A crappy post

I was about to queue this up for quick hits, but then I thought, damn, as long as I’ve been fascinated by fecal transplants, this excellent NYT story deserves its own post.  Lots of good stuff here:

There’s a new war raging in health care, with hundreds of millions of dollars at stake and thousands of lives in the balance. The battle, pitting drug companies against doctors and patient advocates, is being fought over the unlikeliest of substances: human excrement.

The clash is over the future of fecal microbiota transplants, or F.M.T., a revolutionary treatment that has proved remarkably effective in treating Clostridioides difficile, a debilitating bacterial infection that strikes 500,000 Americans a year and kills 30,000.

The therapy transfers fecal matter from healthy donors into the bowels of ailing patients, restoring the beneficial works of the community of gut microbes that have been decimated by antibiotics. Scientists see potential for using these organisms to treat diseasesfrom diabetes to cancer.

At the heart of the controversy is a question of classification: Are the fecal microbiota that cure C. diff a drug, or are they more akin to organs, tissues and blood products that are transferred from the healthy to treat the sick? The answer will determine how the Food and Drug Administration regulates the procedure, how much it costs and who gets to profit. [emphases mine]

“People have good reason to worry because for many patients, fecal transplants are a matter of life and death,” said Catherine Duff, founder of the Fecal Transplant Foundation, a patients group. “The concern is that corporate greed will get in the way of patient access.”

As the F.D.A. nears a final decision, both sides are ramping up the pressure. More than 40 prominent gastroenterologists and infectious disease doctors recently wrote to the agency, urging it to rethink its approach.

Dr. Alexander Khoruts, a gastroenterologist at the University of Minnesota, said he feared the F.D.A. was favoring the interests of what he calls the “poop drug cartel,” a group of companies seeking approval for new ways to deliver the active ingredients in transplanted feces. Three of the companies, RebiotixSeres Therapeutics and Vedanta Biosciences, have raised tens of millions of dollars from investors and they recently formed an association to advance their interests with the F.D.A.

“An obscene amount of money is being thrown around by companies trying to profit off of what nature made,” said Dr. Khoruts. “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.”

I don’t know enough to pretend I know the right way to proceed.  For example, if for-profit companies can come up with a system where you isolate the key bacteria and people can really just take it in a pill instead of an enema a slurry of another person’s feces, that’s amazing and more power (and reasonable profit) to them.  But the power for huge amounts of money at stake to corrupt the process is absolutely something to be very much concerned about.

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About Steve Greene
Professor of Political Science at NC State http://faculty.chass.ncsu.edu/shgreene

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