Recently the FDA issued vague and unclear ruling on regulating fecal transplants. When I first saw this I was quite enraged, upset, however not too surprised. On May 2-3, 2013 the FDA held a conference which was preceded by this letter in Bethesda, MD to talk to doctors who were performing fecal transplants. The FDA is now requiring an IND and treating fecal transplant as a biologic which has pushed back fecal transplant for nearly everyone by 2 months. In reality it will take 2 months for the FDA just to get around to this subject let alone do anything about it. If 14,000 people die from c difficile every year that would say that the FDA will contribute to the death of over 2,000 people.
What is quite interesting is that fecal transplants have been performed since 1958 yet I have never heard of any serious adverse affects or deaths. According to a 2011 ACG meeting about 5% of patients who received fecal transplants also contracted an autoimmune disease after they got the fecal transplant. However it is hard to say if it was from the fecal transplant or something else. It is important to remember that people do actually die from c difficile. In fact the New England Journal article from this January showed that 94% of patients were cured of c difficile compared to the only 31% who received vancyomycin. Even the people running the study said it was unethical to not give the patients fecal transplants.
Dr. Mike Edmond might be the only doctor with some sense on this matter. Basically from the way he explains it doctors will have to apply for an IND number (doctors have to submit their protocol). Then maybe 30 days after the FDA gets the information they will let the doctors know if they can proceed. The FDA won’t even let doctors know what they are looking for.
Just how incompetent is the FDA? Here we have a treatment that cures 80%-90% who have a life threatening illnesses with the only existing therapies being antibiotics such as Dificid and Vancyomycin which can costs thousands of dollars while the fecal transplant is much cheaper. Thousands of fecal transplants have been performed as well. However there never seems to be enough data for the FDA. Perhaps the FDA is incapable of performing a cost/benefit analysis. Actually the most expensive part of the fecal transplant is testing the donor’s stool. However, since the FDA has not approved fecal transplants insurance companies won’t cover it.
The result of the new FDA ruling on fecal transplant will cause more paperwork for doctors, more bureaucracy, more patients having to suffer, and more people dying because the FDA doesn’t seem to think anything is safe enough.