“Gain-of-function” is the euphemism for biological research aimed at increasing the virulence and lethality of pathogens and viruses. GoF research is government funded; its focus is on enhancing the pathogens’ ability to infect different species and to increase their deadly impact as airborne pathogens and viruses. Ostensibly, GoF research is conducted for biodefense purposes.  These experiments, however, are extremely dangerous. Those deadly science-enhanced pathogens can, and do escape into the community where they infect and kill people. What’s more, this line of research  can be used for biological warfare.

  • Rumors that Iraq was preparing to use weaponized anthrax – as a “weapon of mass destruction” – provided the US government with a justification for the 2003 invasion.

In 1992, Meryl Nass, MD, analyzed the characteristics of an anthrax epidemic in Zimbabwe, Rhodesia in 1978-1980, that was claimed to be a natural occurrence. Dr. Nass demonstrated that the pattern of the epidemic, the spread, and weather conditions, could not have occurred due to a natural event; it must, therefore, have been triggered as a bioweapon. She reported her findings in the journal Physicians for Social Responsibility Quarterly, 1992.[1]

Government officials and the recipients of government grants and contracts for “gain-of-function” research argue that these experiments are critical for understanding the subtle changes that can make a bird virus a pandemic threat.

Anthony Fauci, MD

Dr. Anthony Fauci, who has headed the National Institute of Allergy and Infectious Diseases (NIAID) since 1984, has played a major role in promoting and funding gain-of-function research, both in the US and China. Newsweek reported: “He argued that the research was worth the risk it entailed because it enables scientists to make preparations [  ] that could be useful if and when a pandemic occurred.

  • Those claims are belied by the empirical evidence
     GoF experiments have neither prevented a pandemic, nor provided useful information about safe and effective pandemic countermeasures. Numerous prominent scientists argue that these experiments deviate from morally justifiable research, and the experimentally altered pathogens have put the entire human species at risk.

However, GoF research is defended by a closed circle of scientists within government and those who are contracted by government to conduct this line of research.

Drs. Yoshihiro Kawaoka & Ron Fouchier

In 2011, controversy erupted when two separate teams of researchers – one headed by Ron Fouchier from the Netherlands, another headed by Yoshihiro Kawaoka from the University of Wisconsin and the University of Tokyo – announced that they had modified the H5N1 avian flu virus so that it jumped from birds to mammals and between mammals.[2],[3]  Both research teams were funded by the NIH – NIAID. They used reverse genetics to build a more lethal virus by combining directed mutations and natural selection, suggesting that this H5N1 variant could be efficiently transmitted between humans.

The UK Independent reported: “An increasing number of scientists outside the influenza field have expressed concern over attempts to deliberately increase the human transmissibility of the H5N1 bird-flu virus. This is done by mutating the virus so that it can pass by airborne droplets between laboratory ferrets, the standard “animal model” of human influenza.

Scientists, who are committed to the precautionary principle in medicine, medical research, and in public health policy, eschew GoF experimentation. These critics cite the Nuremberg Code prohibition against conducting experiments that pose a risk to human life. Such experiments “should be undertaken only if they provide humanitarian benefits that sufficiently offset the risks and if these benefits are unachievable by safer means.

The risks posed by influenza GoF experiments include frequent documented escapes of deadly pathogens into the community, which have a potential for triggering a pandemic. These risks far outweigh any speculative benefits. What’s more, as Dr. Marc Lipsitch of Harvard and Dr. Alison Galvani of Yale argue:“the creation and manipulation of potential pandemic pathogens are too risky to justify…there are safer more effective experimental approaches that are both more scientifically informative and more straightforward to translate into improved public health.” [PLoS Medicine, 2014][4]

Prof. Mark Lipsitch, PhD

Dr. Marc Lipsitch, director of the Center for Communicable Disease Dynamics at Harvard School of Public Health stated that recent disease-enhancing experiments “have given us modest scientific knowledge and done almost nothing to improve our preparedness for pandemics, and yet [these experiments] risked creating an accidental pandemic.[5]

Alison Galvani, PhD

Alison Galvani, PhD, Professor of Epidemiology (Microbial Diseases); Director of the Center for Infectious Disease Modeling and Analysis (CIDMA) of Yale University. Dr. Galvani is one of Yale’s youngest-ever tenured faculty member. She went to Oxford for her undergraduate degree and did her PhD in theoretical epidemiology with Robert May, the former head of the UK Royal Society. She received a Blavatnik Award from the New York Academy of Sciences . Dr. Galvani is an interdisciplinary scientist who prides herself on challenging dogma.

 

Andrew Pavia, MD

The considerable risk of laboratory enhanced transmitability of influenza viruses was obvious. Dr. Andrew Pavia, Chief, Division of Pediatric Infectious Diseases at the University of Utah stated: “A readily transmitted H5N1 virus could be extraordinarily lethal; therefore, the risk for accidental release is significant, and deliberate misuse of the data to create a biological weapon is possible.”[6]

The controversy escalated when the National Science Advisory Board for Biosecurity (NSABB) issued its recommendation (December 2011) that the controversial H5N1 reports be published with significant redactions.“Methodological and other details that could enable replication of the experiments by those who would seek to do harm” are to be redacted. The research and the NSABB recommendation polarized the scientific community which recognized that the easily transmitted H5N1 laboratory creation could be extraordinarily lethal. This laboratory-engineered virus poses a significant risk for accidental release into the community.[7]

Dr. Michael Osterholm

Michael Osterholm, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and a vocal critic of the decision to publish the H5N1 research, stated that the flu research community has not rigorously weighed the risks and benefits of gain-of-function studies. He stated that proponents of “gain-of-function” research have overstated the benefits, including the potential for developing better vaccines and antiviral drugs, or improving surveillance measures. “We still do H5N1 surveillance in the same way a year later.”

Adel A. F. Mahmoud, an infectious disease specialist at Princeton University and the former president of Merck Vaccines is quoted in Science: “The scientific justification presented for doing this work is very flimsy, to put it mildly, and the claims that it will lead to anything useful are lightweight… The mutations guided nothing.

Richard Ebright, PhD

Richard Ebright, a molecular biologist at Rutgers University in Piscataway, New Jersey, cautioned that the security precautions are “insufficient and amazingly lame.” He stated in the journal Science:

“this work should never have been done”

A New York Times editorial in 2012, dubbed the experiment “An Engineered Doomsday.

Now scientists financed by the National Institutes of Health have shown in a laboratory how [an avian influenza virus] could kill tens or hundreds of millions of people if it escaped confinement or was stolen by terrorists. […]

The most frightening research was done by scientists at the Erasmus Medical Center in Rotterdam, who sought to discover how likely it is that the “bird flu” virus, designated A(H5N1), might mutate from a form that seldom infects or spreads among humans into a form highly transmissible by coughing or sneezing. Thus far the virus has infected close to 600 humans and killed more than half of them, a fatality rate that far exceeds the 2 percent rate in the 1918 influenza pandemic that killed as many as 100 million people.

it looks like the research should never have been undertaken because the potential harm is so catastrophic and the potential benefits from studying the virus so speculative.” 

Prof. Lord May

Professor Lord May of Oxford, the former president of the Royal Society and a former chief science adviser to the UK government, is an outspoken critic about this line of research.

The work they are doing is absolutely crazy. The whole thing is exceedingly dangerous.”

Yes, there is a danger, but it’s not arising  from the viruses out there in the animals, it’s arising from the labs of grossly ambitious people.” [5]

He noted China’s poor safety track record: “The record of containment in labs like this is not reassuring. They are taking it upon themselves to create human-to-human transmission of very dangerous viruses. It’s appallingly irresponsible.”[Independent, 2013

Prof. Simon Wain-Hobson, PhD

Professor Simon Wain-Hobson, PhD, an eminent virologist at the Pasteur Institute in Paris is an outspoken critic of viral-engineering, and the risk this research poses. In a column in the journal  Nature (2013), Dr. Wain-Hobson noted:

Influenza virologists are going down a blind alley and the powers that be are blindly letting them go down that alley.

He said it is very likely that some or all of “these hybrids could pass easily between humans and possess some or all of the highly lethal characteristics of H5N1 bird-flu.”

H5N1 GOF work — indeed all virological GOF work — should be suspended until virologists open up and engage in public discussion of their work and the issues it raises. Given that the flu community failed utterly to use the year-long hiatus to good effect, it is clear that an independent risk–benefit assessment of GOF work is needed.” Read H5N1 Viral-Engineering Dangers, Nature.pdf

Prof. Wain-Hobson stated: “The virological basis of this work is not strong. It is of no use for vaccine development and the benefit in terms of surveillance for new flu viruses is oversold.” He emphasized in Nature News the fact that this chimeric virus “grows remarkably well” in human cells: “if the virus escaped, nobody could predict the trajectory.”

Sam Husseni

As veteran investigative reporter, Sam Husseini, the communications director of the non-profit, Institute for Public Accuracy, who has closely followed this line of research, states there are probably hundreds of high containment biosafety (BSL-3 and BSL-4) laboratories. As of 2017, at least 263 laboratories were registered in the US as level BSL-3 and level BSL-4.

According to a report by the Center for Arms Control and Non-Proliferation, the probability of a flu virus release from a government laboratory into the community could become pandemic requires that “the Precautionary Principle should apply [in proceeding with this line of research]”.  Numerous pathogen escaped accidents have occurred at BSL-3 and BSL-4 labs.

The journal SCIENCE reported that multiple laboratory accidents at CDC’s highest security laboratories released smallpox vials, anthrax samples, H5N1 influenza samples, and H9N2 avian influenza pathogen. The lapses, Science reported, “at the world-renowned infectious disease research agency, are sure to raise questions about safety at other labs studying highly pathogenic agents, including university labs that are modifying influenza strains to make them more virulent.:

Dr. Thomas Frieden

Former CDC director, Dr. Thomas Frieden stated:
whatever you think about [such so-called gain-of-function studies],“I think it’s clearly the case that these incidents indicate that we need to really ensure that whatever work is done needs to be done safely and securely.

These accidents led the government to temporarily suspend funding for gain-of-function research from 2014 to 2017 for SARS, MERS and avian flu viruses.

Husseini notes that exceptions from suspended funding included laboratories at Harvard University, the University of North Carolina, and the Wuhan Institute of Virology (WIV) laboratory, whose high risk coronavirus research was backed by Dr. Anthony Fauci, who awarded the Wuhan laboratory with a $3.7 million contract AFTER the government had suspended funding for avian flu viruses research.

When the “Ban on Making Lethal Viruses [was] Lifted,” the review process became even more secretive and opaque. Dr Francis Collins, head of the NIH, announced that there would be no public disclosure about the projects funded by the government.  Critics, including  microbiologist Richard Ebright of Rutgers University stated the lack of openness is “disturbing and indefensible.” He stated that clearer minimum safety standards and a mandate that the benefits ‘outweigh’ the risks were needed, rather than merely ‘justifying’ them.”

The Washington Post reported that in January 2018, urgent cables from the US Embassy warned that the Wuhan laboratory’s operations had serious safety problems. One of the cables specifically warned that the lab’s work on bat coronaviruses and their potential human transmission represented a risk of a new SARS-like pandemic.[8]

Dr. Fauci appears to have ignored those cables and the Wuhan Institute’s requests for assistance. Despite alarms raised about lax safety at the Wuhan laboratory, Dr. Fauci provided  an additional $3.7 million grant in 2019 for “gain-of-function research for the purpose of understanding how bat coronaviruses could mutate to attack humans

Currently, a heated disagreement about the origin of the global COVID-19 pandemic is raging because the proponents of GoF research – those who fund and those who receive funds – are  desperate to distance the COVID-19 pandemic, and the Chinese laboratory that has engaged in high risk GoF experiments; experiments that put humanity at risk.
Read: Is COVID-19 the Result of a US Government- Funded Experiment in China?

Newsweek reported that this phase of the research at the Wuhan laboratory in 2019, was  run by Peter Daszak, of EcoHealth Alliance, a so-called nonprofit that has received millions of dollars from the US government during the Obama and Trump administration .

Peter Daszak

On May 12th,  The Washington Post reported that EcoHealth is a “longtime partner” of the Wuhan Institute of Virology.  Given the Post’s earlier report about the US Embassy cables warning about major safety hazards at the Wuhan lab, and in light of the Chinese government refusal to allow an independent investigation into the origins of the global pandemic, the Washington Post acknowledged:

“Theoretically, an accident during such activities could prompt an outbreak. If researchers, for example, had found SARS-CoV-2, the virus that causes covid-19, and cultured the virus in the lab, it could have infected humans as the result of a mishap.”

Daszak, who has a multi-million dollar stake in Chinese bat research, dismissed the possibility outright: “I have never heard anything suspicious from this lab. It’s a preposterous idea”.

Honest scientists recognize and warn about the danger posed by GoF research and the potential for unleashing a lethal pandemic. Documented indisputable evidence confirms continued safety hazards at the high security laboratories from which pathogens regularly escaped into the community.

A report by GM Watch (May 20th)  focuses on the hazardous bat and coronavirus experiments at the Wuhan laboratory. Dr Richard Ebright alerted the public about evidence that the Wuhan Institute and US-based researchers were genetically engineering bat viruses to investigate their ability to infect humans. He stated that they experimented with commonly used methods that leave no sign or signature of human manipulation. He cited a scientific paper published in PLoS (2017) by Wuhan scientists, including Shi Zhengli, the virologist leading the research into bat coronaviruses, who worked in collaboration with Peter Daszak.

that funding for the experiment was shared between Chinese and US institutions, including the National Institutes of Health and US Agency for International Development.

“The researchers report having conducted virus infectivity experiments where genetic material is combined from different varieties of SARS-related coronaviruses to form novel “chimeric” versions. This formed part of their research into what mutations were needed to allow certain bat coronaviruses to bind to the human ACE2 receptor – a key step in the human infectivity of SARS-CoV-2.

The WIV scientists did this, Ebright points out, “using ‘seamless ligation’ procedures that leave no signatures of human manipulation”. This is noteworthy because it is a type of genetic engineering that Andersen and his team excluded from their investigation into whether SARS-CoV-2 could have been engineered  – and it was in use at the very lab that is the prime suspect for a lab escape.

The evidence rebuts claims by journalists and some scientists that the SARS-CoV-2 virus responsible for the current COVID-19 pandemic could not have been genetically engineered because it lacks the “signs” or “signatures” that supposedly would be left behind by genetic engineering techniques.”

Dr. Ebright cited a just-published pre-print scientific report by the Wuhan scientists who describe how they “spiked proteins from bat SARS-related CoV (SARSr-CoV), among other coronaviruses, to bind to bat and human ACE2 receptors – in other words, how efficiently they infect humans.” He points out that the paper states, “All work with the infectious virus was performed under biosafety level 2 conditions” which is not suitable for such high risk experimentation. This level is suitable for work involving agents of only “moderate potential hazard to personnel and the environment”.

Jonathan Latham, PhD

Dr Jonathan Latham, a virologist, is Executive Director of the Bioscience Resource Project, which conducts independent scientific analysis of genetic engineering and its risks. He is the Editor of Independent Science News. He  criticised the research on bat coronaviruses that has been taking place in Wuhan and the US. He argues that these experiments are “providing an evolutionary opportunity” for such viruses “to jump into humans.”  He emphasized that the experiments were “providing opportunities for contamination events and leakages from labs, which happen on a routine basis”.

GM Watch notes: “Given that lab accidents are common, including in China where the SARS virus has escaped from high-level containment facilities multiple times, the details emerging about the research activities of the WIV and US scientists again underline the need for a credible independent investigation of the most forensic kind into the origins of the current pandemic. And a broader investigation is also needed into the full range of biological threats arising from various areas of potentially hazardous but laxly regulated biotechnology research.”

Inside America’s Secretive Biolabs, an investigative report by USA Today May 2015 reveals hundreds of accidents, safety violations and near misses put people at risk.

“Vials of bioterror bacteria have gone missing. Lab mice infected with deadly viruses have escaped, and wild rodents have been found making nests with research waste. Cattle infected in a university’s vaccine experiments were repeatedly sent to slaughter and their meat sold for human consumption. Gear meant to protect lab workers from lethal viruses such as Ebola and bird flu has failed, repeatedly.

A team of reporters who work for the USA TODAY Network of Gannett newspapers and TV stations identified more than 200 of these high-containment lab facilities in all 50 states and the District of Columbia operated by government agencies, universities and private companies. They’re scattered across the country from the heart of New York City to a valley in Montana; from an area near Seattle’s Space Needle to just a few blocks from Kansas City’s Country Club Plaza restaurant and shopping district.”

Human Error in High-Biocontainment Labs: A Likely Pandemic Threat, by Lynn Klotz, Bulletin of the Atomic Scientists, 2019

“Incidents causing potential exposures to pathogens occur frequently in the high security laboratories often known by their acronyms, BSL3 (Biosafety Level 3) and BSL4. Lab incidents that lead to undetected or unreported laboratory-acquired infections can lead to the release of a disease into the community outside the lab; lab workers with such infections will leave work carrying the pathogen with them. If the agent involved were a potential pandemic pathogen, such a community release could lead to a worldwide pandemic with many fatalities. Of greatest concern is a release of a lab-created, mammalian-airborne-transmissible, highly pathogenic avian influenza virus, such as the airborne-transmissible H5N1 viruses created in the laboratories of Ron Fouchier in the Netherlands and Yoshihiro Kawaoka In Madison Wisconsin.

Such releases are fairly likely over time, as there are at least 14 labs (mostly in Asia) now carrying out this research. Whatever release probability the world is gambling with, it is clearly far too high a risk to human lives. Mammal-transmissible bird flu research poses a real danger of a worldwide pandemic that could kill human beings on a vast scale.”

Dr. Fauci, the head of the NIAID since 1984, has been in the forefront in supporting highest risk pathogen experiments. Dr. Fauci bears grave responsibility for having ignored a continuous series of documented  reports — all of which warned of impending catastrophic pandemics, directly caused by experimental. laboratory-created pathogens.

It should be evident to everyone, that as long as irresponsible government officials continue to fund and promote experiments whose aim is to increase the virulence and lethal capacity of biological pathogens and viruses, the risk that those lethal pathogens can, have, and will escape from laboratories, is certain.

  • Those accidental escapes pose catastrophic existential risk for the global human community.
  • If we want to preserve our existence on the planet, our government must stop funding this line of research.

 

Partial list of References

[1] “Anthrax epizootic in Zimbabwe, 1978–1980: Due to Deliberate spread?, Meryl Nass, MD, Physicians for Social Responsibility Quarterly, 1992.  See also: The History of the Use of Bacteriological and Chemical Agents during Zimbabwe’s Liberation War of 1965-80 by Rhodesian Forces by Ian Martinez, Third World Quarterly, Dec. 2002 Vol. 23, No. 6 (Dec., 2002), pp. 1159-1179

[2] Infectious Diseases. Controversial Studies Give a Deadly Flu Virus Wings, M Enserink, Science. 2011

[3] Exclusive: Controversial Experiments that Could Make Bird Flu More Risky Poised to Resume, Jocelyn Kaiser, SCIENCE, 2019

[4] Ethical Alternatives to Experiments with Novel Potential Pandemic Pathogens, Marck Lipsitch and Alison P. Galvani, PLoS

[5]  A Federal Ban on Making Lethal Viruses Is Lifted, Donald McNeil, Jr. The New York Times, December 2017

[6] Laboratory Creation of a Highly Transmissible H5N1 Influenza Virus: Balancing Substantial Risks and Real Benefits, Andrew T. Pavia, MD, Annals of Internal Medicine, 2012

[7] Making Viruses in the Lab Deadlier and More Ale to Spread: An Accident Waiting to Happen, Tatyana Novossiolova and Malcolm Dando, Bulletin of Atomic Scientists, 2014

[8] State Department Cables Warned Of Safety Issues At Wuhan Lab Studying Bat Coronaviruses, John Bogin, The Washington Post, April 2020