Thursday, February 20, 2014

The feds are overregulating poop

Clostridium dificile bacteria is a minor normal component of your gut flora but when antibiotics kill the rest of your normal balanced population, out of control C diff is nasty problem to have. You can even die of it. It kills about 14,000 people in the US and 110,000 globally every year and the trend is going up.

Medically we've found a way to cure the problem and for once, it's a relatively cheap, if disgusting to contemplate, fix. It's called a fecal matter transplant (FMT) and it is exactly what it sounds like. You get a stool sample from a volunteer, make sure that their sample isn't going to make you sicker because they have a disease, parasite, or infection (CPT 44705 costing $500-$1500) and then get a GI guy to insert the sample from either end depending on where the problematic infection is. A colonoscopy is covered by multiple codes and can run from $740 to $8,500. That's an absurdly large variation but it's pretty clear that cash patients will not be going to the more expensive doctors. Whether a colonoscopy is even necessary or a simple enema is sufficient is under investigation.

Compared to surgery that yanks out sections of your colon, the major alternative when things go really bad with this sort of infection, this is getting off light. And even at the beginning phase, the transplant option outperforms vancomycin 94% to 27%. A study comparing the two options was terminated early because it was considered unethical to keep half the study population on the antibiotic.

The cash price for the "low dose" variant of 125mg vancomycin 4 times a day for 10 days is approximately $1000 to $1700 and for the "high dose" variant of 500mg 4/10 is $3900-$4300 so the cost of transplants is competitive.

Unfortunately, the FDA has decided to regulate poop as medicine instead of as a transplant. More specifically, everybody was going to have to go through a month long process of getting each FMT individually approved through the Investigational New Drug (IND) process but the benefits of FMT were so obvious over alternative therapies in the case of c-diff that for that purpose and only that purpose, the process is virtually unregulated. For everything else, the IND process rules and people are actually going the DIY route with poop slurry enemas because of a lack of doctors willing to go through the hassle and expense to go through the IND paperwork hoops.

This is politicizing medicine which is a lot more disgusting that poop transplants. The IND process shouldn't be used for something that isn't a drug. People are suffering and even dying because this area of medicine is being held up by paperwork.