Foreign Affairs

NIH Justifies Giving Green Light To Researchers To Boost Viruses Before Flagging Experiments For Gain-Of-Function Review

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• The National Institutes of Health (NIH) said it allows its grantees, including EcoHealth Alliance, to create lab viruses boosted by a factor of 10 before reporting back to the agency for a gain-of-function oversight review.
• An NIH spokesperson told the Daily Caller News Foundation that it created the “conservative benchmark of increased viral growth by 1 log” during the 2014-2017 federal funding pause on gain-of-function research.
• “Allowing researchers to generate artificial, laboratory-enhanced viruses that grow up to 10-times faster before requiring researchers to stop work and report results is not ‘conservative.’ It is irresponsible, and it is reckless,” said Rutgers University professor Richard Ebright.
• Jack Nunberg, a virologist who previously said EcoHealth was “sort of crazy” for tinkering with MERS viruses in Wuhan, said the one log benchmark was reasonable. 
• “Anything less than 1 log is difficult to measure/believe with any confidence,” Nunberg said.

The National Institutes of Health justified allowing EcoHealth Alliance to create boosted lab-made viruses with the Wuhan Institute of Virology with up to one log — or 10 times — increased growth before requiring the lab to pause experiments and report to the agency for a gain-of-function oversight review.

Documents first reported by The Intercept in September revealed that the National Institute of Allergy and Infectious Diseases (NIAID) directed EcoHealth to notify the agency only in the event it creates a lab-made chimeric coronavirus in Wuhan “with enhanced growth by more than 1 log compared to wild type strains.” The P3CO review process, which dictates oversight of gain-of-function research, contains no such mention of a viral enhancement benchmark that must be met before additional oversight begins.

An NIH spokesperson told the DCNF that it created the “conservative benchmark” during the 2014-2017 federal funding pause on gain-of-function research.

“At the time, there were no established animal models to assess pathogenicity or transmissibility for certain coronaviruses such as MERS. NIAID consulted with internal and external coronavirus experts to assess what would be considered a reasonable, conservative benchmark in the absence of animal data,” the spokesperson said. “The benchmark would be used to prompt further assessment of experiments should unexpected results occur. This discussion resulted in the establishment of the conservative benchmark of increased viral growth by 1 log.”

Rutgers University professor Richard Ebright, a vocal opponent of gain of function research, railed against the NIAID for allowing researchers to engage in a limited amount of gain of function research before requiring them to report in for additional oversight.

“Allowing researchers to generate artificial, laboratory-enhanced viruses that grow up to 10-times faster before requiring researchers to stop work and report results is not ‘conservative.’ It is irresponsible, and it is reckless,” Ebright told the DCNF. “In addition, it violates both the letter and the spirit of federal policies in effect in 2014-2017 and 2017-present.”

Documents obtained by the White Coat Waste Project and provided to the DCNF on Nov. 3 revealed that EcoHealth President Peter Daszak first proposed to the NIAID in June 2016 that he would notify the agency immediately if his organization’s lab-created viruses in Wuhan were enhanced by over one log, or ten times, compared to the natural strain used to construct it. The NIAID accepted Daszak’s terms in a July 2016 letter that stated EcoHealth’s proposed experiments did not fall under the federal gain of function funding pause active at the time.

Daszak expressed joy in a July 2016 email to multiple NIAID staffers after the agency gave him the green light to conduct experiments with the Wuhan Institute of Virology.

“This is terrific!” Daszak said. “We are very happy to hear that our Gain of Function research funding pause has been lifted.”

Peter Daszak email to NIAID staffers on July 11, 2016. (Screenshot)

The NIH spokesperson rejected The Intercept’s characterization that the documents showed the agency allowed EcoHealth to craft its own oversight language.

“EcoHealth Alliance did not ‘craft oversight’ language for their own award. Similar language referencing the conservative benchmark of 1 log increased growth predated the assessment of the EHA grant,” the spokesperson said. “Such language was used on MERS/SARS projects assessed under the funding pause throughout 2015 and 2016.”

NIH Principal Deputy Director Lawrence Tabak informed lawmakers on Oct. 20 that EcoHealth failed to immediately notify the agency that it created a lab-made chimeric coronavirus in Wuhan prior to the pandemic that exhibited a greater than 10-times increase in growth.

Despite Tabak’s letter, NIAID Director Dr. Anthony Fauci and the NIH maintain that the experiments they funded with the Wuhan Institute of Virology (WIV) did not involve gain of function research.

Fauci and the NIH also maintain that it is “molecularly impossible” for the viruses that EcoHealth and the WIV were tinkering with to have turned into the virus that causes COVID-19.

Simon Wain-Hobson, a virologist at the Pasteur Institute in Paris, also said it was irresponsible for the NIH to allow researchers to boost viruses tenfold before notifying the agency for oversight.

“They simply shouldn’t have been doing these experiments,” Wain-Hobson told the DCNF.

However, Wain-Hobson noted that tenfold enhanced viral growth isn’t something that most virologists would get too worked up over.

“Viral growth, indeed the enhanced growth of any pathogenic microbe is not good news,” Wain-Hobson explained. “That said, and given the intrinsic variation in our assays, virologists would probably not [get] too worked up if a virus grew 2, 5 or 10 during the growth of a virus in culture. 100 fold yes. Please understand that we’re not like physicists who can give values with errors sometimes less than 1%.”

“The growth conditions can be very sensitive to the state of the cells when infected, how that are manipulated and so on,” he added. “2-5 fold differences would produce a yawn. This is not professional incompetence, just the nature of our work. Students get used to it fast.”

Jack Nunberg, a virologist who previously told The Intercept that EcoHealth was “sort of crazy” for tinkering with MERS viruses in Wuhan, said the NIAID’s one log benchmark was reasonable.

“Anything less than 1 log is difficult to measure/believe with any confidence, and the scrutiny occurs at all levels – in peer review and administratively,” said Nunberg, who serves as director of the Montana Biotechnology Center at the University of Montana.

“NIH cannot (and should not) micromanage research and relies on the integrity of its principal investigators and their responsible institutions,” Nunberg told the DCNF. “This trust turns out to have been misguided in the case of the Beltway bandit Daszak and his Chinese collaborators, but we need be careful not to throw out the baby with the bathwater. The onus was on the PI to immediately disclose this information to NIH – Daszak did not.”