The empire strikes back

Stung by court orders and new FDA policies aimed at reducing the indiscriminate use of antibiotics in animal feed, the National Beef Cattle Association is mounting an "education" campaign in Congress.

Some 80% of all antibiotics sold in the US are given to livestock. The primary use is not to treat individual sick animals, but to cause them to gain weight more rapidly. Feed antibiotics are given a subtherapeutic levels and appear to alter the gut microbiome in a manner that leads to increased fat accumulation

The NCBAs press release mentions none of this of course. It claims that antibiotics improve animal health and thus protect the food supply - all good stuff. In fact, the opposite is true. The danger of spreading antibiotic resistance through this practice has long been recognized, and the entrance of resistant organisms into the food supply has been confirmed.

It's pretty clear what's going on here. The FDAs guidelines are voluntary because it does not have statutory authority to enforce them without exposing itself to hundreds of appeals from well-funded industry groups. Congress could change this - and that is what the cattlemen are trying to prevent. Presumably they will use the same tactics that are employed by climate-change deniers: throw out a bunch of half-truths and distortions, and then use the resultant confusion to claim that there is a controversy that provides an excuse not to act.

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FDA flexibility with FMT

The FDA issued a statement Monday stating that it will not require filing and review of an IND for Fecal Microbiota Transplant procedures, so long as there is adequate informed consent. The agency still asserts its authority to regulate the procedure, and intends to issue guidance covering this "enforcement discretion".

This seems about right to me - adequate informed consent would be a part of any responsible practitioner's protocol at present anyway, so no one will be denied treatment. In the meantime there is an opportunity to have a conversation about how to ensure the procedure can be made safe and effective and part of the medical mainstream. The worst outcome would be to leave it unregulated and suffer the inevitable disaster that will discredit FMT.

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Stools, fans and glands

There is a fair amount of outrage over the FDAs decision to begin regulating fecal stool transplants.  After all, it is a method that appears to be truly effective  for treating refractory C. difficile infections, which will kill some 14,000 Americans this year. Since the treatment has not been cleared by the FDA, practitioners will have to file an Investigational New Drug application for each study. The time for preparation and approval will be well over a month, meaning that this therapy will effectively become unavailable for acutely ill patients. The frustration that is being felt by patients and doctors is entirely understandable.

But the FDAs position is equally understandable and should result in greater benefit to the patient population in the long run. Fecal transplantation is now practiced by a small cadre of expert physicians and microbiologists who are well-informed and highly motivated to make the procedure work.  But every aspect of the procedure - from making the fecal "cocktail" to testing its safety to administering the dose - is a home brew based on some science, a little bit of experience, and fairly large doses of intuition.

Possibly the optimal conditions for these parameters are so broad and so forgiving that the precise details really don't matter much. That would be great. But we'll never really know until standardized protocols are tested against each other. In the meantime, we are sure to see a lot of jockeying for credit.  After all, there is probably a Nobel Prize at stake here, as there should be for the creators of a treatment that might save many thousands of lives.

 My experience with research scientists is that they tend to have the bitterest fights over the least important details of protocols: when they are all equivalent, the precise choice of procedure is a marker of personal validation, and emotions run high. I expect doctors to be no less insecure and egotistical.

So if the FDA were to do nothing here is what we could expect:

• Dramatic differences in quality of treatment between institutions
• Belated discovery of serious side effects
• Inconclusive and unresolvable controversies over best practices

All this would end up discrediting the procedure for a long time, possibly forever, as confused physicians turn to other, more mainstream alternatives such as fidaxomicin. 

The FDAs actions will undoubtedly deprive some patients of a valuable therapy. But it will keep fecal transplantation from becoming the modern equivalent of goat gland therapy