{"id":2787,"date":"2021-11-04T21:54:39","date_gmt":"2021-11-04T21:54:39","guid":{"rendered":"https:\/\/www.pbmv.com\/blog\/?p=2787"},"modified":"2021-11-04T21:54:39","modified_gmt":"2021-11-04T21:54:39","slug":"nih-officials-worked-with-ecohealth-alliance-to-evade-restrictions-on-coronavirus-experiments","status":"publish","type":"post","link":"https:\/\/www.pbmv.com\/blog\/?p=2787","title":{"rendered":"NIH Officials Worked With EcoHealth Alliance to Evade Restrictions on Coronavirus Experiments"},"content":{"rendered":"

by Sharon Lerner, Mara Hvistendahl<\/a><\/p>\n

\"peter_daszak2.jpg\"Peter Daszak, the head of EcoHealth Alliance, arrives at the Wuhan Institute of Virology in China\u2019s central Hubei province on Feb. 3, 2021<\/i><\/b><\/p>\n

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.<\/p>\n

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.<\/p>\n

Serious Risks<\/h3>\n

In December 2017, the funding for some gain-of-function research was resumed under carefully constructed guidelines for \u201cPotential Pandemic Pathogen Care and Oversight,\u201d or P3CO \u2014 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 \u2014 which had been conducted a few months earlier \u2014 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.<\/p>\n

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. \u201cThe discussions reveal that neither party is taking the risks sufficiently seriously,\u201d said Bloom. \u201cMERS-CoV has killed hundreds of people and is thought to pose a pandemic risk, so it\u2019s difficult to see how chimeras of MERS-CoV with other high risk bat coronaviruses shouldn\u2019t also be considered a pandemic risk.\u201d<\/p>\n

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 \u201cout of an abundance of caution.\u201d Similarly, in a letter<\/a> sent to the House Committee on Oversight and Reform last month, NIH principal deputy director Lawrence Tabak called the rule \u201can additional layer of oversight,\u201d implying that the agency had devised the rule itself. But the notes reviewed by The Intercept show that the language was inserted at Daszak\u2019s suggestion and that the NIH and EcoHealth Alliance worked together to evade additional oversight.<\/p>\n

Daszak responded to the NIH on June 8, 2016, arguing that, because EcoHealth Alliance\u2019s 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.<\/p>\n

Daszak also pointed out that WIV1, the parent of the proposed chimeric SARS-like viruses, \u201chas never been demonstrated to infect humans or cause human disease,\u201d according to the transcribed emails. And he said that previous research \u201cstrongly suggests that the chimeric bat spike\/bat backbone viruses should not have enhanced pathogenicity in animals.\u201d The NIH would go on to accept these arguments.<\/p>\n

But the group\u2019s 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. \u201cThe entire rationale of EcoHealth\u2019s grant renewal on SARS-related CoVs is that viruses with spikes substantially (10-25%) diverged from SARS-CoV-1 pose a pandemic risk,\u201d said Bloom. \u201cGiven that this is the entire rationale for the work, how can they simultaneously argue these viruses should not be regulated as potential pandemic pathogens?\u201d<\/p>\n

The NIH has not made the correspondence public. Instead, the agency arranged for an \u201cin camera\u201d review for select congressional staff. The staffers were allowed to read and take notes on printed copies of the written exchange \u2014 an unusual approach for grant communications that are in the public interest. The Intercept reviewed notes taken by congressional staff.<\/p>\n

\u201cGiven the importance and interest in this topic, it\u2019s 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,\u201d said Bloom.<\/p>\n

The Escape Clause<\/h3>\n

Regulating risky research is the NIH\u2019s 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.<\/p>\n

In a July 7 letter to EcoHealth Alliance, NIH\u2019s Greer and Stemmy formally accepted Daszak\u2019s proposed rule. The chimeric viruses were \u201cnot reasonably anticipated\u201d to \u201chave enhanced pathogenicity and\/or transmissibility in mammals via the respiratory route,\u201d the administrators concluded, according to the transcribed emails.<\/p>\n

The language that the NIH later inserted into the grant was strikingly similar to what Daszak proposed: \u201cShould 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.\u201d<\/p>\n

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 \u2014 or 10,000 times \u2014 greater than the parent virus. Even so, the work was allowed to proceed.<\/p>\n

Despite the careful wording meant to assure the agency that the research would be immediately halted if it enhanced the viruses\u2019 pathogenicity or transmissibility, EcoHealth violated its own rule and did not immediately report the concerning results to NIH, according to the letter<\/a> from NIH\u2019s Tabak.<\/p>\n

In a letter sent to NIH on October 26<\/a>, 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 \u2014 and that no one at the agency responded to the description of the experiment. \u201cAt no time did program staff indicate to us that this work required further clarification or secondary review,\u201d he wrote.<\/p>\n

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. \u201cThe experiment we reported to NIH actually shows genome copies per gram not viral titer.\u201d<\/p>\n

Daszak emphasized that the growth of the chimeric viruses in the genetically engineered mice was enhanced only in the early part of the experiment. \u201cBy day 6-8, there was no discernably significant difference among the different viral types,\u201d he wrote.<\/p>\n

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.<\/p>\n

\u201cI don\u2019t agree with their interpretation,\u201d said Wain-Hobson, of the Pasteur Institute. He described the EcoHealth Alliance\u2019s response as \u201chairsplitting\u201d and said that viral growth inevitably peters out. \u201cEvery growth of a virus comes to a plateau. This has been known since time immemorial,\u201d said Wain-Hobson, who explained that the eventual cessation of viral growth is due to a lack of nutrients. \u201cThey have chosen this interpretation because it suits them.\u201d<\/p>\n

NIH officials have previously stated unequivocally that the agency did not fund any gain-of-function research in Wuhan. \u201cThe NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology,\u201d said Anthony Fauci, the head of the NIAID, during a Senate hearing<\/a> in May. Fauci is scheduled to testify before the Senate health committee tomorrow morning.<\/p>\n

In its statement to The Intercept, an NIH spokesperson wrote, \u201cthe Agency did not support the kind of \u2018gain of function\u2019 research warranting the additional and unique P3CO oversight identified by stakeholders during extensive prior policy development. To claim otherwise is incorrect and irresponsible.\u201d And in his letter<\/a> last month, Tabak reiterated the claim that the research was not gain-of-function.<\/p>\n

But the correspondence with Daszak makes clear that at least some at the agency were concerned that EcoHealth Alliance\u2019s proposed experiments met the criteria for gain-of-function research of concern as early as 2016.<\/p>\n

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\u2019s regulatory failure. \u201cThis 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\u2019s no need to hand it in,\u201d said Ebright. \u201cThe oversight process clearly failed.\u201d<\/p>\n

Beyond the question of oversight, others question whether these experiments should be conducted at all.<\/p>\n

\u201cIn addition to the legalistic questions of whether EcoHealth and NIH were adhering to current guidelines,\u201d said Bloom, \u201cwe urgently need a broader discussion about whether it\u2019s a good idea to be making novel chimeras of coronaviruses that are at this point universally acknowledged to pose a pandemic risk to humans.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

by Sharon Lerner, Mara Hvistendahl Peter Daszak, the head of EcoHealth Alliance, arrives at the Wuhan Institute of Virology in China\u2019s central Hubei province on Feb. 3, 2021 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 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2787","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.pbmv.com\/blog\/index.php?rest_route=\/wp\/v2\/posts\/2787","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pbmv.com\/blog\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pbmv.com\/blog\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pbmv.com\/blog\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pbmv.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2787"}],"version-history":[{"count":2,"href":"https:\/\/www.pbmv.com\/blog\/index.php?rest_route=\/wp\/v2\/posts\/2787\/revisions"}],"predecessor-version":[{"id":2789,"href":"https:\/\/www.pbmv.com\/blog\/index.php?rest_route=\/wp\/v2\/posts\/2787\/revisions\/2789"}],"wp:attachment":[{"href":"https:\/\/www.pbmv.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2787"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pbmv.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2787"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pbmv.com\/blog\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2787"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}