The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 16 No. 7 • August 2013


Latest Blockbuster Treatment for Life Threatening Bacterial Infection:
Feces Transplantation!

Recurrent Clostridium difficile infection is reportedly difficult to treat. The responsible bug, an enterocolitis bacteria, recurs after antibiotic treatment in about 25% of patients.1 Those who suffer a recurrence are more likely to have a second recurrence after treatment, with the subsequent recurrence rates surpassing 50%.1

Amazingly, about 50 years ago, doctors tried an infusion of donor feces (fecal microbiota transplantation) for these these life-threatening resistant C. difficile infections and found an “immediate and dramatic” response. Yet it appears the treatment has not won favor with medical practitioners despite what the New England Journal of Medicine calls an “alarming increase in the incidence and severity of this disorder.”1 According to the Journal, only the most desperate patients are likely to want feces transplantation. The reasons for the failure of this treatment to catch on are given in the article as: “it is aesthetically unappealing, it is logistically challenging (in terms of harvesting and processing suitable donor material), and there is a lack of efficacy data from randomized, controlled trials.” The problem of lack of data from randomized, controlled trials has been solved by the publication2 of a clinical trial of the treatment.

The results of the trial2 showed that fecal microbiota transplantation (FMT) was effective in 81% of patients. As the authors of the paper declared, “[t]he results of this study represent a clear precedent in which planned therapeutic manipulation of the human intestinal microbiota can lead to demonstrable, clinically important benefits, thereby bringing FMT to the mainstream of modern, evidence-based medical practice.” The author of the commentary on the clinical trial study1 suggests similar trials of this sort of therapy for other indications, such as inflammatory bowel disease, irritable bowel syndrome, prevention of colorectal carcinoma, and metabolic disorders, as examples. “As such, it heralds the delayed adolescence of a broad and exciting new branch of human therapeutics.”1

The authors of the trial2 noted that patients receiving the feces transplantation had increased fecal bacterial diversity, similar to that in healthy donors, with an increased quantity of Bacteroidetes species and clostridium clusters IV and XIVa and a decrease in Proteobacteria species.

There is something very amusing about this, as one visualizes the source of the therapeutic medicine. And especially nice to see a disorder that was killing people reined in, even by the likes of resident bacteria in shit. Now we wonder how the FDA will generate rules and regulations to make sure the shit is under their control and, hence, very expensive. To start with, note that the shit is regulated by them as a drug (biological).

Shit Wars

The FDA Against Medicinal Poop

Now, however, in a more recent report on feces transplantation published this year in Nature,3 we learn that the FDA has declared feces transplantation to be under its authority and has begun issuing rules that will slow down this development and even risk the lives of critically ill people who will be made to wait for the FDA to decide whether to grant their doctor an Investigative New Drug Application before the doctor can proceed with the treatment (the FDA has 30 days to stop an experiment). In typical FDA fashion, the agency simply decreed its regulatory authority over feces transplantation without waiting for Congress to grant them the authority via statute; hence, the FDA has no legitimate authority over medicinal shit.

The June 20, 2013 GenomeWeb Daily News reports that the FDA’s attempt to take over regulation of feces transplants has run into an outcry by doctors pointing out that seriously ill patients don’t have time to wait for the FDA to grant an Investigative New Drug Application. In response, the FDA is reported to be exercising enforcement discretion (e.g., they are still claiming to be in CONTROL of feces transplantation but will (maybe) not prevent (on a case by case basis) a doctor from performing the procedure, depending on whether the agency bureaucrats feel magnanimous that day or not. The rule of law means nothing when all decisions are made at the discretion of bureaucrats.

There is some good news, however. The article1 points out that, interestingly, “[r]esourceful individuals can [ ] get in on the act at home, by following step-by-step enema instructions from online videos.” The FDA is likely to find it a great deal more difficult to stop the production of how-to-do-it videos, as the First Amendment has the authority (last we heard) over free speech. It might be safer (as well as a lot less messy), however, if people could get the procedure done by a qualified doctor rather than doing it themselves.

One concern is that the fecal material being transplanted is not “standardized” and that there may be considerable variation in their contents. We think that attempting to standardize feces transplants at this point is a mistake because of the limited amount of information on what are the important components (including the probiotics) that produce positive results. More experimentation with different varieties of feces makes sense to us than deciding by decree, in the absence of a lot more experimental data, what would be appropriate in a “standardized” version of feces. One researcher, infection-disease specialist Trevor Van Schooneveld of the University of Nebraska Medical Center in Omaha was reported in the article as having performed about 20 feces transplants since 2011, but in the past few weeks he has had to turn down patients while he submits his Investigative New Drug application. “Van Schooneveld questions whether the agency should preside over an organic, personal substance, rather than a drug. ‘How the FDA plans to regulate human feces is a mystery to me,’ he says.”

We couldn’t agree with Dr. Van Schooneveld more. But the most serious problem of FDA meddling is what happens to people facing a potentially fatal infection and having to wait 30 days while the FDA decides whether it is going to allow their doctors to proceed with a feces transplantation. Is the FDA going to pay for the damages resulting from the delay, including the possible death of the patient? Of course not. Too bad if you die while they are playing games with your brother’s, sister’s, mother’s, or father’s shit. We truly can’t understand how a large majority of the public actually believes that the FDA is protecting the public health!

References

  1. Kelly. Fecal microbiota transplantation - an old therapy comes of age. N Engl J Med. 368(5):474-5 (Jan. 31, 2013).
  2. van Nood et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 368:407-15 (2013).
  3. Mole. FDA gets to grips with faeces. Nature. 498:147 (13 June 2013).

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