A procedure that was hailed for its revolutionary approach left one person dead and another severely ill last Spring. The doctors involved have now come forward to explain what happened.
In an article published in the New England Journal of Medicine on Wednesday, a group of doctors from Massachusetts General Hospital detail their mistakes in the fatal fecal microbiota transplantation (FMT), and hope to eliminate some fears about the still-new technology.
“It’s been professionally very challenging,”Dr. Elizabeth L. Hohmann, the lead author of the article, told The New York Times. “But this is a cautionary tale about the risks of cutting edge projects.”
Clinical trials are still ongoing for FMT procedures, which transfer feces from a healthy donor to the intestinal tract of sick patients in an effort to restore healthy bacteria to the gut. The new field has not been approved by the Food and Drug Administration, according to the Times, but the treatment has been successful in treating Clostridium difficile, which is a life-threatening bacterial infection.
The man who died last year was a 73-year-old cancer patient. He and the other patient who fell ill, 69, were reportedly being treated with the same stool in two different experimental trials of FMT — leukemia and liver disease, respectively.
According to the Times, the doctors say that the stool used to treat the two patients had been contaminated with a strand of E. coli bacteria. Hohmann explained to the outlet that no one had thought to test the material before it was used on the patients.
“It wasn’t obvious to a lot of smart people here,” she told the outlet. “We didn’t think to go back in time.”
After the contaminated stool was transferred to the two men, they both fell ill. The liver patient was treated with powerful antibiotics and was able to recover, but the cancer patient had recently taken drugs to suppress his immune system as part of a bone marrow transplant. He died within 10 days of his last FMT treatment.
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Following the incidents, the FDA issued a nationwide warning, and now doctors are testing stool donations for several infectious and emerging diseases.
Next week, the agency plans to hold a public hearing in Washington D.C. to discuss the risks and benefits of the procedure.