The FDA Wants to Regulate Your Poop


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.


3 thoughts on “The FDA Wants to Regulate Your Poop

  1. What an extraordinarily interesting post. Alas, I don’t use social media – all I can do is press ‘Like’ and hope this appears in my ‘posts’ I like and hope one of my followers or readers, links to this and does send it through social media.

    You have given me information which I had ABSOLUTELY NO IDEA existed – its information which rather needs to go viral.

    Perhaps the only opportunity for change is revolution from the ground up – it seems as if there is a lot of ignorance out there, some enlightened and thoughtful people who are being PROPERLY scientific (rather than pseudo scientific and wearing money-tinted spectacles!!) and exploring what works, however strange and counter intuitive it might sound. If more of US (patients/clients) knew about all this, we could perhaps help by asking our clinicians if they knew about this, and, who knows, compassionate clinicians who really care about their patients (and I do believes this will be most clinicians) would be able to exert influence on their professional bodies to exert influence on some enlightened ‘maverick’ politicians to take up the case of non-harmful (and non-mega buck shareholder profit making enterprises for corrupt industries!!)

    I like the idea of revolutionary new healing paradigms coming from ‘waste’ – its a curiously mystical concept in what goes round, comes round, and what might seem to be shadow/hidden/shameful/unwanted in psychospiritual terms, is the place from which healing starts.

    I’m really not being funny, bur while I started reading your post, at first intellectually curious and thinking ‘yuck’ – and then beginning to giggle a bit at the bizarre possibilities for black humour within it – it has actually given me some quite deep metaphysical pause for thought. Thank you.

    • Thank you so much. And yes, the idea of stool transplants is downright revolting (no pun intended). That is why I find it amazing that anyone tried this before just using probiotics. Blows my mind. And you have no idea how much I want this information to spread. Not only patients but my fellow doctors that I work with at the hospital didn’t know 90% of this information until I opened their eyes. And yet, even with the information our ability to change practice style is still amazingly hampered by regulations, laws, and risk of lawsuit. It needs to change. And I am not sure how you go about it in the UK but here in the USA I am realizing I may need to start a letter writing campaign to senators and representatives. I have given all of this a LOT of thought and this is one, if not the only, way I can think of to dramatically decrease healthcare costs in a politically popular way. And lets face it, politicians aren’t going to do anything that is politically unpopular. Here is a way to save billions of healthcare dollars without decreasing services, denying care or sacrificing health. In fact we may save money and be healthier as well.

      Thank you again. Your words give me renewed motivation

  2. Pingback: Sounds disgusting, sounds repellent – but………. | Lady Fancifull

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