Lentis/Medicine and Disgust

This chapter examines the social interface of medical therapies where disgust can undermine technical effectiveness.

Case Study: Fecal Microbiota Transplants

The Clostridium difficile Infection

Clostridium difficile (C. diff) is a pathogen best known to cause antibiotic-associated diarrhea by disruption of a patient’s colonic flora content after antibiotic use. The infection’s prevalence is high in hospitals, with an incidence range from 0.5 to 30 cases per 1000 discharges. The immediate area surrounding an affected patient becomes highly contaminated with C. diff spores, which may spread the infection. In 2010, the incidence of C. diff was approximated at 500,000 cases per year with mortality rates as high as 20,000 cases per year in the United States.

Symptoms of C. diff include mild diarrhea to live-threatening colitis. Its primary treatment method is with further antibiotic treatment, however the infection has been rising in incidence, gaining antibiotic resistance, and becoming increasingly difficult to treat.

Fecal Microbiota Transplants, an alternative treatment

Fecal microbiota transplantation (FMT) is a method of injecting a donor stool sample into a patient suffering from C. diff in order to replenish the patient’s flora content and eliminate the infection. There is not a clear methodology for FMT, but the general preparation is completed in the hospital. A donor stool sample is taken and combined with a fluid (e.g. water or saline solution) and then lightly blended to create a homogeneous fluid mixture. The amount of fluid combined and blending time are decided on a case to case basis determined by the consistency of the donor stool sample. The blending of stool often releases terrible fumes which add to the already "gross" nature of handling another person's stool. The mixture is then filtered and divided into appropriate volumes for delivery. There is not a current consensus to the most appropriate form of FMT delivery, but current methods include: colonoscope insertion of FMT to the proximal colon, FMT delivery into the distal lower GI tract using a rectal enema, and FMT administration to the upper GI tract through the use of a nasogastric tube.

History of Feces as a Therapeutic

Fecal microbiota transplants are a subset of a larger group of treatments classified as gut flora repopulation. One of the first recorded instances of gut repopulation therapy in modern history is the discovery of Bacillus subtilis as a cure for dysentery. During World War II, Nazi German forces that were engaged with British forces in Africa were experiencing high mortality rates from dysentery. The Germans knew the disease was caused by contaminated food and water but they had no cure for the symptoms. Upon observation of the native Bedouins, who were not dying at the same rate as the German soldiers, they realized that the native Bedouins also contracted dysentery. The Bedouins, however, proceeded to consume fresh camel dung and were subsequently cured. The Germans reasoned that something in the dung must abate the symptoms of dysentery. The dung consumption only worked if the dung was fresh because the active ingredient in the dung was identified as Bacillus subtilis, a microorganism that overwhelms almost all harmful microorganisms in the intestinal tract.

The Germans produced Bacillus subtilis in labs and shipped it out to their forces in Africa, halting the dysentery epidemic. The dysentery cure was sold worldwide as a medicinal product and was the leading treatment for dysentery until the 1960s.

FMT Therapeutic Effectiveness

File:FMTeffectiveness.png

Effectiveness of FMT. Excerpt from Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile, Van Nood et al. 2013

Prior to 2013, many Doctors had not even considered FMT as only anecdotal evidence was reported through case studies and patient success stories as well as in most hospitals the procedure was seen as disgusting. Case studies have shown FMT cure rates ranging from 85% to 92%.

As FMT has only recently seen an increase in popularity it was only in January of 2013 that the first randomized controlled trial of fecal transplant in the treatment of recurrent C. diff infection was published. This study directly compared the effectiveness between the FMT and the Vancomycin treatments in curing patients without relapse. Vancomycin is an antibiotic therapy that is based upon a theory that relapses may be due to the presence of persistent spores that survive therapy. Vancomycin is more expensive than FMT and the emergence of vancomycin-resistant enterococci and relapse are both concerns. The study showed that the overall cure rate for recurrent C. diff was 93.8% by the infusion of donor feces overall and 30.8% by Vancomycin. Antibiotics have been shown to decrease in effectiveness with infection recurrences and as most patients had several relapses before the study the effectiveness of Vancomycin was lower than expected. In addition, the study showed that the infusion of donor feces was able to replenish the patient’s flora content back to a healthy state. In contrast, the antibiotics used in treatments eliminate the healthy and non-healthy bacteria to rid the infection.

Barriers to Adoption

Disgust

Humans have an evolutionarily hardwired distaste for feces that is universal across different cultures, known as a core disgust elicitor to disgust researchers. It is theorized that this reaction stems from the health risks posed by excrement, where feces have been shown to be the source of over 20 known bacterial, viral, and protozoan causes of intestinal tract infections. Our instinctual avoidance of the substance is thus a natural barrier towards adopting fecal transplants as commonplace treatments for C. diff and potentially many other intestinal infections.

Doctors and Institutions

FMT is currently not widely accepted and recommended by doctors or professional societies. As of 2011, only about a dozen U.S. physicians have admitted, via publishing cases in medical journals, to using FMT on their patients, though this number is purportedly increasing. Additionally, institutions must be tolerant of their doctors performing this unofficially experimental procedure, as its unregulated nature can be detrimental in malpractice suits.

Regulatory Hurdles

Several regulatory hurdles currently prevent this therapy from being further researched and standardized. In May of 2013, the FDA announced that FMT is not yet approved for any therapeutic purposes, and its use will require the doctor to file an investigational new drug (IND) application, a time consuming and costly application most associated with the start of a clinical trial. Following opposition from FMT advocates, in June of 2013, the FDA instead decided it will exercise “regulatory discretion” over the therapy, though doctors are still “strongly encouraged” to comply with the FDA’s IND regulations. For FMT, the practical efficacy of the therapy is counteracted by the highly variable nature of different donors’ stool samples and the resulting safety concerns of regulatory bodies.

Economic Factors

Mainstream options for treating C. diff include courses of antibiotics such as Dificid and Vancomycin. The cost for a 10-day course of treatment with Dificid is $2,800. Vancocin, an oral form of Vancomycin, costs $1,000 to $1,500 for a 10- to 14- day course of treatment at the lowest dose. On the other hand, feces are abundant, free, and unpatentable, though the testing and screening costs for the donor in a FMT may cost up to $1,500. Though comparable in cost, FMT, however, has a much lower incidence of C. diff relapse after the initial treatment making it more economical. However, insurance companies often do not cover the screening costs for FMT, distorting this economic advantage to the patient.

Antibiotics are a major source of revenue for pharmaceutical companies. Pharmaceutical companies, as major funders of US biomedical research, are thus unlikely to support research on standardizing and validating FMT as an alternative to antibiotic treatment.

Participants

The adoption of FMT is governed by the various participants who will be affected by changes in the standard of therapy administration. The large groups are doctors, researchers, patients, nurses, regulatory bodies, and pharmaceutical companies.

Gastroenterologist, doctors who specialize in the gastroenterology, are an organized group. The American College of Gastroenterology (ACG) is a professional society of over 12,000 gastroenterologists. The stated mission of ACG is "Advancing gastroenterology, improving patient care." ACG publishes a journal called The American Journal of Gastroenterology which has featured journal articles about FMT.

Researchers of gastroenterology are organized in American Gastrology Association (AGA). The AGA has a stated purpose of "Advancing the Science and Practice of Gastroenterology" and a membership of 17,000 scientists and physicians. The AGA publishes two journals, Gastroenterology and Clinical Gastroenterology and Hepatology.

Button promoting fecal matter transplant as a therapy produced by a blog about hospital infections

Patients of gastroenterologists are a disorganized group. Patient advocacy groups, such as the International Organization of Patients' Associations, seek to provide a global voice for patients and provide the best treatment options for patients. Small organizations, such as The Power of Poop, are composed of former patients, and families and friends of former patients, that try to spread the word about FMT through online networks. The mission statement of The Power of Poop is "promoting safe, accessible fecal microbiota transplant for all who need it".

Nurses and other hospital staffers specialized in gastroenterology are organized in the Society of Gastroenterology Nurses and Associates (SGNA). The SGNA is "dedicated to the safe and effective practice of gastroenterology and endoscopy nursing."

Regulatory agencies such as the Federal Drug Administration in the United States and Health Canada are charged with ensuring the safety of treatment options.

Pharmaceutical companies are organized in the Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization. Both organizations lobby on behalf of the pharmaceutical industry, spending $800 million from 1997 to 2004 on 1600 congressional bills.

The Power of Disgust

The sense of disgust has evolved in humans as a useful defense mechanism, stymieing potentially harmful behavior such as incest, cannibalism, and coprophagia. It is the reason why we avoid spoiled food or feces, which carry the risk of harboring harmful bacteria or parasites. However, scientists disagree on the value of this instinct when it is removed from the context in which the instinct was developed. Some argue that it leads us to reject technologies that defy the core of our humanity (e.g. human reproductive cloning) while others cite that it has been used to justify persecution (e.g. racism, anti-Semitism, sexism, and homophobia).

Graphic design mocking reclaimed water projects as "Porcelain Springs" water

In 2006, bioethicist Arthur Caplan coined the term the “yuck factor” to describe our instinctual response against new technologies. In the case of FMT, without discounting other economic and institutional factors, the yuck factor can help explain part of the gap between FMT’s demonstrated efficacy and its usage. Currently the treatment is used as a last resort therapy for patients suffering from chronically reoccurring C. diff, many of whom are more than willing to overcome this yuck factor. However, advocates of the treatment believe FMT should be used as the first resort, primary treatment, which would require a larger extent of patients and doctors alike to be able to stomach the therapy.

Outside of medicine, the yuck factor has derailed wastewater reclamation projects in drought-stricken areas, with opponents labeling the technology as ‘toilet-to-tap’ in order to elicit a reaction of disgust. With public acceptance and support crucial to the successful implementation of this technology, the treated wastewater usually goes through additional, unnecessary treatment processes to assuage public concern.