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Controversy intensifies over fecal transplantation

A paper published on February 19 in the journal Nature which requested that the fecal transplants should be regulated as a tissue, such as a blood donation
A paper published on February 19 in the journal Nature which requested that the fecal transplants should be regulated as a tissue, such as a blood donation
Robin Wulffson, M.D.

Although it sounds gross, fecal transplantation has been successful for treating certain intestinal infections, including Clostridium difficile, which is a bacterium that can cause a severe, difficult to treat intestinal infection that can result in death. However, the Food and Drug Administration (FDA) has imposed strict regulations on the procedure and deemed it to be a drug treatment. The move made it more difficult for patients to receive fecal transplants. Researchers at the Massachusetts Institute of Technology (MIT) and Brown University published a paper on February 19 in the journal Nature, which requested that the transplants should be regulated as a tissue, such as a blood donation.

The researchers argued that the new regulations are likely to promote an underground market for the transplants. In addition, they stressed that further research is needed on the long-term effects of fecal transplants. They noted that regulating fecal transplants as a tissue is likely to facilitate improved research on their possible uses in treatments, while protecting patients from harm. Fecal transplants have been tested since the 1958; in January 2013, a clinical trial published in The New England Journal of Medicine reported a strong benefit for patients who suffered from recurrent C. difficile infections, which kills 14,000 people every year in the US. Following the report, however, some physicians began offering fecal transplants for other conditions, including those for which any potential benefit remains unproven. As a result, the FDA took action in May 2013 and classified the treatment as a drug. This classification requires physicians to submit an arduous Investigational New Drug (IND) application before performing a fecal transfusion.

At a public meeting hosted in May 2013 by the FDA and the US National Institutes of Health (NIH), patients, physicians and representatives of the Centers for Disease Control and Prevention (CDC) and several professional medical societies expressed concern regarding restricting access to care for these increasingly prevalent intestinal infections. Six weeks later, the FDA revised its position and decided, for the time being, not to enforce the IND requirement for recurrent C. difficile infections. The study authors note that this compassionate exception is now empowering many individuals to receive care. However, they stress that the long-term status of fecal transplantation for C. difficile infection is unresolved; thus, regulatory policy is complicating research into the exploration of fecal transfusions for other conditions, such as inflammatory bowel diseases or obesity.

The authors note that if and when the therapeutic potential of fecal transfusions comes to fruition will depend on how the FDA and other agencies regulate the use of fecal material. Treating it as a drug creates strict requirements to protect patients; however, it limits access to care. They contend that reclassifying feces as a tissue product or giving it its own classification (as the FDA does for blood) would keep patients safe, ensure broad access, and facilitate research.

In regard to risks of fecal transfusion, the authors note that few human studies have followed patients prospectively to assess for future adverse outcomes. Transitory abdominal discomfort and bloating have been reported after fecal transfusion; however, data on long-term safety is currently not available. In addition, there are real risks that transplanting fecal material can spread infectious diseases such as HIV or hepatitis. To date, no incidents have occurred with fecal transplantation; however, in the 1970s and 1980s, before today's strict blood-donation regulations were introduced, thousands of individuals with hemophilia in the US were infected with HIV from contaminated blood products. The authors note that there are also theoretical hazards that fecal transfusion could change the microbiome (bacterial makeup of the intestines); thus, making individuals more susceptible to chronic conditions such as obesity or autoimmune disorders.

The authors note that the aforementioned risks can be minimized by mandating rigorous screening. They cautioned, however, that overly restrictive rules might encourage individuals to seek treatment outside the medical establishment. Instructions for do-it-yourself fecal transplants are available online. Videos have been posted on YouTube with tens of thousands of views; in addition, books are available that advocate at-home procedures using stool from acquaintances or family members.

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