Drug Companies and Doctors Battle Over the Future of Fecal Transplants

Your doctor tells you "You need a Poop Transplant" . Really ???

Donated fecal material in the middle of the processing procedure at OpenBiome, a nonprofit stool bank.

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.

An oral fecal microbiota transplantation product made by OpenBiome, a public stool bank 

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

The therapy transfers fecal matter from healthy donors into the bowels of ailing patients, restoring the beneficial works of the community of gut microbes that have been decimated by antibiotics. Scientists see potential for using these organisms to treat diseases from diabetes to cancer.

Frozen processed samples at OpenBiome.

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. If the FDA gains regulatory authority over FTM the cost would escalate significantly.  The question remains is this a drug, alternative therapy and does the manufacturing process need to be regulated. There are strong reasons on both sides for the decision making process.

What Is a Fecal Transplant, and Why Would I Want One?

Would you like to become a poop donor?

WARNING Experts offer this final piece of sage advice: “It is not recommended to perform stool transplantation at home without guidance from a physician.”

SOURCES:

Pubmed

New York Times, Washington Post

Drug Companies and Doctors Battle Over the Future of Fecal Transplants - The New York Times: 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.