Now the FDA Wants to Regulate...Poop?
No, you didn’t read that wrong. We’ve all made jokes at some point about the government charging us for the air we breathe, or telling us when we’re allowed to burp. So this may sound like just another tasteless joke but it isn’t: the FDA, in its infinite wisdom, wants to regulate poop.
And they don’t just want to regulate it as a normal biological substance like blood or skin. No. They want to treat it as an “investigational new drug” and make poop-sellers jump through all the hoops that drug manufacturers have to go through before they market a product.
Once again, yes you read that right. I said poop-sellers. And yes, there are companies out there that sell…well, frozen poop. For as much a $400 per…pop. Why? Who on earth is buying it, let alone paying hundreds of dollars? And what does the FDA have to do with human waste? Let me explain.
Medicine’s stomach-churning new treatment saves lives
Fair warning: if you don’t have a strong stomach, what I’m about to talk about may make you queasy. If you do have a strong stomach, however, you may have read about this in one context or another already. In either case, let’s go ahead and get the question of why anyone would buy poop out of the way. Here goes:
For several years, medicine has been doing what it calls a “fecal transplant” as a treatment for some serious issues, most notably in cases of Clostridium difficile infections which don’t respond to antibiotics. If you’ve been following the health news, you’ve probably heard about C. difficile or “C. diff.” It’s an intestinal infection that at its mildest causes severe diarrhea and at its most severe can cause sepsis and death. And it’s becoming increasingly common thanks to the overuse of antibiotics.
C. difficile are one of the many types of bacteria that live in most people’s gut. Normally they don’t pose a problem. The gut has other bacteria that keep the C. difficile population under control. But when something—certain antibiotics, for example—wipe out these other bacteria, C. difficile can reproduce unchecked and as the C. diff population grows, the person harboring them becomes ill. In most cases, certain antibiotics which kill C. difficile are the only treatment that’s needed. But like too many other types of bacteria, there are antibiotic-resistant strains of C. diff and if you’re infected with one of these, you’re out of luck.
Or at least you were. Somewhere along the line, some brilliant doctor with a cast-iron stomach discovered that “transplanting” poop from a healthy person to a person sick with antibiotic-resistant C. difficile cured the infection. The “good” bacteria in the healthy poop repopulated the sick person’s gut and wiped out the C. diff where antibiotics failed. As revolting as it sounds, many lives have been saved this way.
Where there’s a market, there’s someone with a product to sell
Of course some enterprising entrepreneur saw this as an opportunity. Because you shouldn’t “transplant” just any old poop. The “donor” needs to be healthy. They need to be free of disease—there are many types of infectious disease that could be passed along this way otherwise. They shouldn’t be obese—studies have found that transplanting poop from obese mice into skinny ones makes them obese and vice versa.
This means that people need to be screened for health problems, poop needs to be tested for disease, etc. And of course there’s always the issue of approaching a friend or family member and asking them to…donate poop. So in 2013 OpenBiome, the country’s first “human stool bank” opened its doors. It promised to take the hassle out of finding donor poop for doctors (and the embarrassment out of it for patients.)
That’s when the FDA decided to step in. The FDA told doctors that going forward, it would treat poop for fecal transplants as a drug. That any doctor wanting to do a fecal transplant would have to file an “investigational new drug application” or IND with the FDA—just like Big Pharma has to do before launching clinical drug trials.
Doctors were in an uproar. Those who’ve actually been through the process say that INDs take weeks to complete. And they can take more than a month to be approved. According to one doctor, simply completing the IND took two weeks of 12-hour days and the final document weighed 23 pounds.
If that’s not insane enough, here’s the thing: this treatment works when nothing else does. It’s simple. It’s low-risk. And there’s no question that it saves lives. But people with antibiotic-resistant C. difficile can’t afford to wait 2 months or more for an IND to be completed and approved. In those two months, they may die. They may have to have their entire colon removed. And there’s absolutely no reason they should have to. No matter how FDA may twist it, poop is not a drug.
So why did the FDA take this stance?
Business as usual at the FDA: Big Pharma wins, patients lose
First let me say that in 2013 the FDA did listen to doctors’ criticism and back off slightly. There’s other research with fecal transplants going on—research into “curing” obesity and treating diabetes, for example. So they grudgingly agreed that in the case of life-threatening C. diff cases, doctors could continue without the IND. But only in the most serious cases. All other scenarios required an IND.
But this year the FDA has changed its mind yet again. Now they not only want to require an IND for each sample doctors propose to “transplant,” they want to limit the procedure to large hospitals. That means that it will only be available to a handful of patients and when it is available it will be very, very expensive.
Moreover, this rule applies only to poop purchased from a stool bank. It wouldn’t apply to poop donated by a friend, family member, neighbor, or random stranger on the street. It wouldn’t apply to poop collected at and stored by hospitals themselves. In other words, it’s a rule intended to put stool banks out of business.
If you guessed “Because Big Pharma,” you’re right. A company called Rebiotix is testing a “poop-like drug” containing gut bacteria from healthy people, intended to treat C. difficile. It’s in Phase 2 clinical trials right now and it’s expected to cost—wait for it—three to ten thousand dollars.
With possible profits like that, it’s no wonder they’ve pushed the FDA to kill the competition. And it’s also not surprising that the FDA is has obliged. Meanwhile, people are going through horrendous surgery or dying because of this Big Pharma back-scratching. People are even trying “do-it-yourself fecal transplants” at home. Thanks, FDA. We can all sleep a lot better knowing that you’re there to protect our health.
Now, where did I put my bottle of Vioxx…
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