Tuesday, March 05, 2019

Interesting and important story on fecal transplants in @nytimes



This is definitely worth a read:

Drug Companies and Doctors Battle Over the Future of Fecal Transplants - The New York Times. By Andrew Jacobs. March 3, 2019.

The lead in is good:
CAMBRIDGE, Mass. — 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 battle, pitting drug companies against doctors and patient advocates, is being fought over the unlikeliest of substances: human excrement.
The story is both interesting and includes some very important stuff going on behind the scenes that may affect the future of fecal transplants as a treatment in t. It seems that a variety of folks including those from companies who are trying to develop treatments mimicking fecal transplants are trying to get the FDA to crack down on the use of actual feces for carrying out fecal transplants.
“The first principle of medicine is do no harm, and at the moment we don’t have a long-term track record of F.M.T.’s adverse effects,” said Dr. Sahil Khanna, an associate professor of gastroenterology at the Mayo Clinic who has conducted industry-funded clinical trials on fecal transplants. “We also need to move away from transferring poo from one person to another.”
and
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.
On the other side are those from places like OpenBiome as well as many clinicians who think that the regulation may have already gone far enough or even too far.
“It is very frustrating to see hyperregulation again ruining a good thing in health care,” said Dr. Colleen Kelly, a gastroenterologist at the Brown University medical school.
and
“I never imagined the solution to my nightmare could be so simple,” he said. “I just hope Big Pharma doesn’t make it unaffordable for the people like me.”

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