Drug Companies and Doctors Battle Over the Future of Fecal Transplants

“For now, most of the material used in fecal transplants comes from OpenBiome, the public stool bank in Cambridge that embraces its mission with both humor and gravitas. Giant poop emojis decorate its offices, conference rooms are named after sections of the intestinal tract and employee birthday cakes invariably come in one flavor: chocolate.

The organization produces 900 to 1,000 monthly treatments, most of them bottled liquids that are packed in dry ice and sent overnight to clinics across the country. Any unpleasant odors are confined to an airtight production facility, where employees in white hazmat suits gingerly handle clear plastic bags filled with a mud-colored slurry.

The material comes from donors who earn $40 a pop and must pass intensive screenings and regular medical checkups. “It’s harder to become a stool donor than it is to get into M.I.T.,” said Carolyn Edelstein, who runs the organization.

In 2012, Ms. Edelstein created OpenBiome with Dr. Smith, now her fiancé, after her cousin contracted recurrent C. diff and, facing a six-month wait for the procedure, did it at home with a roommate’s stool.

A few months later they started OpenBiome with seed money from a foundation and sent out six treatments that first year. “It’s been a wild ride,” Ms. Edelstein said as she showed off a room full of mammoth freezers that hold thousands of screened stool samples.

But OpenBiome and other stool banks are facing an uncertain future. Drug companies, which have been struggling to funnel patients into the clinical studies that are required for F.D.A. approval, would like federal officials to restrict the stool bank’s ability to distribute fecal matter in the hope that more patients will enroll in their trials.

The F.D.A. has ramped up oversight of OpenBiome’s production, leading to more rigorous testing and higher prices, which will double to $1,600 this month.

Patient advocates expect those prices to jump exponentially should the F.D.A. grant market exclusivity to one of the companies that are in the final stages of testing alternatives to raw stool transplants.”