For patients suffering from C. difficile colitis—a stubbornly persistant severe bowel inflammation that often evades conventional treatment—a stool transplant from a family member, friend or even doctor can often fix the problem. Over the past several years, an increasing number of patients have found relief through fecal transplants, which involves an injection of sterile communities of gut microbes from another person—not actual feces. Patients undergoing such procedures have seen seemingly miraculous results. Some trials show that up to 94 percent of patients’ C. difficile infections clear up following a transplant.

But now, as Scientific American writes, “the sh*t has hit the fan.” The Food and Drug Administration has caught a whiff of the controversial new treatment and has declared fecal transplants as a biologic therapy, meaning any doctor who wants to use it will have to file an investigational new drug application. For patients, this means more paperwork, a longer wait for treatment and a potential application rejection from the FDA.

This isn’t exactly welcome news for doctors, either. Judy Stone, an infectious disease specialist, further delves into the issue in SciAm:

Yes, there are many questions involving FMT that do warrant further study. For example, what is the best diluent for the stool? Saline or water or milk or other? What is the most efficacious route of administration—colonoscopy vs enema vs nasoduodenal tube?

However, she writes, fecal transplants do display better efficacy in patients than many other treatments—some already approved by the FDA, others not—which also tend to cost more and may cause serious side effects.

I think it is reasonable for the FDA to provide guidance and to try to collect data in some standardized format so that we can learn more about best approaches. My understanding is that individual physicians will have to develop and submit their own plan for treatment—which is both burdensome and will not result in any generalizable conclusions. While the FDA says that in emergencies, physicians can seek urgent approval, rather than wait for a 30 day turnaround time on their IND submission, in practical terms, this isn’t going to happen.

On MedPageToday, infectious disease expert William Schaffner at Vanderbilt University, predicted that the new regulation would significantly increase cost to researchers (though he could not put a number on that figure). Michael Edmond, a physician at Virginia Commonwealth University, complains on his blog Controversies in Hospital Infection Prevention:

Over the past several days I have spent a lot of time talking to patients, trying to explain why I’ve had to cancel their upcoming fecal transplant. So now I must apply for an IND number, which requires that I send the FDA my protocol. On the 30th day after receipt of my documents the FDA will let me know whether I can proceed. When I talked to the FDA officer yesterday she informed me that the FDA is only interested in fecal transplants with regards to safety. They want to ensure that donors are appropriately screened. Thus, I need to send them my protocol for donor testing and then I will get a ruling. I asked the officer what the FDA was looking for and was told that they can’t say but will either approve or not approve my protocol. Now wouldn’t it have made more sense for the FDA to review the literature and consult experts about what optimal testing of donors and safeguards should be for the procedure and simply require practitioners to follow their guideline instead of the guess-what-I’m-thinking-and-wait-30-days game?

Other doctors are put out, but more understanding of the FDA’s decision. MedPageToday writes:

Herbert DuPont, MD, of the University of Texas Medical Center in Houston, who is gearing up for a major fecal transplantation program there, said he already had his protocol approved by the center’s Institutional Review Board (IRB). “Am I disappointed? Yes,” DuPont told MedPage Today. “Do I have problems with the outcome? Absolutely not.” DuPont, who also attended the hearing, said he understood the FDA’s concerns about needing to set standards for safety and efficacy with procedures such as fecal transplant.

Dr. Stone suggests instead that the FDA clinicians to pursue the treatment in certain patients who qualify, and exclude them from the lengthy approval process. Otherwise, just like so-called worm therapy, or deliberate infection with parasitic worms to treat diseases ranging from asthma to Crohn’s disease to multiple sclerosis, patients may try to perform the procedure at home and a blackmarket may even emerge for fecal transplants. So, while law-abiding patients suffer in the hospital from C. difficile infections, others will try to perform their own DIY fecal transplants at home, which will likely cause additional health and safety issues when things in the bathroom go awry.

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