Here at Jezebel dot com, we’ve been closely following the development of fecal transplants as a treatment for a variety of digestive ailments. Poop as a miracle cure! What’s not to like? However, it’s turning into a massive headache for the Food and Drug Administration.
The AP reports on the FDA’s struggle to figure out what the hell to do about poop. See, fecal transplants show tremendous promise, especially for treating brutal, recurring C. diff infections (even the drug-resistant variety). “We’re dealing with something that is pretty close to miraculous,” according to one doc who’s performed several transplants.
But the FDA’s policies weren’t exactly created with this sort of thing in mind. The procedure is currently being treated as an experimental drug, which generally means it’s a no-no without getting the agency’s sign-off for research. And the FDA isn’t talking out of its butt; we are dealing with human excrement, here. Nobody knows what the long-term side effects might be, and a patient could catch all kinds of nasties without proper screening.
Then again, patients with recurring C. diff infections are often desperately ill and frantic for any possible treatment, even if it means going D.I.Y.:
Regulating stool samples as a drug presents other challenges. While it’s easy to limit access to experimental drugs, everyone has access to stool. And with detailed instructions available on websites like thepowerofpoop.com, there’s nothing to stop patients from trying the procedure at home – especially if they can’t find a doctor to perform it.
“Some of these patients are very desperate and they’re not going to take no for an answer,” says Dr. Michael Edmond of Virginia Commonwealth University, who has performed fecal transplants for patients who travel from as far away as Ohio.
Which puts the FDA in a tough spot. Requiring years of clinical trials and mountains of paperwork may well just push more despairing patients to just give it a go unsupervised. So the FDA made an exception for docs dealing with C. diff sufferers. Which is great, but even MORE confusing for anyone considering performing one:
Duff says the unresolved status of FDA’s oversight discourages more doctors from offering the treatment. “There are so many doctors who are suspicious that the FDA could change their mind at any given moment and decide to not exercise discretion,” Duff says.
But it sounds like the FDA is at least making a good-faith effort at responsiveness, here, so all the best as the agency attempts to get its arms around poop. Give the people what they want!
Photo via LI CHAOSHU/Shutterstock.