Should the FDA mess with the success of fecal transplants and tighten regulations?
Pseudomembranous colitis (PMC) is a very serious, and potentially life threatening condition for many who received antibiotic, particularly older , hospitalized patients.
In fact, according to the CDC, C. diff infection has become ever more deadly over the past decade with the bacterial toxin implicated in 14,000 deaths in the US annually. Fatalities related to C. diff have increased 400% during the first seven years of the last decade.
PMC is caused by Clostridium difficile, or C. diff, which is a bacteria seen in normally in your intestine where other flora “keeps it in check”. No harm, No foul.
However, the problem is when there is a decrease of normal intestinal flora typically due to the use of antibiotics (the list of antibiotics is quite long). This allows the C. difficile that is normally in check, to flourish and produce some potent toxins that results in diarrhea or the potentially life-threatening PMC.
Treating the C. diff with expensive, potent antibiotics like vancomycin is a mixed bag. Even in people who are treated successfully, pseudomembranous colitis can return weeks to months after treatment has been completed, requiring a second or third round of antibiotics to resolve the condition.
In recent years, a therapy called fecal transplants, where healthy stool, usually from a close relative or member of your household, is homogenized and then inserted into your colon. The donor stool can restore the balance of healthy bacteria in your colon.
The treatment is used in many institutions such as Wake Forest and the Mayo Clinic with great success.
Wake Forest Baptist Medical Center gastroenterologist, Dr Richard Bloomfield, told WXII 12 recently, “people who have had this condition (C. diff), have no problem with something that’s going to get them better. And having seen people this sick with C diff colitis, I have no problem going through this procedure to see them get well.”
In the Jan. 31 issue of the New England Journal of Medicine, researchers from Amsterdam randomly assigned patients with recurrent Clostridium difficile infection to receive one of three therapies: an initial vancomycin regimen (500 mg orally four times per day for 4 days), followed by bowel lavage and subsequent infusion of a solution of donor feces through a nasoduodenal tube; a standard vancomycin regimen (500 mg orally four times per day for 14 days); or a standard vancomycin regimen with bowel lavage.
Researchers showed great success, resolution of diarrhea associated with C. difficile infection without relapse after 10 weeks, with the fecal infusion therapy. 81% of those tested had resolution of C. difficile–associated diarrhea after the first infusion.
This compares very favorably against vancomycin alone (31%) and vancomycin with bowel lavage (23%).
Sound great, right? If you are suffering from this condition, fecal transplantation is a godsend.
Hold up–we need some government regulation!
Yup, you guessed it, the Food and Drug Administration (FDA) has decided that fecal transplants meet the definition of a biologic therapy, thus we need regulation.
During a workshop last month, the FDA said “the efficacy of this intervention has not yet been demonstrated in controlled clinical trials. Such controlled trials are needed to demonstrate the safety and effectiveness of FMT products for C. difficile infection refractory to conventional therapy.
“Clinical studies to evaluate the safety and efficacy of FMT are regulated by FDA. FDA’s primary objectives in reviewing an investigational new drug application are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phases 2 and 3, to help insure that the quality of the scientific evaluation of the product is adequate to permit an evaluation of safety and effectiveness. In addition, the complex nature of FMT products presents specific scientific and regulatory challenges. ”
“According to current federal law, a product intended for such use(s) would be an Investigational New Drug for which an Investigational New Drug application (IND) must be submitted,” FDA spokesperson Curtis Allen stated by email. “An IND is intended to assure that subjects are not exposed to unreasonable risks.”
Under these guidelines, doctors must submit a lengthy application to the FDA before administering any fecal transplant, including a detailed medical analysis of both the patient and donor. Upon completing the process, physicians must wait up to 30 days to receive the FDA’s green light.
Although the FDA has not issued a formal rule, researchers and healthcare professionals performing fecal transplants have been told they need to file an Investigational New Drug (IND) application and receive approval before performing the procedure.
This has not pleased many who swear by the procedure.
Lawrence J. Brandt, MD, professor of medicine and surgery, Albert Einstein College of Medicine, New York City and emeritus chief, Division of Gastroenterology, Montefiore Medical Center, New York City,said, “I have the greatest respect for the FDA and for the responsibility it has to protect the population against injury from inappropriate and unsafe products. I do think, however, that the restrictions placed on FMT in the treatment of recurrent Clostridium difficile infection are unduly restrictive”, Pharmacy Practice News reported.
In addition he said that thousands of FMT cases have been presented in various formats, with “an acknowledged serious adverse event frequency of close to zero.”
Dr. Brandt continued: “I do agree with the FDA that FMT therapy should be restricted to Clostridium difficile infection, with use of a standard protocol for testing the recipient and donor and administering the transplant. I also believe that the results of every FMT should be entered into a central registry where the data can be periodically reviewed. … Paperwork for the registry should be minimal so it doesn’t place an administrative burden on the already overworked physician.”
Is this excessive burden and regulation on a well proven therapy and is it really necessary? or,
Is the FDA doing their job in good faith to protect the public health?
For more infectious disease news and information, visit and “like” the Infectious Disease News Facebook page