The front page of the New York Times on March 4 gave a good description of the pending battle lines over the therapeutic use of human excrement.
“Battle Erupts Over Treatment That Once Repelled: F.D.A Ruling Will Pick Who Prospers From Fecal Transplants”
Readers of this blog know that the subject of the human microbiome is one near and dear to both my gut and my heart. I am a firm and long-time believer in the power of that neglected organ (our guts) and the vast array of highly variable bacteria and viruses that choose to inhabit us. I have written of E.D Yong’s book, I Contain Multitudes and have touched on this subject often as I believe it holds a series of keys to detecting, diagnosing and preventing human illness, including cancer.
One place where this is indisputable is the treatment of Clostridioides difficle, the bacterial overgrowth that incapacitates half a million Americans per year, mostly due to the overuse of powerful antibacterial agents. Equally inarguably, fecal transplants seem curative for C. difficile and now there is a race on in the laboratories, board rooms and courtrooms of America to see who profits from this discovery. Are fecal transplants drugs and thus under the auspices of the FDA or are they like kidney transplants and not so regulated?
The fight goes on.
This is most unfortunate because it appears that a solution to the problem has already been invented. There is a nonprofit stool bank in Cambridge, MA (OpenBiome) that is ready, willing and able to supply the needed transplant material for patients, but their costs are rising with increased FDA scrutiny of its operations. There are also three drug companies, the “poop drug cartel,” just as ready to make a profit from the fecal transplants being declared a drug. The battle lines are drawn between the big boys saying safety wants the corporatization of this new industry and the DIY crew that brews up their own cures in a blender. Both seem to work.
As the article says, human feces has become a “gold mine” and everyone has an angle from safety to efficacy to gain a foothold in this new therapeutic world. The expected annual capitalization of that world is $1.7 billion by 2026. My guess is that is a fraction of the market once off-label use gets cranked up and people find it can alter the natural history of many inflammatory processes, central nervous system disorders and, maybe, malignancy as well.
If therapeutic poop becomes an FDA-regulated drug, you can bet on two certainties. First, its price will explode. Second, the black market will go nuts. I mean how can you stop someone from using fecal matter illicitly?
This can be a wonderful test of the government actually helping a situation.
Do not regulate this therapy as a drug. Rather fund more research including clinical trials on exactly how it works and what really needs to be in the transplanted material. My guess is that it will not be the same for everyone or for every disease and that a great deal more investigation is needed. That should be encouraged. If a drug company synthesizes or extracts a single molecule that is as effective as a fecal transplant, let them patent it and make it a drug. But if the real winner is just a fecal transplant, that should not be a regulated new molecular entity.
The NIH needs to greatly expand grant funding for this research. There may not be a more likely place to find new therapies and prevention strategies than in the human microbiome.
Right now, the government should step in and make sure the drug companies do not price this out of the reach of people who need it while also encouraging new applications to the technology.
The use of fecal transplantation will have a long and winding history toward its eventual application for a host of human disorders. But it should not be so regulated as to add to the skyrocketing cost of drugs in this country. Right now, the FDA needs to seize the high ground and encourage more research while making sure this potentially valuable, and surprising source of relief of human misery does not go the way of monoclonal antibodies, PDL drugs, and new chemotherapeutics.
We have to get our s—t together on this one!