Tuesday, July 16, 2013

Extremely Promising, Highly Inexpensive Treatment of Some Type of Colitis Gets Low Priority

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.

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