Lab-made flu viruses not worth the risk, researchers say

Citing the Nuremburg Code for ethical research—developed in the wake of Nazi medical experiments—epidemiologists from Yale and Harvard are calling for a halt to projects aimed at creating potentially dangerous new viruses.

Scientists create such viruses, known as “potential pandemic pathogens” (PPPs), in an effort to predict how existing germs might mutate so they can jump easily from livestock to people, and then spread among human beings.

But “there is a quantifiable possibility that these novel pathogens could be accidentally or deliberately released” from the lab, epidemologists Marc Lipsitch ’91 of Harvard and Alison Galvani of Yale write in a recent article in PLOS Medicine.

“The dangers are not just hypothetical,” they continue: “The H1N1 influenza strain [swine flu] responsible for significant morbidity and mortality around the world from 1977 to 2009 is thought to have originated from a laboratory accident.”

More recently, researchers have published reports on their creation of new strains of H5N1. That virus, also called avian flu, “is highly contagious among birds, and can be deadly to them, especially domestic poultry,” according to the US Centers for Disease Control.

The infection can be deadly to human beings as well, but it doesn't spread easily from person to person. Scientists in the Netherlands and the US stirred controversy by publishing reports on their creation of mutations that are easily transmitted among ferrets, which are often considered a good model for human transmission of flu viruses.

In the May 20 PLOS Medicine article, Lipsitch—a Yale College alumnus who is director of Harvard's Center for Communicable Disease Dynamics—and Galvani, who heads Yale's Center for Infectious Disease Modeling, estimate the “quantifiable possibility” that an experimental virus will accidentally infect a lab worker.

A “moderate research program,” consisting of ten laboratories experimenting at high safety levels for a decade, would run “a nearly 20 percent risk of resulting in at least one laboratory-acquired infection,” they write. That single infection, “in turn, may initiate a chain of transmission” in the general population.

Galvani and Lipsitch see it as an area in which scientific know-how has outpaced risk assessment.

The Nuremberg Code, which governs research on human subjects, specifies that risks should never exceed “the humanitarian importance of the problem to be solved,” and that the hoped-for results should be “unprocurable by other methods.”

Those principles should govern lab-engineered viruses, since they could endanger human lives, Lipsitch and Galvani argue. They want the US Department of Health and Human Services and other funders to carry out a “quantitative risk-benefit analysis guided by the principles of the Nuremberg Code” before sponsoring any more studies.

“We want to move the discussion from ‘should PPP experiments be banned?’ to ‘Is there a unique public health benefit of PPP experiments, unachievable by safer means, that outweighs their risk?’” Lipsitch writes in an e-mail.

He and Galvani appear to have reached their own conclusion.

“We believe that the safer alternative approaches we advocate (all of which are currently being pursued, albeit with limited funds) are more likely to lead to public health benefits,” Lipsitch writes.

By publishing their article, “We would like to raise awareness of this issue among our colleagues and to directly influence funders to decide how to spend their funds based on accepted ethical principles.”

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The Yale Alumni Magazine is published by Yale Alumni Publications Inc., an alumni-based nonprofit that is not run by Yale University. Its content does not necessarily reflect the views of the university administration.