Ban on deadly pathogen research lifts, but controversy remains

Marc Lipstick poster "the Big Three"

January 8, 2018 – Last month, the U.S. government lifted a three-year moratorium on funding risky research to genetically alter deadly viruses in ways that could make them even more lethal. Epidemiologist Marc Lipsitch of Harvard Chan School thinks the move could create an accidental pandemic.

Why is there such a fierce debate about the end of the moratorium?

Those who support such research think that it is necessary to develop strategies to fight rapidly evolving pathogens that pose a threat to public health, such as the flu virus, the viruses causing Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), or Ebola. For instance, some of this so-called “gain-of-function” research—which aims to make germs more contagious, more deadly, or both—has aimed to create viruses that can easily pass between ferrets, so that researchers can understand how those changes occur and potentially how viruses go from infecting animals in the wild to transmitting between humans.

But others, like myself, worry that human error could lead to the accidental release of a virus that has been enhanced in the lab so that it is more deadly or more contagious than it already is. There have already been accidents involving pathogens. For example, in 2014, dozens of workers at a U.S. Centers for Disease Control and Prevention lab were accidentally exposed to anthrax that was improperly handled. Another accident like that—if it involved a virus that was both newly created and highly contagious—has the potential to jeopardize millions of people.

In lifting the funding ban, the U.S. government has said that it will establish scientific review panels to ensure that the benefits of such research justify the risks. What do you think of this approach?

My overall take is that this is a small step forward. The government has indeed proposed a review for the most concerning kinds of research. However, I also believe that gain-of-function experiments to date have given us only modest scientific knowledge and have done almost nothing to improve our preparedness for pandemics, yet they have risked creating an accidental pandemic. Therefore, I think that a review of the sort proposed by the government should disallow most of these risky experiments.

Do you have a sense of what these government review panels will consider when making their determinations?

It’s unclear. Under the new guidelines, there is an ambiguous statement that suggests that the review panel would potentially allow a risky experiment only if there is no safer alternative method of addressing the same question. There are certain narrow questions—such as how does one specific virus change to become more contagious—that can be answered only by a dangerous experiment. But these are not the questions we need to answer for public health. The more informative questions—for example, about what makes flu viruses more easily transmissable—can be, and have been, answered by safe approaches, such as comparisons of genetic sequences and experiments that use parts of a virus, rather than a whole live virus. These approaches, besides being safe, can be done on a larger scale with many different types of viruses and can yield much more generalizable information than dangerous gain-of-function experiments. Gain-of-function is only one of many techniques, so avoiding it would be a very small modification to the overall research program on flu and other pandemic threats, but one that would considerably increase our safety.

Karen Feldscher

Learn more

Read Foreign Affairs article co-authored by Marc Lipsitch: New game, new rules: Limiting the risks of biological engineering

Read Scientific American article by Lipsitch: Make the Pause on Risky Pathogen Research Permanent

Read Journal of Medical Ethics article co-authored by Lipsitch: The Ethics of Biosafety Considerations in Gain-of-Function Research Resulting in the Creation of Potential Pandemic Pathogens

Watch debate between Lipsitch and Prof. Derek Smith of the Cambridge Center for the Study of Existential Risk