The GLP is committed to full transparency. Download and review our 2019 Annual Report

Patient death prompts new rules for fecal transplants: ‘Why weren’t these guidelines already in place?’

| | August 29, 2019
download
Image: Jeff McIntosh/Associated Press
This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

In June [2019], after a patient died and another was sickened from a fecal transplant that contained drug-resistant bacteria, the Food and Drug Administration stepped in and set new guidelines for the procedure.

The guidelines specified that both donors and their stool should be screened for the presence of “multidrug-resistant organisms.” They were included in an alert issued by the agency stating that the two patients who got sick had weakened immune systems, and that the donor stool they received had not been tested for the specific superbug that made them ill.

The announcement raised more questions than it answered. Chief among them: What happened, exactly, in the two cases? And, given the increasing threat posed by drug-resistant bacteria, why weren’t these guidelines already in place?

There’s no question that FMT’s popularity has soared in recent years. On clinicaltrials.gov, there are more than 300 registered trials looking at FMT for a wide variety of conditions, many of which go far beyond the original intended use, including transplant rejection, obesity and cancer, as well as some of the more expected gastrointestinal disorders, such as irritable bowel syndrome and ulcerative colitis.

Read full, original post: There were no guidelines for fecal transplants. Then, a patient died.

Related article:  Synthetic biologists developing cells programmed to target, destroy cancer
News on human & agricultural genetics and biotechnology delivered to your inbox.
Optional. Mail on special occasions.

Send this to a friend