- Fecal microbiota transplantation—the medical euphemism for taking poop from a healthy person, blending it up, and putting it in a sick person’s intestines—has shown extraordinary promise in treating C. difficile infections. There’s also some suggestion it could help treat other painful chronic conditions, including ulcerative colitis and Crohn’s disease.
In 2013, the FDA announced that it would have to regulate the transplanted fecal microbiome as a drug. When stool is used to treat disease, the agency explained, it falls within the broad statutory definition of a “drug.” But Sachs and Edelstein have mixed feelings about FDA regulation.
“Not only does stool defy the typical scientific characterization that the FDA has long applied to small-molecule and biologic drugs, but the potential do-it-yourself nature of the treatment poses particular concerns in the context of a regime involving periods of regulatory exclusivity.”
From the paper:
- Protocols for encapsulating stool have also been validated and published.
- In the first clinical trial evaluating the therapy, FMT proved so superior to standard antibiotics that the study’s data and safety monitoring board stopped enrollment early, concluding that it was unethical to withhold the treatment from the members of the control group.
And a mention of “OpenBiome, a public stool bank” which pays donors in Massachusetts up to $250 a week for "samples"!
"Earn prizes!" ("biggest single donation of the month" — not making this up) "Free drinks!"