According to a story from The Indian Express, doctors and drug developers are at a crossroads over an innovative form of therapy called fecal microbiota transplants. These transplants are essentially fecal matter from a healthy donor that is transplanted into the bowel of a sick patient to restore normal gut function. While fecal microbiota transplants have the potential to treat a number of diseases affecting the digestive tract and beyond, such as diabetes and even cancer, they have proven remarkably effective in treating Clostridioides difficile infections.
The controversy surrounding this therapy is how it should be regarded and regulated in the medical field. Drug companies want to classify fecal microbiota transplants as a drug that can be marketed and sold. Meanwhile, doctors are more inclined to regard fecal transplant as more similar blood products or tissue/organs that are merely transplanted from a healthy person to aid a sick one.
The decision will ultimately lie with the US Food and Drug Administration (FDA). The agency has consistently grown closer to the pharma industry in recent decades. The latest statement made by the agency was in 2013 when it was announced that the FDA would regulate fecal microbiota transplant as a drug. However, this was issued with the caveat that the agency would continue to study the matter before a final decision was made.
At this juncture, many patients who need fecal microbiota transplants rely on a nonprofit stool bank called OpenBiome located in Cambridge. Critics of the concept of regulating fecal transplants as a drug say that it is merely another opportunity for corporate profiteers to get in the way of adequate treatment access. In addition, they also claim that this approach is based on obsolete science.
Catherine Duff, who founded the Fecal Transplant Foundation, shares the concerns of critics who are worried about access:
“People have good reason to worry because for many patients, faecal transplants are a matter of life and death.”
Some researchers also say that these decisions could determine the future of microbiota based treatment; new research has revealed the critical importance of the human microbiome for overall health and immune system function. The FDA is expected to make a decision soon.
Drug company reps have also been pressuring the FDA. They argue that the drug model is essential for ensuring effectiveness and safety of fecal transplants. They also advocate to refining the process of treatment so that person-to-person transplant is not necessary; this would also further the argument to regulate fecal microbiota as drug instead of an organ transplant or blood product.
Perhaps the best approach is an all-new regulatory category altogether that reflects the unique capabilities and characteristics of fecal microbiota transplants.