Emily Eakin provided a fascinating description in The New Yorker of the developments occurring
in one of the most interesting and rapidly developing areas of medical science.
It was titled The Excrement Experiment: Treating Disease with Fecal Transplants.
It has become clear that antibiotics can kill some or all
of the bacteria that control functions occurring in our digestive system. While usually beneficial, antibiotics can
cause both long-term and short-term changes in our microbial makeup (our
microbiome) leading to chronic illnesses and, occasionally, immediate threat of
death. Abnormal excursions in bacterial
population can occur in cases that may not be associated with antibiotics and
are suspected of causing other serious health problems. Since so little is understood concerning our microbiome,
the most direct way to introduce a “healthy” distribution of bacteria into the
digestive tract is via insertion of what has come to be known as a fecal
transplant from a healthy person. This
procedure has now received the more official descriptor fecal microbiota
transplantation (FMT).
Although fast moving now, the idea of using human
excrement to address intestinal issues was first addressed by a Chinese
physician well over a thousand years ago.
“In the United States, the first
description of FMT appeared sixteen centuries later, in 1958, when Ben Eiseman,
a surgeon at the V.A. Hospital in Denver, published four case reports in the
journal Surgery. Stool was then widely
assumed to be mainly a source of disease; there was little empirical support
for the notion that bowel bacteria were important for health. Several of
Eiseman’s patients had become deathly ill after the requisite preoperative
course of antibiotics, however, and he concluded that the drugs were destroying
normal gut flora. He sent a resident to collect stool specimens from a nearby
maternity ward, reasoning that pregnant women were likely to be young and
healthy and to have avoided antibiotics. The stool, transferred to Eiseman’s
patients, saved their lives.”
What was probably occurring with Eiseman’s patients was
due to the nasty bug known as Clostridium
difficile. This is a naturally
occurring microbe in our digestive systems that is held in control by the array
of other bacteria. However, when massive
doses of antibiotics are applied, usually in hospital settings, C. difficile,
can be the last microbe left standing since it is highly resistant to known
antibiotics. Left alone it causes severe
diarrhea and can be fatal.
“Scattered case reports in the
medical literature described C. difficile
patients, some on their deathbeds, who received fecal transplants and
recovered, often within hours. Then, in January, 2013, The New England Journal of
Medicine published the results of the first randomized controlled
trial involving FMT, comparing the therapy to treatment with vancomycin for
patients with recurrent disease. The trial was ended early when doctors
realized that it would be unethical to continue: fewer than a third of the
patients given vancomycin recovered, compared with ninety-four per cent of
those who underwent fecal transplants—the vast majority after a single
treatment. A glowing editorial accompanying the article declared that the
trial’s significance ‘goes far beyond the treatment of recurrent or severe C. difficile’ and predicted a spate of research
into the benefits of fecal transplants for other diseases.”
For this application, a 94% success rate puts feces in
the miracle drug category. It is not
surprising that other applications for FMT would become of interest. Eakin points out that Eiseman’s results were
not totally ignored.
“For years, virtually the only
proponent of FMT was Thomas Borody, a gastroenterologist in Sydney, Australia,
who, in 1988, after reading Eiseman’s paper, decided to try a fecal transplant
on a patient who had contracted an intestinal ailment in Fiji. The patient
recovered, and Borody estimates that he has since performed the procedure five
thousand times, including, with stool supplied by his father, on his mother,
who suffered from crippling constipation. In addition to C. difficile patients, Borody says that he has
successfully treated people with autoimmune disorders, including Crohn’s and
multiple sclerosis.”
It is not surprising that researchers have begun to
postulate and investigate all sorts of disorders that might be associated with
dysfunctions of the microbiome, from obesity to autism.
“The Cleveland Clinic named
fecal transplantation one of the top ten medical innovations for 2014, and
biotech companies are competing to put stool-based therapies through clinical
trials and onto the market. In medicine, at any rate, human excrement has
become a precious commodity.”
It is also not surprising that with such a readily
available product there is a lot of self medicating going on. Eakins goes into great detail providing the
history of Tom Gravel who suffered from Crohn’s disease which causes inflammation
of a bowel section accompanied by pain and severe diarrhea. Gravel suffered through ineffective medical interventions
for over three years before he decided to try self-administered fecal doses
provided by a presumably healthy neighbor. Gravel was able to obtain relief in
this way and intends to continue this procedure indefinitely.
On the one hand there are how-to books and YouTube videos
demonstrating how individuals can try the procedure on their own; on the other
hand you have the FDA which is legally bound to treat excrement as a drug.
“The agency defines a drug as
any material that is intended for “use in the diagnosis, cure, mitigation,
treatment, or prevention of disease.” An exception has been written into law
for body parts, including skin, bone, and cartilage, which are classified as
tissue. But the statute excludes most human secretions from this category.”
“Substances labeled drugs are
subject to a rigorous approval process. Pharmaceutical companies typically
spend many years and millions of dollars researching and testing a drug before
submitting it to the agency for approval. Until the F.D.A. approved a
fecal-transplant therapy, the procedure would be considered experimental. In
order to offer it to patients, doctors would need to file an investigational
new-drug application, or I.N.D., and obtain the agency’s permission.”
“I.N.D.s are intended to capture
every aspect of a prospective therapy in exacting detail….one
gastroenterologist said that it had taken her hundreds of hours to complete the
paperwork. Many others lacked the resources and staff to devote to such a task.”
The FDA is torn between the need to follow a lengthy
process designed to insure patient safety and verify effectiveness of drugs,
and evidence that thousands of sufferers could be provided immediate relief by
a simple and inexpensive procedure.
“’What do we do with the fifteen
thousand patients who are really desperate for something that works?’ a doctor
from the Mayo Clinic asked F.D.A. officials. ‘If your mother shows up with
severe or recurrent C. difficile, are
you going to not offer something that you know how to do safely, effectively,
and say, ‘I can’t do it because the regulatory agencies in the United States
have decided that this requires a special licensure’?”
The FDA appears to be trying to be accommodating.
“….the F.D.A. declared an
exception for doctors treating recurrent C. difficile:
they would be allowed to perform fecal transplants without an I.N.D. In
revising its position, the agency said that it would be exercising ‘enforcement
discretion’—a temporary measure. As an F.D.A. spokeswoman later explained in an
e-mail, the directive did not reflect a change of policy; it was intended as an
acknowledgment that ‘there are often few or no other treatment options for
these patients’.”
There are good reasons for the FDA to follow the
traditional path for drug approval.
However, as Eakin points out, that encourages sufferers to try the
procedure on their own. These people are,
in fact, producing a wealth of clinical data that is going to be lost. A less onerous process that allows doctors to
participate in administering doses while monitoring the patients and reporting
the results would rapidly accumulate more data than drug manufacturers could
ever produce.
The seemingly irreconcilable problem is that excluding
excrement from the requirement that it be treated as a drug would require
congressional legislation. Even if
congress were so moved to act, it is unlikely that the pharmaceutical industry
would ever give them permission to threaten a potentially large profit source.
Consequently, we are being forced to endure an expensive
and lengthy process that only drug companies can afford to pursue. Eventually they will claim to have turned shit into gold and
sell it back to us at as high a price as the market will bear.
The community has already decided on what to call these
wonder pills when they finally emerge: crapsules.
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