Yesterday, the Office of the Inspector General at the U.S. Government Accountability Office released its audit into NIH/NIAID’s funding of EcoHealth Alliance’s (“EHA”) research at the Wuhan Institute of Virology (“WIV”). The audit found NIH failed to engage in proper oversight of EHA’s research at WIV, in violation of federal regulations designed to mitigate public risk. (45 Code of Federal Regulations § 75.)
The audit focused on an EHA research proposal called “Understanding the Risk of Bat Coronavirus Emergence” (Federal Award Identification Number R01AI110964). NIAID program officers tasked with reviewing EHA’s research proposal initially thought the experiments “appear to involve research covered under the [2016] pause [on gain-of-function research implemented by the Obama administration].” Despite these initial concerns, NIAID approved funding for the research, after Dr. Peter Daszak, President of EHA, promised to stop EHA’s experiments and inform NIAID in the event a novel SARS chimera showed evidence of enhanced viral growth greater than 1 log (10 times) over the original viruses. In 2018, one of EHA’s experiments resulted in a novel SARS chimera with 4 log (10,000 times) greater growth than the parent virus.
Last year, Law and Politics complained about NIH’s oversight of EHA’s research, and speculated that EHA might have failed to report the offending experiment in a timely manner.
It appears NIH out-sourced its oversight responsibilities to EHA in the mistaken expectation EHA would duly self-report violations.
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It is not clear whether NIH included the reporting condition Daszak suggested or whether NIH simply required EHA to “immediately” stop all experiments if they triggered the specified criteria. (“1 log or 10 times over the original viruses and grow more efficiently in human lung cells.”) Nor is it clear whether NIH required EcoHealth to inform their NIAID program officer immediately or only to stop working on the chimera immediately.
Presuming Daszak’s suggestion to include the reporting requirement was implemented by NIH as a condition of funding; presuming there was a requirement to report to the NIH program officer immediately; and presuming the due date for the year four progress report was on or around May 31, 2018, the timeline between the results of the 2018 research triggering the reporting requirement and the year four progress report is not yet established. We do not know whether EHA reported their research in a timely manner or delayed reporting the violation in a separate writing in order to bury the violation in a lengthy annual report.
(See “It’s Just The Flu: A comprehensive catalogue of COVID-19 disinformation from ‘trusted authorities.’”)
The OIG’s audit now establishes that NIH did not engage in proper oversight of EHA’s research; that EHA violated an explicit condition of their funding; and that EHA failed to report their offending experiment for more than two years. Further, the audit shows NIH and EHA failed to monitor subawards to WIV.
Specifically, NIH did not ensure EcoHealth in a timely manner submitted a progress report that was 2 years late and that NIH concluded contained evidence of a virus with growth that should have been reported immediately; did not ensure EcoHealth publicly reported required subaward data; and did not follow proper procedures to terminate an award to EcoHealth.
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[W]e found that EcoHealth did not ensure that subawards were compliant with Federal requirements, did not ensure compliance with subrecipient monitoring and reporting requirements, and did not comply with certain public disclosure requirements associated with reporting subaward funding. In addition, EcoHealth did not always use its grant funds in accordance with Federal requirements, resulting in $89,171 in unallowable costs. These deficiencies occurred because NIH and EcoHealth did not follow established policies and procedures.
Although NIH and EcoHealth had established monitoring procedures, lapses in complying with those procedures limited NIH and EcoHealth’s ability to: (1) effectively monitor Federal grant awards and subawards to understand the nature of the research conducted, identify potential problem areas, and take corrective action; (2) provide the visibility and transparency to determine how these grant funds were used; and (3) mitigate the risk of noncompliance with Federal requirements and internal policies and procedures.
(“NIH and EcoHealth Did Not Effectively Monitor Awards and Subawards (A-05-21-00025),” at 7-8).
In short, the audit reveals the total inadequacy of NIH/NIAID’s laissez-faire approach to overseeing dangerous gain-of-function (“GoF”) research, and highlights the short-comings of the HHS P3CO Framework with regards to regulating ePPPs.
In response to the OIG’s audit, Representative Guy Reschenthaler (R-PA) introduced legislation that would ban EHA from receiving federal funding. (EHA currently has 12 active U.S. government grants totaling more than $34 million.) Senators James Lankford (R-OK) and Roger Marshall (R-KS) reintroduced legislation to place a moratorium on all federal research grants involving GoF research on potential pandemic pathogens. Senator Marshall observed, in a thinly-veiled reference to NIAID Director Dr. Anthony Fauci, that “for the past few years, a select group of individuals at NIH and other federal agencies have undermined congressional oversight instead of being transparent or accountable to the American people.” Senator Tuberville (R-AL) said, “The dereliction of oversight duty at the NIH is not only unacceptable, it’s dangerous.” Senator Wicker (R-MI) opined, “Taxpayers should not have to finance research that could lead to another disastrous pandemic. It is clear there has been a failure of oversight, and it would be irresponsible to let this work move forward.” Senator Braun (R-IN) concluded, “American taxpayers should not be funding dangerous gain-of-function projects.” And Senator Blackburn (R-TN) argued GoF research should be halted until proper oversight is in place.
In light of the GAO’s new report, it has become abundantly clear that the NIH is currently incapable of properly enforcing statutorily mandated oversight standards. There is no room for negligence in researching potential pandemic pathogens. These projects should not be allowed to continue until oversight is improved and safety guardrails become a guarantee.
The silence from Democrats, reflecting their apparent disinterest in discovering the proximate origins of SARS-CoV-2, which has taken almost 7 million lives to date, is deafening.
Senator Rubio (R-FL) believes “serious questions remain regarding [COVID-19’s] origins and possible connection to federally-funded gain of function of research in China.” Both Senators Cotton (R-AK) and Paul (R-KY) repeated the claim there is “evidence COVID-19 originated” at WIV.
The evidence falls into three categories.
First, there is no proof of a natural origin to COVID-19. Despite three years and millions in dollars in funding, proponents of the zoonosis hypothesis have not yet identified the species of bat (or pangolin or other animal) that carried the virus prior to the virus entering the human population. Although there is no proof of a natural origin, a meta-analysis of peer-reviewed literature concluded that the overwhelming evidence supports a natural origin. However, this analysis was led by none other than Daszack.
The acrimonious debate over the origins of the COVID-19 pandemic flared up again this week with a report from an expert panel concluding that SARS-CoV-2 likely spread naturally in a zoonotic jump from an animal to humans—without help from a lab.
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The panel’s own history reflects the intensity of the debate. Originally convened as a task force of the Lancet COVID-19 Commission, a wide-reaching effort to derive lessons from the pandemic, it was disbanded by Columbia University economist Jeffrey Sachs, the commission’s chair. Sachs alleged that several members had conflicts of interest that would bias them against the lab-origin hypothesis.
Sachs and other researchers who contend the scientific community has too blithely dismissed the lab-leak possibility aren’t persuaded by the new analysis. The task force’s literature analysis was a good idea, says Jesse Bloom, a virologist at the Fred Hutchinson Cancer Center who has pushed for more investigations of the lab-leak hypothesis. But he says the zoonosis proponents haven’t provided much new data. “What we’ve seen is mostly reanalysis and reinterpretation of existing evidence.”
Sachs adds that the task force report does not “systematically address” the possible research-related origins of the pandemic. And he contends there was a “rush to judgment” by the National Institutes of Health and “a small group of virologists” to dismiss the possible research-related origins of the pandemic. In September, The Lancet published a report from his commission that gave equal weight to both hypotheses.
When Sachs launched the Lancet origin task force in December 2020, he tapped conservation biologist Peter Daszak to lead it. Daszak heads the nonprofit EcoHealth Alliance, which has funded work on bat coronaviruses at the Wuhan Institute of Virology (WIV). Because the first COVID-19 cases were reported in Wuhan, China, some scientists suspect research conducted at WIV led to the spread of SARS-CoV-2. Sachs came to believe Daszak and other task force members who had links to WIV and the EcoHealth Alliance could not assess that possibility fairly and should step down. After fierce infighting over issues including transparency and access to information, Sachs pulled the plug on the task force in September 2021.
But the members continued to meet.
Daszak et al. published their research even after Sachs disbanded the panel because the panel was biased against the lab leak hypothesis. Sachs et al.’s report, published in The Lancet on September 14, 2022, gives equal weight to both theories of origin.
The proximal origins of SARS-CoV-2 are still not known. Identifying these origins would provide greater clarity into not only the causes of the current pandemic but also vulnerabilities to future outbreaks and strategies to prevent them. We concur with the position of 18 leading scientists who wrote in Science magazine44 in May, 2021: “We must take hypotheses about both natural and laboratory spillovers seriously until we have sufficient data.” As a group of 16 scientists communicated in The Lancet45 in October, 2021: “Overwhelming evidence for either a zoonotic or research-related origin is lacking: the jury is still out.” More than 2 years into the pandemic, the search for the origin of SARS-CoV-2 remains incomplete and inconclusive.46, 47 Independent experts consulted by the Lancet COVID-19 Commission shared the view that hypotheses about both natural and laboratory spillovers are in play and need further investigation.
Although the proximal origins are unknown, SARS-CoV-2 is thought to derive from a bat SARS-CoV-related coronavirus with a furin cleavage site that enhances the capacity of the virus to infect human cells.48, 49 Furin cleavage sites are found naturally in almost every family of coronavirus,50, 51 although they have not been observed in other SARS-related coronaviruses (subgenus Sarbecoronavirus). Since 2006, following the emergence of severe acute respiratory syndrome, furin cleavage sites have also been the subject of laboratory manipulation, including their insertion into coronavirus spike proteins.52 The presence of the furin cleavage site in SARS-CoV-2 therefore does not by itself identify the proximal origin of the virus, whether natural or laboratory.
The proximal origins of SARS-CoV-2 are still not known. Identifying these origins would provide greater clarity into not only the causes of the current pandemic but also vulnerabilities to future outbreaks and strategies to prevent them. We concur with the position of 18 leading scientists who wrote in Science magazine44 in May, 2021: “We must take hypotheses about both natural and laboratory spillovers seriously until we have sufficient data.” As a group of 16 scientists communicated in The Lancet45 in October, 2021: “Overwhelming evidence for either a zoonotic or research-related origin is lacking: the jury is still out.” More than 2 years into the pandemic, the search for the origin of SARS-CoV-2 remains incomplete and inconclusive.46, 47 Independent experts consulted by the Lancet COVID-19 Commission shared the view that hypotheses about both natural and laboratory spillovers are in play and need further investigation.
Although the proximal origins are unknown, SARS-CoV-2 is thought to derive from a bat SARS-CoV-related coronavirus with a furin cleavage site that enhances the capacity of the virus to infect human cells.48, 49 Furin cleavage sites are found naturally in almost every family of coronavirus,50, 51 although they have not been observed in other SARS-related coronaviruses (subgenus Sarbecoronavirus). Since 2006, following the emergence of severe acute respiratory syndrome, furin cleavage sites have also been the subject of laboratory manipulation, including their insertion into coronavirus spike proteins.52 The presence of the furin cleavage site in SARS-CoV-2 therefore does not by itself identify the proximal origin of the virus, whether natural or laboratory.
Second, according to Prof. Richard H. Ebright, Professor of Chemistry and Chemical Biology at Rutgers University, there is strong scientific and circumstantial evidence that COVID-19 was more likely than not engineered.
In summary, none of the 100+ SARS-like coronaviruses known to occur naturally have a furin cleavage site (“FCS”). But SARS-CoV-2 has a FCS at the spike gene S1-S2 border. And COVID-19 demonstrates a high affinity for binding to human cells, because its FCS has the exact amino-acid-sequence identity to the FSC of human ENaCA. As it so happens, prior to the COVID-19 pandemic, but after creating a novel SARS chimera that dramatically increased the lethality and transmissibility of a coronavirus in humanized mice, EHA proposed to insert novel spike genes and a FCS at the S1-S2 border in bat SARS-like coronaviruses. What an amazing coincidence.
Third, other circumstantial evidence, not related specifically to the genetic make-up of the virus itself, strongly suggests WIV is the source of COVID-19.
WIV is located 8.1 miles from the first hotspot at the wet-market in Wuhan.
EHA’s GoF research at WIV was not subject to NIH oversight.
EHA did not report its GoF research to NIH for more than 2 years, in violation of an explicit condition of continued funding, during which time additional unauthorized research may have been ongoing.
EHA’s GoF research at WIV occurred in Bio-Safety Level 2 conditions, when such experiments are required by regulation to take place at a BSL-4 lab.
U.S. State Department officials warned in 2018 that WIV had safety problems.
The Obama administration suspended the kind of research EHA was doing at WIV precisely because the risk of an ePPP leaking from a lab was unacceptably high.
WIV deleted its public database that detailed its coronavirus research in Sept. 2019, shortly before the outbreak at the wet-market in Dec. 2019.
Chinese, U.S., and European officials, as well as their media and Big Tech lapdogs, used mass disinformation and intimidation techniques throughout 2020 to dissuade objective investigation into the lab origin hypothesis by journalists and scientists.
The most senior CCP military scientist, Dr. Zhou Yusen, patented a vaccine for COVID-19 on February 24, 2020, only a few weeks after the outbreak in Wuhan occurred.
Given WIV apparently deleted evidence and the CCP denied any independent inspection of WIV at the time, evidence for a lab origin will likely never amount to conclusive proof, absent a WIV insider blowing the whistle. But, until proponents of the zoonosis hypothesis can show how COVID-19 jumped from bats to humans, the weight of evidence clearly weighs in favor of a lab origin.
Prudent policy clearly requires further investigation into the issue of COVID-19’s origin, beginning with why NIH erred on the side of excluding EHA’s research from inclusion in the more rigorous department-level review required for ePPP-related experiments. GoF research should be suspended until we have more evidence as to COVID’s origins and a better understanding of the culture at NIH and NIAID that led to the failure to properly oversee EHA’s dangerous research at WIV.
This is Law and Politics. Until next time . . . .