How Government Officials Manipulate Definitions to Suit Their Agenda

Revisiting the meaning of "Gain-of-Function" Research

I have been reading through the transcript of testimony given by Dr. Francis Collins, former head of the National Institutes of Health (NIH), to the Select Subcommittee on the Coronavirus Pandemic on January 12, 2024. Dr. Collins helped lead the government’s COVID-19 pandemic response as the Director of NIH until his resignation at the end of 2021.

Source: https://oversight.house.gov/release/wenstrup-releases-former-nih-director-francis-collinss-transcript-highlights-key-takeaways-in-new-memo/

It is interesting how little Collins knows about what was going on in his own agency. It makes me wonder what his job duties were during his tenure as Director of NIH. He claimed to be Fauci’s supervisor but does not know what Fauci’s role or job duties were and based on his answer Collins was not knowledgeable about how the research funding process works.

One of the key takeaways from Collins testimony was NIH often lacks the necessary subject matter expertise to ensure U.S. taxpayer funds are spent safely. Concerningly, Dr. Collins was unaware of any NIH policy that ensures foreign laboratories comply with U.S. standards and are not at odds with U.S. national interests.

There has been much deliberation about “gain-of-function” research during this investigation.

I previously wrote about gain-of-function research here:

Gain-of-Function Research is Central to the Claim the Virus Originated in the Wuhan Lab and Evidence of This Research is Irrefutable

You may recall Senator Rand Paul (R-KY) and Dr. Anthony Fauci, having a heated exchange about the funding of gain-of-function (GoF) research at the Wuhan Virology Institute in China and whether Fauci supported it. Dr. Fauci denied that there was funding of the research, saying, "We have not funded gain of function research on this virus in the Wuhan Institute of Virology. No matter how many times you say it, it didn't happen."

It is now clear that there were several definitions of “gain-of-function” (GoF) that have been floating around at NIH and which definition was used depended upon who you were speaking with at the time.

The various shades of gain-of-function (GoF)

The first definition pulled off the NIH website, is GoF is defined as a type of research that modifies a biological agent, so that it confers new or enhanced activity to that agent through genetic changes, which can naturally occur or by experimental genetic modifications. According to Collins and Fauci, this is a very broad definition of the term.

Gain-of-Function research on viruses is defined as enhancing transmissibility, virus replication, virulence, host range, immune evasion or drug and vaccine resistance to get insights into the viral mechanisms, to create and analyze animal models, to accelerate drug and vaccine development and to improve pandemic preparedness.

As we start to drill down, there is a subset of GoF that is defined as GoF research of concern (GOFROC) on enhanced potentially pandemic pathogens (ePPPs) that could be harmful for humans.

"A potential pandemic pathogen (PPP) is a pathogen that satisfies both of the following: 1. It is likely highly transmissible and likely capable of wide and uncontrollable spread in human populations; and, 2. It is likely highly virulent and likely to cause significant morbidity and/or mortality in humans."

Source: https://sciencepolicyreview.org/2021/08/preventing-next-pandemic/

If you're working on a potential pandemic pathogen, you have to be guided and constrained by the P3CO definition, the Department of Health and Human Services Framework for Guiding Funding Decisions About Proposed Research Involving Enhanced Potential Pandemic Pathogens, which is the most detailed set of definitions.

These policies were developed after a three-year deliberative process during which the U.S. government initiated a funding pause from 2014-2017 for select research that was reasonably anticipated to enhance pathogenicity and/or transmissibility of influenza, MERS or SARS viruses in mammals via the respiratory route. The research funding pause did not apply to characterization or testing of naturally occurring influenza, MERS, and SARS viruses, unless the tests were reasonably anticipated to increase transmissibility and/or pathogenicity. Influenza and coronaviruses were main research targets for this moratorium, because it was anticipated that they may cause pandemics by airborne infections.

Several people have testified before the select subcommittee that only pathogens that are known to infect humans and have already been shown to be infectious in humans fall under the P3CO guidelines for regulatory oversight. This is encapsulated in the P3CO Framework.

"An enhanced PPP is defined as a PPP resulting from the enhancement of the transmissibility and/or virulence of a pathogen. Enhanced PPPs do not include naturally occurring pathogens that are circulating in or have been recovered from nature, regardless of their pandemic potential."

Gain-of-function Research of Concern performed in North Carolina

There was an experiment performed at UNC Chapel Hill using a virus that had been isolated from a bat, a bat coronavirus named WIV1-CoV. Not only was this virus identified as having the ability to use ACE2 orthologs and mediated low-level replication in human cells, the researchers showed that a chimeric virus utilizing spike protein from WIV1-CoV on the SARS-CoV-1 (the virus that emerged in 2002-2003) backbone allowed the virus to replicate to higher titers in mice and killed mice by day 4 post-infection. In addition, both full-length and chimeric WIV1-CoV readily replicated efficiently in human airway cultures and in vivo, suggesting capability of direct transmission to humans.

Source: https://www.pnas.org/doi/abs/10.1073/pnas.1517719113

Given this manuscript was published in 2016, the authors were keen to point out:

These studies were initiated before the US Government Deliberative Process Research Funding Pause on Selected Gain of Function Research Involving Influenza, MERS, and SARS Viruses (www.phe.gov/s3/dualuse/Documents/gain-of-function.pdf), and the current paper has been reviewed by the funding agency, the National Institutes of Health (NIH). Continuation of these studies has been requested and approved by the NIH.

From this study, the authors concluded “…the results indicate that the WIV1-coronavirus (CoV) cluster has the ability to directly infect and may undergo limited transmission in human populations.” and “..the results indicate a significant threat posed by WIV1-CoV.” The researchers wrote that their data suggested that the virus had significant pathogenic potential not captured by current small animal models.

The authors go on to point out “...building new and chimeric reagents must be carefully weighed against potential gain-of-function (GOF) concerns. Whereas not generally expected to increase pathogenicity, studies that build reagents based on viruses from animal sources cannot exclude the possibility of increased virulence or altered immunogenicity that promote escape from current countermeasures. As such, the potential of a threat, real or perceived, may cause similar exploratory studies to be limited out of an “abundance of caution.” Importantly, the government pause on GOF studies may have already impacted the scope and direction of these studies.” They go on to say, “Although limits and standards for these types of experiments must be established, erring on the side of caution is not without its own risks and balancing the benefits of these types of studies must also be weighed against the potential hazards.”

It is well-known that scientists at the WIV also created chimeras of SARS-like coronaviruses through genetic engineering involving techniques similar to those used at UNC. But the language in the P3CO Framework wouldn't apply to research on these types of bat viruses, even creating chimeras, because this virus was not known to have infected humans.

Therefore, when Fauci stated emphatically that neither NIH nor NIAID had funded GoF research, he was referring to the P3CO Framework definition. Under that definition he was correct in saying that work done at UNC and the WIV was not GoF, based on the regulatory definition even though it fit the broad definition of GoF. None of these bat coronaviruses had been shown to be transmissible to humans. Both Fauci and Collins suggest that when talking about a pathogen, people should automatically flip to the P3CO definition. And this is the loophole they used to fund manipulating viruses at WIV.

Thus Mitch Benzine, Staff Director for the majority staff of the Select Subcommittee stipulates during questioning of Collins:

"I am willing to stipulate in every single interview for all mankind that what EcoHealth did, did not fall under the P3CO definition."

Biden admin to exclude avian influenza, SARS-CoV-2 from risky research rules

Source: https://www.theepochtimes.com/health/biden-admin-to-exclude-avian-influenza-covid-from-risky-research-rules-5645434

President Joe Biden’s administration has proposed updated rules governing risky research, excluding avian influenza and current forms of SARS-CoV-2, the virus that causes COVID-19.

As of May, SARS-CoV-2 is not considered a PPP “because of the development of vaccines and other effective medical countermeasures, as well as the rise of population immunity.”

The National Science and Technology Council also said that the highly pathogenic avian influenza strain H5N1 and the Ebola virus are not potential pandemic pathogens.

The policy is currently set to take effect on May 6, 2025.

Looks like they now want to have it both ways. They are fear mongering saying avian influenza is poised for becoming the next pandemic and could potentially kill millions of people while at the same time saying it’s not dangerous enough to be regulated as these viruses have not been shown to transmit person-to-person.

Should research manipulating viruses whether they have shown to have infected and transmitted in humans or not be subject to regulation? Let me know what you think by leaving a comment.