EXCLUSIVE: Fauci’s Agency Scrambled to Answer Questions on Changing Remdesivir Trial Endpoint: Emails

EXCLUSIVE: Fauci’s Agency Scrambled to Answer Questions on Changing Remdesivir Trial Endpoint: Emails

By Zachary Stieber
April 16, 2022 Updated: April 16, 2022
Dr. Anthony Fauci and top officials at the agency he heads scrambled in April 2020 to answer questions about altering the endpoint in a trial testing the antiviral drug called remdesivir, newly obtained emails show.

The endpoint was changed in the middle of the trial from measuring the effectiveness against death and various forms of hospitalization on day 15 to time to recovery through day 29.

Gilead Sciences, which makes the drug, announced the results of the trial in early April 29, 2020. Within hours, Fauci, the longtime head of the National Institute of Allergy and Infectious Diseases (NIAID), was trumpeting them to reporters at the White House.

The trial results proved that remdesivir “can block the virus” that causes COVID-19, said Fauci, who didn’t mention the change in endpoint.

Just hours later, doctors and reporters started questioning researchers involved with the trial and NIAID, which funded the study and said its officials were behind the change.

Officials at the agency were not prepared for questions about the matter, according to emails obtained by The Epoch Times and never published before.

Dr. Andre Kalil, an infectious disease expert at Nebraska Medicine Omaha who was helping run one of the trial sites, told Fauci, Dr. Clifford Lane, and John Beigel, all top NIAID officials, at 3:19 a.m. on April 30, 2020, that he had received multiple requests from colleagues and reporters on why the primary outcome was changed while the trial was underway.

“Believe or not, but I even heard nonsense things such as a conspiracy theory that Gilead opened the database and changed the primary outcome to favor the trial results,” Kalil wrote. “In order to prevent more conspiracies, I thought about a transparent and objective way to respond to these questions, so we can all be on the same page.”

The statement he proposed was redacted. NIAID, which released the emails based on a Freedom of Information Act request, cited an exemption that allows the government to shield inter-agency or intra-agency memorandums or letters “which would not be available by law to a party other than an agency in litigation with the agency.”

About two hours later, Lori Dodd, an NIAID statistician, responded by saying she liked what Kalil wrote. Soon after, Beigel, the trial’s principal investigator, said he was “merging the two” in an email that was otherwise redacted and on which Kalil had been cut out.

A draft statement was sent to the Food and Drug Administration, which “cleared with Gilead” a paragraph about the regulator’s “commitment to expediting” COVID-19 treatments and how the agency had been in touch with Gilead about making remdesivir available to patients “as quickly as possible, as appropriate,” the emails show.

The statement was still being adjusted at 3:20 p.m., according to a missive from Jennifer Routh, an NIAID spokeswoman, sent to Beigel, Lane, and others.

“We now have 10 media inquiries asking about why the primary endpoint in the remdesivir study changed,” she said, adding later: “We need a statement to respond as soon as possible. Is this OK to send or is this still under review?”

The draft statement was redacted.

Reporters from the Wall Street Journal, CNN, and the Washington Post, among others, had reached out, with the latter later quoting Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, as saying government scientists shifted the endpoint because they “thought they weren’t going to win, and they wanted to change it to something they could win on.”

Another expert, Henry Drysdale of the University of Oxford, panned the NIAID’s statement, saying, “Whenever I see an explanation like this, when an outcome-switching has happened, that’s fine, but you were not open about this when you reported your quote-unquote exciting results.”

NIAID ultimately sent a statement out around 4:30 p.m., with The Epoch Times being one of the outlets that obtained it.

Drug-remdesivir-COVID-19
Rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in March 2020. (Gilead Sciences via AP)

“Little was known regarding the natural course of COVID-19 when the trial was initially designed, and the initial endpoint chosen specified a single timepoint for evaluation, namely day 14. However, with the growing knowledge during the epidemic, we learned that COVID-19 had a more protracted course than previously known. Further concerns were raised about the reliance on a single time point for evaluating treatment effects,” the agency said.

“While still blinded to treatment assignment, NIAID statisticians performed modeling of what happens if the right day is not picked for assessment, which revealed that meaningful treatment effects could be missed with that primary endpoint. Time to recovery avoids this issue, and the change in primary endpoint seemed appropriate given the evolving clinical data. This change in primary endpoint was made without any knowledge of data from ACTT, before any interim data was available.”

ACTT is the name of the trial.

Biegel, Dodd, Kalil, and others involved in the study wrote in the New England Journal of Medicine following peer review of the results that the change was proposed on March 22, 2020—after 72 patients had been enrolled—by statisticians who were “unaware of treatment assignments and had no knowledge of outcome data.” The change was finalized on April 2, 2020, he said, and the primary measure became one of many secondary outcomes.

On the trial’s official page, the change in outcome was not reported until April 16, 2020.

Additionally, during an April 24, 2020, teleconference that included then-National Institutes of Health (NIH) Director Dr. Francis Collins, the original primary endpoint was still listed as the main endpoint, according to slides obtained by The Epoch Times. The data in the slides was listed current as of April 6, 2020.

Executives and scientists from Pfizer, Johnson & Johnson, and AstraZeneca, among others, took part in the meeting. Bill Lee, Gilead’s executive vice president of research, was listed as a “tentative” attendee but it wasn’t clear whether he ended up attending.

Gilead, NIAID, and Fauci did not respond to requests for comment.

The emails also showed that Fauci listed erroneous statistics at the White House.

Fauci “used the old mortality numbers,” Routh wrote shortly after the doctor spoke during an appearance with then-President Donald Trump.

“Just spoke with Dr. Fauci on phone. He confirmed he has the new numbers,” Kimberly Barasch, with the office of the NIAID director, said.

“To be clear though, he USED the old numbers,” Courtney Billet, an NIAID spokeswoman, responded. “And I talked to him just now on the phone and he confirmed we should stick with those in written statement.”

“Fauci was great. Good job to all who prepped him, and thanks for trying to squeeze in the updated numbers,” Dodd later wrote.

“Thanks to all for the help—the process wasn’t pretty but it worked out in the end!” Billet said.

The impact of the trial results was dramatic. Remdesivir was immediately declared the new standard of care, or the standard treatment for COVID-19 patients, in a time when cases, hospitalizations, and deaths were overwhelming some hospitals. No other treatment had received such positive promotion from top government officials at that time.

Before the results were announced, meanwhile, Gilead sent Beigel a press release that the company planned to issue “just before the market opens tomorrow AM.”

“There will be a lot of interest after that statement,” Beigel wrote, sharing the release with Routh, Lane, and others with NIAID.

Fauci quickly reviewed the release and had no issues with it, Routh said.

After the Gilead and NIAID announcements on April 29, 2020, Tomas Cihlar, a senior vice president at Gilead, wrote to Lane thanking him for the ACTT trial “and the amazing work your clinical team did.”

“Congratulations,” Cihlar said.

The first part of Lane’s response was redacted.

“I am glad for Gilead as well,” Lane also wrote.

Natural Immunity is Usually Life Long

Corona Investigative Committee

American’s Grand JuryReal Evidence of Alleged Crimes for Real World Prosecution

Fauci Was Told Privately by Key Scientists That COVID-19 Natural Origin Was ‘Highly Unlikely,’ Newly Unredacted Emails Confirm

Fauci Was Told Privately by Key Scientists That COVID-19 Natural Origin Was ‘Highly Unlikely,’ Newly Unredacted Emails Confirm

“I just can’t figure out how this gets accomplished in nature”
January 11, 2022 Updated: January 11, 2022

 

News Analysis

Top U.S. health officials, including Dr. Anthony Fauci, scrambled in early 2020 to respond to public reporting of a potential connection between COVID-19 and the Wuhan Institute of Virology in China.

This response, which included a secret Feb. 1, 2020, teleconference, was loosely detailed in previously released and heavily redacted emails. Those emails strongly suggested that Fauci and a small group of top scientists sought to promote the natural origin theory, despite having evidence and internal expert opinions that pointed to the possibility of a leak from the Wuhan lab.

Unredacted versions of some of the emails made public by lawmakers on Jan. 11 further confirm this.

The newly unredacted emails, released by House Oversight Committee Republicans, confirm and illustrate a pattern of lies and coverup. From the emails, it appears the effort was spearheaded by Fauci himself but also involved his boss, recently retired National Institutes of Health (NIH) Director Dr. Francis Collins, as well as Jeremy Farrar, the head of the British Wellcome Trust.

It was previously revealed that at least two scientists, both of whom had received funding from the NIH, had told Fauci during the teleconference that they were 60 to 80 percent sure that COVID had come out of a lab.

The most significant new revelations in the unredacted emails come from two of these scientists, Robert Garry and Mike Farzan, who both noted the difficulties presented by the presence of a furin cleavage site in the COVID-19 virus—a feature that would later be cited as the defining characteristic of the virus.

‘Bothered by the Furin Site’

Farzan, an immunologist who in 2005 discovered the receptor of the original severe acute respiratory syndrome (SARS) virus, sent his post-teleconference notes to Farrar, who then shared them with Collins, Fauci, and Lawrence Tabak—top officials at the NIH. In those notes, Farzan wrote that he was “bothered by the furin site” and had difficulty explaining it “as an event outside the lab.” Farzan noted that it was theoretically possible the virus’s furin cleavage site could have arisen in nature but that it was “highly unlikely.”

The furin cleavage site is the defining feature that gives COVID-19 the ability to easily infect humans and has long been puzzled over by scientists, since no such site has ever been observed in naturally occurring SARS-related coronaviruses.

Farzan, like scientist Kristian Andersen, who has received funding from Fauci’s NIAID, works at the Scripps laboratory. As was already known from previously released emails, Andersen had privately told Fauci on Jan. 31, 2020 that the virus looked engineered. Andersen would later spearhead Fauci’s efforts to promote a natural origin narrative.

Epoch Times Photo
Then-NIH Director Dr. Francis Collins listens during a Senate Appropriations Labor, Health and Human Services Subcommittee hearing looking into the budget estimates for National Institute of Health (NIH) and state of medical research on Capitol Hill in Washington on May 26, 2021. (Sarah Silbiger-Pool/Getty Images)

Farzan told the senior members of Fauci’s teleconference group that “a likely explanation could be something as simple as passage SARS-live CoVs in tissue culture on human cell lines” for an “extended period of time,” which could lead to the accidental creation of “a virus that would be primed for rapid transmission between humans.” This mutated virus would likely have specific “adaptation to human ACE2 receptor via repeated passage.”

recent study in the science journal Nature noted that the COVID-19 virus was uniquely adapted to infect humans, as it “exhibited the highest binding to human (h)ACE2 of all the species tested.”

In layman’s terms, Farzan concluded that the pandemic likely originated from a lab in which live coronaviruses were passed through human-like tissue over and over, accelerating virus mutations with the end result being that one of the mutated viruses may have leaked from the lab. Farzan placed the likelihood of a leak from a Wuhan lab at 60 to 70 percent likely.

The emails indicate that Farzan was cognizant that the Wuhan lab conducted these types of dangerous experiments in Level 2 labs, which have a very low biosecurity standard. This fact was later admitted by the Wuhan lab’s director, Shi Zhengli, in July 2020. Notably, since the start of the pandemic, Farzan has received grants totaling almost $20 million from Collins’s NIH and Fauci’s NIAID.

‘Can’t Figure Out How This Gets Accomplished in Nature’

Further revelations in the newly unredacted emails came from Garry, another scientist funded by Fauci’s NIAID, who told the senior members of the teleconference group in no uncertain terms that “I really can’t think of a plausible natural scenario where you get from the bat virus” to COVID-19.

Garry cited the remarkable sequences that would have to occur naturally, telling the group that “I just can’t figure out how this gets accomplished in nature. Do the alignment of the spikes at the amino acid level – it’s stunning.” He noted that a lab-created virus would readily explain the data he was seeing, telling Fauci’s group that “Of course, in the lab, it would be easy to generate the perfect 12 base insert that you wanted.”

Epoch Times Photo
The P4 laboratory on the campus of the Wuhan Institute of Virology in Wuhan, Hubei Province, China, on May 13, 2020. (Hector Retamal/AFP via Getty Images)

Along the same lines of what Farzan had said, Garry was telling Fauci’s group that it was extremely unlikely that the furin cleavage site could have evolved naturally, whereas creating it in a lab was easy.

The primary difference between Farzan’s and Garry’s view lies in whether the lab created the furin cleavage site through serial passage in human-like tissue or through direct insertion of the site. In either case, both scientists thought it was likely that the virus came out of the Wuhan lab rather than having originated in nature.

Scientist’s Private Views Conflicted With Public Statements

Garry’s privately stated view is even more remarkable because only a day earlier, on Feb. 1, 2020, Garry had helped to complete the first draft of the Proximal Origin paper that promoted the idea that the virus had originated in nature. That paper became the media’s and the public health establishment’s go-to evidence for a natural origin for the COVID virus.

It was published online on Feb. 16, 2020, and firmly excluded the possibility of a lab leak.

One of Garry’s co-authors for the Proximal Origin paper, Andrew Rambaut, also is cited in the newly redacted emails. In congruence with the other two scientists, Rambaut told Fauci’s teleconference group that he also was bothered by the unusual furin cleavage site. But unlike Garry or Farzan, he speculated that the virus might have arisen in another animal, a so-called intermediate host.

Epoch Times Photo
Peter Daszak, right, the president of the EcoHealth Alliance, is seen in Wuhan, China, on Feb. 3, 2021. (Hector Retamal/AFP via Getty Images)

Two years later, no such host has been identified. In the case of the original SARS virus as well as the Middle East respiratory syndrome (MERS) virus, the intermediate host was found within a few months. Rambaut also recognized immediately the peculiar fact that the furin cleavage site “insertion has resulted in an extremely fit virus in humans—we can also deduce that it is not optimal for transmission in bat species.”

Rambaut lamented the lack of data being shared by Wuhan scientists and concluded that only the Wuhan Institute of Virology knew what had happened.

Fauci’s Group Misleads National Academy of Sciences

The day after these three scientists shared their views with the senior members of the group, on Feb. 3, 2020, Fauci attended a meeting at the National Academies of Sciences, Engineering, and Medicine (NASEM). That meeting had been urgently convened at the behest of White House Director of Science and Technology Kelvin Droegmeier, who wrote that he was seeking answers about the origins of COVID-19.

Epoch Times Photo
Dr. Anthony Fauci, White House chief medical advisor and director of the NIAID, shows a screengrab of a campaign website for Sen. Rand Paul (R-Ky.) while answering questions at a Senate Health, Education, Labor, and Pensions Committee hearing on Capitol Hill on Jan. 11, 2022. (Greg Nash-Pool/Getty Images)

The meeting, which included a presentation by Fauci, was also attended by Peter Daszak–the person through whom Fauci had funded the Wuhan Institute of Virology–and Kristian Andersen. Fauci and his group promoted the natural origin theory to the Academy, despite having just been told on the teleconference and in subsequent emails that a lab leak provided the most likely explanation for the virus.

While they were pushing their natural origin narrative to NASEM, and by extension to the White House, Fauci and his group made no mention of their private discussions—which were taking place at the same time—that the virus most likely originated in a Wuhan lab.

NIH Hiding Behind Unjustifiable Redactions

The new emails fill some of the gaps left by previous redactions, but still only cover a small portion of the many emails that remain redacted. A close examination of the newly unredacted emails reveals that none of the usual justifications for redactions, such as private information about people or threats to sources and methods, apply. Instead, it appears that all of the redactions were made solely on the basis of shielding the NIH from scrutiny over its coverup of the virus’s origins.

These efforts at obfuscation tie in with the fact that we only found out about these new emails after a months-long battle between the Department of Health and Human Services (HHS), the parent organization of Fauci’s NIH and NIAID, and House Republicans.

Epoch Times Photo
The Capitol building in Washington in a file photo. (Samira Bouaou/The Epoch Times)

In order to obtain this information, House Republicans were forced to avail themselves of a rarely used law from 1928, the so-called Seven Member Rule. Under this law, an executive agency, such as HHS, is required to provide requested information when requested by seven members of the House Committee on Government Operations (now called the Committee on Oversight and Reform).

It isn’t known why Republicans haven’t used this law earlier or with greater frequency.

Eventually, HHS allowed the House Republicans’ congressional staffers to view the unredacted emails in person. The staffers then transcribed what they saw, which is how we came to know about these new revelations.

NIH Silences Dissenting Views

These new emails are crucial in that they confirm that by Feb. 2, 2020, Fauci’s teleconference group had identified evidence pointing to a lab leak at the Wuhan Institute of Virology. These scientists knew that the virus’s unique furin cleavage site was very likely the result of experiments conducted at the Wuhan lab. Notably, they also knew that these experiments were being conducted in minimum biosecurity Level 2 labs.

These facts presented a major problem for the heads of the NIH, who had funded the experiments.

Dr. Martin Kulldorff
Dr. Martin Kulldorff, a professor of medicine at Harvard Medical School and a biostatistician and epidemiologist at the Brigham and Women’s Hospital, in Connecticut on Aug. 7, 2021. (York Du/The Epoch Times)

As the new emails confirm, their response was to cover up the lab leak evidence and push a natural origin narrative.

Then-NIH Director Collins, who would later call for the public “takedown” of the authors of the Great Barrington Declaration, asked his group for a “swift convening of experts” in order to prevent the “voices of conspiracy” from doing “great potential harm to science and international harmony…” through public discussion of a lab leak theory.

Collins’s view was mirrored by another participant in Fauci’s teleconference, Dutch virologist Ron Fouchier, who told the group that “Further debate about such accusations would unnecessarily distract top researchers from their active duties and do unnecessary harm to science in general and science in China in particular.”

Jeff Carlson

Jeff Carlson co-hosts the show Truth Over News on Epoch TV. He is a CFA-registered Charterholder and worked for 20 years as an analyst and portfolio manager in the high-yield bond market. He also runs the website TheMarketsWork.com and can be followed on Twitter @themarketswork.

Hans Mahncke

Hans Mahncke co-hosts the show Truth Over News on Epoch TV. He holds LL.B., LL.M. and Ph.D. degrees in law. He is the author of numerous law books and his research has been published in a range of international journals. Hans can be followed on Twitter @hansmahncke

 

Project Veritas: Military Documents About Gain of Function Contradict Fauci Testimony Under Oath

Military Documents About Gain of Function Contradict Fauci Testimony Under Oath

Reiner Füllmich & 50 lawyers: ”The vaccines are designed to kill and depopulate the planet”

Dr. Fauci: “Heck, No, I Haven’t Been Vaccinated”

Dr. Fauci: “Heck, No, I Haven’t Been Vaccinated”

The Deep State’s primary Covid-19 vaccine peddler, Dr. Anthony Fauci, boasted to colleagues at the NIH that he has not taken and will not take the Covid jab, said a former NIH employee who claims Fauci personally fired him in June for “violating or considering to violate non-disclosure agreements” pertaining to vaccination protocols.

Our source, who wishes to remain anonymous at this time, told Real Raw News that he’d been wrongfully terminated—unjustifiably because he never signed non-disclosure paperwork on the Institute’s Covid-19 policies. And the reason he never signed said paperwork is that he had worked for NIH’s Division of AIDS, which was largely excluded from Covid-19 plandemic response meetings and vaccine development.

For ease of reading, RRN will refer to our source as Brian Stowers. RRN has vetted Stowers’ education and employment history, and we found no reason to believe he had a vendetta against Fauci or that he would engage in deception; his credentials seemed unimpeachable. As a Level 2 lab technician, his primary duty at the NIH was spinning blood through a centrifuge and passing results to his superiors. Nothing glamorous.

Although he had no exposure to Covid-19 data, he had been exposed to Dr. Anthony Fauci’s hubris and overbearing presence.

“At least once a week, Fauci made rounds through the departments. He liked to stick his nose in everyone’s business, belittle and ridicule people for no good reason. Anyway, on February 15, 2021, about two months after the FDA gave emergency use authorization to Pfizer’s vaccine, Fauci strolls into our department and tells us that we ought to encourage our friends and family to get vaccinated at the earliest possible date. But he tells us lab workers—there were about 9 in the lab at that moment—to delay getting vaccinated until, as he put it, ‘we see what happens,’” Stowers said.

A long, uncomfortable silence followed Fauci’s statement, our source added.

According to him, one lab worker asked Fauci why the vaccine was safe for friends and family but not for NIH employees.

“Fauci’s face turned red. He was clearly angered by the question. He started berating us, telling us we weren’t qualified to question his judgement. If we didn’t follow his guidance, we’d be jeopardizing the health of our friends and family, Fauci told us. He was on a tirade for like 5 minutes, and cussing like a sailor,” Stowers said.

Then Stowers asked Fauci, respectfully, whether he had been vaccinated.

“What kind of question is that? Not that it’s any business of yours, but, no, heck no, I haven’t been vaccinated. And I don’t plan to be, at least not for a long time, if at all…If I take the vaccine and get sick from it, then what? I’m too important here to take that risk. You all are, too—that’s why I’m telling you to wait. But you can be replaced; I’m irreplaceable. The administration needs me to helm this response,” Fauci reportedly said.

Four months later, unexpectedly, Stowers received a termination letter claiming he had violated the Institute’s confidentiality clause. The notice bore Fauci’s handwritten signature.

“I knew fighting would be pointless. I got 6-month’s severance package and figured that would be enough to hold me until I found new work, and I have,” Stowers said.

In closing, Stowers said Fauci never wore a mask inside NIH facilities, only when, in Fauci’s words, “outsiders and interlopers and media” were nearby.

BREAKING: Shocking Image Surfaces of Dr. Fauci with George Soros, Bill Gates Sr., David Rockefeller & More

@HowleyReporter
WOW: A high-level source just sent me this photo, says that it shows Dr. FAUCI with George SOROS and Bill Gates’ father among others. Source says it’s from 2001. Fauci identified as man third from the left

Patrick Howley
%d bloggers like this: