4 Mar 2019 New York Times Battle Erupts Over Treatment That Once Repelled: FDA Ruling Will Pick Who Prospers From Fecal Transplants
' There's a new war raging in health care, with hundreds of millions of dollars at stake and thousands of lives in the balance. 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.
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At the heart of the controversy is a question of classification: Are the fecal microbiota that cure C. difficile a drug, or are they more akin to organs, tissues and blood products that are transferred from the healthy to treat the sick?
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In 2012, Ms. Edelstein created OpenBiome, with Dr. Smith, now her fiance, after her cousin contracted recurrent C. difficile and, facing a six-month wait for the procedure, did it at home with a room-mate's stool A few months later they started OpenBiome with seed money and sent out six treatments that first year.
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"It is very frustrating to see hyper-regulation again ruining a good thing in health care," said Dr. Coleen Kelly, a gastroenterologist at the Brown University medical school.....In late December, Dr. Kelly administered a fecal transplant via colonoscopy, and within hours, Mr. Shaw started feeling better. By Christimas his bowel movements had returned to normal.'
The FDA wants to regulate something it does not know the action of. Further studies should reveal the 'allelopathy' involved when these introduced microorganisms overpower C. difficile.
' There's a new war raging in health care, with hundreds of millions of dollars at stake and thousands of lives in the balance. 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. difficile a drug, or are they more akin to organs, tissues and blood products that are transferred from the healthy to treat the sick?
....
In 2012, Ms. Edelstein created OpenBiome, with Dr. Smith, now her fiance, after her cousin contracted recurrent C. difficile and, facing a six-month wait for the procedure, did it at home with a room-mate's stool A few months later they started OpenBiome with seed money and sent out six treatments that first year.
....
"It is very frustrating to see hyper-regulation again ruining a good thing in health care," said Dr. Coleen Kelly, a gastroenterologist at the Brown University medical school.....In late December, Dr. Kelly administered a fecal transplant via colonoscopy, and within hours, Mr. Shaw started feeling better. By Christimas his bowel movements had returned to normal.'
The FDA wants to regulate something it does not know the action of. Further studies should reveal the 'allelopathy' involved when these introduced microorganisms overpower C. difficile.
