Saturday, May 18, 2013

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:


  1. Unfortunately humankind cannot be trusted to always do the right thing - history is littered with Adolph Hitlers - and today idealism has been replaced by money power/greed. It won't take long for someone to abuse the use of microbes and unbalance the planet accordingly. Most discoveries will be trumpeted as a medical cure to the potential of human death...and we will all buy into that...but the net result will always be about some money interests...sad but true. I am also opposed to inflicting a disease upon a healthy animal in order to test the outcome of a scientific discovery. Just because we are humans does not mean we have the right to be inhumane. If there are doubts about the test in vitro, then the scientist has the obligation to not continue until all doubt is eliminated. I firmly believe that we should accept life on this planet where birth and death have equal opportunities, but due to our intervention, death is now at a disadvantage - but will inevitably succeed....somehow our 'top-of-the-food-chain' brains cannot grasp that fact. So if we are going to mess with bacteria, let it be controlled and ethical. I am not opposed to science, just opposed to irresponsible and unethical science.

  2. Ok I will play devils advocate. Is it fair for treatments that can be life saving and performed en masse today to be buried under years of government regulation before ever having substantial impact? We live in a world today where the consumer (patient) is able to do real research on a company/product irrespective of whether or not they have a phd in microbiology. And isnt this the point of community science, to let the public drive health innovations with input and cooperation from the "experts?" I say let the science and the public govern themselves, NOT govt and their token scientists who are biased and opinionated.