"NIH allowed a US nonprofit it funds to police its own..research on bat coronaviruses in China, raising new concerns about insufficient oversight at the agency."

NIH officials worked with EcoHealth Alliance to evade restrictions on coronavirus experiments interc.pt/3wdPCcz
"Detailed notes on NIH communications obtained by The Intercept show that beginning..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"
"The plans triggered concerns at NIH. Two staff members—grants management specialist, and..program officer handling coronavirus research—wrote to EcoHealth..to say..experiments..appear to involve research covered under the pause'" referring to a..moratorium on..gain-of-function"
"[T]he correspondence..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."
"NIH..appeared intent on enforcing..pause. The..administrators requested additional information from EcoHealth..within 15 days..They also asked..group to provide..description of changes that would allow..researchers to pursue..aims without conducting..dangerous experiments."
"But what happened next sets off alarm bells for biosafety advocates: Agency staff adopted language that EcoHealth Alliance crafted to govern its own work"
Jesse Bloom: "The discussions reveal that neither party is taking the risks..seriously..MERS-CoV..killed hundreds..and is thought to pose..pandemic risk, so it’s difficult to see how chimeras of MERS-CoV with other high risk..viruses shouldn’t also be considered a pandemic risk."
Bloom: "The entire rationale of EcoHealth’s grant..on SARS-related CoVs is that viruses with spikes..diverged from SARS-CoV..pose..pandemic risk..Given that this is the entire rationale.., how can they..argue these viruses should not be regulated as potential pandemic pathogens?"
Bloom: "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."
Simon Wain-Hobson: "It’s absolutely outrageous..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."
"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..the scientist would immediately stop..and inform..NIAID"
"In..July 7 letter to EcoHealth.., NIH..accepted Daszak’s proposed rule..The language..NIH..inserted..was.. strikingly similar to what Daszak proposed: 'Should..chimeras generated under this grant show evidence of enhanced virus growth greater than 1 log..stop all experiments'"
"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"
"Daszak..[risibly] argued..that the viral growth,,in the experiment did not correspond to the viral growth in the rule ..'The experiment we reported to NIH..shows genome copies per gram not viral titer.'"

"Yet virologists contacted by The Intercept dismissed..the distinction"
"[T]he fact that the NIH allowed EcoHealth Alliance to write its own rules is further evidence of the NIH’s regulatory failure"
Ebright: "This is like a 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,..The oversight process clearly failed."
Bloom: "In addition to the legal..questions of whether EcoHealth and NIH were adhering to..guidelines..we urgently need a broader discussion about whether it’s a good idea to be making novel chimeras of coronaviruses..universally acknowledged to pose..pandemic risk to humans.”

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More from @R_H_Ebright

3 Nov
"Two subordinates of..Fauci raised concerns in May 2016 that a taxpayer-funded grant may include gain-of-function experiments on bat coronaviruses at a Wuhan lab, but dropped the issue after nonprofit group EcoHealth Alliance downplayed the concerns"

"National Institutes of Allergies and Infectious Disease staffers Jenny Greer and Erik Stemmy told EcoHealth in a May 28, 2016, letter that a proposed grant 'may include' gain of function research, according to documents obtained through..information request."
"The National Institutes of Allergies and Infectious Diseases staffers reversed course after requesting EcoHealth Alliance President Peter Daszak submitted a 'determination' to the agency that downplayed the risks of his proposed experiments, the records show"
Read 6 tweets
3 Nov
"During the U.S. gain-of-function (GOF) pause, undisclosed correspondence between NIH and EcoHealth Alliance now reveal that NIH was concerned it was funding such risky research"

republicans-energycommerce.house.gov/news/ec-republ… via @HouseCommerce
"In May 2016 – in response to EcoHealth Alliance’s Year Two progress report – NIH raised concerns that EcoHealth Alliance may have been conducting GOF research in the Wuhan lab."
In June 2016 – in response to NIH’s concerns – EcoHealth Alliance President Peter Daszak dismissed NIH’s concerns, [falsely] asserting their experiments on chimeric viruses did not amount to GOF.
Read 7 tweets
3 Nov
"'As noted by Stanford University microbiologist David Relman, “[The WIV] were essentially playing Russian roulette with the virus that the world’s expert had labelled poised for human emergence.'"

"Further, the one condition imposed by the NIH was the requirement that EcoHealth stop the humanized mice experiment and notify..NIH if the result was a virus with enhanced growth by more than ten times (or one log) compared to the parental backbone or strains found in nature."
"EcoHealth grant documents indicated such a reportable result from the experiment, but there is no evidence of EcoHealth taking the required actions, or the NIH raising any questions after getting the results of the experiment from EcoHealth."
Read 5 tweets
3 Nov
"HHS allowed bipartisan Committee staff to see..letters from NIH to EcoHealth (May 18, 2016, July 7, 2016, and July 5, 2018) and..from EcoHealth to NIH (June 8, 2016) in an in camera review..To our knowledge, NIH has not publicly disclosed these letters"

"In response to the experiment descriptions in EcoHealth’s research progress report, NIH wrote to
EcoHealth on May 28, 2016..to advise that NIAID determined the R01AI110964 grant research
project may include GOF experiments subject to the 2014 GOF research pause."
"Under the signature of..Peter Daszak.., its president.., EcoHealth replied to NIH on June 8, 2016, asserting[, risibly,] their research was not GOF..'We believe that this work would not be considered GOF'"
Read 6 tweets
3 Nov
"NIH..failed to report EcoHealth’s noncompliance and grant suspension..to..database that alerts..US..agencies to risky grant recipients..NIH,..USAID..and Department of Defense..paid EcoHealth..$23.4 million in new and renewed..awards since April 2020"

"Despite NIH’s notification to EcoHealth on July 8, 2020, that no funds would be provided, NIH issued..payment..to EcoHealth on July 13, 2020..In its revised award notice..NIH designated..allocations of $76,301 for..WIV, and $75,600 for..Institute of Pathogen Biology in Beijing"
"After paying an illegible grant recipient in July 2020, the NIH in August 2020 announced its award of two [new] multimillion-dollar grants to EcoHealth for NIAID’s $3.05 million project number U01AI151797, and NIAID’s $1.2 million project number U01AI153420."
Read 4 tweets
29 Oct
"NIH..said EcoHealth had failed to immediately report findings that suggested a 2018 experiment..improved how well a bat virus could grow..violating a condition for a secondary review of research that could potentially make viruses more dangerous."

":The agency said it gave EcoHealth five days to hand over “any and all” unpublished data from funded experiments."
"EcoHealth hit back on Tuesday, saying it 'did in fact comply with all reporting requirements'"
Read 4 tweets

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