The Lab Leaks

Two theories of origin, only one can be true

Photo by Guido Hofmann on Unsplash

I concluded that COVID-19 was the result of a lab leak and wrote in detail about it in September 2022 and all the reasons why — the science, the lab safety culture, the regulations in China, international law and the lack of a patient zero. With the White House now making the lab leak the official position of the Administration, here is why I called it 2 1/2 years ago.

Gain of Function research has been at the center of Congressional inquiries about the origin of COVID-19.

What is Gain of Function?

Terms like “dual use” were developed to identify those pathogens that could be both used for helpful life-saving research or used for developing bioweapons. These required increased scrutiny and oversight, particularly for DURC (Dual Use Research of Concern), for those pathogens capable of being used as bioweapons or at higher risk for work in the laboratory.

“Gain of function” (GOF) is the research method of enhancing a characteristic of a virus or bacteria in order to be able to study and observe its mechanisms for that characteristic, such as infectivity, virulence or even its fatality rate. These experiments were so potentially dangerous that a special review was required to determine if the risk of the research was worth the value of the potential increase in knowledge about the subject virus or bacteria.

In 2014, the White House announced a moratorium on gain of function research while they engaged in a process to determine its safety:

During this pause, the U.S. Government will not fund any new projects involving these experiments and encourages those currently conducting this type of work – whether federally funded or not – to voluntarily pause their research while risks and benefits are being reassessed.¹

However, there was a specific exclusion for SARS (Severe Acute Respiratory Syndrome), which is the class of virus of COVID-19, as explained in the next line in the White House announcement:

The funding pause will not apply to the characterization or testing of naturally occurring influenza, MERS, and SARS viruses unless there is a reasonable expectation that these tests would increase transmissibility or pathogenicity. 

Increasing transmissibility and pathogenicity would be the two characteristics most likely to be selected for gain of function research, so a “reasonable expectation” was the standard for whether one could do research with SARS using gain of function — a low standard, with room for exceptions.

The National Science Advisory Board for Biosecurity (NSABB), an advisory board established for advice on research involving dangerous pathogens, was asked to review the gain of function oversight in 2016. In their report they made seven recommendations for gain of function (GOF), but there is an additional subcategory also defined by the NSABB: Gain of Function Research of Concern (GOFROC) for that subset of the pathogens carrying the greatest risk. Only one of the recommendations focused specifically on GOFROC:

As part of this recommendation, the NSABB working group has proposed a conceptual approach for guiding funding decisions about GOFROC. First, the working group identified the attributes of GOFROC, which is research that could generate a pathogen that is: 1) highly transmissible and likely capable of wide and uncontrollable spread in human populations; and 2) highly virulent and likely to cause significant morbidity and/or mortality in humans. Next, the working group identified a set of principles that should guide funding decisions for GOFROC. Only research that is determined to be in line with these principles should be funded. Additional risk mitigation measures may be required for certain research studies to be deemed acceptable for funding.²

Many scientists in the research community deemed this type of research to be too risky to ever be outweighed by any potential knowledge gained from it.³ I, too, had begun to believe gain of function was too dangerous even with oversight.

COVID-19, a coronavirus

One group of scientists concludes that COVID-19 emerged as an evolutionary zoonotic result of a virus jumping from an animal to a human. But their reports about the COVID-19 origin came far too early for credibility. It was just like the emergence of SARS we saw with the civet to human transformation in 2003, they said. But this time, they deemed it to be the pangolin (which has since been discredited).⁴ The second group of scientists argues this is a laboratory accident from experimenting with SARS using GOF techniques, enhancing its viral characteristics for infecting humans. A smaller group believes that the virus was intentionally engineered as a bioweapon.

Unlike SARS, there was never a Patient-Zero identified, which is usually the first step in resolving the epidemiology of an epidemic or pandemic. Identifying Patient-Zero would have likely given us an answer to which of these theories of emergence are true, but China was not forthcoming and resisted any attempt to determine a Patient-Zero with COVID19.

Experimenting with SARS

The focus on SARS continued and China was particularly interested given its emergence there, now determined to have origins in bats, based on DNA analysis. The laboratory that continued to work with SARS was the Wuhan Institute of Virology (WIV). While China has regulations to control dangerous pathogens in the laboratory, just as extensive as the U.S. regulations, China lacks the rigorous enforcement and strength of the rule of law in making sure there is compliance. So while regulations may exist, safety failures occurred due in part to uncertainty about compliance.

The regulations in China’s Art. 33, provide for the report of any accidental “leakage”:

In case of any theft, robbery, loss or leakage of highly pathogenic microorganisms in the laboratory, the establisher of the laboratory shall make a report thereon in accordance with Article 17 of these Regulations.⁵

An article published in 2004 about the accidental release of a SARS sample in the laboratory, and found SARS escaped from a Beijing laboratory -- twice.⁶ So the likelihood of an accidental release is not unreasonable.

Photo by CDC on Unsplash

You may remember this risk and consequence chart from an article I wrote, “Pandemics & Asteroids” which you can find in the archives. This chart is also important when thinking about whether a GOF experiment is worth more than its risk. But the entire concept of GOF captures the black swan event with a low probability of the consequences of the experiment going in a wrong direction, but with high consequences if it does. This makes it attractive to engage in a program where scientists are seeing the possibility of breakthrough in a virus that has eluded understanding for countless decades. Scientists are dedicated people and thinking about a problem night and day, changes the level of risk they feel is safe or even necessary to save lives. They have a narrow view of their own virus research and its risks because it is so familiar to them⁷ and so only those factors go into the decision to give such a risky experiment the “green light”.

Is it plausible and possible that it was a lab leak?

One of the first alarming results from changing the characteristics of a dangerous pathogen was in 2001 when a group of Australian researchers in hopes of reducing their massive mouse populations, created an engineered mousepox with the increased ability to suppress the mouse immune system in order to more effectively infect and kill the mouse.⁸ This included disabling any vaccine-induced immunity. If this has not taken your breath away at this point, let me stress that this mouse model could likely also be used for other dangerous pathogens, similarly engineered to disable the human immune system in order to infect and kill humans. The researchers said it was an accident.⁹ They also said they decided to publish the results so everyone would know the technology to engineer a virus to elude and suppress immunity was possible and available.

In 2012, the first GOF experiment raised concerns when researchers increased the infectivity of H5N1, avian influenza, in order to study it. The research was published after NSABB review in June 2012.¹⁰

Investigations

In March 2021, the World Health Organization, Director General, Tedros Adhanom Ghebreyesus, concluded about their investigation that “whether the coronavirus entered the human population as a result of a laboratory incident was not ‘extensive enough,’ and that he believes it requires further investigation.”¹¹ However, due to a lack of support from China, the second investigation was no more meaningful.¹² One observer went so far as to say the second proposed phase of this research never went forward at all.¹³

In June 29, 2021, Brett Giroir, testified before the U.S. House of Representatives, Select Subcommittee on the Coronavirus Crisis, that "There is now an increasing body of circumstantial evidence pointing to a lab leak origin of the virus. . . “¹⁴

The Director of National Intelligence in August 2021 concluded in the unclassified summary of their report, that either theory was plausible:

"After examining all available intelligence reporting and other information, though, the IC [Intelligence Community] remains divided on the most likely origin of COVID-19. All agencies assess that two hypotheses are plausible: natural exposure to an infected animal and a laboratory-associated incident."¹⁵

On February 14, 2022. the U.S. House of Representatives, Committee on Energy and Commerce, launched an investigation into whether there was fraud in covering the origins of COVID-19 by the National Institutes of Health (NIH), specifically the National Institute of Allergies and Infectious Diseases (NIAID) the funding agency for the federal research of infectious diseases.¹⁶

Indeed, there is evidence of grants awarded to institutions in the U.S. as well as to the Wuhan Institute of Virology (WIV) through EcoAlliance laboratories, and this became the focus of the investigation of Congress in Spring 2022. The moratorium on GOF research for dangerous pathogens did not include SARS viruses, so this kind of research could have moved forward under the existing legal framework. Therefore, confirming that GOF experimentation took place and that it was funded by NIH, directly or indirectly, will not indicate a failure to comply with the directive, given the language that makes room for exceptions.

The Origin of COVID-19 as an Accidental Laboratory Release

Probably due to my exposure (yes I know it’s a tasteless pun) to the risks of biosafety and biosecurity regulation of laboratories, with a focus on the laboratory accidents, I have to conclude that it was likely an accidental laboratory release of an experiment involving gain of function of a SARS virus.

First, the lack of accidental releases to show there was none related to COVID-19, should have been produced by the Wuhan Institute of Virology (WIV) upon investigation. Second, a Patient-Zero was found early in the 2003 SARS investigation, and yet China has not yet identified a Patient-Zero for COVID-19. That would be likely dispositive as to the two theories of COVID19’s orgin. Third, investigations and previous genetic engineering have found the laboratory accidental release a plausible theory, and just as plausible as the competing theory. China’s refusal to cooperate with the international community in an investigation of the origin of the virus in Wuhan — which is not in dispute — deprives the world of answers that could save humanity in the next pandemic.

My recommendation is to assume, based on the foregoing, that China is responsible for a laboratory accident and shift the burden of proof to China.

Let the sanctions begin.

---

Special thanks to Susan A. Ehrlich, former NSABB founding member and former judge, Arizona Court of Appeals (retired) for her review of this article before publication.

1. https://obamawhitehouse.archives.gov/blog/2014/10/17/doing-diligence-assess-risks-and-benefits-life-sciences-gain-function-research

2. https://osp.od.nih.gov/wp-content/uploads/2016/06/NSABB_Final_Report_Recommendations_Evaluation_Oversight_Proposed_Gain_of_Function_Research.pdf

3. The Center for Biodefense Law & Public Policy at Texas Tech University served as the main core for law, ethics and policy during the decade of funding for the Centers of Excellence for Emerging Infectious Diseases (The Center was funded from 2005-2013). Dr. Anthony Fauci was leading the NIAID section of NIH, where this national effort was created and administered. Most of the focus was on regulating select agents that were considered dangerous pathogens that could be modeled into biological weapons. This is my personal assessment from private conversations with research scientists.

4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7405773/

5. Art. 33, Republic of China, Regulations on Administration of Biosafety in Pathogenic Microorganism Laboratories, Adopted at the 69th Executive Meeting of the State Council on November 5, 2004, promulgated by Decree No. 424 of the State Council of the People’s Republic of China on November 12, 2004, and effective as of the date of promulgation (this was the source, but this page is no longer available: http://www.biosecuritycodes.org/china.htm).

6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7096887/ .

7. Risk perception research has shown that the more familiar a risk is to the individual, the less risky it is perceived to be by that individual. See https://www.psandman.com/col/familiarity.htm .

8. https://www.newscientist.com/article/dn311-killer-mousepox-virus-raises-bioterror-fears/

9. https://www.newscientist.com/article/dn311-killer-mousepox-virus-raises-bioterror-fears/

10. Herfst et al. Airborne Transmission of Influenza A/H5N1 Virus Between Ferrets. Science 336, 22 June 2012 at https://www.science.org/doi/10.1126/science.1213362 .

11. https://www.foxnews.com/health/who-chief-coronavirus-origin-report-not-extensive-enough-lab-assessment

12. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/origins-of-the-virus .

13. Gigi Kwik Gronvall (2021) The Contested Origin of SARS-CoV-2, Survival, 63:6, 7-36, DOI: 10.1080/00396338.2021.2006442 at 22 at https://www.tandfonline.com/doi/full/10.1080/00396338.2021.2006442 .

14. https://www.c-span.org/video/?c4968339/user-clip-trump-testing-czar-giroir-lab-accident-most-origin

15. https://www.dni.gov/files/ODNI/documents/assessments/Unclassified-Summary-of-Assessment-on-COVID-19-Origins.pdf (created Aug 27, 2021).

16. https://republicans-energycommerce.house.gov/the-covid-19-origins-investigation/