The FDA is Regulating Human Poop? What Gives?
A recent report in Scientific American may raise a few eyebrows. It’s all about the FDA’s efforts to regulate and standardize a “drug” almost nobody wants to be prescribed: fecal transplants. And yes, they’re exactly what they sound like.
If you’ve never heard of a fecal transplant before (and even if you have), it sounds pretty surreal. Basically, the transplants are a way to treat people with severe, antibiotic-resistant intestinal infections — in particular, a bug called Clostridium difficile, which kills an estimated 14,000 people in the U.S. every year. The transplants work, too, eliminating up to 92% of recurring C. difficile infections which don’t respond to antibiotics. Usually a single treatment is enough to eradicate the illness completely.
So how does this treatment actually work? Our guts are filled with trillions of helpful bacteria, which help digest food and fight off infection. But when a health condition or a medication wipes out the “good” bacteria, sometimes people are left only with dangerous bacteria in their guts. Those bacteria gain a foothold and start wreaking havoc on the body. Antibiotics may only make the situation worse by wiping out beneficial bacteria that might fight off C. difficile. When stool from a healthy person is transplanted into the body, it allows the guts to become colonized with friendly bacteria once again.
It may be gross, but it turns out the most shocking thing about fecal transplants isn’t the treatment itself. It’s that until recently, there’s been no government regulation of this extreme treatment. In fact, doctors can’t even agree how a transplant should be performed –they’re still debating storage methods and how “fresh” the samples need to be to cure infections. The lack of regulation gets scary when you realize there aren’t always adequate screening measures in place to prevent the possible transmission of new diseases to the already-sick patient.
That’s all changing after a public workshop at the US National Institutes of Health last month. The FDA announced it’s going to regulate feces like a drug — and that doctors performing transplants from here on out must submit an Investigative New Drug application detailing their methods. The added paperwork is just the first step, they say, in ensuring that the treatment is actually safe. Over time, they hope to develop a standard treatment protocol.
Some doctors aren’t too happy about the shift. Dr. Michael Edmond, a doctor of internal medicine at Virginia Commonwealth University, has been particularly outspoken about the crackdown. In an interview with The Verge, he explained why he no longer offers the procedure:
“It’s really burdensome, it’s just an enormous amount of time to invest,” Edmond tells The Verge, noting that fecal transplants are time-intensive in their own right, and often result in comparatively small reimbursements for physicians. If he were to perform them now, he would have to get approval not only from the FDA, but from his own institution as well, adding even more paperwork and hours to every case.
“I feel bad about it because I of course want to help the patients, but it just got to a point where I couldn’t really justify the time,” he says. “You can only do what you can do.”
In the meantime, because of the high cost and the regulatory hurdles, some are predicting that fecal transplants are actually going to be driven underground. Already online communities are popping up offering DIY instructions for desperate disease sufferers. If the concern is the spread of disease and lack of screening donors for parasites and diseases, home transplants aren’t likely to make matters better.
In the end, the best treatment may end up being a synthetic version of the real thing. Enterprising doctors like Elaine Petrof are working on synthetic stools that pose fewer potential health risks by culturing bacteria from healthy people and mixing them in the correct proportions for effective treatment. And maybe once the “gross” factor is removed, more doctors will be willing to try the treatment when antibiotics fail.
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