This Germ Could Save Your Life | Popular Science (archiving magazine articles)

This Germ Could Save Your Life | Popular Science: "The trouble was that Hillman now had a true transgenic—an organism that expressed the genes of two different species. The prospect of tests in humans meant that he had to go to the FDA for approval. The FDA eventually referred his case to the National Institutes of Health’s Recombinant DNA Advisory Committee, created in 1974 in response to public concern over the safety of interspecies gene transfer. The committee, which includes ethicists and patients as well as scientists and physicians, reviews any application for a transgenic intended to be used outside a sealed laboratory.

In 2004, the committee gave Hillman the green light. Usually, this is enough for full FDA approval. But not this time. FDA regulators asked Hillman to cripple his bug to guarantee that it could be removed should it ever cause problems. “When we asked them what kind of problems, they had no idea,” he recalls. “I guess we were setting a precedent.”

The regulators saw a genetically modified bacteria that was robust enough to take over any person’s mouth, and they were worried about its unchecked spread. Their decision reflected a common criticism of GMO biotherapeutics. “The main problem . . . is that [GMOs] are usually poorly contained,” argues geneticist Joe Cummins. Recently retired from"