Blog | Wednesday, June 26, 2013

FDA shoots self in the foot


Last week I blogged about the FDA's ruling to classify human stool as an investigational new drug, making it more difficult for patients with recurrent C. difficile infection to undergo fecal transplantation, an incredibly effective therapy.

I was scheduled to perform a fecal transplant on a patient this morning, but notified her a few weeks ago that we could not proceed because of the new ruling. She asked to keep the appointment with me anyway. She presented to clinic this morning and informed me that she had performed the transplant at home a few days ago. And she was happy to report that she was feeling much better!

As it turns out, I have at least three more patients in the process of preparing for self-administered fecal transplant at home. The instructions for doing so are readily available on the Internet. I suspect this do-it-yourself movement will now become widespread. It's ironic that the attempt by the FDA to regulate this procedure in the interest of safety appears to be driving a completely unregulated and more risky response.

Someone should have reminded the FDA that unlike the usual investigational new drug, which is impossible to obtain outside of a highly regulated and structured mechanism, human stool is readily available, easy to procure, and impossible to regulate. These patients are highly motivated, know the data on effectiveness, and won't be told no!

Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Richmond, Va., with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. This post originally appeared at the blog Controversies in Hospital Infection Prevention.