gain of function research

Recent controversy regarding the research at Boston University’s National Emerging Infectious Diseases Laboratories (NEIDL) has again revived the concerns regarding continuation of certain types of high-risk biological research. As reported, a team of 14 scientists here has developed a new strain of COVID-19 that killed 80% of the mice infected with the virus in a laboratory setting. NEIDL has denied any serious hazards relating to this research but several critics have raised serious issues.

Francis Boyle, Professor of International Law at the University of Illinois, a biosafety expert of repute who was also involved in framing laws relation to this, has recalled how he and others were involved in a law suit to oppose the setting up of this high-risk lab facility but could not succeed in their effort. He has said that such dangerous research should stop. A scientist from Israel, Shmuel Shapira has stated—This should be totally forbidden. It is playing with fire. Senator Roger Marshall, a doctor, has stated that this research involved ‘lethal gain of function virus research’ that creates the ‘potential to kill more people than any single nuclear weapon.’

This research was partially funded by the National Institute of Allergy and Infectious Diseases (NIAID) which has come under pressure as it was involved earlier also in the financing of high-risk research. Dr. Emily Erbelding of NIAID has stated that the research team’s original grant application did not specify that the scientists wanted to do this precise work. The research group did not make it clear that it was doing experiments that might involve enhancing a pathogen of pandemic potential, this senior official from NIAID has stated.

The allegation that the researchers had held back critical information even from funders has further raised speculations regarding their intentions, although NEIDL scientists have of course firmly denied the risks for which their project has drawn much criticism. The wider question is that of bio-safety concerns, a hotly debated subject in recent times, which remains highly relevant even if the scientists involved in this particular context are able to offer a more convincing explanation regarding safety of their research.

High level of concern has persisted among several senior scientists regarding unacceptably high risks relating to research which involves the creation of novel potential pandemic pathogens. These concerns were strong enough for the US government to impose a two to three year moratorium on some aspects of this research. This and some other related research is sometimes referred to as gains-of-function research. The US Government moratorium order defined such research as research that improves the ability of a pathogen to cause disease.

This order of the US government issued in October 2015 is titled ‘US Government Gain-of-Function Deliberative Process and Research Funding Pause on Selective Gain-of-Function Research Involving Influenza, MERS and SARS Viruses’. This order mentioned that such research has some benefits but also entails bio-safety and bio-security safety risks; hence the risks and benefits of gain-of-function research should be evaluated. Till a robust scientific review of this can be completed, a moratorium on US government funding of more risky aspects of such research will be imposed. More specifically this much-discussed  order stated, “ New US funding will not be released for gain-of-function research projects that may be reasonably anticipated to confer attributes to influenza, MERS or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route.”

In addition this order said that the US government encourages others also (in the case of grants not funded by the US government) to join in adopting a voluntary pause on research that meets the stated definition.

This order became a big discussion point among scientists. However the moratorium was not very complete as an escape clause had been left. This stated—An exemption from the research pause may be obtained if the head of the US funding agency determines that the research is urgently necessary to protect the public health or national security. This exemption was in fact used to continue to fund some research of the pause category even during the period of the moratorium. One such highly controversial project relating to altered corona viruses experimented on humanized mice was being implemented in the Wuhan Institute of Virology in China, a rare case of such research in China being financed by the USA. It will be very useful to know whether the exemption to continue this funding was made on grounds of public health or national security!

Those senior scientists who on the whole were pleased with the coming in of the moratorium were disappointed when the moratorium was lifted all too soon in December 2017 after the stated completion of the review process.

Dr Mark Lipsitch, a senior epidemiologist,  was  among those scientists who had welcomed the moratorium. He teamed up with Dr. Thomas V. Inglesby to write an important paper in mBio—Journal of American Society of Microbiology dated Nov-Dec. 2014 titled ‘ Moratarium on Research Intended to Create Novel Potential Pandemic Pathogens (PPPs)’. This paper while welcoming the moratorium stated that as some gain-of-function research can also be useful, it may be more relevant to talk of reducing the risk of novel PPPs. This paper stated that experiments which create the possibility of initiating a pandemic should be subjected to rigorous quantitative risk assessment and there should be search for safer alternatives. This paper regretted that despite the serious risks involved a rigorous and transparent risk assessment for this work has not yet been established. The authors emphasized that assessment should be completely unbiased and should be of a quantitative nature, not just qualitative. Any risk estimates should include estimates of the probabilities of accidental infection and extensive spread as well as estimates of the impacts of these events should they occur.

Further this paper went ahead of several other papers on this issue by specifically arguing that during the moratorium, progress should also be made in calculating the risks associated with potential deliberate misuse of PPP strains and with potential deliberate misuse of the information that is created and published following PPP experimental work. This calculation should take into account the possibility of deliberate theft and dissemination by either persons working within a lab or theft by those outside the lab. The paper pointed out that this possibility may be rare, but there have been precedents already of scientists using pathogens from their own labs to cause harm. Further the paper said that this assessment should take into account the possibility that some scientists may deliberately misuse the knowledge gained and published following the experiments by recreating the novel PPP strains in another laboratory using methods from published papers and then purposefully disseminate it.

When the moratorium was lifted Dr. Lipsitch expressed concern at this decision. He was joined by some other senior scientists like Dr. Richard Ebright in this opposition.

Earlier a paper by Lynn C. Klotz Edward and J. Sylvester published in the Bulletin of Atomic Scientists had stated that SARS virus had already escaped from labs 3 times between 2003 and 2011 . Even the security of the  highest category BSL4 labs was not adequate as there had  been 3 escapes from  such highest safety labs between 1990 and 2011—one in Taiwan, one in England and one in the Soviet Union. This paper  argued that assuming a rather low probability of accident, the possibility of accidental leak from the  nearly 42 labs engaged then in live PPP research relating to three of the more dangerous viruses, escape of a dangerous virus from lab amounted to 80 per cent in at least one lab  in 12.8 years, a very high probability indeed.

Clearly there is a very serious threat from novel PPPs and efforts should be continued to restrict such research and reduce its inherent dangers in various ways. A worldwide moratorium should be considered, followed by an international commission of scientists and bioethicists, selected carefully to exclude those who derive personal gain from such research, to examine comprehensively, in an entirely unbiased way and with the precautionary principle as guide, all aspects of this controversial issue and to make recommendations based on this. The concerns raised following news regarding recent research at NEIDL should further alert the world to the urgency of important bio-safety reforms.

Bharat Dogra is a journalist and author,  is Honorary Coordinator of Campaign to Save Earth Now. His recent books include Planet in Peril, A Day in 2071 and Protecting Earth for Children.

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