Pilar N. Ossorio, professor of law and professional ethics at the University of Wisconsin-Madison’s Morgridge Institute, discusses the latest on Fecal Microbiome Transplants (FMT). FMT has been surprisingly controversial – some people say it is unethical, even to conduct clinical testing on, while others think it is saving lives. FMT is of particular interest to patients with C-diff, which can be fatal without effective treatment. FMT has also been a subject of much hype, leading to the rise of a “Do-It Yourself” FMT movement.
The over-hype regarding FMT has been a challenge for researchers, as it has already being put into practice before research has really gotten underway. Most efficacy claims regarding FMT were based on a single, small, unblinded clinical trial, although when donors and feces are properly screened, it does seem to be relatively safe. DIY FMTs have caused health problems in some cases. Researchers eagerly anticipated a 2016 paper, the first randomized, controlled and double-blinded study of FMT for recurrent C. diff. The study found that FMT achieved a 90% clinical cure rate. However, 62% of control group participants also achieved a clinical cure (these people were treated with their own feces) – twice the rate that would be expected with antibiotic treatment.
These results point to Ossorio’s primary concern: we don’t actually know what’s going on in FMT. She and others are also wary of the potential for FMT to give people something even more harmful than what they are being treated for, reminiscent of the transmission of AIDS from blood transfusions. Appropriate donors may also be difficult to find – one study found that only 12 of 116 potential donors were cleared for transplants – many apparently healthy folks had gut pathogens that could have been harmful to people with C-diff.
“Feces as a medical product” are difficult to regulate, though all experts agree that fecal-derived products should be regulated as drugs. We are in a difficult situation where we disincentivizing people from doing FMT research or participating in trials, yet if we over-regulate, we will drive people towards potentially unsafe DIY options. Ossorio believes regulating feces as an unapproved human drug is the best approach for now.