- Emails reveal the National Institutes of Health colluded with EcoHealth Alliance to circumvent federal restrictions on gain-of-function (GOF) research and avoid oversight
- NIH officials allowed EcoHealth Alliance to craft oversight language governing its own GOF experiments
- At least two NIH officials expressed concern that the experiment might fall under the designation of GOF banned under federal moratorium. They later accepted EcoHealth’s illogical justification for why the research should not be restricted
- The NIH is now trying to evade responsibility by shifting blame for the unlawful research onto EcoHealth Alliance, saying they violated the grant rules
- According to EcoHealth president Peter Daszak, the parent virus for his proposed chimeric SARS-like viruses, WIV1, had “never been demonstrated to infect humans.” Yet three months earlier, his collaborator, Ralph Baric, Ph.D., had published a paper showing WIV1 did indeed have the ability to infect humans and posed a threat to the human population
The walls are closing in on Dr. Anthony Fauci as emails reveal the National Institutes of Health colluded with EcoHealth Alliance to circumvent federal restrictions on gain-of-function (GOF) research.
The damning revelations were published by The Intercept1 and Daily Caller,2 November 3, 2021. While the NIH has kept the grant correspondence secret, only allowing select congressional staff to review the documentation in a private session, The Intercept was given access to their personal notes.
Considering federal grants are of clear public interest, the NIH’s decision to not make the correspondence public is suspicious in and of itself. Are they hiding something? You bet. As reported by Intercept journalists Sharon Lerner and Mara Hvistendahl:3
“Emails show that NIH officials allowed EcoHealth Alliance to craft oversight language governing its own gain-of-function research …
Detailed notes on NIH communications obtained by The Intercept show that beginning in May 2016, agency staff had an unusual exchange with Peter Daszak, the head of EcoHealth Alliance, about experiments his group was planning to conduct on coronaviruses under an NIH grant called ‘Understanding the Risk of Bat Coronavirus Emergence’4 …
EcoHealth was entering the third year of the five-year, $3.1 million grant that included research with the Wuhan Institute of Virology and other partners. In a 2016 progress report, the group described to NIH its plans to carry out two planned experiments infecting humanized mice with hybrid viruses, known as ‘chimeras.’
The plans triggered concerns at NIH. Two staff members — Jenny Greer, a grants management specialist, and Erik Stemmy, a program officer handling coronavirus research — wrote to EcoHealth Alliance to say that the experiments ‘appear to involve research covered under the pause,’ referring to a temporary moratorium5 on funding for gain-of-function research that would be reasonably anticipated to make MERS and SARS viruses more pathogenic or transmissible in mammals …
Initially, NIH staff appeared intent on enforcing the funding pause … But what happened next sets off alarm bells for biosafety advocates: Agency staff adopted language that EcoHealth Alliance crafted to govern its own work.
The agency inserted several sentences into grant materials describing immediate actions the group would take if the viruses they created proved to become more transmissible or disease-causing as the result of the experiments.”
NIH Tries to Evade Responsibility
The NIH is now trying to evade responsibility by shifting blame for the unlawful research onto EcoHealth Alliance. October 21, 2021, NIH principal deputy director Lawrence Tabak, Ph.D., sent a letter6,7,8 to James Comer, ranking member of the Committee on Oversight and Reform, “to provide additional information and documents regarding NIH’s grant to EcoHealth Alliance Inc.”
In the letter, Tabak acknowledged that Fauci lied to Congress when he emphatically insisted the NIH/NIAID have never funded GOF research. However, when it comes to circumventing the research moratorium, Tabak lays the blame squarely at the feet of EcoHealth. According to Tabak:9
“The limited experiment described in the final progress report provided by EcoHealth Alliance was testing if spike proteins from naturally occurring bat coronaviruses circulating in China were capable of binding to the human ACE2 receptor in a mouse model …
In this limited experiment, laboratory mice infected with the SHC014 WIV 1 bat coronavirus became sicker than those infected with the WIV1 bat coronavirus. As sometimes occurs in science, this was an unexpected result of the research, as opposed to something that the researchers set out to do …
The research plan was reviewed by NIH in advance of funding, and NIH determined that it did not to fit the definition of research involving enhanced pathogens of pandemic potential (ePPP) because these bat coronaviruses had not been shown to infect humans. As such, the research was not subject to departmental review under the HHS P3CO Framework.
However, out of an abundance of caution and as an additional layer of oversight, language was included in the terms and conditions of the grant award to EcoHealth that outlined criteria for a secondary review, such as a requirement that the grantee report immediately a one log increase in growth.
These measures would prompt a secondary review to determine whether the research aims should be re-evaluated or new biosafety measures should be enacted. EcoHealth failed to report this finding right away, as was required by the terms of the grant.”
In other words, EcoHealth’s experiment “accidentally” turned into GOF. At that point, EcoHealth should have alerted the NIH, but allegedly didn’t. So, according to Tabak, NIH bears no responsibility as they relied on EcoHealth to follow the terms of the grant.
EcoHealth has denied this charge, saying “These data were reported as soon as we were made aware, in our year four report in April 2018 … At no time did program staff indicate to us that this work required further clarification or secondary review.”10,11
As noted by The Intercept,12 Tabak implies the NIH created that reporting rule “out of an abundance of caution,” but according to the correspondence The Intercept reviewed, “the language was inserted at Daszak’s suggestion,” and “the NIH and EcoHealth Alliance worked together to evade additional oversight.”
How did they evade additional oversight? Through illogical and contradictory risk assessments. While Tabak claims the resulting virulence was unintentional, how could that be, since the experiment in question was supposed to test the “emergency potential” of bat coronaviruses in the human population?
The name of the grant itself tells us they’re going to assess the possibility of a bat coronavirus mutating into something that can affect humans, and to do that, they will likely try to manipulate the virus to see if it can gain that function.
EcoHealth president, zoologist Peter Daszak, suggested to the NIH that the experiment should not be categorized as restricted GOF because his proposed hybrid viruses were so different from the SARS virus (which is known to infect humans). The Intercept continues:13
“Daszak also pointed out that WIV1, the parent of the proposed chimeric SARS-like viruses, ‘has never been demonstrated to infect humans or cause human disease,’ according to the transcribed emails.
And he said that previous research ‘strongly suggests that the chimeric bat spike/bat backbone viruses should not have enhanced pathogenicity in animals.’ The NIH would go on to accept these arguments.
But the group’s argument that its viral research did not pose a risk of infection appears to contradict the justification for the work: that these pathogens could potentially cause a pandemic.
‘The entire rationale of EcoHealth’s grant renewal on SARS-related CoVs is that viruses with spikes substantially (10-25%) diverged from SARS-CoV-1 pose a pandemic risk,’ said [Fred Hutchinson Cancer Research Center virologist, Jesse] Bloom.
‘Given that this is the entire rationale for the work, how can they simultaneously argue these viruses should not be regulated as potential pandemic pathogens?’”
But Daszak’s justification makes no sense for yet another reason. Three months before Daszak wrote that determination for the NIH — where he suggests the WIV1 virus they were going to use as the backbone for the chimeras had “never been demonstrated to infect humans or cause human disease” — his collaborator, Ralph Baric, Ph.D., had published a paper14 showing WIV1 did indeed have the ability to infect humans.15
This is terrific! We are very happy to hear that our Gain of Function research funding pause has been lifted. ~ Dr. Peter Daszak, email to NIH
Baric, who works at UNC Chapel Hill, had found the WIV1 virus “readily replicated efficiently in human airway cultures and in vivo,” and posed an “ongoing threat” to the human population. This completely contradicts Daszak’s statement, and it’s doubtful that Daszak would not be aware of the paper published by Baric three months earlier. It’s doubtful the NIH would be ignorant of Baric’s finding as well.
NIH Accepted Daszak’s Escape Clause
As explained by The Intercept, Daszak came up with a solution that would allow his group and the NIH to perform research they all knew was prohibited at the time:16
“If the recombinant viruses grew more quickly than the original viruses on which they were based, [Daszak] suggested, EcoHealth Alliance and its collaborators would immediately stop its research and inform their NIAID program officer …
In a July 7 letter to EcoHealth Alliance, NIH’s Greer and Stemmy formally accepted Daszak’s proposed rule. The chimeric viruses were ‘not reasonably anticipated’ to ‘have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route,’ the administrators concluded …
The language that the NIH later inserted into the grant was strikingly similar to what Daszak proposed: ‘Should any of the MERS-like or SARS-like chimeras generated under this grant show evidence of enhanced virus growth greater than 1 log over the parental backbone strain you must stop all experiments with these viruses.’”
In a July 2016 email to the NIH, Daszak expresses his satisfaction that the agency decided to accept his justifications for why the research should not be considered restricted GOF. “This is terrific!” he wrote. “We are very happy to hear that our Gain of Function research funding pause has been lifted.”17 Daszak even admits that what they’re REALLY doing is GOF right in that email.
Clear Regulatory Failure
When EcoHealth’s scientists performed the experiment, one of the chimeric viruses grew much faster than the others during the first week of the experiment, producing a viral load that was four logs greater than the parent virus.
As noted earlier, Tabak claims EcoHealth didn’t inform the NIH program officer about this gain of function, and EcoHealth claims it did, and was permitted by default to continue, as no one at the NIH objected.
Incidentally, Daszak was relying on Wuhan Institute of Virology researcher Shi Zhengli — known to have ties to the Chinese military — to notify him if any of the viruses in the experiment had enhanced replication. Daszak in turn informed the NIH about this chain of reporting, so they knew the legality of the research basically rested in the hands of a Chinese operative, who may or may not have incentive to downplay such findings.
Richard Ebright, a molecular biologist at Rutgers University who has criticized the lack of oversight of gain-of-function research, told The Intercept that the correspondence between the NIH and EcoHealth points to clear regulatory failure. “The oversight process clearly failed,” he said. Ebright also spoke to the Daily Caller, stating:18
“The NIH, incredibly, accepted EcoHealth’s belief that this work would not be considered gain of function, and accepted EcoHealth’s rationale for this belief, and accepted EcoHealth’s policy-noncompliant proposal for a [10 times] allowance for increased viral growth before stopping work and reporting results.
The NIH, in effect, delegated to EcoHealth Alliance the authority to determine whether its research was, or was not gain of function research subject to the funding pause, the authority to set criteria for the determination, and the authority to over-ride federal policies implemented by the White House …”
The same sentiment was expressed by House Energy and Commerce Committee ranking member Rep. Cathy McMorris Rodgers and several other Republican lawmakers in an October 27, 2021, letter19,20 to NIH director Dr. Francis Collins. As reported by Daily Caller:21
“’EcoHealth portrayed the risks of these experiments as if they were not of concern, and the NIH accepted EcoHealth’s assertions without a searching inquiry,’ the Republican lawmakers told Collins. ‘However, the assessment of the risks by both EcoHealth and the NIH do not seem to square with the understanding of the research risks at that time …
Although the engineered viruses at the WIV were far from SARS CoV-2 on the coronavirus family tree, this research reflected a high tolerance for risk,’ the lawmakers said, adding that there is no evidence that EcoHealth took action to notify the NIH that it created viruses that exhibited enhanced growth in humanized cells.
‘If EcoHealth and NIH could not handle compliance and oversight of such a basic policy, it raises more concerns about the overall adequacy of the oversight of this research, which leaves the public vulnerable to a serious lab accident,’ the lawmakers wrote.”
CNN Grills NIH Director
In a rare attempt at real journalism, CNN’s Pamela Brown kept Collins strapped to the hot seat in a recent interview, repeatedly grilling him about why the NIH was funding dangerous GOF research.22 Even Josh Rogin from the liberal Washington Post picked up on Brown’s dogged demands for Collins to come clean on the issue in the face of Collins’ attempts to sidetrack her:
“Everyone should watch this interview with outgoing NIH director Francis Collins to see how Collins uses misleading talking points to avoid any acknowledgement NIH was caught completely unaware its grantee was doing risky bat coronavirus research in Wuhan … Collins uses every rhetoric trick to dissemble and distract …” Rogin tweeted.23
To her credit, Brown repeatedly brought the interview back on track, pressing Collins for answers, demanding to know:
“Why should Americans trust you and the NIH on the issue of COVID origins, when you didn’t even know about the programs it was funding with taxpayer dollars in China?”
When Collins tried to circumvent the question by diving into semantics about the definition of GOF, Brown interrupted him, again asking how he can be so certain that NIH funding isn’t being used for GOF, when he claims the NIH only recently found out about how the money was used in 2016?
Collins also reiterated that while EcoHealth “did some things they should have told us about … they did not do the kind of gain-of-function research that requires special, high-level oversight.” Really? As noted by ZeroHedge:24
“… if EcoHealth HAD reported its research results, it WOULD HAVE triggered extra, high-level oversight. Why is Collins pretending he knows they would have been exempt from that?”
Despite Collins’ insistence that the NIH was above-board and honest in all its communications, Brown refused to let him off the hook, ending the interview with: “This is U.S. taxpayer dollars going to risky research and I believe every American deserves to know about it.”
On a sidenote, like Fauci’s, Collins’ halo is rapidly tarnishing as alternative media have started digging into their backgrounds. While appearing squeaky clean on the surface, a closer look reveals both men have supported all sorts of questionable research, including research on aborted fetuses.
For an overview of Collins’ alleged sins, see First Things’ article, “The Cautionary Tale of Francis Collins.”25 Unlike Fauci, though, Collins seems to sense he won’t escape public judgment. In October 2021, he announced his retirement from the NIH. He’s reportedly planning to step down by the end of the year. Time will tell if Fauci will have the good sense to resign, or if our political leaders will finally boot him out and press charges.
We Must Ban GOF Research
The evidence of regulatory failure by the NIH further strengthens the call for a permanent ban on most kinds of GOF. As Bloom told The Intercept:26
“We urgently need a broader discussion about whether it’s a good idea to be making novel chimeras of coronaviruses that are at this point universally acknowledged to pose a pandemic risk to humans.”
Indeed, it appears we got off easy this time. SARS-CoV-2 has a very low mortality rate, despite spreading quite easily. The next Frankenstein pathogen to escape from a lab might not be as benign.
Seeing how the people in charge of making decisions about what research is to be allowed cannot be trusted with making sensible decisions, the public really needs to step up and let our representatives know we will not tolerate federal funds — taxpayer money — being used for research that has the potential to wipe us all out.
Emails show that NIH officials allowed EcoHealth Alliance to craft oversight language governing its own gain-of-function research.
The National Institutes of Health allowed a U.S. nonprofit it funds to police its own controversial research on bat coronaviruses in China, raising new concerns about insufficient oversight at the agency.
Detailed notes on NIH communications obtained by The Intercept show that beginning in May 2016, agency staff had an unusual exchange with Peter Daszak, the head of EcoHealth Alliance, about experiments his group was planning to conduct on coronaviruses under an NIH grant called “Understanding the Risk of Bat Coronavirus Emergence.” The notes were taken by congressional staff who transcribed the emails.
EcoHealth was entering the third year of the five-year, $3.1 million grant that included research with the Wuhan Institute of Virology and other partners. In a 2016 progress report, the group described to NIH its plans to carry out two planned experiments infecting humanized mice with hybrid viruses, known as “chimeras.”Join Our NewsletterOriginal reporting. Fearless journalism. Delivered to you.I’m in
The plans triggered concerns at NIH. Two staff members — Jenny Greer, a grants management specialist, and Erik Stemmy, a program officer handling coronavirus research — wrote to EcoHealth Alliance to say that the experiments “appear to involve research covered under the pause,” referring to a temporary moratorium on funding for gain-of-function research that would be reasonably anticipated to make MERS and SARS viruses more pathogenic or transmissible in mammals. Generally, gain-of-function research involves manipulating viruses to give them new attributes; it becomes of concern to the government when the altered viruses appear likely to cause more severe disease or spread more easily among humans.
One of the experiments proposed by EcoHealth Alliance involved making chimeras from the MERS virus. The other experiment used chimeras developed from bat viruses related to SARS. The researchers went on to infect the genetically engineered mice with the altered viruses.
Initially, NIH staff appeared intent on enforcing the funding pause. The two administrators requested additional information from EcoHealth Alliance within 15 days and noted that the next round of funding would be withheld until the information was received. They also asked the group to provide a detailed description of changes that would allow the researchers to pursue their aims without conducting the dangerous experiments.Agency staff adopted language that EcoHealth Alliance crafted to govern its own work.
But what happened next sets off alarm bells for biosafety advocates: Agency staff adopted language that EcoHealth Alliance crafted to govern its own work. The agency inserted several sentences into grant materials describing immediate actions the group would take if the viruses they created proved to become more transmissible or disease-causing as the result of the experiments.
Although the experiments demonstrate a lack of oversight and present dangers to public health, according to several scientists contacted by The Intercept, none of the viruses involved in the work are related closely enough to SARS-CoV-2 to have sparked the pandemic.
In December 2017, the funding for some gain-of-function research was resumed under carefully constructed guidelines for “Potential Pandemic Pathogen Care and Oversight,” or P3CO — but the language suggested by Daszak helped the group evade this oversight as well. In July 2018, NIAID program officers decided that the experiments on humanized mice — which had been conducted a few months earlier — would get a pass from these restrictions as long as EcoHealth Alliance immediately notified appropriate agency officials according to the circumstances that the group had laid out.
While it is not unusual for grantees to communicate with their federal program officers, the negotiation of this matter did not appropriately reflect the gravity of the situation, according to Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center. “The discussions reveal that neither party is taking the risks sufficiently seriously,” said Bloom. “MERS-CoV has killed hundreds of people and is thought to pose a pandemic risk, so it’s difficult to see how chimeras of MERS-CoV with other high risk bat coronaviruses shouldn’t also be considered a pandemic risk.”“The NIH is bending over backward to help people it’s funded.”
“It’s absolutely outrageous,” said Simon Wain-Hobson, a virologist at the Pasteur Institute in Paris. “The NIH is bending over backward to help people it’s funded. It isn’t clear that the NIH is protecting the U.S. taxpayer.”
The NIH did not respond to questions about the communications with Daszak. EcoHealth Alliance did not immediately respond to questions.
In a written response to questions submitted in September and October, an NIH spokesperson told The Intercept that the rule that was supposed to trigger a stop to the research was added “out of an abundance of caution.” Similarly, in a letter sent to the House Committee on Oversight and Reform last month, NIH principal deputy director Lawrence Tabak called the rule “an additional layer of oversight,” implying that the agency had devised the rule itself. But the notes reviewed by The Intercept show that the language was inserted at Daszak’s suggestion and that the NIH and EcoHealth Alliance worked together to evade additional oversight.
Daszak responded to the NIH on June 8, 2016, arguing that, because EcoHealth Alliance’s proposed hybrid viruses were significantly different from the SARS virus, which was already known to infect humans, the experiments were not gain-of-function research and should not be restricted.
Daszak also pointed out that WIV1, the parent of the proposed chimeric SARS-like viruses, “has never been demonstrated to infect humans or cause human disease,” according to the transcribed emails. And he said that previous research “strongly suggests that the chimeric bat spike/bat backbone viruses should not have enhanced pathogenicity in animals.” The NIH would go on to accept these arguments.
But the group’s argument that its viral research did not pose a risk of infection appears to contradict the justification for the work: that these pathogens could potentially cause a pandemic. “The entire rationale of EcoHealth’s grant renewal on SARS-related CoVs is that viruses with spikes substantially (10-25%) diverged from SARS-CoV-1 pose a pandemic risk,” said Bloom. “Given that this is the entire rationale for the work, how can they simultaneously argue these viruses should not be regulated as potential pandemic pathogens?”
The NIH has not made the correspondence public. Instead, the agency arranged for an “in camera” review for select congressional staff. The staffers were allowed to read and take notes on printed copies of the written exchange — an unusual approach for grant communications that are in the public interest. The Intercept reviewed notes taken by congressional staff.
“Given the importance and interest in this topic, it’s important for the NIH to be fully transparent about the research they support and how they make crucial decisions about the regulation of research on potential pandemic pathogens,” said Bloom.
The Escape Clause
Regulating risky research is the NIH’s role. But Daszak gave his group a way out. If the recombinant viruses grew more quickly than the original viruses on which they were based, he suggested, EcoHealth Alliance and its collaborators would immediately stop its research and inform their NIAID program officer. Specifically, he suggested a threshold beyond which his researchers would not go: If the novel SARS or MERS chimeras showed evidence of enhanced virus growth greater than 1 log (or 10 times) over the original viruses and grow more efficiently in human lung cells, the scientist would immediately stop their experiments with the mutant viruses and inform their NIAID program officer.
In a July 7 letter to EcoHealth Alliance, NIH’s Greer and Stemmy formally accepted Daszak’s proposed rule. The chimeric viruses were “not reasonably anticipated” to “have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route,” the administrators concluded, according to the transcribed emails.
The language that the NIH later inserted into the grant was strikingly similar to what Daszak proposed: “Should any of the MERS-like or SARS-like chimeras generated under this grant show evidence of enhanced virus growth greater than 1 log over the parental backbone strain you must stop all experiments with these viruses.”
But when the scientists conducted the experiments in 2018, one of the chimeric viruses grew at a rate that produced a viral load of log 4 — or 10,000 times — greater than the parent virus. Even so, the work was allowed to proceed.
Despite the careful wording meant to assure the agency that the research would be immediately halted if it enhanced the viruses’ pathogenicity or transmissibility, EcoHealth violated its own rule and did not immediately report the concerning results to NIH, according to the letter from NIH’s Tabak.
In a letter sent to NIH on October 26, Daszak insisted EcoHealth Alliance did comply with all the requirements of its NIH grant, pointing out that the group reported the results of its experiment in its year four progress report, which it submitted to the agency in April 2018 — and that no one at the agency responded to the description of the experiment. “At no time did program staff indicate to us that this work required further clarification or secondary review,” he wrote.
Daszak also argued in the letter that the viral growth reported in the year four progress report did not correspond to the viral growth outlined in the rule he himself had devised. “The experiment we reported to NIH actually shows genome copies per gram not viral titer.”
Daszak emphasized that the growth of the chimeric viruses in the genetically engineered mice was enhanced only in the early part of the experiment. “By day 6-8, there was no discernably significant difference among the different viral types,” he wrote.
Yet virologists contacted by The Intercept dismissed both the distinction between viral titer and viral growth and the focus on the latter part of the mouse experiment, when the rate of growth between the viruses had evened out.
“I don’t agree with their interpretation,” said Wain-Hobson, of the Pasteur Institute. He described the EcoHealth Alliance’s response as “hairsplitting” and said that viral growth inevitably peters out. “Every growth of a virus comes to a plateau. This has been known since time immemorial,” said Wain-Hobson. “They have chosen this interpretation because it suits them.”
NIH officials have previously stated unequivocally that the agency did not fund any gain-of-function research in Wuhan. “The NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology,” said Anthony Fauci, the head of the NIAID, during a Senate hearing in May. Fauci is scheduled to testify before the Senate health committee tomorrow morning.
In its statement to The Intercept, an NIH spokesperson wrote, “the Agency did not support the kind of ‘gain of function’ research warranting the additional and unique P3CO oversight identified by stakeholders during extensive prior policy development. To claim otherwise is incorrect and irresponsible.” And in his letter last month, Tabak reiterated the claim that the research was not gain-of-function.
But the correspondence with Daszak makes clear that at least some at the agency were concerned that EcoHealth Alliance’s proposed experiments met the criteria for gain-of-function research of concern as early as 2016.
According to Richard Ebright, a molecular biologist at Rutgers University who has criticized the lack of federal oversight of gain-of-function research, the fact that the NIH allowed EcoHealth Alliance to write its own rules is further evidence of the NIH’s regulatory failure. “This is like the teacher giving you the opportunity to write your own homework problem and grade your own homework when you turn it in. Then you decide the teacher is so lenient, there’s no need to hand it in,” said Ebright. “The oversight process clearly failed.”
Beyond the question of oversight, others question whether these experiments should be conducted at all.
“In addition to the legalistic questions of whether EcoHealth and NIH were adhering to current guidelines,” said Bloom, “we urgently need a broader discussion about whether it’s a good idea to be making novel chimeras of coronaviruses that are at this point universally acknowledged to pose a pandemic risk to humans.”