NIH DOCUMENTS PROVIDE NEW EVIDENCE U.S. FUNDED GAIN-OF-FUNCTION RESEARCH IN WUHAN

U.S.-funded experiment in China posed biosafety risks but did not cause Covid-19 pandemic, scientists say.

Sharon LernerMara HvistendahlMaia HibbettSharon Lerner, Mara Hvistendahl, Maia Hibbett

September 10 2021, 8:03 a.m.

DOCUMENTS OBTAINED BY The Intercept contain new evidence that the Wuhan Institute of Virology and the nearby Wuhan University Center for Animal Experiment, along with their collaborator, the U.S.-based nonprofit EcoHealth Alliance, have engaged in what the U.S. government defines as “gain-of-function research of concern,” intentionally making viruses more pathogenic or transmissible in order to study them, despite stipulations from a U.S. funding agency that the money not be used for that purpose.

Grant money for the controversial experiment came from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, which is headed by Anthony Fauci. The award to EcoHealth Alliance, a research organization which studies the spread of viruses from animals to humans, included subawards to Wuhan Institute of Virology and East China Normal University. The principal investigator on the grant is EcoHealth Alliance President Peter Daszak, who has been a key voice in the search for Covid-19’s origins.

Scientists unanimously told The Intercept that the experiment, which involved infecting genetically engineered mice with “chimeric” hybrid viruses, could not have directly sparked the pandemic. None of the viruses listed in the write-ups of the experiment are related to the virus that causes Covid-19, SARS-CoV-2, closely enough to have evolved into it. Still, several scientists said the new information, which the NIH released after it was sued by The Intercept, points to biosafety concerns, highlighting a general lack of oversight for research on pathogens and raising questions about what other information has not been publicly disclosed.

“As a virologist, I personally think creating chimeras of SARS-related bat coronaviruses that are thought to pose high risk to humans entails unacceptable risks,” said Jesse Bloom, who studies the evolution of viruses at the Fred Hutchinson Cancer Research Center. Severe acute respiratory syndrome, or SARS, is a disease caused, like Covid-19, by an airborne coronavirus.

National Institute of Allergy and Infectious Diseases Director Anthony Fauci listens during a briefing on the coronavirus pandemic at the White House on March 26, 2020 in Washington, DC.National Institute of Allergy and Infectious Diseases Director Anthony Fauci listens during a briefing on the coronavirus pandemic at the White House on March 26, 2020, in Washington, D.C. Photo: Drew Angerer/Getty Images

The experiment also raises questions about assertions from Fauci and NIH Director Francis Collins that NIH-funded projects at the Wuhan Institute of Virology did not involve gain-of-function research. In May, Fauci testified before Congress: “The NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology.” The documents do not establish whether Fauci was directly aware of the work.

Scientists working under a 2014 NIH grant to the EcoHealth Alliance to study bat coronaviruses combined the genetic material from a “parent” coronavirus known as WIV1 with other viruses. They twice submitted summaries of their work that showed that, when in the lungs of genetically engineered mice, three altered bat coronaviruses at times reproduced far more quickly than the original virus on which they were based. The altered viruses were also somewhat more pathogenic, with one causing the mice to lose significant weight. The researchers reported, “These results demonstrate varying pathogenicity of SARSr-CoVs with different spike proteins in humanized mice.”

But the terms of the grant clearly stipulated that the funding could not be used for gain-of-function experiments. The grant conditions also required the researchers to immediately report potentially dangerous results and stop their experiments pending further NIH review. According to both the EcoHealth Alliance and NIH, the results were reported to the agency, but NIH determined that rules designed to restrict gain-of-function research did not apply.

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The Intercept consulted 11 scientists who are virologists or work in adjacent fields and hold a range of views on both the ethics of gain-of-function research and the Covid-19 origins search. Seven said that the work appears to meet NIH’s criteria for gain-of-function research.

One said that the experiment “absolutely does not meet the bar” for gain-of-function research. “You can’t predict that these viruses would be more pathogenic, or even pathogenic at all in people,” said Angela Rasmussen, a virologist with the Vaccine and Infectious Disease Organization at the University of Saskatchewan. “They also did not study transmissibility at all in these experiments,” meaning that the scientists did not look at whether the viruses could spread across a population.

Three experts said that, while they did not have enough knowledge of U.S. policies to comment on whether the research met NIH criteria, the experiment involving humanized mice was unnecessarily risky.

One virologist, Vincent Racaniello, a professor of microbiology and immunology at Columbia University, said while he considered the mouse experiment described in the document to clearly fall into the gain-of-function category, he didn’t see it as problematic. “You can do some kinds of gain-of-function research that then has unforeseen consequences and may be a problem, but that’s not the case here,” said Racaniello.

Robert Kessler, communications manager for EcoHealth Alliance, denied that the work on the humanized mice met the definition of gain-of-function research. Kessler insisted that bat viruses are not potential pandemic pathogens because, he said, “a bat virus is not known to be able to infect humans.” The proposal justified the work on WIV1 by explaining that it is “not a select agent” — referring to a list of closely monitored toxins and biological agents that have the potential to pose a severe threat to public health — and “has not been shown to cause human infections, and has not been shown to be transmissible between humans.”

Understanding-Risk-Bat-Coronavirus-Emergence-Grant-Notice

528 pages

But the group’s bat coronavirus research was focused on the very threat that bat viruses pose to people. Kessler did acknowledge that, while the original bat coronavirus in the experiment did not spread among humans, the research was designed to gauge how bat coronaviruses could evolve to infect humans.

All but two of the scientists consulted agreed that, whatever title it is given, the newly public experiment raised serious concerns about the safety and oversight of federally funded research. “In my point of view, the debate about the definition of ‘gain-of-function’ has been too much focused on technical aspects,” said Jacques van Helden, a professor of bioinformatics at Aix-Marseille Université. “The real question is whether or not research has the potential to create or facilitate the selection of viruses that might infect humans.” The experiments described in the proposal clearly do have that potential, he said.

NIH spokesperson Elizabeth Deatrick said that the agency had considered the research — and decided not to restrict it under its own rules. “In 2016, NIAID determined that the work was not subject to the Gain-of-Function (GoF) research funding pause and the subsequent HHS P3CO Framework,” Deatrick wrote, referring to criteria put in place in 2017 to guide the agency’s funding decisions about research that involves, or is reasonably anticipated to involve, potential pandemic pathogens.

The Coronavirus Crisis

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The Coronavirus Crisis

Republican members of Congress have alleged, without sufficient evidence, that gain-of-function research in Wuhan sparked the coronavirus pandemic. As part of an inquiry into the origins of the pandemic, they have twice grilled Fauci in Congress on his role as NIAID director.

In a heated exchange in July, Republican Sen. Rand Paul accused Fauci of lying when he claimed that NIH did not fund gain-of-function research at the Wuhan Institute of Virology.

Experts now say that the documents support the contention that NIH funded gain-of-function work, though not in the specific instance where Paul alleged it. “There’s no question,” said Racaniello, of Columbia University, who pointed to the decreased weight of the mice infected with the chimeric viruses that was described in the research summaries sent to NIH. “From the weight loss, it’s gain of function. Tony Fauci is wrong saying it’s not.”

But the documents do not prove Paul’s claim that Fauci was lying, as they do not make clear whether Fauci read them. Nor do they in any way support Paul’s allegation that Fauci was “responsible for 4 million people around the world dying of a pandemic” — or that anyone intentionally caused Covid-19. What is clear is that program officers at NIAID, the agency that Fauci oversees, did know about the research.

A paragraph describing the research, as well as two figures illustrating its results, were included in both a 2018 progress report on the bat coronavirus grant and an application for its 2019 renewal. And NIH confirmed that it reviewed them.

“NIH has never approved any research that would make a coronavirus more dangerous to humans,” the agency said in a statement, echoing remarks by Collins, the NIH director, posted to its website in May. “The research we supported in China, where coronaviruses are prevalent, sought to understand the behavior of coronaviruses circulating in bats that have the potential to cause widespread disease.” Similar research funded by NIH had aided in the development of vaccines against the coronavirus, the statement continued.

The White House did not respond to questions about the research.

The main building of the National Institutes of Health is seen in Bethesda, Md., in this Aug. 17, 2009.The main building of the National Institutes of Health located in Bethesda, Md., seen on Aug. 17, 2009. Photo: J. Scott Applewhite/AP

Shifting Definitions, Growing Viral Load

The humanized mouse experiment fits with the overall goal of the $3.1 million grant, which was titled “Understanding the Risk of Bat Coronavirus Emergence” and aimed at preventing a pandemic by predicting the circumstances under which a bat coronavirus could evolve to infect humans. The researchers took an ambitious three-pronged approach: screening people with high exposure to wildlife, mathematical modeling, and lab experiments on viruses. Peter Daszak, the EcoHealth Alliance president, has worked closely with scientists in China for years, and roughly $750,000 of the grant was allocated for the Wuhan Institute of Virology. An additional nearly $300,000 went to East China Normal University, where researchers did field sampling.

In a 2005 paper, Daszak’s team showed that the first SARS virus originated in bats. Middle East respiratory syndrome, or MERS, is caused by a coronavirus that emerged in 2012 and also believed to come from bats, which are now a prime target for virologists trying to understand and combat emerging diseases. Daszak has long maintained that his research is critical to preventing outbreaks.

But the research on the bat viruses in Wuhan showed that infecting live animals with altered viruses can have unpredictable consequences. A report to NIH on the project’s progress in the year ending in May 2018 described scientists creating new coronaviruses by changing parts of WIV1 and exposing genetically engineered mice to the new chimeric viruses. Research published in 2017 in the journal PLOS Pathogen showed that, in cells in a laboratory, similar chimeric viruses reproduced less effectively than the original. NIH cited that research as one of the reasons the moratorium on gain-of-function research of concern didn’t apply to this experiment. “It was a loss of function, not a gain of function,” the email from NIH explained. (NIH also pointed out that the changes to the chimeric viruses “would not be anticipated to increase virulence or transmissibility in humans.”)

Inside the lungs of the humanized mice, however, the novel viruses appear to have reproduced far more quickly than the original virus that was used to create them, according to a bar graph shown in the documents. The viral load in the lung tissue of the mice was, at certain points, up to 10,000 times higher in the mice infected with the altered viruses than in those infected with WIV1. According to Deatrick, the NIH spokesperson, the difference in the rates of viral reproduction — which were particularly pronounced two and four days after the mice were infected with the virus — didn’t amount to gain of function because, by the end of the experiment, the amount of virus produced by the parent and chimeric strains evened out. “Viral titers were equivalent by the end of the experimental time-course,” Deatrick wrote. The email also said, “NIH supports this type of research to better understand the characteristics of animal viruses that have the potential to spill over to humans and cause widespread disease.”

Scientists The Intercept consulted expressed differing views on whether the increase in viral load could be translated to an increase in transmissibility, which relies on the virus’s ability to replicate. To some, the jump in viral load indicated that the modified RNA virus could replicate far more rapidly than the original in the lungs of the mice, likely leading to increased pathogenicity and spread. Rasmussen, of the Vaccine and Infectious Disease Organization, pointed out that viral load is not identical to reproduction rate, noting: “This shows the chimeric viruses replicated a little faster, but that tells us exactly nothing about transmissibility. Furthermore, WIV1 caught up by the end of the experiment. We see differences in the rate of viral replication all the time, but it is often not directly correlated with pathogenicity.”

Another figure in the documents suggests that at least one of the altered viruses not only enhanced viral reproduction, but also caused the humanized mice to lose more weight than those exposed to the original virus — a measure of the severity of illness.

table-1A graph from a report on NIH-funded research in Wuhan shows viral load in lung tissues of humanized mice. Screenshot: FOIA Document

NIH requires the increase in viral reproduction to be immediately reported, according to a note in the Notice of Award the agency issued in July 2016. “No funds are provided and no funds can be used to support gain-of-function research covered under the October 17, 2014 White House Announcement,” the note said. If any new MERS-like or SARS-like chimeras show “enhanced virus growth greater than 1 log over the parental backbone strain,” the note continued, the researchers were instructed to stop all experiments with the viruses and send the data to NIAID grant specialists, as well as to the Wuhan Institute of Virology biosafety committee. The enhanced growth of the chimeric coronaviruses in the humanized mice was, at one point, up to 4 log greater — or 10,000 times — the rate of the original virus. But there are no indications the research was stopped.

In fact, the bat coronavirus grant was renewed for a five-year period in 2019, although the Trump administration suspended funding in April 2020 amid the Covid-19 pandemic and spiraling concerns about its origins. (Funding was later reinstated but under strict conditions that Daszak said were impossible for his group to meet.)

Kessler, EcoHealth Alliance’s communications manager, also pointed to the fact that the grant was renewed in 2019 — after EcoHealth Alliance had twice submitted documents detailing the experiment — as evidence that the organization did nothing wrong. “If there had been any violations, they would not have done so,” he said.

Long History of Controversy

The practice of making chimeric viruses in order to study how they might become more contagious was under scrutiny long before the pandemic. Proponents of such gain-of-function research argued that it can help virologists better understand and defend against natural outbreaks. But critics said that they were unreasonably dangerous.

In October 2014, the federal government put a moratorium on funding gain-of-function research on potential pandemic pathogens that could be “reasonably anticipated” to lead to spread in humans, as outlined in a 2017 guidance from the Department of Health and Human Services. In December 2017, the moratorium was lifted and replaced with new guidelines for oversight of research using potential pandemic pathogens. The grantees reported that the humanized mouse experiment was done between June 2017 and May 2018. Gain-of-function research was thrust into the spotlight again in 2020, amid speculation that the Wuhan Institute of Virology had conducted such research and that it was somehow linked to the pandemic.

While the new information about the research on humanized mice does not provide the “smoking gun” for proponents of what has become known as the “lab leak theory,” it lends the hypothesis credence, according to Stuart Newman, a professor of cell biology who directs the developmental biology laboratory at New York Medical College. “Making chimeric coronaviruses, mixing and matching RBDs [a part of the virus that allows it to attach to receptors] and spike proteins is exactly the scenario imagined by many lab-leak scenario proponents,” said Newman. “The fact that this was an established research paradigm in the Wuhan lab … definitely makes the laboratory origin more plausible.”

The documents about the research were released by NIH after The Intercept submitted a Freedom of Information Act request in September 2020, later suing to have it fulfilled. The request sought copies of these and other grant proposals that Daszak submitted to the agency, as well as the agency’s communications about the proposals. NIH originally denied The Intercept’s request on the grounds that releasing Daszak’s proposals would undermine an ongoing investigation. Counsel for the agency later admitted that NIH had not reviewed many of the records before making that assertion.

“The contents of the grants raise serious questions about the review processes and oversight relating to risky pathogen research,” said Alina Chan, a Boston-based scientist and co-author of the upcoming book “Viral: The Search for the Origin of Covid-19.” The new information in the documents warrants further inquiry into whether researchers may have omitted information about other concerning experiments, she said. “The question is: What else did they do in more recent years that we’re not aware of?”

THE QUEST FOR COVID’S ORIGINS

Recent reporting by The Intercept demonstrates a lack of transparency in the search for the origins of Covid-19.

InterceptedIntercepted

October 6 2021, 10:01 a.m.

IN LATE SEPTEMBER, the World Health Organization announced that it had assembled a new team of scientists to revive its investigation into the origins of the virus that causes Covid-19. The new group will be tasked with examining whether the virus could have originated in a lab, months after its predecessor deemed the possibility too unlikely for serious consideration.

This week on Intercepted: Intercept investigative reporters Sharon Lerner and Mara Hvistendahl join editor Maia Hibbett to discuss the competing theories on the origins of Covid-19. The Intercept obtained documents that shed new light on controversial lab experiments, raising questions about the origins of the coronavirus pandemic. With neither of the main theories — natural spillover versus a lab leak — yet proved true, the Intercept is seeking answers as to how much officials knew about proposed behind-the-scenes experiments. As the University of Saskatchewan and Georgetown virologist Angela Rasmussen, a staunch critic of the lab-leak theory, said after the first WHO investigation, “There are still major stones that need to be unturned.”

[Intro music.]

Jeremy Scahill: This is Intercepted.

Maia Hibbett: I’m Maia Hibbett, editor with The Intercept.

It’s been a year and a half since the World Health Organization labeled Covid-19 a pandemic.

Harris Faulkner: Alright, we have breaking news now. Let’s get to it. It has to do with Covid-19 and the World Health Organization has just declared a global coronavirus. It is a pandemic at this point.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus: And we’re deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction. We have therefore made the assessment that Covid-19 can be characterized as a pandemic.

MH: But when the novel coronavirus started spreading across the world, most people were more concerned with whether they were going to catch it than where it came from. But there was one unhinged executive who quickly found a culprit.

President Donald J. Trump: But you don’t hear them talking about Covid. Covid — to be specific, Covid-19. That name gets further and further away from China as opposed to calling it “the Chinese virus.” [Audience boos.]

MH: Like so many of his comments, Trump’s claims were not only racist, xenophobic, and stupid, but they were also an unfortunate flattening force. The former president’s supporters and subscribers in the government and media spread this rhetoric — and the notion that the pandemic-causing disease was cooked up in a Chinese lab spread on the right, almost as quickly as the virus itself did.

Tucker Carlson: China, the same country that controls 96 percent of antibiotics we use in this nation, the same country that is wanting to cut off drug exports to the U.S. to kill Americans, is now trying to hide the reality of where coronavirus came from.

MH: And on the left, the notion’s dismissal as a conspiracy theory happened just as quickly, with just as little scrutiny from the majority of people who peddled it.

Peter Daszak: Well, I’m a scientist, and what I do is I look at the evidence around a hypothesis. There is a huge amount of evidence that these viruses repeatedly emerge into people from wild animals in rural areas through things like hunting and eating wildlife. There is zero evidence that this virus came out of a lab in China.

MH: The partisan divide had done it again: There was almost no room for serious inquiry or debate.

But what Trump didn’t realize — or maybe just didn’t care about — was that if the coronavirus did emerge from a lab in Wuhan, China, there were members of his government in Washington, D.C., who could arguably be complicit.

The National Institutes of Health had provided funding to the Wuhan Institute of Virology and the nearby Wuhan University Center for Animal Experiment — two institutions that wound up uncomfortably close to the presumed genesis of the pandemic. The money had often come through the EcoHealth Alliance, a New York-based nonprofit that administers federal grants for a variety of scientific projects.

But what’s striking is the scientific community’s swift and complete dismissal in the mainstream of the possibility that the virus could’ve originated from a lab.

In science, you’re not really supposed to eliminate a possibility until you’ve proven that it doesn’t work. But so many of the world’s top virologists seemed not at all interested in asking the question.

Recent reporting has revealed that not only was the type of work happening that could, hypothetically, have taught a bat coronavirus to infect people, but there were some pretty specific plans that laid out just the type of experiment that could’ve done it.

In the past month, The Intercept has gotten a hold of some of those plans — and we don’t know how much more there might be.

Mara Hvistendahl, an investigative reporter with The Intercept, spent eight years as a science reporter in China, three of those as the China bureau chief for Science.

Mara Hvistendahl: One of the things I learned during that time is that there’s been this expectation and fear, for many years, that a pandemic could arise in Asia.

MH: And Sharon Lerner, also an investigative reporter with The Intercept, agrees:

Sharon Lerner: Yeah. And there was this early presumption, right, because we’d seen with SARS, that outbreak in 2003, traced directly to that natural spillover from a bat.

MH: “Natural spillover from a bat.” That’s what we knew — or thought we knew — about the origins of the Covid-19 pandemic. But it’s messier than that. Much messier.

SL: Well, we have these two opposing theories. The natural spillover theory, and the lab leak theory, which is shorthand. But basically, what they’re both trying to answer is: How did this virus get from bats to people? There’s an agreement there.

MH: I recently sat down with Mara and Sharon to discuss their latest reporting on documents they’ve obtained, raising more questions about the origins of the coronavirus than we previously thought.

Mara Hvistendahl: So, I think, early on, there was not much surprise that a virus like this could have come out of China, because there had been this expectation for so many years that something like this could happen. And previous outbreaks have largely had a natural origin. That was the case with the first SARS virus in the early 2000s. So there was, I think, a presumption among many scientists that that can be the case here.

As time went on, it became clear that this is not a typical outbreak of infectious diseases. We haven’t had a pandemic on this scale.

SL: There was also, I think, pretty early on a recognition that as — Jon Stewart has famously called attention to — that there was a lab in Wuhan, the very city that was the place where the pandemic began, that was looking into the very viruses that were similar to the one that had caused the pandemic. And just that geographic coincidence — or not coincidence — I think, alone, had some people thinking from the very beginning, people who were aware that labs like this sometimes have a history of having incidents that can cause disease; that that could be a question: Was there a role for the Wuhan Institute of Virology in this pandemic? And I think that also was a question that arose early.

Mara Hvistendahl: Right, and that while there was this expectation, or fear, for many years, that you could have an outbreak of natural origin in China, the focus was really on Southern China. So one of the closest known ancestors of SARS-CoV-2, the virus that causes the pandemic, was found in southwestern China, in Yunnan Province; scientists also recently identified other close ancestors in Southeast Asia. And Wuhan is in central China, there is a wildlife trade there, but it’s not the region where people were really looking at, closely, as a hotspot for the emergence of new infectious diseases of this sort.

MH: And so what is the idea behind the so-called lab-leak theory, centered on that lab in Wuhan?

SL: Well, with the natural spillover folks, the idea is that it did spillover naturally from it; that there was no intervention basically, that it went from from a bat and from maybe a bat biting a human into becoming a human pathogen. And, on the other side, you have this idea that that the virus enters humans through some of the work that was going on in the lab, and it isn’t necessarily that it was an accident, which you often hear a lab accident, though it certainly could be that — that someone working in the lab didn’t follow proper procedures, or there was some sort of an accident, a spill or something like that. There’s also been lots of attention to the fact that the Wuhan Institute of Virology was involved in the collection of bat viruses, sampling thousands of viruses going to these remote locations, and actually bringing them back with them to Wuhan, to the lab. And the process of collecting them, and storing them, and gathering them in itself is a risky thing.

And then there’s kind of the third part of this which is so called gain-of-function research of concern, which is something that we have written about. And this is research that was going on in the Wuhan Institute of Virology that takes viruses and does experiments with them in which they alter how they are and behave.

MH: Let’s back up a little bit, because you mentioned gain-of-function research of concern. And gain-of-function is this very broad term that has been misused in many cases. So let’s define what gain-of-function research is, and what makes it so-called “of concern” to the U.S. government.

SL: Yeah. So gain-of-function, I think the term basically means that you’re changing how a virus functions. And the “gain” is that you make it more, perhaps, transmissible, or virulent, or pathogenic, right? And so these are experiments where you change a virus, and perhaps it ends up having more of one of these functions. And that’s gain of function.

When you have gain-of-function research of concern, this is a particular subset of gain-of-function research. And the concern is that it involves a potential pandemic pathogen — or something that’s likely to become a potential pandemic pathogen — so something that could start in a pandemic and we know that SARS-CoV-2 is not just a potential pandemic pathogen, but a pandemic pathogen.

So when you start dealing with viruses that could impact humans the way we have seen SARS-CoV-2 impact humans, then that’s a concern.

Mara Hvistendahl: And it’s important to note that there was a huge controversy surrounding this research before the start of the pandemic. That controversy was mainly within the scientific community — it wasn’t an issue that most Americans or most people in the world had thought about in any way — but there was an enormous debate around the topic. And there U.S. government committees that were convened to consider what the appropriate protocols surrounding this research should be.

It went all the way back to 2011, when there were these studies published involving research on flu viruses to make them potentially more transmissible to humans. And essentially, the scientific community divided into two camps. There were, and there still are today, virologists who maintain that it’s important to do these experiments, because by understanding how viruses can be more easily transmitted, we can prevent a pandemic; we can prevent a major outbreak.

But then there’s another camp, which tends to be more filled with biosafety experts, with people who are kind of tasked with monitoring science who say: Hold on, these experiments could also start a pandemic.

And so you have these two very different worldviews that were there before the pandemic. And I think this is one of the things that many have not understood in the context of the debate surrounding the origins of the pandemic, that this was a very political issue before 2020 and that many scientists had a stake in the outcome of the origins of the pandemic.

MH: For this 2011 study that Mara mentioned, these experiments had to do with passaging the avian flu within ferrets, so that was having mammals be able to transmit a bird flu, just through the air. It was the kind of enhanced transmissibility that those experiments demonstrated that raised alarms for all these people in the scientific community and actually led to a temporary pause on funding gain-of-function research, especially when it involves these potential pandemic pathogens.

So since that pause, let’s discuss how the government regulates this research and how it decides whether or not something is worth funding?

SL: So it’s interesting because the pause was lifted in 2017. And the grant that Mara and I got through the FOIA was ongoing during that period: It started in 2014 and went through 2019. And in the documents we got there is this description of a particular experiment. Many of the experts we spoke with said that they believe this experiment qualified as gain-of-function research of concern — and, in particular, I should say, have met the National Institutes of Health’s definition of gain-of-function research of concern.

And basically in this experiment, what they did is that they took bat coronaviruses, and they put together different parts of other viruses to make chimeric viruses, these sort of hybrids. And they injected those viruses into mouse cells that had been genetically engineered to respond like human cells. And when they did that, they saw that the viruses reproduced far more quickly within the humanized mice.

The experts we spoke with said that even when you kind of take away the question of whether it was gain of function research of concern, which is a much-contested term — overwhelmingly, they said, whether or not it was gaining function research, it was dangerous.

So when the pause was lifted in 2017, what they did was they said that they were going to institute these guidelines that would govern and oversee any kind of gain-of-function research. And yet, when we reached out to NIH about this experiment, it turned out that they said that they just decided that it did not need to be regulated under those guidelines. I was pretty amazed by that. Because what that means is that we have these policymakers who spent years putting together these guidelines that are designed to very carefully protect us from dangerous research of this kind. And what the NIH was saying, essentially, is like: Well, we decided we didn’t have those guidelines didn’t apply here. What we’re really not clear about is why.

One of the things we learned, though, is that these guidelines, again, that took years to come up with, only three experiments actually wound up being considered under them and regulated under them. So it’s a pretty big loophole, I would say — which is, it’s not even really a loophole. But what they’ve said [is] that: We have all these great minds that came up with these ways to safeguard against disaster. And basically what happened, it looks like, in this case, is that they drove right around it and they just bypassed the guidelines altogether.

So moving forward, the question is: How are we going to oversee this research if it’s going to continue at all?

Mara Hvistendahl: Before we obtained these documents from NIH through a FOIA lawsuit, there was this prominent critique among people who advocated for better biosafety, that the very comprehensive protocol that had been developed to try to ensure that research was safe was just not being applied; that in some cases, you had the fox guarding the henhouse. And that you had these robust guidelines that just weren’t being implemented. And the grant documents, after we did obtain them, just sort of underscores that point.

MH: Some scientists in the virology community, and people who are proponents of gain-of-function research, have argued that the inquiry into whether the pandemic could have originated in a lab is just totally off-base, because the people who are inquiring don’t have the base of knowledge to understand what they’re talking about to kind of like interpret and analyze the evidence effectively.

So I think we should define a few things before we proceed: Sharon, you mentioned the humanized mice used in the experiment. What that term means is that there are mice that have been genetically engineered to express an enzyme in their lungs called ACE2. And that enzyme is what a lot of respiratory coronaviruses, including SARS-CoV-2, use in order to bind to human lung cells.

The SARS-CoV-2 virus also has something called a furin cleavage site, which is on the spike protein and essentially helps the virus break into the cell.

We already discussed the types of experiments outlined in the NIH proposal you obtained through the FOIA lawsuit. But then we also reported on another grant proposal to the Defense Agency known as DARPA, which DARPA rejected. Could you talk a little about what the project proposed to do?

SL: So that proposal, as you mentioned, was not funded. And it was a proposal that was first released by the online group DRASTIC, which is this kind of group of — some anonymous, some not — researchers who have been looking into the origins of the virus.

So they released this proposal, which was from the EcoHealth Alliance with many sub-awardees, to DARPA, and there are a number of interesting things in this proposal, which basically laid out a plan to vaccinate bats. But as part — there are a number of different sections and different plans they had that were outlined in this proposal and one of the things described inserting this furin cleavage site we’ve been talking about into chimeric viruses. This really caught a lot of people’s attention because this furin cleavage site has for a long time now been a focal point in this debate over the origins of the pandemic. And that’s because it’s a very rare thing in this type of bat coronavirus. And so people were speculating: Where did this come from? How did this furin cleavage site get into this virus?

So there was the question of like: Well, could it perhaps have been inserted there? Could it have been engineered? And many on the natural spillover side of things dismissed this idea as — well — crazy, and also sort of a conspiracy theory. And the gist was: Why would anyone ever do that? And what was notable, one of the notable things about this proposal was that it outlined this exact thing, the insertion of the furin cleavage site into a bat coronavirus. And so you know, there are a lot of questions about it. We still don’t know what — if any — of the work that was outlined in the proposal was done, because again, it wasn’t funded. Many people told us that when researchers put together this kind of proposal, often some of the work that they’re describing has already been done. And, of course, they don’t just have one funding source. So even though DARPA didn’t fund them, it doesn’t mean that they didn’t have money from elsewhere to do this work.

Here is this question: Could someone have done it? Well, certainly someone considered doing it. And the folks who were on this grant, among them Peter Daszak, who is the head of the EcoHealth Alliance, and another researcher named Linfa Wang, who is a subawardee on the proposal, it really struck a lot of the people who we spoke to, their silence on this issue. So even though it’s been a really focal point in the debate, and many people on the spillover side were saying this would never happen, the two of these guys knew that there was a proposal that described this very experiment, and didn’t mention it.

Again, the DARPA proposal was not funded. But it raised really important questions about not only what do we not know, but what some people know and refuse to share. And I think, in some ways, [it] sort of deepened the divide among some of the scientific community about this, and deepened some of the mistrust. Because people said to me: OK, well, how is it that they could have been embarking — or at least thinking about embarking on this research — and not disclosed it when it’s so central to the questions that we’re all trying to answer right now.

Mara Hvistendahl: And just to give you a sense of the politics around the furin cleavage site, earlier this year, the Nobel laureate, the eminent virologist David Baltimore, told the science writer Nicholas Wade that when he saw the furin cleavage site, learned about it, he told his wife that it was the smoking gun for the origin of the pandemic. And that caused a huge controversy within the scientific community, to the point where Dr. Baltimore eventually said that he overstated the importance of the furin cleavage site and somewhat walked back to his quote.

And it was at the point where it was so controversial for someone to say something like that. And yet there was this plan for this experiment that several people knew about that they did not mention at that time.

MH: So Peter Daszak, the president of the EcoHealth Alliance and his silence on the issue, for those who are not aware of his position and the amount of influence he’s had over inquiries into the origins of the pandemic, what’s his role and kind of what has he done in the past year and a half?

Mara Hvistendahl: So very early in the pandemic, in January and February 2020, Peter Daszak became a leading voice in the media and elsewhere on the coronavirus. He had, of course, a big conflict of interest for people who thought that there was a possible lab origin, because he had led the team that oversaw work at the Wuhan Institute of Virology. But he organized a group of scientists to publish a letter in The Lancet decrying the idea of lab origin as a conspiracy theory. And he went on “60 Minutes” in the spring of 2020, to talk about how he was being attacked, how his research was actually critical to preventing outbreaks and to preventing the pandemic. And he was able to very deftly get himself portrayed as being unfairly attacked by the Trump administration — which there was an element of truth to it, because Trump, and Pompeo, and several others, of course, went completely overboard in their critiques of the Wuhan Institute of Virology and of people associated with it. So he very quickly won sympathy from the left and from the scientific community, and managed to emerge as a supposed voice of reason in the debate.

SL: And not only that, so he’s the voice of reason, but he’s also portraying everyone else who disagrees with him as completely nuts.

PD: They’re coming at this with a belief system that there is a cabal of mysterious international folks who are trying to kill people, design a vaccine to make money, or it’s a nefarious government who’s working to release a virus for their own political purposes, to subjugate the West, etc. So they’re coming at it with a belief system to start off with, so logic drops out of the window at that level.

SL: But I mean, partly, to be fair, this quote is from 2020. And I think partly what it shows is how much has changed since then. Because it was pretty easy in a sentence or two to dismiss anyone who thought differently from him as a conspiracy theorist back then, and it’s not so easy now. Much harder.

Mara Hvistendahl: Peter Daszak was aided, and has made an effort to become the voice of reason in the pandemic by the politics at the time. You had Trump and Pompeo accusing China of making a bioweapon, which is something that very few scientists believe is a possible origin of the pandemic. And so you had genuine conspiracy theories out there in the ecosystem that unfortunately got conflated with a possible lab accident or with research that we know commonly happens at labs. And that was happening at the Wuhan Institute of Virology — all of that got mixed together. And Trump was just spouting so many crazy ideas at the point that I think there was this reflex among the left and among people who felt like they are rational believers in science to immediately kind of veer in the other direction.

MH: The crazy and partisan narrative, we didn’t leave it in 2020 entirely. There’s that infamous moment this summer, when Rand Paul accused Anthony Fauci of lying about whether or not the U.S. had funded gain-of-function research at the Wuhan Institute of Virology.

Sen. Rand Paul: Dr. Fauci knowing that it is a crime to lie to Congress, do you wish to retract your statement of May 11, where you claimed that the NIH never funded gain-of-function research in Wuhan?

Dr. Anthony Fauci: Sen. Paul, I have never lied before the Congress, and I do not retract that statement. This paper that you’re referring to, was judged by qualified staff up and down the chain as not being gain-of-function — let me finish.

RP: You pick an animal virus, and you increase its transmissibility to humans, you’re saying that’s not gain-of-function?

AF: Yeah, that is correct. And Sen. Paul, you do not know what you are talking about, quite frankly. And I want to say that officially. You do not know what you are talking about.

MH: This is still largely an issue of the right and in many circles, and I wanted to bring that up because we haven’t really addressed the question of Fauci and the NIH and the NIAID, National Institutes of Allergy and Infectious Diseases, which Fauci directs and heads. And in that moment when Rand Paul accused Fauci of lying, was Fauci lying, and what do the NIH documents that you two obtained, how do they inform that conversation?

SL: I don’t know he has a leg to stand on the question of whether it was not gain-of-function research. But I think there are real questions about what he knew, as an individual, as opposed to what his staff knew. But that, again, speaks to me to this real lack of transparency. It’s been very hard to figure out who knew what exactly. Who was doing the reviewing; who signed off on these things; who again decided that it didn’t have to go through and meet the guidelines. We don’t know if Fauci was involved with that. We just don’t know.

MH: As we’ve been talking about some of these proposals, it’s important to note that the actual genetic manipulation of the viruses, the experiment to insert the furin cleavage site into the spike protein, was supposed to occur first at the University of North Carolina, not in Wuhan. This doesn’t mean that if it was done, that they couldn’t essentially print out the genome sequence, or send the instructions to do that to the Wuhan Institute of Virology. But we have to remember that these experiments weren’t just happening in Wuhan. There were also prominent U.S.-based virologists potentially working on this project.

Mara Hvistendahl: Yeah, in 2020, the debate around the origin of the pandemic was often: Did work in a Chinese lab lead to the pandemic, or was it of natural origin? And the Trump administration did everything they could to blame China for the outbreak. There was, of course, a huge uptick in hate crimes against Asian Americans. And it’s been a very unfortunate outgrowth of this entire controversy.

And what we see is, in fact, a much more complicated picture; it’s that if there is a connection to a lab, it would be a project that was potentially funded by the United States, by the U.S. government, that involves U.S. researchers working in collaboration with Chinese researchers and researchers from elsewhere. And so it’s not such a clear-cut issue of blame.

MH: And just to further complicate things even a little more, in the NIH grant documents that you obtained via FOIA, I understand that there was a date on one of the annual progress reports that was inconsistent with what it was supposed to be. So could you tell us a little bit about, first of all, what an annual progress report is, and what it’s supposed to tell us, and then what the potential significance of the changed date is?

Mara Hvistendahl: I mean, this would be unusual with any project, but the fact that it happened with this grant, and that there was an is this controversy surrounding EcoHealth Alliance at the time that the progress report was submitted, means that it is worth understanding what happened in that case. And we went to NIH and EcoHealth Alliance several times with questions about this progress report; they did not get back to us. So we then went to scientists who have knowledge of the NIH grant process, who, you know, confirmed to us that this is unusual.

So the context is that this is just the latest in a string of examples of missing or incomplete or deleted data from the early days of the pandemic. You know, there have been genetic sequences taken from people in Wuhan in 2019 that were found to be mysteriously deleted, and then later recovered. The WHO had to recently revise data on early patients from Wuhan following a report in the Washington Post that pointed out discrepancies. So this is not something that they did on their own. They did it only following critical journalism, and that pattern has played out again and again. And so it does raise questions about what happened with this report. Is there a benign explanation, or what’s going on?

SL: From my end, the more I think about this, and the more I write about it, the more questions I have. I don’t know how many questions we’re answering here, but we’re sort of in the business of collecting questions right now, and there are so many of them, and there are so many good minds thinking about this. And a lot of people have said: There’s no way to answer this question of how the pandemic began. And that may be true. But we’re definitely not done amassing and asking questions.

And I think the politics have made it really uncomfortable for many journalists to try to get to the bottom of it. I’m really glad to be part of a group that’s asking these questions. Whether or not we’re going to get them answered in a definitive way they should be asked in the best way possible.

Mara Hvistendahl: We’ve spent the past few months talking to a wide variety of sources. And there are scientists who tilt toward a natural origin, who think that the pandemic likely grew out of close contact between people and animals in the wild or at a market, who nonetheless think that these experiments raise very important questions about biosafety and that EcoHealth Alliance’s work deserves scrutiny, whether or not it led to the pandemic. And I think that’s an important point. And so the question for me is not just: Did EcoHealth Alliance cause a pandemic? But it’s a larger question of how can we ensure that laboratories are safe going forward; we know that there have been lab accidents, we know that this sort of research has been highly contentious — how can we address that issue going forward and prevent a possible pandemic arising from that research in the future, regardless of the origin of the current pandemic?

SL: Maia, you and I have talked to people, scientists who work very closely on these issues, whose opinions have shifted as a result of seeing these documents. It’s not just the political landscape that’s shifting; I think that some scientific opinion is shifting to, because they’re learning about details about what has occurred that they did not know or understand before.

MH: Yeah, I agree that that’s significant.

And I also think it’s worth noting that, for all the scientists who believe that lab origin is technically possible, even if it’s not the most plausible explanation, in their view, for the most part, people do at least concede that it’s a possible explanation. And it’s doubly concerning when a scientist who’s supposed to kind of make a living asking questions and never be satisfied until they’ve come up with a concrete answer decides to just rule out one set of possibilities entirely and shuts themselves off to an entire line of inquiry, just because it’s either politically inconvenient or professionally inconvenient, perhaps.

SL: Yeah. And I keep coming back to when the consequences of that sort of irresponsible shift, I mean, we’re talking about a pandemic that’s caused four and a half million deaths; you want to be really sure when you roll something out. The stakes are high.

Mara Hvistendahl: At this point, President Biden convened the intelligence community to investigate the origin of the pandemic for three months. In August, they came back with inconclusive results, and were split on what could have happened and did not have high confidence in any possible origin. So it’s not something the intelligence community has been able to solve. The WHO committee, the Lancet Committee, have clear problems and there’s a recognition even at the WHO that that tactic is not working.

But there are a lot of people who said: Well China’s not going to let in another committee to investigate in any serious way. We may never know the origin of the pandemic. So what’s the point? What can we do?

And what these documents show is that we can uncover useful information by looking at what U.S. federal agencies have funded. There’s a lot of information available in the United States, using just the Freedom of Information Act. Or if Congress were to subpoena documents, they would be able to obtain a lot more. And that information is freely available and deserves to be examined.

In the end, it may point toward a natural origin. Who knows, as more information comes out. But the documents that we’ve already obtained have pushed the discussion already much further than it was.

MH: Sharon, Mara, thanks for joining us.

Mara Hvistendahl: Thank you for having us.

SL: Yeah, thank you.

[Credits music.]

MH: And that does it for this episode of Intercepted. Follow us on Twitter @Intercepted and on Instagram @InterceptedPodcast.

Intercepted is a production of First Look Media and The Intercept. Lead producer is José Olivares. Supervising producer is Laura Flynn. Betsy Reed is editor in chief of The Intercept. And Rick Kwan mixed our show. Our theme music, as always, was composed by DJ Spooky.

Until next time, I’m Maia Hibbett.

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