FMTs (otherwise known as poo) to be treated as a drug

Over the past several years there has been a growing interest in Fecal Microbiota Transplantation – the ‘transplantation’ of healthy-bacteria-filled faeces from a well person’s gut  into the guts of those suffering from a range of inflammatory digestive and bowel conditions whose bowel flora have been depleted by their illness. The idea is that the transplanted healthy bacteria colonise the gut, control the inflammation and return all to good working order.

Despite the inevitable ‘eugh!!!’ reaction of many, the treatment does seem to have a good success rate not only in the treatment of inflammatory conditions such as Ulcerative Colitis  or Crohn’s disease, but (of more immediate interest to health authorities) in controlling bacterial infections such as Clostridium Difficile. (See  the various reports collected for us by John Scott here on the FoodsMatter FMT pages.)

But while the outcome of successful transplantation may be good, there are quite reasonable concerns over using faeces, so often the carrier of deadly diseases, as a therapeutic treatment. So it is quite right that the health authorities should take an active interest in what is going on and look to establish controls and standards. But that does not appear to be what is happening – well, in the US anyhow.

According to a letter to the American Gastroenterological Association from the FDA’s Public Health Service in April this year, the FDA proposes that, instead of regulating FMT to ensure that it is properly and hygienically delivered, they will treat it as a drug, ‘for which  an Investigational New Drug (IND) application must be submitted’. A lengthy and immensely costly procedure which would prevent any therapeutic use of faeces until approval had been granted. Now, I wonder why that might be?…..

The pharmaceutical industry has been struggling for some years to come up with new ‘miracle’ drugs, so the microbiome, the trillions of micro-organisms that live in the human body and keep us functioning, is a fertile field of research for them. If they can isolate the bacteria relevant to, say, Clostridium difficile or Ulcerative Colitis, they can patent it and sell it. But if wholesale faecal transplants (which belong to no-one apart from the donor and are not patentable) are allowed to go ahead, and prove successful, then what role for the drug companies? (Take a look at this press release from Second Genome to see where they are going with this research.)

All other considerations aside, the microbiome is staggeringly complex and we, as yet, understand relatively little about it – and even less about the synergistic relationship that its trillions of inhabitants may have with each other. While transplanting the whole population of a health gut, intact, may indeed regenerate the microbiome of an unhealthy gut, we have virtually no idea what effect isolating tiny fractions of that microbiome and applying them selectively may have.

The result of the FDA’s attempt to ‘pharmaeuticalise’ FMT will be that its delivery remains unregulated and open to exploitation as sufferers from the many conditions that appear to benefit from FMT take to the internet to find treatments that they cannot access via their physicians. Scarcely a situation to be desired by anyone.