Shit storm

Clostridium difficile infection is the very divil [prev], not least because they've renamed it Clostridioides difficile. It's more familiar as C.diff because few can pronounce the difficile - me I prefer it as Italian diffíchilleh. It is 'difficult' because very hard to shake if once it takes hold of your gut. Much better not to get it at all but a) people with a healthy gut flora will often harbour manageable quantities of the bad boy b) the most common route of infection is nosocomial - in hospital - where / when your flora has been cleaned out by a regimen of antibiotics to treat some other infectious disease. Then it turns out that C.diff is resistant to every other antibiotic in the hospital's medicine chest.

FMT has been one of the most unexpected, most wonderful, most appropriate technology solutions to the difficile problem. The idea behind fecal microbial transplant FMT is that my intestinal flora - the whole community down there in the dark - is able to keep C.diff in check . . . so what say we throw in the whole microbial black box and see what happens. Miracle happens: within days the symptoms - bloody watery frequent diarrhea, heart racing, abdominal cramping, fever, nausea, loss of appetite - subside and disappear permanently. Nobody knows how it works - and FMT only really works for C.diff  it's no good for bowelly shite like IBD, Crohn's, ulcerative colitis: let alone for depression, autism, multiple sclerosis or Parkinson's. As 10,000 people shit themselves to death from C.diff  each year in the USA alone, it's hard not to like FMT. And since it was given an experimental licence in 2013, some 50,000 people have been treated many of them successfully. Obviously it depends on the quality of the fecal matter and there may well be horses-for-courses compatibility issues. I guess there are sooper poopers out there whose discard is as keenly sought after as Premier Cru Bâtard-Montrachet.

The FDA and EMA, the regulatory authorities in the USA and EU respectively, are deeply ambivalent about FMT. They want to licence any efficacious therapy, yes, but they also want to have quality control and that requires a) purity and b) the vendors knowing what's in their product. Then again, they really want to licence a few commercial [accountable, quality assured, protocol following] products because there are too many people who are doing the transplant themselves in the utility room. They say that all you need is a blender, a sieve, some clean water and a turkey-baster. Yes yes, that same turkey-baster which your lesbian pals used to get pregnant two years ago. And yes yes, they put it through the hottest dish-washer cycle twice.

Now the FDA is reporting a dark lining to this silver cloud with half a dozen cases of people who got sick after FMT. Seems that there have been 2 cases of enteropathogenic E coli (EPEC) infections, while 4 people came down with Shiga toxin–producing E coli (STEC). All the FMT doses involved came from OpenBiome a Massachusetts supplier of quality poop. This is a profitable non-profit turning over €7,250,000 in 2017 - there are six executives on six-figure 'compensation'. That same year they shipped ~10,500 treatments from their stool bank. For the last couple of years, I've been supervising MSc students on our Pharmaceutical Regulatory Affairs [Pharm-Regs] course at The Institute. From reading about and discussing the differences between Europe and America, it seems that the EMA is rather more risk-averse; while the FDA more utilitarian: being prepared to tolerate some shit happening, if the overall benefit is positive. I can't see them closing down the authorised supply-chain because 1/1000 of the products is contaminated with over-aggressive coliforms. The benefits - medical, psychological, economic, social - of having a workable treatment for C. diff outweigh the costs. If the FDA can hold their nerve and OpenBiome can up-grade their screen protocol then these 6 adverse outcomes will fizzle out to a storm in a tea-cup.