Poop Wars and the Poop Drug Cartel
March 4, 2019 8:00 PM Subscribe
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. (SLNYT) Fecal transplants previously.
The clash is over the future of fecal microbiota transplants, or F.M.T.
Very oddly, F.M.T. was actually the acronym a new-wave band I worked with (back in the distant early 80's) commonly used for their full name, which was "Faith in Medical Technology". Absolutely true story, and I have no idea what to make of it.
posted by Greg_Ace at 8:07 PM on March 4, 2019 [4 favorites]
Very oddly, F.M.T. was actually the acronym a new-wave band I worked with (back in the distant early 80's) commonly used for their full name, which was "Faith in Medical Technology". Absolutely true story, and I have no idea what to make of it.
posted by Greg_Ace at 8:07 PM on March 4, 2019 [4 favorites]
Fecal February! Merde March! Anal April!
posted by Harvey Kilobit at 8:11 PM on March 4, 2019 [6 favorites]
posted by Harvey Kilobit at 8:11 PM on March 4, 2019 [6 favorites]
So last month.
posted by Abehammerb Lincoln at 8:26 PM on March 4, 2019 [5 favorites]
posted by Abehammerb Lincoln at 8:26 PM on March 4, 2019 [5 favorites]
*holding syringe full of poop*
"Push in your stool for you, sir?"
posted by turbid dahlia at 8:26 PM on March 4, 2019 [9 favorites]
"Push in your stool for you, sir?"
posted by turbid dahlia at 8:26 PM on March 4, 2019 [9 favorites]
Poop Month will NEVER end (as long as the BigPoopHead is still President).
Have I mentioned that MAD Magazine just published "Mary Poopins Goes to the White House"?
posted by oneswellfoop at 8:33 PM on March 4, 2019 [2 favorites]
Have I mentioned that MAD Magazine just published "Mary Poopins Goes to the White House"?
posted by oneswellfoop at 8:33 PM on March 4, 2019 [2 favorites]
Rent Seeking Oligarchs even want to extract rents from our shit! The Bloody Revolution cannot come soon enough!
posted by monotreme at 8:46 PM on March 4, 2019 [5 favorites]
posted by monotreme at 8:46 PM on March 4, 2019 [5 favorites]
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.
YOU DON'T SAY
posted by grumpybear69 at 8:50 PM on March 4, 2019 [3 favorites]
YOU DON'T SAY
posted by grumpybear69 at 8:50 PM on March 4, 2019 [3 favorites]
Wow, Johnny, you've really lowered the bar from all the dog & cat posts...shiiiiiiiiit. (I kid; I'm totes fecal)
posted by GospelofWesleyWillis at 8:50 PM on March 4, 2019 [1 favorite]
posted by GospelofWesleyWillis at 8:50 PM on March 4, 2019 [1 favorite]
“The whole field is screaming forward faster than anyone could have imagined,”
That's what you get when your extraction technology lags behind.
posted by allium cepa at 9:03 PM on March 4, 2019 [3 favorites]
That's what you get when your extraction technology lags behind.
posted by allium cepa at 9:03 PM on March 4, 2019 [3 favorites]
On a less snide note, fuck the whole system that is desperately seeking to construct a legal precedent to enrich itself by claiming ownership over cures derived from human shit.
The hell with this system.
posted by allium cepa at 9:06 PM on March 4, 2019 [10 favorites]
The hell with this system.
posted by allium cepa at 9:06 PM on March 4, 2019 [10 favorites]
Rent Seeking Oligarchs even want to extract rents from our shit! The Bloody Revolution cannot come soon enough!
Seriously, you do NOT want to cross those streams.
posted by Greg_Ace at 9:12 PM on March 4, 2019 [1 favorite]
Seriously, you do NOT want to cross those streams.
posted by Greg_Ace at 9:12 PM on March 4, 2019 [1 favorite]
I'm glad to see this area maturing. For years I've wanted to open health clinics in airports that could give your intestines a kickstart on adapting to the local intestinal flora and fauna via fecal transplants. Every day it's looking more plausible.
posted by Tell Me No Lies at 9:14 PM on March 4, 2019 [6 favorites]
posted by Tell Me No Lies at 9:14 PM on March 4, 2019 [6 favorites]
NO. NO I DO NOT.
posted by Greg_Ace at 9:45 PM on March 4, 2019 [4 favorites]
posted by Greg_Ace at 9:45 PM on March 4, 2019 [4 favorites]
I would be curious what the path is to ensure efficacy of treatment and consistency of preparation if not regulated as a drug. A treatment for diabetes, cancer, Alzheimer's--listeners of the Sawbones podcasts will remember their line about cure alls.
I am in the pharma industry (though I don't touch poop) so maybe it's self interest plus this being the one regulatory framework I know. We have experience with what happens without regulation as well, and it's not all altruistic doctors and rational patients reaching the happy outcomes.
I've been following (as a layperson) a lot of the gut flora stuff for years and I think it's exciting science, but FWIW the link that says "remarkably effective" in TFA goes to a study that had 21 patients and a p value of 0.2.
posted by mark k at 9:55 PM on March 4, 2019 [7 favorites]
I am in the pharma industry (though I don't touch poop) so maybe it's self interest plus this being the one regulatory framework I know. We have experience with what happens without regulation as well, and it's not all altruistic doctors and rational patients reaching the happy outcomes.
I've been following (as a layperson) a lot of the gut flora stuff for years and I think it's exciting science, but FWIW the link that says "remarkably effective" in TFA goes to a study that had 21 patients and a p value of 0.2.
posted by mark k at 9:55 PM on March 4, 2019 [7 favorites]
It sounds like a new regulatory category for FMT is a great idea. It could also help bring new forms of phage therapy into the clinic, since (as I learned from Blasdelb on this very site) some phage treatments involve natural mixtures that, while poorly-characterized by the standards of drugs, are empirically effective.
Basically, the alternative that some of these microbiome startups are going after is a defined mixture of specific strains of bacteria that you can grow in culture. It's a worthy goal in some ways: there are supply problems with pre-screened donor stool, and moving to specific bacterial strains is probably less risky. It's also definitely more appealing to a lot of patients than the thought of ingesting poop, though the popularity of DIY treatments suggests that people are also willing to try anything they think will actually work. The problem is that as far as I know -- may be outdated info on my part but I suspect I'd have heard otherwise -- defined mixtures have yet to reach the effectiveness of FMT. It's not even really clear why certain things engraft successfully from the donor and others don't, so there's a ton of research yet to be done. (Very carefully supervised FMT has even been successfully used in immunocompromised people, which is kind of crazy if you think about it.)
Anyway, defined strain collections are an exciting area of research (potentially for other indications besides C. diff), and shouldn't really be in opposition to treatment using whole stool, but this is America so here we are I guess.
posted by en forme de poire at 9:56 PM on March 4, 2019 [3 favorites]
Basically, the alternative that some of these microbiome startups are going after is a defined mixture of specific strains of bacteria that you can grow in culture. It's a worthy goal in some ways: there are supply problems with pre-screened donor stool, and moving to specific bacterial strains is probably less risky. It's also definitely more appealing to a lot of patients than the thought of ingesting poop, though the popularity of DIY treatments suggests that people are also willing to try anything they think will actually work. The problem is that as far as I know -- may be outdated info on my part but I suspect I'd have heard otherwise -- defined mixtures have yet to reach the effectiveness of FMT. It's not even really clear why certain things engraft successfully from the donor and others don't, so there's a ton of research yet to be done. (Very carefully supervised FMT has even been successfully used in immunocompromised people, which is kind of crazy if you think about it.)
Anyway, defined strain collections are an exciting area of research (potentially for other indications besides C. diff), and shouldn't really be in opposition to treatment using whole stool, but this is America so here we are I guess.
posted by en forme de poire at 9:56 PM on March 4, 2019 [3 favorites]
Metafilter: I don't touch poop
Also, "Defined Strained Culture" is the name of my new Alt-Indie band.
posted by Greg_Ace at 10:07 PM on March 4, 2019 [3 favorites]
Also, "Defined Strained Culture" is the name of my new Alt-Indie band.
posted by Greg_Ace at 10:07 PM on March 4, 2019 [3 favorites]
stahp
posted by Greg_Ace at 10:44 PM on March 4, 2019 [4 favorites]
posted by Greg_Ace at 10:44 PM on March 4, 2019 [4 favorites]
BTW, just to be clear, the p-value of 0.2 in that study comes from a comparison with metronidazole. It's not comparing FMT to placebo. Anyway, there are now enough studies to do meta-analyses on the effectiveness of FMT for C. diff and the results look robust. (My sense is that one big reason that some of the studies are pretty small is that it is hard, or at least used to be hard, to get approval to use FMT unless patients had previously failed treatment or relapsed.)
There is certainly a lot of hype around FMT and the microbiome more generally, I think partly because it seems like a more "natural" treatment than drugs and so it appeals to people who are skeptical of pharma/doctors. I could probably go on about this for hours but one result of the hype is that there are a lot of very premature/weird attempts to cash in (e.g. sequencing your cat's poop), and another is that there are now people trying DIY FMTs for things like their irritable bowel syndrome or depression, based on research that is shall we say, speculative. But it's also important not to throw out the baby with the bathwater, and I don't think it's particularly controversial that FMT really is effective as a treatment for C. diff.
posted by en forme de poire at 10:46 PM on March 4, 2019 [5 favorites]
There is certainly a lot of hype around FMT and the microbiome more generally, I think partly because it seems like a more "natural" treatment than drugs and so it appeals to people who are skeptical of pharma/doctors. I could probably go on about this for hours but one result of the hype is that there are a lot of very premature/weird attempts to cash in (e.g. sequencing your cat's poop), and another is that there are now people trying DIY FMTs for things like their irritable bowel syndrome or depression, based on research that is shall we say, speculative. But it's also important not to throw out the baby with the bathwater, and I don't think it's particularly controversial that FMT really is effective as a treatment for C. diff.
posted by en forme de poire at 10:46 PM on March 4, 2019 [5 favorites]
Poop crime? Meet Poop Cop. Indeed, JW's poop posts are getting a bit nutty.
posted by zaixfeep at 3:58 AM on March 5, 2019
posted by zaixfeep at 3:58 AM on March 5, 2019
Filthy lucre, as in Freud and Norman O. Brown
posted by DJZouke at 5:21 AM on March 5, 2019 [1 favorite]
posted by DJZouke at 5:21 AM on March 5, 2019 [1 favorite]
Is Metafilter just poop articles now?
posted by Young Kullervo at 5:30 AM on March 5, 2019 [4 favorites]
posted by Young Kullervo at 5:30 AM on March 5, 2019 [4 favorites]
There is a lot of reason for concern and alarm at the direction that FMT is has been headed in the US without adequate regulatory oversight. Just how poorly we understand the fire that we have been playing with has few real parallels in modern medicine. What FMT represents is real control over the microbiome, something we know is extraordinarily powerful, but lack even the most basic of comprehension as to how.
For example, we know that the gut microbiome is critical component of all manner of aspects of cognition in humans and animals, from personality to intelligence to mood and anxiety to social behavior, but we really have fuck all in the way of ideas as to how. Indeed, you can make crafty, cautious, misanthropic, and anxious Balb/c mice act like dumb, trusting, and cuddly NIH Swiss mice, and vice versa, by switching out their poop with mouse FMT. Are we, right now, blindly doing the same thing with people? We also now know that Parkinsons, and likely other neurological disorders, likely mediated at least in part by gut microbiome composition. Are we spreading those disorders? We have no idea. There is almost no real oversight and there is precious little in the way of evidence to address these questions.
At the moment FMT is an Investigational New Drug (IND) that is functionally not subject to almost any of the rules for INDs. This means that patients are being treated despite us having no real answers to even the clearly inadequate array of huge safety questions we can think to ask. It also means that the patients being treated do not have the protections of clinical trial regulation, data from their treatments is for the most part going uncollected, and the kinds of physicians who lack the professional competence to even fill out an IND application with CBER are taking money directly from patients' pockets.
This current state of affairs has been entirely justifiable given the state of the field, the extraordinary amount of evidence for efficacy, and the desperate straights of C. diff patients - but there damn well better be no future in it. We need evidence collected from patients in real phase three trials, we need at least some kind of standardization regardless of what that looks like, and the current standard of pharmacovigilance needs to go way up. All of this necessarily means prices going up regardless of the model for FMT but, especially as FMT increasingly gets used on healthier and healthier patients, it also means we will have the tools we'll need to not hurt people.
posted by Blasdelb at 5:56 AM on March 5, 2019 [11 favorites]
For example, we know that the gut microbiome is critical component of all manner of aspects of cognition in humans and animals, from personality to intelligence to mood and anxiety to social behavior, but we really have fuck all in the way of ideas as to how. Indeed, you can make crafty, cautious, misanthropic, and anxious Balb/c mice act like dumb, trusting, and cuddly NIH Swiss mice, and vice versa, by switching out their poop with mouse FMT. Are we, right now, blindly doing the same thing with people? We also now know that Parkinsons, and likely other neurological disorders, likely mediated at least in part by gut microbiome composition. Are we spreading those disorders? We have no idea. There is almost no real oversight and there is precious little in the way of evidence to address these questions.
At the moment FMT is an Investigational New Drug (IND) that is functionally not subject to almost any of the rules for INDs. This means that patients are being treated despite us having no real answers to even the clearly inadequate array of huge safety questions we can think to ask. It also means that the patients being treated do not have the protections of clinical trial regulation, data from their treatments is for the most part going uncollected, and the kinds of physicians who lack the professional competence to even fill out an IND application with CBER are taking money directly from patients' pockets.
This current state of affairs has been entirely justifiable given the state of the field, the extraordinary amount of evidence for efficacy, and the desperate straights of C. diff patients - but there damn well better be no future in it. We need evidence collected from patients in real phase three trials, we need at least some kind of standardization regardless of what that looks like, and the current standard of pharmacovigilance needs to go way up. All of this necessarily means prices going up regardless of the model for FMT but, especially as FMT increasingly gets used on healthier and healthier patients, it also means we will have the tools we'll need to not hurt people.
posted by Blasdelb at 5:56 AM on March 5, 2019 [11 favorites]
From the article:
“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..."
Wow. Are you sure about that?
posted by jonnay at 6:19 AM on March 5, 2019
“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..."
Wow. Are you sure about that?
posted by jonnay at 6:19 AM on March 5, 2019
We make fecal transplants in my lab. There is not a ton of oversight, especially compared to something like blood banking. The donor does get tested prior to donation to rule out diseases like hepatitis and HIV. They also have to accommodate any food allergies the recipient may have. We also use familial donors instead of fecal banks.
posted by MaritaCov at 6:30 AM on March 5, 2019 [2 favorites]
posted by MaritaCov at 6:30 AM on March 5, 2019 [2 favorites]
Over regulate if you must, but there are some serious True Believers in FMT out there and they'll just go underground and turn to the Brown Market for new poo sources.
So if you want turd burglars, I guess that's how you get turd burglars.
posted by robocop is bleeding at 6:47 AM on March 5, 2019 [3 favorites]
So if you want turd burglars, I guess that's how you get turd burglars.
posted by robocop is bleeding at 6:47 AM on March 5, 2019 [3 favorites]
BTW, just to be clear, the p-value of 0.2 in that study comes from a comparison with metronidazole. It's not comparing FMT to placebo.
Sure, which to be clear is how drug trials are run. You compare to standard of care, in this case a fifty year old antibiotic that doesn't have patent / exclusivity constraints.
It wasn't rhetorical curiosity when I said I wanted to know what the regulatory oversight would be. The FDA doesn't give patents, but it can give marketing exclusivity for going through the regulatory process (including performing clinical trials). This would also subject it to manufacturing controls and mandatory adverse event reporting. It would seem weird to me if their were one "fecal transplant drug" so exclusive might not mean other people can't do it, just not using the same process?
This type of exclusivity has been abused on occasion. I don't think the FDA has the option to adjust the length of exclusivity, but it would be a good compromise in a lot of cases. If offering two years of exclusivity is enough to get Phase III trials done then that should be what is available, not a decade or more.
posted by mark k at 7:05 AM on March 5, 2019
Sure, which to be clear is how drug trials are run. You compare to standard of care, in this case a fifty year old antibiotic that doesn't have patent / exclusivity constraints.
It wasn't rhetorical curiosity when I said I wanted to know what the regulatory oversight would be. The FDA doesn't give patents, but it can give marketing exclusivity for going through the regulatory process (including performing clinical trials). This would also subject it to manufacturing controls and mandatory adverse event reporting. It would seem weird to me if their were one "fecal transplant drug" so exclusive might not mean other people can't do it, just not using the same process?
This type of exclusivity has been abused on occasion. I don't think the FDA has the option to adjust the length of exclusivity, but it would be a good compromise in a lot of cases. If offering two years of exclusivity is enough to get Phase III trials done then that should be what is available, not a decade or more.
posted by mark k at 7:05 AM on March 5, 2019
Are there problems with treating FMT the same way we treat blood or plasma? At least in the way OpenBiome is enabling?
en forme de poire: "It's also definitely more appealing to a lot of patients than the thought of ingesting poop, though the popularity of DIY treatments suggests that people are also willing to try anything they think will actually work."
Having seen my father deal with C. Diff. on at least a half dozen occasions I can't imagine anyone with it balking at taking a pill/suppository with dried fecal matter for even a minute.
posted by Mitheral at 7:34 AM on March 5, 2019 [1 favorite]
en forme de poire: "It's also definitely more appealing to a lot of patients than the thought of ingesting poop, though the popularity of DIY treatments suggests that people are also willing to try anything they think will actually work."
Having seen my father deal with C. Diff. on at least a half dozen occasions I can't imagine anyone with it balking at taking a pill/suppository with dried fecal matter for even a minute.
posted by Mitheral at 7:34 AM on March 5, 2019 [1 favorite]
If we could identify people whose transplants were especially successful they could probably make a living from fecal donations, turning brown into gold. Super poopers, if you will.
posted by Joe in Australia at 3:42 PM on March 5, 2019
posted by Joe in Australia at 3:42 PM on March 5, 2019
Joe in Australia: "Super poopers, if you will."
You'd have to imagine that, if all the hype is anywhere near true, that there would be someone out there whose intestinal fauna can reverse C.Diff, make an obese person skinny, halt or reverse Alzheimers, cure IBD, and maybe even treat schizophrenia. His poop would be worth alot . Like I'd bet they'd be able to comfortably retire on a single bowel movement a day.
It would be an interesting life. They'd be over the top paranoid about catching any disease that would effect their ability to donate. No travelling by air/train/bus; no going to anything where large numbers of people congregate. And there would probably be dietary restrictions as well; at a minimum you'd think they'd have to give up gluten, peanuts, lactose, and shell fish so as to support a broad market.
Still, not bad work if you can get it.
posted by Mitheral at 10:27 PM on March 5, 2019
You'd have to imagine that, if all the hype is anywhere near true, that there would be someone out there whose intestinal fauna can reverse C.Diff, make an obese person skinny, halt or reverse Alzheimers, cure IBD, and maybe even treat schizophrenia. His poop would be worth alot . Like I'd bet they'd be able to comfortably retire on a single bowel movement a day.
It would be an interesting life. They'd be over the top paranoid about catching any disease that would effect their ability to donate. No travelling by air/train/bus; no going to anything where large numbers of people congregate. And there would probably be dietary restrictions as well; at a minimum you'd think they'd have to give up gluten, peanuts, lactose, and shell fish so as to support a broad market.
Still, not bad work if you can get it.
posted by Mitheral at 10:27 PM on March 5, 2019
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posted by Greg_Ace at 8:03 PM on March 4, 2019 [10 favorites]