Why? - Read On – (Yes, Money is Involved and Thankfully No Illustrations Here)
| No, don't donate this to Goodwill after you are finished. |
The opinion pages of the New York Times have a rather long first person report on using FMT to treat a severe ulcer condition. What is FMT? Well the article is about a friend of the author named ‘Gene’.
That’s
when Gene started reading about a procedure called fecal microbiota transplant,
or F.M.T.
Transplanting
the stool from one person into the digestive tract of another seems, well,
repulsive, but it also makes sense. The majority of the matter in stool —
roughly 60 percent — is bacteria, dead and alive, but mostly alive. While
bacteria can make us sick, they also constitute a large part of who we are; the
hundreds of trillions of cells in an individual’s microbiome, as this
collective is known, outnumber human cells 10 to 1. The bacteria serve many
functions, including in metabolism, hormone regulation and the immune system.
Does it work? Well
apparently yes.
Many
people who suffer from clostridium
difficile, a dangerous strain of bacteria that is becoming epidemic in
hospitals and nursing homes, got it this way. The idea behind fecal transfers
is that restoring colonies of healthy bacteria can either dilute or crowd out
these harmful strains. And it seems to work: in January, The New
England Journal of Medicine reported that the first randomized
clinical trial of F.M.T.’s for clostridium difficile had been halted because
the treatment worked so well that it was unethical to withhold it from the
control group.
But for treating ulcer conditions the FDA has stepped
in and mucked things up, maybe reasonably so.
Gene
finally secured an appointment with Dr.
Lawrence Brandt, one of the most experienced F.M.T. practitioners, only to
find out, just before his visit, that Dr. Brandt was suspending his F.M.T.
practice for ulcerative colitis on the advice of the hospital’s lawyers, in
order to comply with a new Food and Drug Administration decision. In April, the
F.D.A. decided to classify human stool that is used therapeutically as a drug,
and thus approved for use only within an F.D.A.-approved clinical study.
But Gene was dying, or at least so ill that his
quality of life was destroyed. So what
to do? Well how about at DIY approach. All you need is a donor, which the author was
willing to be, and some basic equipment.
The
procedure is, of course, messy and odoriferous, but it’s also simplicity
itself. Gene’s marching orders were to procure a dedicated blender and sieve,
enema tubing and syringe, and lots and lots of newspaper. F.M.T. basically
consists of blending stool with saline, straining it, and reintroducing it into
the colon via enema.
Anyway, without going further into the details, the
procedure worked after a number of applications. The question here though is why, if this is
such a great, inexpensive effective solution to the problem, why isn’t it on a
fast track for approval and implementation?
Here’s why.
More
studies are needed. But at the same time, the F.D.A. needs to fast-track
research into this field, though it is neither glamorous nor capable of
promising a blockbuster drug payoff for some corporation.
Right, there you have it, no big bucks for a large
drug company here. So no pressure to get
this procedure up and running and available even though
The
upside for patients would be huge. In a maelstrom of skyrocketing health care
costs, think of what we could save, in terms of quality of life and money, with
this procedure. Clostridium difficile infections alone kill about 30,000 a year
and cost billions of dollars. The prescription drugs for Gene’s ulcerative
colitis, let alone the doctor visits and one hospitalization, ran into the tens
of thousands of dollars. The F.M.T. was basically the cost of the blender and
the enema materials.
Just another day in America ’s ill designed, extremely
expensive and relative poor health care system. And yes, the blender is really a single use item in this case.
No comments:
Post a Comment