Interesting and important story on fecal transplants in @nytimes

This is definitely worth a read:

Drug Companies and Doctors Battle Over the Future of Fecal Transplants - The New York Times. By Andrew Jacobs. March 3, 2019.

The lead in is good:

CAMBRIDGE, Mass. — There’s a new war raging in health care, with hundreds of millions of dollars at stake and thousands of lives in the balance. The battle, pitting drug companies against doctors and patient advocates, is being fought over the unlikeliest of substances: human excrement.

The story is both interesting and includes some very important stuff going on behind the scenes that may affect the future of fecal transplants as a treatment in t. It seems that a variety of folks including those from companies who are trying to develop treatments mimicking fecal transplants are trying to get the FDA to crack down on the use of actual feces for carrying out fecal transplants.

“The first principle of medicine is do no harm, and at the moment we don’t have a long-term track record of F.M.T.’s adverse effects,” said Dr. Sahil Khanna, an associate professor of gastroenterology at the Mayo Clinic who has conducted industry-funded clinical trials on fecal transplants. “We also need to move away from transferring poo from one person to another.”

and

Drug companies, which have been struggling to funnel patients into the clinical studies that are required for F.D.A. approval, would like federal officials to restrict the stool bank’s ability to distribute fecal matter in the hope that more patients will enroll in their trials.

On the other side are those from places like OpenBiome as well as many clinicians who think that the regulation may have already gone far enough or even too far.

“It is very frustrating to see hyperregulation again ruining a good thing in health care,” said Dr. Colleen Kelly, a gastroenterologist at the Brown University medical school.

and

“I never imagined the solution to my nightmare could be so simple,” he said. “I just hope Big Pharma doesn’t make it unaffordable for the people like me.”

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:

• The kibosh (from Controversies in hospital infection prevention)
• Fecal transplants to treat C. diff now need FDA approval
• FDA halts US poop transplants pending further review (Raw Story). 
• FDA: Fecal Transplants Need Investigational New Drug Application ... (JWatch blog)
• Oversight for Fecal Transplants | The Daily Scan | GenomeWeb
• Many Years Young: Fecal Transplant: FDA Wants Regulation
• FDA Declares Stool a Drug -- Not kidding! @ TigerDroppings.com
• Fecal Transplant: FDA Wants Regulation - Digestive Health Center - Everyday Health - EverydayHealth.com

Viruses as food additives

I find it sad that the world has come to this. The FDA announced that it has approved the use of viruses as a food additive. The particular viruses (known as phage in this case) target and kill common bacterial pathogens found in meat. It is entirely possible that this treatment will lead to reduction in deaths and illnesses. However, it is also possible that there will be unexpected consequences of this treatment and thus anything like this should be done with caution. What saddens me about this whole thing is that it is the wrong way to go about solving the problem. Most of the problem comes from the fact that our meat today in this country does not come to us in reasonable condition. The animals are usually kept in unsanitary conditions where diseases and nasty pathogens are prevalent.

The best way to think about this in my opinion is what I read in The Omnivore's Dilemma, the new book by Michael Pollan. In this book he talks about how animals now frequently live in what can be considered the equivalent of the slums of the industrial revolution. Cities of animals, frequently wallowing in excrement, is not the best way to prevent bad microbes from getting in our food.

So in recent years all sorts of practices have been developed to kill these microbes in food products. Irradiation, for example. And now, viruses, sprinkled on your meat, to keep the bacteria from growing too much. Give me meat from animals that have not been swimming in their own shit and piss and I will be happy to take my risks without dumping viruses on top.