How to regulate fecal microbiota transplants
(Medical Xpress)—A small team of researchers at the University of Maryland, some with affiliations to the Veterans Affairs Maryland Health Care System, has written and published a Policy Forum piece in the journal Science outlining the current state of regulating fecal microbiota transplants. In their paper, the group describes the nature of the procedure, why and how it is used, and the ways the government is trying to regulate it.
In some cases, such procedures become the only means of restoring a person to health—patients who develop a Clostridium difficile infection (CDI) afterwards, for example, have few other options. CDI is an infection of the gut that generally occurs after a round of antibiotics has wiped out the natural gut biome—and it can be deadly if not promptly treated. Unfortunately, patients looking for such treatment can run into unexpected hurdles, as the authors of this new paper note—FMTs are now regulated by agencies such as the FDA, because donated stool samples are now housed in stool banks, which, like blood banks, must follow rules meant to keep the public safe.
But, the authors ask, should stool samples be treated the same as blood samples Some think they should be treated like tissue samples, which would add another layer of regulations. Still others suggest regulating them as just another kind of drug. The net result, the group notes, is that the entire industry is not well defined, which is not optimal for patients who need the treatment or regulators who fear as-yet unknown side effects. Adding to the problem is the ease of access to samples—a patient could choose simply to bring a bag of poop from a relative to an appointment, for example. And if regulations get in the way, it is not too difficult to see some patients taking things into their own hands—literally, possibly harming themselves in the process.