Fecal transplantation: Is the FDA full of it?

FDA full of it

If someone said they’ve found a miraculous cure for a deadly infection, and you told them they’re full of crap, you’d probably be right -someone else’s crap, that is. Fecal transplants have emerged as an affordable treatment for Clostridium difficile that works 90% of the times and has negligible side effects. Also known as C-diff, Clostridium difficile is a bacterial infection that affects 500,000 Americans each year and kills 15,000 of them; symptoms include nausea, cramping, and diarrhea. And a fecal transplant is exactly what it sounds like. A doctor takes stool from a healthy person, liquefies it, and drips it into a patient’s colon or pump it into the stomach through a tube inserted into the nose. The healthy bacteria in the donor’s stool helps ward off foreign infections, especially in patients that do not respond to powerful antibiotics.

However, the FDA has shown concern regarding the procedure, because it doesn’t quite mesh with its regular framework, and also because it is worried about the lack of research on possible side effects. The agency has actually stated in writing that stool transplantation "shows promise in treating C. difficile infection that has not been responsive to other therapies;" still at one point it opted for regulating the treatment as an experimental drug. Under that classification, doctors are only allowed to perform transplants after filing an investigational new drug application to be approved by the FDA. The research application must contained very detailed information that may take months and even years to compile. The FDA later backpedaled and it wouldn’t enforce the requirement.

But the damage may have been done nevertheless. Proponents of the procedure argue that the mere looming shadow of the FDA has discouraged healthcare providers from performing, or even recommending fecal transplants. Currently, only fivescore doctors offer stool transplantation, according to the nonprofit Fecal Transplant Foundation. One of them is Dr. Lawrence Brandt of the Montefiore Medical Center in New York, and who has performed more than 200 stool transplants. He says that while the FDA is justifiably concerned, the long-term effects of the procedure are immaterial for patients who are running out of options, and more poignantly, out of time.

In fact, some of these patients aren’t afraid to step in it and take matters into their own hands. That was the case of Catherine Duff, founder of the aforementioned foundation. After unsuccessfully asking three different doctors about a fecal transplant, her gastroenterologist offered to test a sample of her husband’s stool to ensure it wasn’t contaminated. The couple then followed online instructions to create a solution from the sample, mix it with saline, and administered it through an enema. Duff, who made 20-30 trips to the bathroom a day and was a fixture of the hospital due to dehydration, says she felt good enough to go out four out for a walk after the enema. 

Duff knows she was lucky, in particular given the existence of dubious dyi websites, forums and videos. That’s why she set up the Fecal Transplant Foundation to increase awareness and assist patients. Another resource for patients is OpenBiome, a Boston stool bank that reduces the cost of treatment to $250 by screening samples in bulk. A single stool sample screening can cost up to $1,500, which is seldom covered by insurance (late, great writer Gabriel Garcia Marquez once said that the day that stool has any value, the poor will be born without butts; maybe the day has finally come).

Unfortunately, the FDA may put a hamper on that as well. The agency proposed in March that doctors only use stool from ‘known’ donors. If the proposal is accepted, OpenBiome and a few similar establishments that based their operations on anonymous donors would fall by the wayside. However, founder of OpenBiome Mark Smith says he has had productive conversations with FDA regulators, who have actually shown flexibility in their approach. Both the FDA and supporters of fecal transplantation have the best interest of patients in mind.