According to an op-ed in the latest issue of Nature, the FDA should rethink its classification of feces as a drug. Christine Gorman elaborates:
Fecal transplants have become increasingly important over the past few years as a way of basically taking the healthy gut bacteria out of one person and putting them in another person whose own gut bacteria are deficient in some way. … Currently, the FDA has given fecal transplants a kind of waiver from some of the stricter rules that govern the development and testing of medications. But that’s only as long as the treatment is used strictly for C. difficile infections, which cause debilitating gastrointestinal problems and are not otherwise easily curable. Many physicians and patients would like to know if the therapy could be made to work for other bowel problems – such as Crohn’s disease.
But the stricter FDA rules would make it harder to test fecal transplants for no good reason.
Regulating fecal transplants like other tissue products would still keep patients safe, the [Nature] authors argue. And it would undoubtedly keep the cost of treatment lower than would otherwise be possible if some large company with deep pockets had to undertake the sorts of tests that would need to be done to approve fecal transplants as if they were drugs. After all, if there’s something we have a lot of in this world, it’s poop.
Among other things, the researchers worry that people will make themselves sick with DIY transplants:
Websites explaining how to do fecal transplants at home are becoming common, they point out, but patients who pursue this outside of medicine cannot be protected from diseases transferred with the gut contents, or from injuries if the transplant is done badly.
Previous Dish on fecal transplants here and here.
(Graph from Nature)
The Dish 