March 29, 2017

FDA places restrictions on Fecal Transplants

The Food and Drug Administration, the FDA has designated fecal transplant as a biologic drug, meaning that any gastroenterologist performing fecal microbiota transplants needs to obtain an Investigational New Drug permit first before performing the procedure. This is unfortunate because very few doctor currently perform the procedure at all. When they do, fecal microbiota transplants can be done safely and effectively. The problem with putting restrictions on these procedures is that patients are suffering and even dying of complications from Clostridium Difficile bacteria infection. This happened to the father of a good friend of mine just three months ago. Other patients are suffering from chronic diarrhea that has resisted multiple rounds of anti-biotics to the point where they can’t work and are afraid to leave the house for fear of soiling themselves.

Still others like myself suffered for years from Ulcerative Colitis to the point where we were on the verge of surgery to remove the entire colon. Removal of the colon results in having a pouch on the outside of the stomach which has to be emptied 5-6 times day unless there are complications like infections or obstructions of the small intestine. The other alternative often involves a second or even third surgery to attach an internal reservoir, also known as a j-pouch to collect feces, which the person can expel as a bowel movement 5 – 6 times a day.

While fecal transplant may seem new to some due to recent media attention, they have been performed safely in the past as well. This includes this article which tells the story of
fecal microbiota transplants performed in the 1950s The basic procedure of taking fecal matter from a healthy patient and administering it to a person with digestive disease through an enema, gelatin capsules or even a nasal gastric tube is a simple enough process. In some respects it is similar to a blood transfusion, in which you use a donor’s red blood cells to seed the growth of new red blood cells in the body of the recipient patient

It is understandable that the FDA wants to research how this procedure works. It also makes sense to protect the health of patients by making sure established best practices are used. However the consequences of restricting the ability of doctors to properly treat patients without added layers of paperwork also presents risks. The risks include patients with little medical experience doing the procedures at home who have not properly researched how to deal do this or who cannot order tests or prescription drugs which can help the effectiveness of fecal transplants.

In my book I outline how to do fecal transplants at home. While I would have preferred to work with a doctor, and almost did, the process is cumbersome and many doctors do not want to do this procedure because of obstacles put in place by hospitals and government regulations. In the meantime this procedure can be done at home with proper guidance.

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