Poop: Pharma’s Next Goldmine?

March 14, 2019

The FDA wants to turn poop into profit for Big Pharma. We can’t let it happen. Action Alert!

The FDA is on the verge of deciding the future of fecal microbiota transplants (FMT), a promising new treatment that harnesses the power of the gut microbiome to fight illness. The agency is poised to regulate FMT as new drugs, which means patients will be paying thousands of dollars for human poop. This is yet another example of why medicine is so expensive in this country: the FDA takes affordable, natural treatments—as natural and humble as human feces!—and gifts them to Big Pharma to reap mega-profits.

What’s at stake in the short term is the accessibility of a treatment for a debilitating bacterial infection (Clostridioides difficile, or C. diff) that hits 500,000 Americans a year and kills 30,000. FMT, which involves transferring fecal matter from a healthy donor into an infected patient to repair the gut microbiota, has proven remarkably effective at treating C. diff. FMT has an 80% success rate treating C. diff, with some patients requiring just a single dose.

When FMTwas first being developed, researchers pitching the idea to pharmaceutical executives were laughed out of the room. M.I.T microbiologists then founded a public, non-profit stool bank, OpenBiome, that supplies most of the fecal matter for transplants in the US.

Then the FDA stepped in in 2013. While it said it would study the matter further, the agency said that FMT was, for the meantime, subject to FDA regulation, and researchers wishing to study FMT’s ability to treat disease needed to follow the same procedures that a drug company studying a new drug would—that is, file an investigational new drug (IND) application. The agency granted an exception from the IND requirement for FMT to treat C. diff that was unresponsive to antibiotics.

The question for the FDA is whether to regulate FMT as new drugs or as organs, tissues, and blood products that are transferred from a healthy donor to a sick one. News reports suggest that the FDA is expected to reach this decision soon.

We don’t expect the FDA to do the right thing. We’ve written before how the agency allows Big Pharma to take beneficial natural compounds that are widely and cheaply available and turn them into monopoly drugs costing thousands of dollars. CBD oil is becoming a $32,500-a-year drug; L-glutamine has been turned into a $40,500-a-year drug. This, unfortunately, is the trend at the agency that is supposed to be looking out for public health, but instead looks out for drug industry profits.

Regulating FMT as blood or as human cell, tissue, or cellular and tissue-based products (HCT/Ps) prevents the extension of drug monopolies into the FMT market. Generally, blood and HCT/Ps are regulated by the FDA under the Public Health Service (PHS) Act to ensure safety (by, for example, restricting the donor pool and requiring extensive testing of donated blood before it can be transfused). Generic licenses are awarded to blood banks that meet requirements, rather than being awarded exclusively to one manufacturer. This seems to be a good model for FMT.

Some HCT/Ps, however, are still treated like drugs under certain conditions. We discussed these problems in our coverage of the FDA’s treatment of stem cells. Cord blood (blood that remains in the placenta and umbilical cord after child birth which contains stem cells), for example, is treated like a drug if the donor and patient are not related. So there is a danger that, even if FMT is not officially classified as a drug, the FDA continues to treat it as such.

As longas the safety of FMT can be ensured by regulation solely under PHS, this is the path the FDA must pursue to ensure that consumers can continue to access this treatment affordably.

The implications of this decision are enormous. We are discovering more and more about the pivotal role of the gut microbiota for human health. We are 10% “human”—that is, for every human cell that is intrinsic to our body, there are 10 microbes. Ninety-nine percent of the genetic information we contain is microbial. This diverse array of microbes help train and modulate our immune system, and some researchers link the rise in autoimmune disorders in the West to a disruption of our microbiota. The gut microbiome plays a role in the manufacture of neurotransmitters like serotonin and may even help us regulate stress levels—so our gut and our mood are connected. Our microbial inhabitants also help us make key nutrients (vitamin B and K, short-chain fatty acids, and other enzymes and amino acids).

It’s no surprise, then, that there are vast applications for using FMT to treat illness. It is being studied for a wide variety of indications, including ulcerative colitis, Crohn’s Disease, Parkinson’s disease, multiple sclerosis, childhood regressive autism, metabolic disorders, diabetes, and others. FMT could lead to the next generation of medicines that utilize the trillions of microbes living within us to heal.

Pharmaceutical executives are no longer laughing; they must be foaming at the mouth at the gold mine the FDA is preparing to hand to them. There are already microbiome drugs in development for the treatment of C. diff.

Left on its own, we know that the FDA will once again serve Big Pharma by classifying FMT as a new drug. To develop a new drug costs billions of dollars, which can
only be recouped through market exclusivity (read: FDA-granted monopoly).  What can now be had for free will then cost tens of thousands of dollars. The only way we can prevent it is to respond inforce to tell the FDA to keep its hands off our poop!

Action Alert! Write to the FDA and tell them that human poop is not a drug. Please send your message immediately.

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