FMT future ‘still being written,’ ideally with more options for recurrent C. difficile
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From the early days of homemade “poop shakes” blended in a backroom 15 years ago to the current world of FDA-approved live biotherapeutic products, it feels like we are at an inflection point with fecal microbiota transplantation.
With credit to Robert Hunter, collaborator and lyricist for the Grateful Dead: “What a long, strange trip it’s been.”
Image: Adobe Stock
With the recent FDA approval of two new agents — the whole stool enema Rebyota (fecal microbiota, live-jslm, Ferring Pharmaceuticals) and Vowst (fecal microbiota spores, live-brpk, Nestlé Health Science/Seres Therapeutics), the 12-capsule Firmicutes spores regimen — we now have an “official” solution to the clinical challenge of recurrent Clostridioides difficile infection that we, in some ways, have been making up as we went along.
When asked to consider my visceral reaction to this momentous step, I find myself surprisingly mixed. Of course I am happy that we now have not one, but two agents. These agents have two different administration routes, and both have undergone rigorous randomized clinical trials and are manufactured in a highly standardized way. This should, hopefully, radically improve access to biome restorative therapies and make treatment easier for our patients in need.
Despite the proliferation of OpenBiome and other stool bank options, traditional FMT has remained largely confined to regional specialty academic centers or select practitioners with an interest, like me. I hope that an official FDA approval should rapidly disseminate treatment access, as both therapies can be used safely and easily by any practitioner, anywhere. And insurance coverage should improve, too.
When stool bank FMT was “investigational,” per the FDA’s enforcement discretion policy, insurance companies had an easy out to not cover it, but it should be harder for them to deny now. So that is the good news that makes me optimistic: rigorous data, FDA regulatory oversight of manufacturing and, hopefully, routine insurance coverage. But I also have some angst, as I am sure there will be significant hurdles to widespread availability and adoption, starting of course with coverage.
Just because the two therapies are FDA-approved does not mean we will not still be waiting on hold for hours for a prior authorization consultation with one of our peers. Also, these agents cost significantly more than the nonprofit stool banks have been charging in the past.
Additionally, these FDA-approved agents are not miracle cures. Both agents will have significant failure rates in this challenging population, and we are not sure what to do in that case yet: Will we need to repeat treatment with the agent we just used or use the other approved therapy? Should we use more antibiotics?
It would be ideal for our patients to have a third option from an established stool bank like OpenBiome, which despite still operating under an investigational new drug application has an extraordinary safety and efficacy record with well over 65,000 treatments to date.
None of us know yet what the FDA will do with the stool bank model in this new phase, but I would like to think that more options that are less expensive yet still well-tested are better for our patients than fewer options. Also, I hope the FDA will continue to fast-track other emerging microbiome restorative treatments currently under investigation, as this will assuredly not be a one-size-fits-all solution.
We have just crossed this fascinating inflection point, but the future of FMT is still being written. I greet that future with a great deal of optimistic excitement, but still with a bit of trepidation.
- For more information:
- Neil H. Stollman, MD, FACP, FACG, AGAF, is chief of the division of gastroenterology at Alta Bates Summit Medical Center in Oakland, California. He can be reached at neil@stollman.com.
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