But what happened next sounded the alarm bells for biosafety advocates: Agency staff adopted language developed by the EcoHealth Alliance to govern their own work. The agency inserted several sentences in the grant documents describing the immediate actions the group would take if the viruses they created were found to become more transmissible or more pathogenic as a result of the experiments.
Although the experiments show a lack of surveillance and pose dangers to public health, according to several scientists contacted by The Intercept, none of the viruses involved in the work are sufficiently linked to SARS-CoV-2 to have triggered the pandemic.
In December 2017, funding for some gain-of-function research resumed under carefully crafted guidelines for “the care and surveillance of potential pathogens in a pandemic,” or P3CO – but the language suggested by Daszak has also helped the group to escape this oblivion. In July 2018, NIAID program officials decided that experiments on humanized mice – which had been conducted a few months earlier – would be exempt from these restrictions as long as the EcoHealth Alliance immediately notified officials of the appropriate agency in depending on the circumstances that the group had posed. outside.
While it is not unusual for grantees to contact their federal program officers, negotiating this issue did not appropriately reflect the gravity of the situation, according to Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center. . “The talks show that neither side is taking the risks seriously enough,” Bloom said. âMERS-CoV has killed hundreds of people and is believed to pose a pandemic risk, so it’s hard to see how the chimeras of MERS-CoV along with other high-risk bat coronaviruses should not also be considered a pandemic risk. “
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 the research halt was added “out of caution.” Likewise, in a letter Sent to the House Committee on Oversight and Reform last month, NIH Senior Deputy Director Lawrence Tabak called the rule an “additional level of oversight,” implying that the agency designed the rule it -same. 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 further scrutiny.
Daszak responded to the NIH on June 8, 2016, arguing that, because the hybrid viruses proposed by EcoHealth Alliance were significantly different from the SARS virus, which was already known to infect humans, the experiments were not a search for gain of function and should not be limited.
Daszak also pointed out that WIV1, the parent of the proposed SARS-like chimeric viruses, “has never been shown to infect humans or cause human disease,” according to the transcribed emails. And he said previous research “strongly suggests that chimeric bat tip / bat backbone viruses should not have increased pathogenicity in animals.” The NIH would continue to accept these arguments.
But the group’s argument that its viral research did not pose a risk of infection seems to contradict the rationale for the work: that these pathogens could potentially cause a pandemic. “The whole rationale for renewing EcoHealth’s SARS-CoV grant is that viruses with significantly peaks (10-25%) diverging from SARS-CoV-1 pose a pandemic risk,” he said. Bloom said. “Given that this is the whole rationale for the work, how can they simultaneously claim that these viruses should not be regulated as potential pandemic pathogens?” “
The NIH did not make the correspondence public. Instead, the agency organized a âclosed doorâ review for some members of Congress. Staff 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 interception reviewed notes taken by congressional staff.
“Given the importance and interest of this topic, it is important that the NIH be fully transparent about the research it supports and how it makes critical decisions regarding the regulation of research on the subject. potential pandemic pathogens, âBloom said.
The safeguard clause
The role of the NIH is to regulate risky research. But Daszak gave his group a way out. If the recombinant viruses grew faster than the original viruses they were based on, he suggested, the EcoHealth Alliance and collaborators would immediately stop its research and notify their NIAID program manager. Specifically, he suggested a threshold beyond which his researchers would not go: whether new chimeras from SARS or MERS showed evidence of increased viral growth greater than 1 log (or 10-fold) compared to viruses. original and developed more efficiently in human lung cells, the scientist would immediately stop their experiments with the mutant viruses and notify their NIAID program manager.
In a July 7 letter to the EcoHealth Alliance, NIH’s Greer and Stemmy officially agreed to the rule proposed by Daszak. The chimeric viruses were “not reasonably expected” to “have increased pathogenicity and / or transmissibility in mammals via the respiratory route,” the administrators concluded, according to the transcribed emails.
The language the NIH then put into the grant was surprisingly similar to what Daszak proposed: you need to stop all experiments with these viruses.
But when scientists conducted the experiments in 2018, one of the chimeric viruses grew at a rate that produced a log 4 – or 10,000-fold – higher viral load than the parent virus. Despite this, the work was allowed to continue.
Despite the cautious wording meant to assure the agency that research would be immediately halted if it increased the pathogenicity or transmissibility of viruses, EcoHealth broke its own rule and did not immediately report the worrying findings to the NIH, according to the letter by Tabak of the NIH.
In a letter sent to the NIH on October 26, Daszak insisted that the EcoHealth Alliance complied with all the requirements of its NIH grant, noting that the group had reported on the results of its experiment in its progress report. year four, which he submitted to the agency in April 2018 – and no one at the agency responded to the description of the experience. âAt no time did program staff tell us that this work required further clarification or secondary review,â he wrote.
Daszak also argued in the letter that the viral growth reported in the fourth year progress report did not match the viral growth described in the rule he himself made. “The experiment we reported to NIH actually shows genome copies per gram and not viral titer.”
Daszak pointed out that the growth of chimeric viruses in genetically modified mice was only improved in the first part of the experiment. âOn day 6-8, there was no significant difference between the different viral types,â he wrote.
Yet virologists contacted by The Intercept rejected 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 viruses s’ was equalized.
âI don’t agree with their interpretation,â said Wain-Hobson of the Institut Pasteur. He called the EcoHealth Alliance’s response a “punch” and said the viral growth inevitably dies out. âEvery growth of a virus hits a plateau. This has been known from time immemorial, âsaid Wain-Hobson, who explained that the eventual stopping of viral growth is due to a lack of nutrients. âThey chose this interpretation because it suits them.
NIH officials have previously stated unequivocally that the agency is not funding any research into taking office in Wuhan. “The NIH has never funded, and now does not fund, gain-of-office research at the Wuhan Institute of Virology,” NIAID chief Anthony Fauci said at a Senate hearing in May. Fauci is due to testify before the Senate Health Committee tomorrow morning.
In his statement to The Intercept, an NIH spokesperson wrote: âThe agency did not support the type of ‘gain-of-function’ search warranting the additional and unique oversight of P3CO identified by stakeholders during the the development of in-depth prerequisite policies. To claim otherwise is incorrect and irresponsible. And in his letter Last month, Tabak reiterated the claim that research was not a job gain.
But correspondence with Daszak clearly indicates that at least some members of the agency feared that the experiments proposed by the EcoHealth Alliance would meet worrying criteria for seeking job gain as early as 2016.
According to Richard Ebright, a molecular biologist at Rutgers University who criticized the lack of federal oversight of gain-of-function research, the fact that the NIH allowed the EcoHealth Alliance to write its own rules is further evidence of NIH regulatory failure. âIt’s like the teacher gives you the option to write down your own homework problem and jot down your own homework when you hand it in. Then you decide the teacher is so forgiving that you don’t have to hand it over, âEbright said. âThe surveillance process has clearly failed. “
Beyond the question of surveillance, others wonder if these experiments should be carried out.
âIn addition to the legalistic questions of whether EcoHealth and NIH were following current guidelines,â Bloom said, âwe urgently need a larger discussion on whether it’s a good idea to create new coronavirus chimeras. which are at this stage universally recognized as posing a pandemic risk for humans.