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