NY Times: The Battle Over Fecal Transplantation

NY Times: Drug Companies and Doctors Battle Over the Future of Fecal Transplants

This article highlights a concern that pharmaceutical companies may persuade the FDA to regulate fecal transplants similar to medications.  This will exponentially increase the cost and limit the access to beneficial human excrement. Thanks to one of my sons for pointing out this commentary to me.

An excerpt:

As pharmaceutical companies seek to profit from the curative wonders of human feces, doctors worry about new regulations, higher prices and patients attempting DIY cures…

The clash is over the future of fecal microbiota transplants, or F.M.T., a revolutionary treatment that has proved remarkably effective in treating Clostridioides difficile, a debilitating bacterial infection that strikes 500,000 Americans a year and kills 30,000…

At the heart of the controversy is a question of classification: Are the fecal microbiota that cure C. diff a drug, or are they more akin to organs, tissues and blood products that are transferred from the healthy to treat the sick? The answer will determine how the Food and Drug Administration regulates the procedure, how much it costs and who gets to profit…

Human feces, it turns out, are a potential gold mine, for both medical researchers and drug makers…

Inspired by the success of fecal transplants for C. diff, scientists are racing to develop similar treatments for an array of ailments and disorders, among them obesityautismulcerative colitis, and Alzheimer’s and Parkinson’s diseases…

For now, most of the material used in fecal transplants comes from OpenBiome, the public stool bank in Cambridge …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…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.

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