In January of this year, the New England Journal of Medicine reported that just one stool donation treatment was effective for 13 out of 16 suffering from colitis caused by Clostridium difficile -- one of the most intractable and crippling gut diseases out there. Two of the people whose symptoms didn't respond to the first treatment but received a second infusion (from a different donor) got better then. There were no reported complications. Independent reviewers were so impressed with these results that the study was stopped so that stool donation could be offered to everyone in the study's control group.
This procedure is a fecal microbiota transplant (FMT), more commonly known as a fecal transplant. FMT instills healthy stool from a donor into someone with a gut condition that has destroyed his or her healthy bacteria. Stool donors can be a family member, friend, or a healthy volunteer whose donated stool to helps to repopulate the gut with healthy bacteria. C.difficile is associated with the deaths of 14,000 Americans a year and incapacitates thousands more. This study further confirms what anecdotal evidence has shown for some time--this treatment works.
So why is the FDA asking that it be kept from those who need it the most by requiring consent forms and lengthy approvals? In a letter dated April 25, 2013, the director of the FDA Center for Biologics Evaluation and Research initially stated that an Investigational New Drug Application, or IND for short, will be required for all FMT procedures. This process makes it considerably more cumbersome and legally risky for a physician to perform. As was pointed out in an personal essay in the New York Times last Sunday, the IND discourages providers from offering FMT even when they know that the benefits outweigh the cumbersome approval process.