A few years ago, we asked if fecal microbiota transplants (FMT)—that is, human poop—would become a drug. The FDA just gave us the answer: yes!
The FDA recently approved the first FMT drug last week for the treatment of Clostridioides difficile infection (CDI) in patients who have already completed a course of antibiotic treatment. Only by the twisted logic of the FDA could human poop be considered a drug. Yet again, the FDA has taken a treatment that was widely and cheaply available and turned it into a Big Pharma money-maker.
FMT involves transferring fecal matter from a healthy donor into an infected patient to repair the gut microbiota.
Even before the FDA approved Rebyota, the writing was on the wall that the agency wanted FMT to be an agency-approved drug. The FDA had previously signaled its intentions to treat FMT as a drug in 2013, but was forced to backtrack after public backlash. With multiple drug companies pursuing FMT products, non-profit stool banks are closing. OpenBiome, the pioneers of FMT that previously provided most of the samples in the US, announced in 2021 plans to wind down their operations but vowed to continue providing stool samples to clinicians until the first drug treatment was approved.
Where once there were millions of potential donors who could offer a stool sample in addition to stool banks, now there is one company that has a virtual monopoly.
We don’t yet have information on how much Rebyota will cost, but you can bet it will be expensive. It also isn’t clear what benefit the approved drug offers over the previous system where you could get samples from people you knew or use a sample from a bank like OpenBiome. The FDA’s announcement stresses that the drug is prepared from stool donated by qualified individuals, and the donor and the donated stool are tested for a panel of transmissible pathogens. But OpenBiome had similar safeguards in place, including a detailed screening process for donors. OpenBiome also screened the samples themselves. It is unclear if the drug can improve on these safety measures. There is, of course, an inherent risk in using FMT: we don’t know all things for which stool samples should be screened; additionally, donors can be carriers for certain diseases but show no signs of the disease, presenting an additional safety issue.
The risks for certain patients will outweigh the benefits, but the point is that an approved drug does not seem to offer additional safety from stool banks. In fact, for many patients the approved drug may be more dangerous, as it contains PEG, or polyethylene glycol. Recall that this ingredient was also in Pfizer and Moderna’s COVID vaccines and was suspected to be the culprit behind the severe allergic reactions caused by these vaccines. Now, if you want FMT, you’ll have to deal with a potential reaction to PEG.
The package insert for Rebyota does not list an active ingredient. It merely states that the drug is “an opaque fecal microbiota suspension” and that “each 150mL dose of Rebyota contains between 1×108 and 5×1010 colony forming units (CFU) per mL of fecal microbes including >1×105 CFU/mL of Bacteroides.”
It would be absolutely absurd to grant Ferring a monopoly on FMT. The human microbiome is incredibly diverse and varies widely from individual to individual. While we are 99.9 percent identical in terms of our genetic makeup, our microbiomes can be 80-90 percent different. There are 300-500 bacterial species in the microbiota. The Bacteroides genus consists of about 30 species. The gut relies not just on one genus, but a thriving ecosystem that includes other microbes not named by Ferring in their formulation, including bacteria like Firmicutes and Akkermansia muciniphila. Ferring does not identify anything very specific about its formulation, yet by all accounts has a monopoly on all of FMT, no matter what bacteria are present.
This is all part of the FDA’s game to grant drug monopolies and line the pockets of Big Pharma executives. Note that Rebyota received Orphan Drug designation, meaning no other FMT drug can be approved to treat CDI for seven years. Ferring Pharmaceuticals, the manufacturer of Rebyota, won the race, beating out other FMT drugs in development, including one from Seres Therapeutics that had a deal in place with Nestle to commercialize the drug upon approval. A company could, in theory, develop another FMT drug for a different indication, but that period of exclusivity would only last three years according to FDA regulations since FMT has already been approved.
It’s no wonder that drug companies have been foaming at the mouth at the prospects for FMT: it’s had an 80% success rate at treating CDI, an antibiotic resistant bacterial infection that hits 500,000 Americans a year and kills 30,000. Beyond CDI, there are vast applications for using FMT to treat illness. It is being studied for a wide variety of indications, including ulcerative colitis, Crohn’s Disease, Parkinson’s disease, multiple sclerosis, childhood regressive autism, metabolic disorders, diabetes, autism, and others. FMT could lead to the next generation of medicines that utilize the trillions of microbes living within us to heal.
FMT is also crucial as one of the only ways you can get “good” bacteria to actually colonize the gut. Contrary to popular belief, probiotics do not take up residence in the gut, but perform a number of beneficial functions as they move through our GI tract, like suppressing the growth of pathogens, fortifying the intestinal barrier, and helping with immune modulation. Probiotics may also transfer genetic traits linked with better survival to other beneficial microbiota in the GI tract through a process known as horizontal gene transfer. FMT works because it does alter the gut microbiome, and now it is in the hands of Big Pharma, thanks to the FDA. (Note, too, that the FDA is also threatening access to probiotics through its dangerous “new dietary ingredient” guidance.)
The benefits of FMT—of human poop!—should be available to everyone, not just those who can pay for an expensive drug. The FDA continues to oversee and encourage turning natural treatments into patented drugs, as we’ve seen with CBD, l-glutamine, NAC, and most recently, NMN. Until the incentive structure at the agency changes, and the FDA becomes an actual watchdog of the drug industry rather than its cheerleader, we can expect the same thing to continue happening.