Citing potential disclosure requirements from the Food and Drug Administration, lack of insurance coverage and lack of support among clinicians, the founders of stool-donation initiative, OpenBiome, say the organization's efforts to treat Clostridium difficile through fecal transplants may be short-lived, in a report from WBUR.
Fecal transplants are effective for ridding patients of C. diff infections in nearly nine of 10 cases, according to recent research quoted in the report.
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The FDA has recently released a draft of fecal transplant guidelines requiring either the patient or physician to personally know stool donors for the procedure to be performed. OpenBiome operates on a system where donors give anonymous gifts. This could mean the bank could be out of business or scrambling to reconfigure its business model, if the guidelines pass.
Without a stool bank, the future of the procedure could be in jeopardy, since the nature of stool donation – the timing, sanitation risks and lack of regulations involved – haven't made it a very popular one with physicians or hospitals, according to the report. Parts of the procedure, such as screening stool donors for pathogens, aren't covered by insurance, as donors are healthy individuals. The screening alone can cost around $1,000 out-of-pocket, according to the report.
OpenBiome has recently come out with a fecal donation pill, which, barring delays in the approval process, will be in patient trials some time during 2014.
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