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October 7, 2024 Updated October 17, 2024 Agency Capture COVID News

COVID

‘Remdesivir Papers’ Allege Controversial Drug Used to Treat Service Members Led to 601 Deaths

A military whistleblower released a series of documents revealing that the military began “liberally” administering remdesivir to service members who were suspected of having COVID-19 — months before the FDA approved the drug.

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A military whistleblower released a series of documents revealing 601 deaths of military service members and a high rate of serious adverse events in clinical trials involving remdesivir, an antiviral commonly administered to COVID-19 patients during the pandemic.

According to “The Remdesivir Papers,” some clinical trials were improperly run. In the case of at least one study, results were never made public. The whistleblower also alleged a widespread lack of informed consent for trial participants.

“Data derived from the Department of Defense [DOD] Joint Trauma System … by a military whistleblower offers a stark contrast to results of multiple clinical trials involving the liberal usage of remdesivir in military treatment facilities and other civilian facilities, as well as its potential contribution to, at minimum, hundreds of untimely deaths,” the documents state.

Yet according to the documents, the military began “liberally” administering remdesivir to service members who were suspected of having COVID-19 — months before the U.S. Food and Drug Administration (FDA) approved the drug.

The whistleblower, known by the pseudonym Daniel LeMay, shared the documents with investigative journalist J.M. Phelps, who published them last week in The Gateway Pundit.

In interviews with The Defender, LeMay and Phelps discussed the documents and their significance.

LeMay said the DOD’s Joint Trauma System is responsible for tracking “all sorts of patient data.” He told The Defender that the “initial trial depicted data manipulation in favor of remdesivir.”

He also said that based on his analysis of the data, several clinical trials did not have a true placebo group for which results could be compared with the remdesivir-receiving group. “The primary issue is with patient data. If we can’t verify the placebo group … then we can’t determine the actual efficacy of remdesivir.”

Reacting to the revelations, Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense, told The Defender:

“All of the information here needs to be made public and the public officials, including Tony Fauci, need to be held to account for the criminal acts associated with the fraudulent ‘trials’ of ivermectin and hydroxychloroquine that were tainted in order to preclude their use, and making remdesivir the standard of care despite the obvious data showing that it kills people.”

Former victims of the COVID-19 hospital protocols, which included administration of remdesivir, and advocates for those victims welcomed the documents’ release.

Gail Seiler, Texas chairperson of the FormerFedsGroup Freedom Foundation, escaped from a Texas hospital in 2021, where she was given remdesivir and listed as “Do Not Resuscitate” against her and her family’s stated wishes. She said “The Remdesivir Papers” only “scratch the surface as to the homicide toll in military hospitals.”

The documents “tell us that our government orchestrated the needless deaths of COVID patients who did not need to die,” Seiler said.

Charlene Delfico, New Jersey state chair of FormerFedsGroup, previously told The Defender that COVID-19 protocols, including remdesivir, implemented at a New Jersey hospital “ran roughshod” over her parents. She said the new documents “validate our grievances regarding remdesivir and the ‘out the window’ standard of care protocol put in place by our government.”

“The whistleblower highlights what we’ve been saying all along,” Delfico said. “This drug is dangerous, and in most cases, fatal. There’s been no transparency or oversight. This should enrage people and make them push for an immediate investigation by Congress.”

“While people were dying, their deaths were being unlawfully labeled COVID deaths — when the deaths should have been attributed to the treatment protocol,” LeMay told The Gateway Pundit.

Military administered remdesivir despite known risks, leading to 601 deaths

According to the whistleblower’s data, 941 military service members died between March 2020 and March 2024. Of those, 63.9%, or 601 service members, were treated with remdesivir. Deaths peaked between November 2020 and July 2021.

“While the military is only a subset of the larger population, it’s clear that service members and veterans who contracted severe COVID and were subsequently treated with remdesivir had a much higher chance of dying,” the documents state.

According to the documents, the DOD administered remdesivir to service members — despite the drug’s known risks and dangers.

“Gilead had already created a monopoly on the drug” with a U.S. patent it secured in 2017 “valid for up to 20 years,” the documents noted.

The drug, developed to treat Ebola, “was subsequently proven to be lethal in human patients.” According to a 2019 New England Journal of Medicine article, remdesivir resulted in the highest mortality rate among four investigational therapies for Ebola administered in the Democratic Republic of Congo — with 53.1% of patients dying.

In 2017, the documents noted, two University of North Carolina researchers, including Ralph Baric, Ph.D., received a $6 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), then headed by Dr. Anthony Fauci, to “accelerate the development of a promising new drug (remdesivir) in the fight against deadly coronaviruses.”

Despite its deadly history, in February 2020, Gilead Sciences received FDA approval to initiate two Phase 3 clinical trials to evaluate the efficacy of remdesivir in treating COVID-19.

In March 2020, the DOD announced “a cooperative research and development agreement with an industry partner” — Gilead — “to gain access to an antiviral drug for treatment use in our medical centers.”

According to the documents, aside from this expedited approval on the part of the DOD, “remdesivir moved quickly through government scrutiny,” with the FDA issuing emergency use authorization in August 2020 and full approval in October 2020.

“I think the DOD has a track record of making the FDA’s life easy,” LeMay said. “If investment and preparations precede approval, who will say no to the DOD, especially if the president is in agreement on a course of action?”

Phelps noted that Public Law 115-92 allows the FDA “to authorize the emergency use of an otherwise unapproved medical product if the Department of Defense … determines that there is a military emergency involving an agent that may cause imminently life-threatening and specific risk to U.S. forces.”

“The expedited timeline for the FDA’s emergency use authorization is beyond concerning, given remdesivir’s troubling history,” Delfico said. “It was very disturbing to read that the DOD and Gilead directly contracted to do this experiment on our military.”

Clinical studies lacked placebo groups

The documents compared several civilian and military clinical studies involving remdesivir, finding a high rate of deaths and injuries among participants who were administered remdesivir. The documents also showed that studies of remdesivir revealed the drug’s dangers.

According to the documents, a May 2020 study published in The Lancet “brought concerns about the efficacy of remdesivir,” noting that administration of remdesivir was stopped early in China “because of adverse events in 18 (12%)” of patients “versus four (5%) who stopped placebo early.”

And a 2021 study published in JAMA Network Open of over 2,300 veterans hospitalized with COVID-19 found that “remdesivir treatment was not associated with survival,” with more deaths and longer hospital stays among those patients who received remdesivir compared to those who did not receive the drug.

According to the documents, “service members and veterans participated in at least four Phase 3 Adaptive COVID19 Treatment Trials” in 2020 and 2021, all of which were sponsored by NIAID. Another study was sponsored by the U.S. Army Medical Research and Development Command (USAMRDC).

The documents revealed questions about studies and how they were conducted.

In one study, NCT04280705 [ACTT-1], “A true placebo, like saline, wasn’t used other than … where there were limitations on matching placebo supplies” and no distinction was made “as to who received which placebo.” Its findings “ignored those who didn’t finish the trial for various reasons, including adverse events.”

As a result, “this study is problematic due to multiple confounding variables that appear to exist intentionally to present a positive outcome for the remdesivir group,” the documents note. Yet, this study “ended up being the only comparison between remdesivir and a type of placebo.”

According to the documents, three other studies, NCT04401579 [ACTT-2], NCT04492475 [ACTT-3] and NCT04640168 [ACTT-4], had “no true placebo group.” Instead, the two groups in each trial received remdesivir alongside another drug.

In these three trials, all-cause mortality ranged from 3.5% to 7.1%, while the rate of serious adverse events ranged between 14.2% and 24.6%. In NCT04401579, “59 participants didn’t finish the trial due to death, which isn’t characterized as being caused by the investigative treatments.”

Another study, NCT04302766, sponsored by USMARDC, was conducted at 22 military facilities, “involving an undisclosed number of participants.”

But according to the documents, “While the trial examined the effects of remdesivir on the treatment of COVID-19, there are no details available at ClinicalTrials.gov to determine the amount of remdesivir administered to participants. There are no results posted to determine all-cause mortality or serious adverse events.”

“In four of five trials, the use of remdesivir resulted in a minimal positive effect on instances of all-cause mortality and serious adverse side events when compared to the administration of a placebo,” the documents stated.

“In some cases, these patients also had comorbidities (e.g., renal and liver disease) that could have been exacerbated by remdesivir and resulted in some of the reported complications such as acute renal injury and failure, as well as liver dysfunction and hepatic failure,” the documents noted.

“With many clinical trials involving service members and veterans taking place before Secretary of Defense Lloyd Austin’s now-rescinded 2021 shot mandate, I question whether the deaths in these trials should have been attributed to remdesivir, or the overall treatment protocol, rather than COVID,” Phelps asked.

“If this was the case, what better coercion technique is there than to improperly say, “Look at all the people dying from COVID,” when you’re trying to convince someone to take a so-called vaccine that can also wreck people’s lives or send them to their graves?” Phelps added.

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Remdesivir risks withheld from service members

The documents also noted that key details about the risks of remdesivir were concealed from service members, depriving them of being able to provide informed consent.

For instance, participants in NCT04302766 were told “there have not been kidney problems seen in humans who have been given remdesivir,” while there was “no mention that the use of remdesivir resulted in the highest mortality rate among participants” in the African Ebola trial.

Gilead’s lobbying may have played a role in the lack of military or regulatory oversight the drug enjoyed. Between 2018 and 2021, Gilead increased its spending on lobbying from $3 million to $8.1 million. By spring 2020, taxpayers had already funded Gilead to the tune of at least $70.5 million for the development of remdesivir.

Delfico connected Gilead’s lobbying to remdesivir’s inclusion in the National Institutes of Health’s COVID-19 hospital protocols. She said:

“Under the CARES Act [Coronavirus Aid, Relief, and Economic Security Act] hospitals received significant payments for administering specific treatments, including remdesivir, which created a financial incentive for hospitals to use the drug despite its mortality rates.

“The lobbying, financial incentives and treatment protocols raise questions about the motivations behind remdesivir’s widespread use and the potential impact on patient care.”

Questions about the remdesivir clinical trials, missing clinical trial results and the potential lack of informed consent were addressed in a Sept. 27 letter by Rep. Clay Higgins (R-La.) to Austin and the heads of other federal and military agencies, including the FDA.

Separately, on Sept. 24, Phelps submitted a Freedom of Information Act (FOIA) request to the USAMRDC, for the results of the NCT04302766 trial. According to LeMay, “They’ve been unresponsive and will likely continue in that fashion unless there’s an official inquiry by Congress which is specific to this matter.”

Seiler called on “more whistleblowers and victims to come forward.”

Phelps said:

“While emails, a FOIA request, and a congressional inquiry may be ignored, we are writing history. It’s a matter of public record. The American people, especially those who lost loved ones during the pandemic, deserve to know the truth.”

Updated: This article was updated to correct the number of deaths linked to remdesivir.

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