You may not have heard of Fecal Microbiotia Therapy or FMT, but the patient’s whose lives have been saved by it are acutely aware of its efficacy. The beaming mother above used a transplant of her own healthy gut bacteria to save the life of her one year old child. Now all of that will end or be sharply curtailed by the decision that her gut bacteria, for the good of science, must be declared an unapproved drug!
FMT is increasingly used to treat the horrible antibiotic caused gut disease C. difficile (c Diff). The disease can be lethal, causing 14,000 hospital acquired infectious deaths a year. How do you get it? Unsuspecting patients who are hospitalized ingest the spores of this dangerous bacteria and end up in the ICU with horrible watery diarrhea and in severe pain. It’s estimated that about 1 in 10 patients who are hospitalized short-term will get the disease and about 1/2 hospitalized for more than 4 weeks will get it. Taking certain prescription antibiotics or proton pump inhibitors (the little purple pill) can also cause or facilitate the disease. Some researchers believe we’re all getting more susceptible to c Diff as a result of the antibiotics in our food chain (used in livestock). How do you treat it? The treatment for the sickest patients has traditionally involved big gun antibiotics like Vancomycin, a drug that carries the nasty little side effect of making some patients permanently deaf.
c Diff can be very tough to treat. I remember being in medical school and cringing every time I heard about a new c Diff patient. The reason is that traditional therapies try to kill the c Diff bacteria with powerful antibiotics which only further whacks out gut bacteria (which is the cause of the c Diff infection in the first place). You might imagine the happiness of doctors everywhere when they learned that simple, safe and and inexpensive transplant of a healthy person’s gut bacteria can cure the disease with about a 90% success rate (based on the reports of large meta-analyses).
Despite the fact that this procedure transplants some of the same bacteria/cells that are mixed up between consenting adults in various types of sexual intercourse, the FDA has now told the Gastroenterology specialty society that it’s a new drug. Yes, you read that right, your poop is a drug to be regulated by the FDA. Regrettably, this decision will for all intents and purposes kill this therapy. Why? There’s just no way that anyone will ever spend the huge money needed to turn poop into an FDA approved drug.
I always like to follow the money in these decisions. Recently, FMT has been shown to be possibly effective for Ulcerative Collitis (U.C.). So while treating a few hundred thousand c Diff patients in the nation’s ICUs could be a lucrative drug market, the U.C. disease market is much bigger and much more lucrative. There are about 6,000,000 worldwide U.C. patients and all therapies being considered are “lifetime drugs”, or drugs that you must take for a lifetime. These include small molecules, antibodies, and biologics. One of the more common drugs being used right now is Remicade, which costs about $20,000 per patient per year! This stuff is so toxic that one friend on this medication tells me that he has the sensation that he’s being stung by ants all over his body for about 24 hours after an infusion. If a simple poop transplant can get rid of the market for these drugs, while being a great thing for humanity, it’s bad news for the FDA who earns PDUFA fees from new U.C. drugs (these fees make up 1/4 of the total FDA budget and 2/3′rds of the drug approval budget) and the big Pharma manufacturers who make these expensive drugs. One way to kill FMT is simply to declare it a drug using the same logic that has allowed the agency to declare certain types of stem cell treatments a drug. Since nobody in their right mind will every spend the hundreds of millions of dollars to pay for FDA approval on poop in a bottle, the competition is killed with a single stroke of the pen!
The upshot? The only thing more disgusting than a poop transplant is a system that kills simple, low cost, safe and effective new therapies to make way for expensive, often dangerous, but patentable new drugs that are “safe and effective”.
