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Human excrement is the focus of an escalating debate over who will control and harness its lucrative future as a potential remedy for numerous acute and chronic illnesses.

The effectiveness of fecal microbiota transplants (FMT) in treating the often deadly bacterial infection Clostridum difficile (also known as Clostridioides difficile and C. diff) has sparked a cottage industry of fecal processors and forced the U.S. Food and Drug Administration (FDA) to suspend its 2013 decision to classify the product as a drug. While the agency considers whether to return to its original ruling or classify fecal material in the same category as organs, tissue, and blood products, Big Pharma stands ready to secure a monopoly on research, eager to enter a market that is expected to grow to $1.7 billion by 2026.

A drug classification means pharmaceutical companies would be required to spend millions testing their products for safety and efficacy, thus raising costs to consumers. If the FDA agrees with doctors and patient advocates that FMT procedures are no different from an organ transplant or a blood transfusion, the treatment would remain more accessible.

“People have good reason to worry because, for many patients, fecal transplants are a matter of life and death,” Catherine Duff, founder of the patient-advocacy group Fecal Transplant Foundation, told the New York Times. “The concern is that corporate greed will get in the way of patient access.”

Industry representatives argue that FMT, administered via capsule or colonoscopy, lacks a long-term track record and requires further study; they also believe regulators should move to prevent dangerous DIY transfers of fecal material; a DIY FMT was blamed for one death in June 2019.

The skirmish over control of the substance comes as researchers are scrambling to test its efficacy to ameliorate conditions ranging from Alzheimer’s and Parkinson’s to ulcerative colitis, obesity, and autism — with potential to treat even type 2 diabetes and cancer. “The whole field is screaming forward faster than anyone could have imagined,” biotech firm Rebiotix’s chief executive Lee Jones told the Times.

Rebiotix is focusing on products to treat C. diff, the only condition for which the FDA has approved FMT (transplants are approved only when antibiotics have proven inadequate). But Jones and others worry that if the agency rules for Big Pharma on FMT, it could discourage future research on broader microbiome therapies, which, he said, “has the potential to change the way we look at and treat disease.”

By the Numbers

500,000: Number of cases of Clostridium difficile infections annually in the United States — 100,000 of which occur in nursing homes, according to the Centers for Disease Control and Prevention.

80%–96%: Percentage success rate of single- or double-dose fecal microbiota transplants in curing C. diff infections for patients with or without inflammatory bowel disease, according to a 2017 meta-analysis of studies.

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