DRS. OZ AND REZLAN: Fecal transplantation and the FDA
Q: My 78-year-old father developed drug-resistant C. diff and almost died from diarrhea and dehydration. He received a stool transplant from his nephew, and it cleared up the condition quickly! So why is the Food and Drug Administration trying to restrict the use of it? I thought it was an accepted treatment. Can you explain? -- Sally P., Richmond, Va.
A: About 80 percent of people in the U.S. who battle chronic diarrhea and other problems caused by a Clostridium difficile bacterial infection are over age 65 -- and often have been on antibiotics. C. diff can exist naturally in the gut, but taking antibiotics kills off other gut-dwelling bacteria that keep it in check. The result: The bad bacteria flourishes and causes chronic bouts of potentially lethal gastrointestinal distress. We know that fecal-microbiota-transplantation (FMT) -- transferring someone else's bacteria-rich stool into your digestive tract -- can cure the infection 90 percent of the time. (There is some evidence FMT is also effective against ulcerative colitis and Crohn's disease, and some docs use it as a first-line treatment.)
But this past February, the FDA decided FMT should be regulated as a biologic drug and doctors needed to apply for an investigational new drug (IND) application before performing the procedure. This triggered a huge outcry from doctors and patients. As a result, the FDA reversed the decision, now allowing FMT to be used to treat C. diff without applying for an IND.
What the FDA had wanted to accomplish was a way to more carefully monitor the procedure and make sure that FMTs are safe and effective. While there are currently guidelines that call for screening of donors and donor stools for parasites, HIV, hepatitis, etc., more study is needed. So anyone considering FMT should make sure the doctor (and only a doctor) performing the procedure has experience doing it and follows the guidelines. And by the way, at least two drug companies are developing capsules of FMT's that can be as easily and safely used as probiotics, but we expect we're several years from that.
Q: I just got my annual mammogram and have been diagnosed with in situ ductal carcinoma, which freaked me out. Now I read it shouldn't be called cancer at all, and it might be smarter to do nothing about it. I'm confused. -- K. Collins, Edison, N.J.
A: New recommendations by a National Cancer Institute task force say certain conditions now identified as "cancer" should not be, because they're non-cancerous, precancerous or are slow-growing and won't be fatal. Their report specifically mentions ductal carcinoma and high-grade prostatic intraepithelial neoplasia (a potential precursor to prostate cancer). It says removing the words "carcinoma" and "neoplasia" from these diagnoses will reduce the number of unnecessary biopsies and avoid overtreatment with radiation, chemotherapy and surgery. The NCI wants these conditions to be called "indolent lesions of epithelial origin" or IDLE (we kid you not) and to be treated by close monitoring and minimally invasive procedures.
How did we get to this point? Research shows in the past decade, mammograms have led to the overdiagnosis of more than 1 million women who were then subjected to unnecessary and potentially harmful treatments. But backing off on screenings and deciding to NOT treat potentially dangerous conditions isn't an easy decision to make. It's estimated that for every three overdiagnoses of breast cancer, one life is saved! And screening for colon and cervical cancer is very beneficial: It allows for early detection and removal of precancerous polyps and lesions. This has reduced the incidence of colon and cervical cancer, and we see a lot fewer cases of late-stage disease.
So talk with your doctor about how your in situ lesion will be monitored and what tools will be used. Also, find out what you should look for that might signal the need for a more aggressive approach. And if you feel like you're ready to take stronger action, speak up. It's your body and your life.