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Statement on March 12, 2020 FDA Safety Alert regarding Fecal Microbiota Transplants

On March 12, the Food and Drug Administration (FDA) issued a safety alert that eight patients were infected following fecal microbiota transplants (FMT) using material from a company which was later confirmed to be OpenBiome, an independent stool bank. Two of the patients subsequently died. FDA did not name OpenBiome in its safety alert, similar to its omitting Massachusetts General Hospital as the facility where two patients died following FMT using material from its own stool bank in June 2019. However, OpenBiome came forward quickly with a lengthy statement on the matter, which we encourage concerned parties to read.

In response to this incident, Peggy Lillis Foundation’s executive director Christian John Lillis issued the following statement:

“Peggy Lillis Foundation is the leading national patient organization combating C. difficile infections through education and advocacy. As such, learning of deaths resulting from FMT is heartbreaking. Though FMT is considered to be an appropriate therapy for recurrent CDI according to consensus clinical guidelines, there are risks associated with it, including transmission of under-recognized bacteria, viruses and fungi. While we appreciate that OpenBiome and hospital-based stool banks are dedicated to rigorous safety screening, patients should also be aware, and should discuss with their medical providers, that the current screening technology cannot completely eliminate these risks. With the safety of patients in mind, we urge all stool banks to continue to learn and evolve their screening processes to prevent future harm.

PLF does not endorse or take positions on treatments. However, we believe there is enormous potential in the development of microbiome-based therapeutics as a modality for C. difficile infections as well as other infectious and chronic diseases.

We believe that the many C. diff patients who are turning to FMT deserve to know about any potential risks of the procedure in order to make informed decisions about their own health. While we recognize that regulations may limit FDA’s communication about investigational treatments, we are disappointed that they did not identify OpenBiome in the safety alert. We also believe that companies and organizations responsible for testing have an ethical obligation to disclose risks. We note that OpenBiome came forward very quickly to assure patients who need FMT that they had taken steps to prevent additional transmissions. However, Massachusetts General did not come forward when faced with a similar safety lapse in June 2019. Since FDA did not identify Massachusetts General Hospital, patients and providers were left to wonder if the facility they were planning to have the procedure at had a safety lapse. In fact, Massachusetts General Hospital was only revealed to be the site of the June 2019 transmissions when the investigators who were responsible for the trial published their learnings in an academic journal.

PLF believes that the FDA and investigators owe patients much more transparency. We call on FDA to clearly name facilities where future lapses occur. Failure to do so creates uncertainty among Americans suffering from a debilitating and tormenting disease who may forego a potentially life-saving or restoring treatment due to unnecessary fear and lack of information.”

Learn more:
Full FDA Safety Alert
OpenBiome Announces Enhanced Donor Screening Protocols Following FDA Alert
Microbiome Therapeutics Innovation Group Statement

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