One Dead After Fecal Transplant Gone Wrong, FDA Warns (arstechnica.com) 145
fahrbot-bot shares a report from Ars Technica: One patient has died and another became seriously ill after fecal transplants inadvertently seeded their innards with a multi-drug resistant bacterial infection, the Food and Drug Administration warned Thursday. The cases highlight the grave risks of what some consider a relatively safe procedure. They also call attention to the mucky issues of federal oversight for the experimental transplants, which the FDA has struggled to regulate. In its warning Thursday, the agency announced new protections for trials and experimental uses of the procedure.
The FDA shared minimal details from the deadly transplants. Its warning only noted that the cases involved two patients who were immunocompromised prior to the experimental transplants and received stool from the same donor. Subsequent to the transplant, the patients developed invasive infections from an E. coli strain that was resistant to a wide variety of antibiotics in the penicillin and cephalosporin groups. The E. coli strain carried a drug-defeating enzyme called an extended-spectrum beta-lactamase (ESBL), which generally cleaves a ring common to all the chemical structures of those antibiotics. When unnamed researchers who administered the transplant looked back at the donor stool, they found that the stool contained an identical ESBL-producing E. coli. One of the patients died and the fate of the other was not discussed. The agency also did not say how or why the patients were immunocompromised prior to the transplants, what the transplants were attempting to accomplish, how they were carried out, who conducted the transplants, or when they occurred.
The FDA shared minimal details from the deadly transplants. Its warning only noted that the cases involved two patients who were immunocompromised prior to the experimental transplants and received stool from the same donor. Subsequent to the transplant, the patients developed invasive infections from an E. coli strain that was resistant to a wide variety of antibiotics in the penicillin and cephalosporin groups. The E. coli strain carried a drug-defeating enzyme called an extended-spectrum beta-lactamase (ESBL), which generally cleaves a ring common to all the chemical structures of those antibiotics. When unnamed researchers who administered the transplant looked back at the donor stool, they found that the stool contained an identical ESBL-producing E. coli. One of the patients died and the fate of the other was not discussed. The agency also did not say how or why the patients were immunocompromised prior to the transplants, what the transplants were attempting to accomplish, how they were carried out, who conducted the transplants, or when they occurred.
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It turns out that whatabouts are often reasonable and appropriate questions to how or if things should be addressed. Take the blinders off so that you don't narrowly focus on something in an inconsistent way to everything else that's around.
Whatabout when they aren't? I did that on purpose for illustration. Here's the issue with whataboutism. Whataboutism paints the argument or poster as a hypocrite.
Like someone from one political party does something, then the whataboutist says, Well that about so and so from your party? As if that ends the argument. As if yopu aren't allowed to mention that someone else did it.
When in fact, if one is wrong, then both are. What the whataboutism does is exhonerate the person that they are pulling the wh
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Whataoutism max, with anger issues to boot. Chill homie, all that cortisol running around isn't good for ya.
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Should we abandon injections now?
Well quite. Partly. Basically no medical procedures are without risks. Antibiotics have saved millions of lives and yet a few people are deathly allergic to them and have died. Routine surgery has improved lives for millions too, but occasionally people die. Some people can even get anaphalyctic shock from sticking plasters.
On the other hand you're not entirely right. The risks are actively reduced because when things go wrong they are studied and recorded. Feacal transplant
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"let's make sure this doesn't contain a lethal antibiotic resistant bacteria" strikes me as the sort of thing that should reasonably occur to a medical professional.
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Well, the original owner seemed to be ok (and still is) so maybe it's not that lethal. But apparently if your immune system is deliberately suppressed, guess what, those bacteria have free reign!
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If people died by being infected by dirty needles it's interesting, that should only be allowed to happen in extreme situations like war where the likelihood of dying from infection is less than dying from not being treated.
This is a similar situation and it surprises me someone is chosen as a donor without a thorough examination of things like this. Or perhaps it's from a procedural failure?
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There are a lot of regulations regarding injections: who can give them, what can be in them, what are the indications for them, and how sterility is to be guaranteed.
So yeah, shoving dirty needles into unprepared skin isn't allowed.
Fecal transplants are basically experimental. They're not actually approved for anything and haven't been the subject of proper trials to assess their efficacy and risk.
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You're half right. They're still experimental. They've been the subject of a lot of studies over their efficacy, though, and the results have been quite remarkable. Besides being highly effective at eliminating several hard-to-kill gut infections (e.g. a 90% cure rate for c. diff versus a ~20% cure rate per round of antibiotics), they hav
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I said "proper trials" on purpose. Perhaps I should have said "haven't been the subject of *many* proper trials."
There have been lots of studies, sure. There have been a few randomized clinical trials, but not many, and all the ones I found were single-centre, which can have problems. Incidentally, the trials I did found reported much more modest effects (or no effects) than the anecdotal reports.
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You might want to have a word with your wife.
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Do tell. How do you get a fecal transplant into your colon without going through one's ass? Do you even know what this is about?
"fecal transplant"? (Score:1)
What's a "fecal transplant"? When you transplant a turd from one human to another?
Deja Poo (Score:2)
the feeling that this shit has been taken before.
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yes.
the idea is to transfer healthy gut bacteria.
it has been shown to help a lot of people, but its still an evolving area of medical science.
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i eat yogurt everyday, not lots of yogurt, but i do eat a heaping spoonful everyday mixed in a high fiber cold cereal with milk and just a dab of honey, there are enzymes in yogurt that is good for keeping the gut bacteria healthy and aids in digestion
Oh boy are you ever singing from my songbook right there. I'll add that I also vary the yogurt brands. Also real unprocessed cheese. A cheese made from culture and milk. Also differ the fibre as well as the gut flora munches on that stuff. A decent glass of wine or beer once or twice a week is also helpful if you don't go overboard.
These things are so much more appealing than injecting another person's fecal donation. Who ever thought that eating shit would become a medical procedure?
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the idea is to transfer healthy gut bacteria.
It was, and may still be, but recently, in a pilot study of five patients, sterile fecal filtrate was demonstrated to be of comparable efficacy of conventional FMT in the treatment of recurrent CDI. The conclusion from this study was that soluble filtrate components (such as bacteriophages, metabolites, and/ or bacterial components, such as enzymes) may be the key mediators of FMT's efficacy, rather than intact bacteria.
There was an article on Slashdot about phages recently, if memory serves.
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Actually, I doubt it is any of those things. IMO, it is more likely that the complex mix of antibiotics produced by hundreds of different gut bacteria strains in a healthy person are sufficient to kill off the C. diff infection.
The reason I say that is because C. diff occurs mainly in people who are on antibiotics, and is triggered by the person's gut flora getting killed off by the antibiotics. Then C. diff, which isn't as easily killed, takes over. AFAIK, only two interesting things go away on antibio
Tragic but unremarkable (Score:5, Insightful)
This is not highlighting anything new, and "the grave risks" were already obvious.
The interesting part - and what matters for future interventions - is the the donor was, in effect, a carrier for a certain infection, which apparently was not discovered until after the fact. That is something the medical science might be able to learn from.
Re:Tragic but unremarkable (Score:4, Interesting)
This is not highlighting anything new, and "the grave risks" were already obvious.
The interesting part - and what matters for future interventions - is the the donor was, in effect, a carrier for a certain infection, which apparently was not discovered until after the fact. That is something the medical science might be able to learn from.
It certainly outlines some needed extra steps for immunocomprised people who might get a fecal transplant.
Now to my way of thinking, it might be a good idea to isolate the strains of bacteria that are helpful, and deliver them instead of just popping someone else's manure up another persons colon.
A side use of this might be as an experimental process for obese people who have messed up gut bacteria.
Re:Tragic but unremarkable (Score:4, Informative)
Now to my way of thinking, it might be a good idea to isolate the strains of bacteria that are helpful, and deliver them instead of just popping someone else's manure up another persons colon.
Except that is much harder than it seems. I read up in this and it seems that this not just a matter of 'the right strains'. The combination matters. They are really just at the beginning of this field. Transplanting feces from healthy people is the best they can do now.
A side use of this might be as an experimental process for obese people who have messed up gut bacteria.
This is being done. And it seems to work, at least in a lot of cases. This also one of the reasons donors have to be healthy and not obese. If you are a receiver, you want the right mix...
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Except that is much harder than it seems.
Very important, but not reason for despair. It's pointing us in the direction for future research.
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Now to my way of thinking, it might be a good idea to isolate the strains of bacteria that are helpful, and deliver them instead of just popping someone else's manure up another persons colon.
Except that is much harder than it seems. I read up in this and it seems that this not just a matter of 'the right strains'. The combination matters. They are really just at the beginning of this field. Transplanting feces from healthy people is the best they can do now.
And that has some issues, they ate the minimum need to test for pathogens, or perhaps not even do these things on immunocomprised people until they get a handle on it.
Here's an interesting tidbit, and it involves of all people, Adolph Hitler and his personal physician. Adolph as many people know, was a vegetarian. He was having a lot of GI tract problems. He was subsisting mostly on beans at the time. Theodor Morell, a physician, had done work involving gut bacteria, and wanted to try the therapy on Hitl
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Actually, FMTs must be inserted endoscopically or swallowed in frozen form. Otherwise, the bacteria do not colonize the small intestine adequately.
Anyway, the problem with isolating strains is that it isn't one strain. It's the diversity of strains that is the important part. The medical industry already isolates st
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It highlights the problems with low-tech, easy but unavailable treatments like this.
Faecal transplants could be useful for all sorts of conditions. But there isn't much money in them, so not much effort is put into developing those treatments. As such people get desperate and do a DIY faecal transplant, with all the risks of buying unregulated medicines.
People simply aren't willing to wait decades for it. There should be more test programmes running and supplies for people willing to experiment on themselve
Wishing you well (Score:2)
Don't have anything to say in response, except I am terribly sorry to hear of all your pain - I hope you can get closer to a normal life again. Good luck. :-(
"mucky issues" a Freudian slip? (Score:2)
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Shouldn't that have been "murky issues"?
I dunno, I've seen some dog turds that were pretty mucky.
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Shouldn't that have been "murky issues"?
I dunno, I've seen some dog turds that were pretty mucky.
Did you drop trou and try to perform a self-transplant?
Yeah, and now I can't take walks without chasing squirrels. And I love people to rub my belly.
Oh, shit! (Score:3)
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the moral of this story is (Score:2)
you dont want to catch cooties either
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Surely the moral is: don't take shit from anyone.
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Well, no. Your germs might be bad. The moral is someone else's germs might also be bad, or possibly worse.
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I was going to give you shit. But I decided you don't deserve it.
well... (Score:3)
Let me get this right... (Score:3)
The Doctors performing this transplant failed to do their jobs and screen for deadly bacteria from the donor and the FDA says everyone should stop.
Why don't we just start closing roads when people speed? It's the same retarded concept. This is not proper regulation. The stupid doctors should be reviewing their medical malpractice policies instead and a proper review performed so everyone can see how these doctors fucked up to help prevent another fuck up. And if negligence is found, you take the appropriate next steps.
This world is becoming so "risk adverse" that before long the government is going to start telling you what you can and can't eat for your own good... oh shit... we are already doing that. Can't wait until they are shooting people dead over food like they did & do in socialist/communist states.
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It appears that the FDA did exactly what it should.
Fecal transplant is still at an investigational stage. That means the FDA monitors what is going on and,
if patients are found to have serious adverse effects (death definitely being serious!), then a halt
can be called for while procedures are amended.
This can be temporary, as appears to be the case here, and in the worst case investigations can be completely halted
if fundamental problems are found with the therapy being investigated.
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The FDA rarely does it's job. How many times have we had controversial drugs approved and subsequently pulled from the market along with massive class action lawsuits and individual lawsuits? Let's take and old one but a good one.
Phenylpropanolamine. Used in cold preps for decades. But when a member of our "ruling class" has a child die from it we yank it full stop. You see, it does not matter that several OTC meds kill thousands each year, heck if it killed you or your child no one would give a shit.
Y
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Of course, for most studies, this shouldn't require stopping most studies at all, because most of them should already get their samples from a stool bank, and the major stool banks already screen for multiply-resistant bacteria as part of their standard scree
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Why don't we just start closing roads when people speed? It's the same retarded concept.
No, it's not.
Let's take an example of the F-15.
https://en.wikipedia.org/wiki/... [wikipedia.org]
There was a crash of an F-15 that was, perhaps putting it mildly, quite unusual. They didn't ground all aircraft, only the F-15. After some review the newer F-15E was cleared for flight. Then they cleared older F-15 models for flight after they passed inspection, those that didn't pass inspection were repaired.
So far we have the first step, we stop this specific procedure until we can figure out what went wrong. Then we see
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We know exactly what went wrong. They didn't obtain it from a source that screens their samples. There's no need to stop anything other than buying stool samples from stool banks that don't screen their samples.
Stopping the procedure would be approximately as silly as stopping the sale of cantaloupe nationwide because somebody snuck a single uninspected shipment across the border and somebody got sick.
Re:Let me get this right... (Score:5, Informative)
" the FDA says everyone should stop."
Please provide a citation to back up your claim that the FDA ordered fecal transplants to stop.
The safety alert form the FDA highlights the problem and lists some additional protections that should be taken: https://www.fda.gov/vaccines-b... [fda.gov]
If the FDA were ordering fecal transplants to stop, they would would not need to order additional protections for performing fecal transplants.
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In perspective (Score:2)
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How many people are dead from prescription pain killers?
When used as prescribed? My guess is the number is quite low.
When misused or abused? My guess is that the number is far higher.
What we have is a death from a procedure that was considered relatively safe. A procedure that is also considered experimental. From what I read the procedure did not deviate from the norm in how it was applied. Comparing this to deaths from abuse of prescription drugs does not follow.
I can see it now (Score:2)
wait...are you telling me (Score:1)
putting someone else's poop in my body is a BAD idea? Whaaaaa?
Shotgun approach vs. precision ... (Score:3)
Right now, the fecal transplant is a shotgun approach: the entire fecal matter is transplanted.
This is because we do not, yet, understand the details of which bacterial species, or combination of species have the desired effect (be that overcoming a third virulent species, or 'balancing' the flora to avoid certain symptoms, ...etc.).
As research increases in this relatively nascent area, we will understand the relationships between these organisms, and then isolate the individual bacteria in the lab on Petri dishs, then administer the one or few combinations that overcome the specific situation in the patient.
This selective and targeted approach will also avoid injecting harmful species (and parasitic worm eggs, and all sort of other nasty stuff, like we do now).
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You're assuming that it is just a couple of species that are helpful, rather than hundreds. All evidence thus far suggests that gut biome diversity is the difference between getting C. diff (or being a carrier) and not, so I wouldn't assume that..
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My comment was not restricted to C. difficile, or any one case.
There are symptoms and syndromes as varied as being extra gassy, to really bad odour, all the way to IBS and the cases that need to remove the entire colon and live with a colostomy bag. In between ther
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Neither were mine, really; the same is true for protecting against any other invasive bacterium. C. diff just happens to be by far the most common use of FMT (common enough and non-experimental enough for it to usually be covered by insurance).
All bacteria produce and release antibiotics when in the presence of diss
You know who else had a fecal transplant ... (Score:2)
Not sure if it real or fake but I once read that Hitler had severe stomach issues and some quack cured him with a fecal transplant. And thus became a very trustworthy doctor in the inner circle of the nazis.
Fate (Score:2)
One of the patients died and the fate of the other was not discussed.
Well that sounds ominous. (I know it isn't, but that wording)
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Yeah, it makes it sound like the other patient would’ve preferred death to his actual state.
People in critical condition die (Score:2)
It happens. Nothing to see here, really.
Clostridium difficile (Score:1)
Also known as "c. diff." is the only disease for which the US FDA allows fecal transplants. The keyword here is "allows" because it is not approved, merely "allowed", one step above "experimental".
However Clostridium difficile [wikipedia.org] is such a nasty, life threatening disease, which only partially responds to antibiotics, that the FDA has allowed fecal transplants in this case. This allowance is only recent, and many people have been so desperate that DIY fecal at-home fecal transplants [webmd.com] are fairly common.
Far too much secrecy (Score:1)
... the fate of the other was not discussed. The agency also did not say how or why the patients were immunocompromised prior to the transplants, what the transplants were attempting to accomplish, how they were carried out, who conducted the transplants, or when they occurred.
This is totally bogus. Can somebody please file subpoenas to get the FDA to cough up the info?
Eat shit and die... (Score:1)
... no longer just a harmless childish taunt! They've weaponized gradeschool bullying at an entirely new level!
who'd have thunk it? (Score:2)
so putting another person's shit in you could lead to bad things happening? I'm shocked. I'm sure a tenth of the German porn industry is shocked too. What's next, they'll say fucking someone in the rectum could spread bad diseases faster than any other type of sex?
Well.... (Score:1)