The FDA Wants to Regulate Feces Like a Drug

Slang words describing human feces are often used to denote products of poor quality or that have absolutely no value whatsoever. A product that is substandard is sometimes derisively referred to as “crap” — or worse. Now, a company in Massachusetts is collecting fecal material into a “stool bank,” and selling the screened preparations to hospitals for $385 apiece. The material is later injected into sick patients’ digestive tracts infected with Clostridium difficile.  These are difficult-to-treat bacterial infections that kill an estimated 14,000 people annually. The donated feces are obtained from healthy donors, who are paid $40 per donation. The average donation is screened and divided into four preparations, enough to treat four patients. In a clinical trial, the results from using donated fecal material were superior to using antibiotics.

Humans have a love/hate relationship with bacteria. Bacteria spoils food in ways that make food distasteful, inedible or downright dangerous. Throughout human history, food poisoning has been a constant source of death that has altered the course of nations. Numerous historical figures have died of pathogens consumed in either food or water. After conquering much of the ancient world, Alexander the Great died of what many medical experts now believe to be a foodborne or waterborne pathogen, such as Salmonella typhi or typhoid fever.

On the other hand, the human body consists of about 100 trillion microbes. Gut bacteria convert food and nutrients into chemical energy, without which life would not be possible. Nurturing these microbes in specific ways could be used to treat everything from obesity to diabetes. Scientists have even transplanted digestive bacteria from obese mice into slender mice – causing the slender mice to gain weight. Maybe the reverse will someday be possible once specific bacteria is isolated. Numerous firms sell supplements that claim to change the flora and fauna of the bacteria in your gut.

How does a fecal transplant work? Just like in the animal kingdom, bacteria often has to defends itself and protect its territory from incursion by rivals. Many bacteria secrete a substance that inhibits or kills other bacteria so rival bacteria doesn’t hinder its growth. Nicin, for example, is the byproduct of Streptococcus lactis. Nisin is a broad-spectrum antimicrobial substance derived from “food-grade” bacteria. It is used in the food industry as a preservative in cheese and bread to extend shelf life.

Lactic acid bacteria, such as Streptococcus thermophilus and Lactobacillus bulgaricus, is also a type of food preservative. Foods from yogurt to kimchi to sour dough bread rely on lactic acid from bacterial fermentation for flavor and preservation. Lactic acid bacteria boosts the acidity of a growth medium to the point other bacteria cannot grow. Lactic acid bacteria has been used to preserve foods for an estimated 4,000 years.

The bacteria in the gut can get thrown out of balance by consuming pathogens in food or water. It can also get thrown out of balance by antibiotics, allowing harmful bacteria like Clostridium difficile to multiply out of control. Fecal transplants – that is taking beneficial fecal material from a healthy donor and injecting it into the gut of someone suffering from a Clostridium difficile infection, has a 90 percent cure rate, according to the mayo Clinic. The earliest mention of the procedure in the scientific literature dates back to 1958.

Yet, in May of 2013, the U.S. Food and Drug Administration announced it would begin regulating transplanted fecal material as a drug. Before a physician could administer donated fecal material to a new patient, the physician would have to submit an Investigational New Drug Application (INDA) to the FDA. That process could take months. Faced with an enormous backlash, the FDA was forced to backtrack and announced “enforcement discretion” only two months later. The agency resumed allowing limited fecal transplants under specific conditions. In justifying its initial decision to regulate fecal transplant material, the FDA reasoned that the time-consuming process would lead to safer transplants that are standardized and would ultimately lead to commercial drug products.

In a blog headline I called “poop in a pill,” I wrote about one firm that is developing a capsule derived from gut bacteria to fight Clostridium difficile. The drug is not yet approved and there’s no word on what it will cost. Even though there is a simpler way, once the Poop Pill is approved, doctors processing pre-screen feces for transplant will likely be forced to stop. In other words, if you’re incapacitated in the hospital with Clostridium difficile, the FDA doesn’t want you to use a healthy donor’s poop. The agency would prefer you pay, say, $1,000 apiece for capsules of purified donor poop bacteria — that possibly must be taken daily for days on end.

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