOIA request was filed with the U.S. Army Medical Research and Development Command (USAMRDC) on September 24. It has since been assigned a case number with an anticipated completion date of January 10, 2024.

Adding to the scrutiny, a congressional inquiry initiated by Rep. Clay Higgins (R-Louisiana) was addressed to Defense Secretary Lloyd Austin on September 27, duly copying key figures including the U.S. Health and Human Services Secretary and the FDA Commissioner, along with USAMRDC Commanding General Maj. Gen. Paula C. Lodi, among others.

**Interview with R. Davis⁣ Younts, Attorney and Retired ⁢Air Force Lieutenant Colonel**

**Interviewer:** Thank you for joining us today, Mr. Younts. Concerns have ‍recently surfaced regarding informed consent ‍forms used ⁢in the USAMRDC clinical trial for remdesivir. Can you share your perspective on this issue?

**R. Davis Younts:** Thank⁢ you for having⁣ me. ​This issue is critical. The informed consent‍ form ⁤acts fundamentally as a contract between the clinical trial participants and the ⁢researchers. That’s why the principles of contract law apply ⁢here—both parties need to reach a mutual ⁤understanding, which hinges on honest and transparent communication.

**Interviewer:** You’ve raised alarm ⁣over specific wording in ‌the consent form. Can you elaborate on that?

**R. Davis Younts:** Certainly. The ‍form states that ‌“some ​of these people had ⁤side effects” when​ discussing remdesivir’s previous applications. Given that the ⁤New⁢ England Journal of Medicine reported a 53.1% mortality rate⁤ in a trial involving Ebola, this ‌phrase feels grossly misleading. It ⁢downplays the‌ severity of risks ‌associated⁢ with the drug.

**Interviewer:** What are the ethical implications of such misleading ⁣information in‍ informed consent?

**R.‍ Davis Younts:** The essence of informed consent ‍is informed decision-making. If participants are not provided accurate and‌ comprehensive information—such as‍ the historical outcomes of ‍remdesivir in previous trials—they lack ⁤the ability to make informed decisions about their health. This represents a significant ethical ⁤failure.

**Interviewer:** Given the staggering⁢ statistics regarding fatalities, what impacts do you anticipate for ​service members,‌ veterans, and their families?

**R.​ Davis⁢ Younts:** This situation is particularly⁤ troubling for​ service members‍ and veterans who trusted the military’s health protocols. It creates a profound mistrust when individuals ​feel they were misinformed about potential ‍risks. I urge anyone impacted to come forward and share‍ their experiences.

**Interviewer:** Thank you, Mr.⁣ Younts, for your insights. ‍This ⁤is an‌ important issue that warrants continued attention as further investigations unfold.

**R.‍ Davis ⁢Younts:** Thank you for shining a light on​ it. It’s crucial that we ⁣advocate for transparency ‍and accountability, especially in healthcare decisions involving our veterans.

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