Fecal Microbiome Transplants: Growing Success Requires New Ethics And Clear Regulation

Fecal bacteriotherapy or fecal microbiome transplants, have been attracting considerable interest from the medical profession and, perhaps inevitably, the pharmaceutical industry.  

This brings with it questions of regulation – is the product a tissue product or a biologic drug? – and questions of ethics. Just as Richard Titmuss did in relation to blood and blood products, an emerging new therapy needs to be brought under an ethical framework as soon as is practicable and based on a framework that preserves the public good.

Events taking place in the gut are known to play an important role health and disease, in terms of determining the development of metabolic diseases as well as other illnesses, centered on the pathophysiology of gastrointestinal inflammatory diseases. This is in terms of the balance and composition of the intestinal microbiota. In addition, the existence of bidirectional communication between the gut and the brain has been shown to influence both behavior and cognitive function. For these reasons, there is an interest in the gut microbiome and the composition of the gut microbiota. It is also of interest that an imbalance of certain pathogens can be off-set by tilting the balance towards beneficial bacteria. This imbalance is referred to as dysbiosis. This imbalance could be due to the gain or loss of community members or changes in relative abundance of microbes.

To view the article, please see: Fecal Microbiome Transplants: Growing Success Requires New Ethics And Clear Regulation | IVT (ivtnetwork.com)

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)