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The potential for scams seems particularly risky because, thus far, there have been no established guidelines on how to perform fecal transplants, or how to screen donors.
Earlier this year, the Federal Drug Administration issued a letter noting that fecal microbiota falls within the definition of a biological product and drug, and therefore any doctor performing a fecal transplant would need to fill out a lengthy Investigational New Drug (IND) application and wait thirty days for approval. The announcement forced doctors to stop performing the procedure, and the ensuing backlash prompted the FDA to revise its stance. In July, it issued a statement that doctors could continue to perform fecal transplants in cases of severe C. diff, as long as the patient provided informed consent and was made aware of potential risks. A spokesperson from the FDA said trials are currently underway to test the safety and effectiveness of fecal transplants for C. diff.
For now, the question remains of just how fecal transplants will be regulated, and whether the patients who need them most will be able to have access to them.
Between 2001 and 2010, the incidence of C. diff infections nearly doubled, according to data from National Hospital Discharge Surveys. It was during this time, around 2008, that Stollman and three fellow gastroenterologists — Seattle-based Christina Surawicz, New York City-based Lawrence Brandt, and Oklahoma City-based Mark Mellow — started talking about what could be done. Surawicz was the first to suggest fecal transplants as a potential treatment, though she had never performed the procedure herself.
"It seemed weird, strange, and bizarre," Stollman recalled. Surawicz had an especially desperate C. diff patient in the Bay Area and encouraged Stollman to test the treatment on her. "I think I said 'no' at first," he said. "This is not traditional Western medicine, but I'm a traditional doctor." But, realizing the patient had run out of other options, Stollman decided to try it and found success; by 2009, all four doctors were offering the procedure.
"We completely made it up," Stollman said, regarding how they determined the amount of feces required, how to test donors, and how to administer the transplant. "There are no guidelines and there were no studies."
That soon changed. In 2010, Stollman, Surawicz, and Dr. Faith Rohlke introduced the concept in one of the first papers about the procedure, "Fecal Flora Reconstitution for Recurrent Clostridium difficile Infection: Results and Methodology." In 2012, Stollman, Surawicz, Rohlke, Brandt, and Mellow, plus four other doctors, contributed to the more extensive paper "Long-Term Follow-Up of Colonoscopic Fecal Microbiota Transplant for Recurrent Clostridium difficile Infection," which tested 77 patients anywhere from 3 to 68 months after a fecal transplant. It showed that the primary cure rate for C. diff was 91 percent, with none of those patients reporting any new infectious diseases following the treatment. Although four patients developed new disorders, including peripheral neuropathy, Sjögren's syndrome, idiopathic thrombocytopenic purpura, and rheumatoid arthritis, Stollman said there is no way to determine whether the fecal transplants and the immune disorders are connected.
Because the treatment is so new, the American Medical Association still hasn't regulated what doctors can charge for fecal transplants. Stollman only bills his patients for the cost associated with testing a donor's stool sample, which starts at $100, and the colonoscopy that's required of the patient before the procedure, which is about $700. Stollman screens donors for HIV, hepatitis, syphilis, parasites including giardia, and C. diff, which can be dormant in healthy patients.
Kaiser gastroenterologist Theodore Levin said he was skeptical of the treatment at first, but he was also concerned about the many patients he was seeing with recurring C. diff. "It's really hard to get rid of," Levin explained. "These patients are destroyed. People's lives are completely disrupted. They become dependent on the Vancomycin, but as soon as they stop, the symptoms come back with a vengeance."
But without an assigned AMA billing code, Kaiser was hesitant to offer fecal transplants. So Levin, who is friends with Stollman and has closely monitored his success rate, began sending severe C. diff cases his way. "I kept hearing back from patients and I became more convinced it was valuable," Levin said.
As demand for fecal transplants increased, Levin questioned how best to work through hospital policies. Finally, one of Kaiser's infectious disease specialists came to him and said, "Please do this." "That made me go, 'Oh, other people think this is a good idea,'" Levin said.
In June 2012, Kaiser started offering fecal transplants to C. diff patients. Levin said its medical centers in Antioch and Walnut Creek have treated ten patients so far with positive results. "It's striking the impact you can make on their lives, and that becomes a reinforcing factor," Levin said. "One day people are sick and a few days later they are apparently cured."