What is Gain-of-Function Research & Who is at High Risk?

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What is Gain-of-Function Research & Who is at High Risk?

May 19, 2020









“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.


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.


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]


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, 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.
 


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]


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, 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:

Quote :

“this work should never have been done”

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

Quote :

“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.

Quote :

“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


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.”


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.:


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.
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