Big Pharma Wants to be Big Poop
A healthy human digestive tract hosts a typical flora,
a population of many varieties of micro-organisms.
A round of antibiotic treatment can kill most of the patient's gut bacteria,
allowing just one species to dominate.
That leads to medical problems.
One bacterium in particular, commonly known as
is responsible for many troublesome infections.
It can lead to chronic diarrhea.
A strange-sounding treatment, a fecal transplant,
is often helpful.
Just as its name tells us, the procedure only needs some spare feces.
The raw material is easily produced by unskilled labor.
No need for expensive pharmaceuticals of intentionally limited supply.
No obvious way for wealthy corporations to take a cut.
Unless, of course, these corporations convince the U.S. Government
that they should have control as a "poop drug cartel".
formerly known as Clostridium difficile,
or just C. difficile
or C. diff for short,
is ubiquitous on Earth.
It's anaerobic, meaning that it thrives in oxygen-free environments
such as the human digestive tract.
It forms spores, meaning that it can survive harsh conditions
outside its native environment and easily spread.
C. difficile is common in the human digestive system.
However, it is a poor competitor and the other bacteria take the
majority of the available nutrients.
In a healthy digestive tract, C. difficile
remains a small fraction of the microbiome.
When a patient is given antibiotics to treat an infection,
that treatment may make some things worse by killing all or most of
the other micro-organisms.
In such a case, C. difficile frequently fills the ecological vacuum.
It reproduces rapidly.
It can dominate the patient's gastrointestinal microbiome
within a few days to a week.
Newly arising strains of C. difficile
are resistant to standard antibiotic weapons such as
ciprofloxacin and levofloxacin.
Antibiotics remove the competition but don't kill C. difficile,
allowing it to flourish.
C. difficile produces two toxins, enterotoxin and cytotoxin,
both of which can produce diarrhea and inflammation.
That diarrhea is filled with C. difficile spores.
The infection is frequently transmitted between patients in hospitals,
nursing homes, and other medical facilities.
The spores contaminate toilets, sinks, bedding, clothing,
and medical instruments.
The infection usually spreads by the healthcare workers' hands,
as the spores are resistant to heat and alcohol-based sanitizers.
Scanning electron micrograph of Clostridioides difficile,
formerly known as Clostridium difficile.
The U.S. Centers for Disease Control and Prevention estimated in 2015
that there had been almost half a million C. difficile infections
in the U.S. in 2011, leading to 29,000 deaths.
40% of the cases began in nursing homes or community health care settings,
and 24% began in hospitals.
2015 paper estimated
that healthcare-associated infections increased the
cost of U.S. health care by $1.5 billion each year.
Fecal Transplants to the Rescue?
A fecal microbiota transplant
inserts a variety of fecal bacteria from a healthy donor
into the patient.
The transplant flora will contain a healthy cross-section of species.
The hope is that C. difficile will lose its monopoly
control over the patient's microbiome.
The transplantation can be done via a colonoscopy or enema.
Or, through nasogastral intubation, a tube entering through the nose
and running down the throat.
Or, far more pleasantly for everyone involved,
by swallowing a capsule containing freeze-dried fecal material.
The procedure calls for 30 to 100 grams of feces,
fresh so its bacterial flora are thriving.
The sample is usually prepared and implanted within 6 to 8 hours.
Fecal Transplants Aren't New
Ge Hong was a famous physician during the
Dong-jin dynasty in the 4th century in China.
He prescribed human fecal suspensions to be taken by mouth
by patients who had food poisoning or severe diarrhea.
The result was considered a near miraculous recovery,
bringing patients back from the brink of death.
Ge Hong wrote about it in the first Chinese handbook of emergency medicine,
"Zhou Hou Bei Ji Fang" (or "Handy Therapy for Emergencies").
Later, during the Ming dynasty of the 16th century,
Li Shizhen described a series of prescriptions that
used fermented fecal solution, fresh fecal suspension, dry feces,
or infant feces.
His description in the "Ben Cao Gang Mu"
(or "Compendium of Medical Material")
reported that these prescriptions effectively
treated severe diarrhea, fever, pain, vomiting, and constipation.
Li Shizhen reported that physicians didn't describe these
fecal concoctions literally, but called them
"Yellow Soup", "Golden Syrup",
and other patient-friendly names.
Today, they would be called "All Natural" and "Organic".
The technology eventually reached Europe.
The Italian anatomist Fabricius Aquapendente
described using fecal therapy in veterinary medicine during the 17th century.
The first modern medical report seems to be the
paper from 1958,
"Fecal enema as an adjunct in the treatment of
Poop transplants then dropped back off the scientific radar.
FMT or Fecal Microbiota Transplant began drawing
serious medical attention in 2010,
and surged significantly higher in 2012 and 2013.
Is it Just Poop, or is it Controlled Pharmaceuticals?
In May 2013 the U.S. Food and Drug Administration
announced that it was controlling human fecal material as a drug.
A number of professional gastroenterological associations asked for
clarification, and the FDA said that human fecal material
required Investigational New Drug application.
Neither Li Shizhen's nor Ge Hong's books
were considered to be authoritative.
Six years later, in early 2019, the FDA was said to be getting
closer to finally reaching a decision.
Is human fecal material a drug, or is it something more
like blood transferred from the healthy to the sick?
The answer will determine how the FDA regulates the procedure,
how much it will cost,
and who gets the profits.
How much will Big Pharma expand to also become Big Poop?
A March 3, 2019
article in The New York Times
quotes Dr Alexander Khoruts, a gastroenterologist at the University of
Minnesota, as fearing that the FDA was favoring the interests of
what he called the "poop drug cartel".
"An obscene amount of money is being thrown around by companies
trying to profit off of what nature made.
I don't think there are clear villains here,
but I worry that the regulators are not caught up on the latest science
and that the interests of investors may be exceeding those of patients."
— Dr Alexander Khoruts
Three companies — Rebiotix,
and Vendata Biosciences —
have raised tens of millions of dollars from investors
and formed an association to lobby the FDA.
Some physicians have taken the side of Big Poop.
Dr Sahil Khanna, an associate professor of gastroenterology at the
Mayo Clinc, was quoted as saying
"We also need to move away from transferring poo from
one person to another."
Is the push for greatly increased FDA regulation due to worries about
desperate patients risking unlicensed back-alley fecal transplants?
Or is it driven by fear of missed income for Big Pharma?
It's hard to say.
Meanwhile, Bowels Move
OpenBiome opened in late 2012 in Cambridge, Massachusetts.
It's a nonprofit stool bank that now supplies
most of the material for fecal transplants in the U.S.
Tens of thousands of Americans with C. difficile infections
have been cured by fecal transplants since then.
OpenBiome prepares 900 to 1,000 treatments each month.
Most of them take the form of bottles of liquid that are packed in
dry ice and shipped overnight to clinics across the U.S.
Their fecal supply comes from donors who are paid $40 per donation.
It sounds like a good racket to get into.
But, it's hard to become a stool donor.
Intensive screenings and regular medical checkups are required.
There are several stool banks across Europe.
2017 article in BMJ Gut
describes an international European conference
on fecal transplantation protocols.
A team of entrepreneurs established two operations in Hong Kong in 2016:
the Asia Microbiota Bank
to collect and process the material, and the
Hong Kong Digestive Centre
which does the transplantation via both enema and oral capsules.
Fire and Feces