Just in time for #ASM2013 – FDA adding regulations for fecal transplants #microbiome

Well, I guess this could be good news or bad news or both.  The FDA has sniffed the winds of microbiome studies and decided that it wants some more regulation on fecal transplants (aka fecal bacteriotherapy).  See for example Fecal Transplant: FDA Wants Regulation.  Fecal transplants are spreading like crazy these days and every where I go in real life and online I hear and see more about them.   For more on fecal transplants see some of my previous posts such as More (you know you wanted it) on fecal transplants and the microbiome and Fecal transplants in the news and Transfaunation and Fecal Transplants: What Goes Around Comes Around, Literally and Figuratively.

I guess the FDA feels like they have to do something given the spread of FT.   Given how many scam artists and oversellers of the microbiome are out there I think some sort of increased protection or regulation is probably a good thing.  But I am not sure what the best way to do this is.  Clearly some are unhappy with the FDA sticking their noses into fecal transplants (e.g., see here).  But given how little we know about FTs other than as treatment for Clostridium dificile infections it seems like one could make a reasonable argument for more regulation or caution.  It seems strange though that we can do just about anything and everything we want to kill all the microbes around us with very little regulation and yet attempting to manipulate the microbes in and on us or add a few here and there is being regulated more.

What do others think?  Do we need more regulation from the FDA on fecal transplants?

UPDATE – some links to other discussions of this:

Overselling the microbiome award of the month: Integrative medical group of Irvine

Wow.  Just discovered this site: Fecal Transplantation | Integrative Medical Group of Irvine.  Not sure how long it has been out there.  But this is one of the more aggressive and perhaps egregious overselling of the power of the human microbiome that I have seen. They are promoting fecal transplants at their clinic as a way to cure a diverse array of ailments from ulcerative colitis to obesity and imply they can be used for cardiovascular health, emotional status, bone health, and more.  My “favorite” part:

As our understanding of the enormous importance of bowel micro-biota (bacteria) grows, the indications for fecal transplant will expand greatly and public acceptance will follow. But there is no reason for you to wait. Dr. Lee, our naturopathic doctor, is one of only a tiny handful of specialists certified in the use of fecal transplant. She can expertly manage your case.

Yes that is right.  We (the royal We of course) are on the verge of showing that the microbiota does EVERYTHING and therefore, if anything ails you, just wash your troubles away with some shit from a relative.  There is no reason to wait.  Come in to our clinic now.

And for the misleading nature of this site, I am giving this Integrative Medical Group of Irvine my coveted “Overselling the microbiome award.”  Previous winners and discussions of this issue are listed below:

Got poo?: Clinical trial on fecal transplants (aka fecal bacteriotherapy) to treat C. difficile infections

Normally I avoid covering press releases here on my blog but this one is actually worth noting: Groundbreaking Clinical Trial Looks at Fecal Transplant as Treatment for C. Difficile | Women’s Medicine Collaborative.  It details the funding of a clinical trial to study the effectiveness of fecal transplants in treating Clostridium difficile infections.

Fecal transplants have gotten a growing amount of publicity over the last few years.  And they certainly seem to have potential.  But though they have been shown to be safe, they have not yet been shown in a clinical trial to be effective in treating anything.  So it is good to see a funded clinical trial on such transplants (though I note, transplant is probably the wrong word to use – maybe fecal bacteriotherapy is more appropriate.

For some background on fecal transplants see