Awaiting FDA approval.
Yep, that’s right, the FDA has claimed jurisdiction over poop. There is some background to this story first that I have covered in my previous post on probiotics and C diff. Clostridium difficile (C diff) is an infection of the colon that happens to people after they have taken antibiotics and killed off their normal healthy gut flora. This leaves no competition for C diff to grow and cause a bad infectious diarrhea that can range from annoying to deadly. And treatment can range from a 10 day course of antibiotics to an emergent colectomy (surgery to remove the entire colon). Recurrences of the infection after a course of antibiotics is very common.
Going back more than 10 years some physicians have tried in desperation in very sick patients who failed antibiotics to repopulate the normal healthy gut flora by injecting the stool from a healthy person into the colon of the infected patient (a process now commonly known as a stool transplant or fecal microbiota transplantation). And amazingly it works, very well actually. Cure rates in the studies that have been done suggest a cure rate above 90 percent. And that is is in a population that has been tried usually on multiple courses of antibiotics and is quite sick.
Ten years later in steps the FDA. They now state that stool transplants are under their jurisdiction and have required people to file an “investigational new drug application” form before performing a stool transplant. This requires paperwork and a long delay before a response and authorization which may not be granted.
So now the FDA has labeled poop as a drug and is trying to restrict its use. I have so many problems with this. First, it is clearly an overreach of their authority to call poop a drug. Secondly, to call it “investigational” is also misleading. Like so many of the other things I speak of in my posts there is lots of data on stool transplants already. Stool transplants are not only safe, they actually outperform antibiotics by a landslide and that is even with only being used in the sickest patients who have failed antibiotics.
I also can’t help but think that the makers of Dificid (fidaxomicin) have something to do with this. Dificid is a relatively new antibioitic for C diff. The data that led to its approval was not impressive. For treating C diff it was no better than the standard antibiotic flagyl. The advantage it touted was a decreased recurrence of C diff after treatment. But that advantage was very small to almost insignificant. And for this very minor advantage it comes at a price of about $2000 for a 10 day course. That is compared to $10 for the standard treatment with Flagyl. And poop of course is free.
Lastly, and what disturbs me the most, is that despite the extensive press on this issue no one seems to be asking the more obvious question. Why don’t we just research probiotics which do the same thing? Probiotics are designed to repopulate the normal healthy gut flora just like a stool transplant does and it doesn’t have the ick factor like stool transplant. The studies of probiotics that have been done so far are very promising. I can tell you from personal experience that they work. I use probioitics to prevent C diff in my patients taking antibioitics and I have not had a case in over 3 years, which is when I started doing this as standard practice. And when I get a patient who was not been cared for by me and got C diff I given them probiotics along with flagyl to treat their C diff and I have not had one treatment failure or recurrence after treatment while doing this. Prior to starting these practices of use of probiotics I cannot count how many cases of C diff I caused using antibiotics, and patients I cared for frequently failed a single course of flagyl and I had to go on to try vancomycin or both. I still remember one case I cared for that failed all treatments we tried and she had to go for an emergent colectomy (removal of her colon), but even that did not save her and she passed away. That case was 6 years ago and it still haunts me to this day. Could I have saved her with probiotics? Who knows? We have to do the studies to find out. A stool transplant almost certainly would have helped given the data that already exists. Unfortunately the FDA has just taken away that effective tool from us and it is my personal opinion that there will be emergent colectomies and deaths because of this policy. Fortunately, for now, we still have access to probiotics. For now.
Medical Revolt 