Clostridium difficile is a dangerous infection that, as its name implies, is not always easy to treat successfully with antibiotics. In many cases, the infection is actually triggered by antibiotic use during hospitalization; the medications kill beneficial bacteria that keep C. difficile in check.
Now, some doctors are treating the infection with a procedure called fecal transplant, an unappealing but extremely effective approach that involves transferring filtered stool from a healthy donor to a patient afflicted with the disease, to reintroduce the helpful gut bacteria. One randomized trial comparing fecal transplant with antibiotics was stopped early because the non-drug approach was so effective that it would have been unethical to continue treating the other patients with medication. Subsequent studies have placed the cure rate at about 90%; a doctor from Mayo Clinic in Arizona describes a hospital patient who had been bedridden for weeks with C. difficile being discharged within 24 hours of fecal transplant.
Last year, the FDA, concerned about how swiftly the practice was taking hold without oversight, announced that it considered donor feces an “investigational new drug,” which meant an application would have to be filed every time a doctor wanted to perform the procedure. The intent was to ensure the treatment’s safety, but the time and trouble involved would have delayed treatment for very sick patients and might have discouraged some doctors from offering the transplant at all. In addition, the label didn’t fit: Drugs are manufactured in factories where every aspect of their production can be standardized so that one pill is exactly like another. Stool is made by the human body and obviously isn’t going to be all that standardized. Doctors, medical societies and the Centers for Disease Control and Prevention protested, and weeks later, the FDA withdrew from its earlier position.
Since then, though, fecal transplants have been in a regulatory gray area. The procedure is still being performed, but there are no real safety and oversight rules. Yet without agency regulation, how can it become an approved, standard therapy with accepted protocols? In addition, researchers would like to try the therapy as a possible treatment for other ailments such as inflammatory bowel disease, but the path toward experimental approval is unclear.
A group of scientists, writing in the journal Nature, proposed a solution the FDA should seriously consider: Define feces as human tissue, similar to blood or organs donated for transplant. Tissues must be tested to prevent the spread of disease, and careful records must be kept. Fecal transplant shouldn’t be stigmatized as a semi-rogue procedure without strict safety rules; at the same time, the rules should be a good fit for this remarkably helpful treatment.