Michael J Imperiale is professor of microbiology and immunology at the University of Michigan
Gain-of-function studies, as the name implies, are experiments in which a new biological behaviour is conferred upon an existing virus e.g. the ability to be transmitted between mammals in the case of the bird flu virus, H5N1. Earlier this month, the United States (US) Government issued a statement indicating that they would implement a pause of new funding for research involving so-called gain-of-function (GOF) experiments. If research into three respiratory viruses, influenza virus, and MERS and SARS coronaviruses, could be “reasonably anticipated” to result in enhanced pathogenicity or increased transmissibility then their funding would be temporarily halted. The US also asked for a voluntary pause of ongoing projects. During the pause, the US is organising discussions aimed at determining the risks and benefits of such research.
An important question is do we need a “pause” in order to move forward? Those who are opposed to this type of GOF research argue that the risks are too high and that laboratories are proceeding too quickly. They contend that the work must be halted, at least temporarily, while risk-benefit discussions take place. In this manner, society can be assured that only experiments with clear benefits are carried out, and that this occurs with the greatest possible risk mitigation. Those who support GOF research also acknowledge the need for discussion, but argue that the benefits are already clearly delineated, risks have already been minimized, and a pause at this time may have unintended consequences by halting the very research that is necessary to protect us from these deadly viruses.
It is my opinion that everything hinges on the interpretation of the words “reasonably anticipated.” This phrase is very subjective. To put my concern in perspective, one must consider the basics of virus replication. When viruses replicate their genome they make a lot of mistakes called mutations, and therefore the progeny produced are all slightly genetically different. It could certainly be reasonably anticipated that some of these viruses will have a mutation that confers a gain of function, however it is extremely unlikely that that variant will take over the population. Because of this I would not want to put the brakes on all experiments that involve growing the virus. It is my opinion that we must judge the intent of the experiment before trying to calculate the risks. I am also troubled by the open-ended timeframe of the pause. Given the importance of this topic, a firm end date would ensure that the deliberations do not drag out. If we pause the wrong experiments, or pause the experiments about which we should be concerned for too long, we may indeed be shooting ourselves in the foot.
Michael is part of the expert panel at Policy Lates: Dodging a biological bullet – what can we learn from the US and Europe about Biosecurity? Thursday 20th November 2014, 18:00-21:00 – Charles Darwin House, 12 Roger Street, WC1N 2JU. Find more information and book a free place.