Direct fecal transplants (or fecal bacteriotherapy), where there is a transfer gut microbiota from healthy donors, have shown great promise in treating a range of diseases. An alternative name for the process is ‘fecal microbiota transplant’. In crude terms, this is the flushing out of ‘bad’ gut microbes and add in beneficial organisms (diseases like ulcerative colitis are partly the product of the disruption in the balance between the good and bad types of bacteria).
Fecal microbiome therapy (FMT) is emerging as a novel, generally safe and efficacious treatment. Most notably success has been with the treatment of recurrent Clostridium difficile infection. Other clinical developments relate to the gut-brain interaction and the possibility of treating some neurodegenerative disorders. Most treatments currently fall under ‘clinical trials’ or are made by the decisions of local medics (the process is not without its side-effects); however, one day a wider-scale application is likely, and probably one that will be commercialized.
The therapy requires a number of important steps to be followed, including donor selection and screening. Much of this takes place at stool banks, which have generally adopted the model of blood banks. In order to maintain high standards, the regulation of the quality and safety of FMT is essential. For this, current human tissue legislation would appear to be optimal, rather than classifying FMT as a pharmaceutical preparation. Under the pharmaceutical system it is easy to foresee specific species becoming patented and used in preparatory synthetic pills, marketed at exorbitant prices. Moreover, pharmaceutical product classification would provide exclusivity to the sector and restrict patients’ access to the therapy outside of drug company-sponsored trials.
That regulation is needed has been spelt out by the U.S. Food and Drug Administration (FDA). A recent warning issued by the FDA highlighted a lack of control around screening for pathogens based on the fact that it is possible to transfer high levels of a different pathogen into a patient. Yet answering the regulatory question also shapes the future definition of the substance and how it is provided to health services.
In considering both the economic model and an ethical framework, the work of the social policy expert Richard Titmuss in the 1970s presents an interesting area of inquiry. In 1970, in response to what he saw as the inefficiencies in free markets for blood banking and blood products, and motivated by concerns as to what might happen in the U.K., Timuss wrote The Gift Relationship. The book expressed his own philosophy of altruism within healthcare and it expressed the values of public service over private social care and healthcare. The influence of the book extended to a review of regulation on the private blood market exchange by Nixon in the U.S. and it closed off any moves to privatise the U.K. blood transfusion service and blood products (the latter until 2012, when the U.K.’s plasma fractionator was sold off at a low price by Cameron’s government).
Drawing on the experience of blood banks, it is best the fecal therapy remains classed as a human tissue rather than a pharmaceutical product and that its development stands under public health systems, with the treatment made available to those who need it either free at the point of need or at minimal cost. If patenting goes ahead in the hands of major corporations, this will be to the detriment of society as a whole.
To fall under tissue regulations, the sample must be a ‘Tissue’ or ‘Cell’ and be intended for ‘Human application’ (under European legislation this is as per the Human Tissue Directive 2004/23/EC. Given that fecal material contains human cells, this definition does not need to be extended by much. Human tissue regulations provide the necessary traceability, quality oversight ( including Good Manufacturing Practices), pharmacovigilance and transparency to the patients, to protect the public and to ensure greater availability of a novel therapy.
