The Death of a Patient and the Future of Fecal Transplants

“Last month the Food and Drug Administration sent out an emergency alert: Two people who had undergone fecal transplants developed multi-drug-resistant infections from bacteria in the stool they were given, and one died.

The death and illness may be the first serious adverse events associated with the poopy procedure, out of tens of thou sands of times it’s believed to have been performed in the US. If those numbers are accurate, that’s an awfully good safety record. But it’s hard to know for sure, because roughly a decade since the procedure became mainstream, it still occupies a legal gray area, and thus whatever data is being collected isn’t comprehensive or public. …

“The material in these cases did not come from OpenBiome,” says Majdi Osman, a physician and the clinical program director at the stool bank, which screens for health risks so thoroughly that it boasts of excluding more than 97 percent of potential donors.

It seems likely the first effect of the patient’s death will be new requirements for thorough donor screening at any place performing transplants. That isn’t yet universal because the relevant professional societies, which typically write such detailed standards, haven’t tackled fecal transplants so far. But in a follow-up to the announcement of the death, the FDA said it will require the places performing poop trans­plants not only to check donations for pathogens, but to question donors about their daily-life risks of exposure to bad bugs.”