In Praise of Extreme Medicine

This Buzzfeed article on unauthorized poop transplants has much of interest:

A spate of studies over the last decade have convinced microbiologists and doctors that “fecal microbiota transplantation,” or FMT, works for at least one disease: a deadly bacterial infection in the gut known as Clostridium difficile, or C. diff. No one knows whether the procedures work on other conditions, though dozens of clinical trials are testing them on people with irritable bowel syndromeCrohn’s diseaseobesitydiabetesepilepsyautism, and even HIV.

The science is advancing rapidly, with more and more scientists excited about the potential and potency of fecal matter and the microbes in it. The FDA regulations on these procedures, however, keep them out of reach for most patients: Since 2013, the agency has banned doctors from doing fecal transplants on anything except C. diff.

A rogue clinic in Tampa, however, provides the carefully sourced material and explains to patients how the procedure is done. Since the procedure is simple, lots of experimentation is going on which upsets some people.

Poop from an unscreened stranger could carry serious infections, like hepatitis or gonorrhea, or dormant viruses.

No doubt–this is why we also ban sex and french kissing.

I suspect that many of the so-called treatments are crazy but people do a lot of crazy things. It’s odd that we allow some crazy things and ban others—even more that the crazy things we allow are sometimes socially useless while the crazy things that we ban are sometimes socially valuable.

The case for banning extreme sports, for example, is much stronger than the case for banning extreme medicine. Extreme sports don’t provide much benefit to the rest of humanity, other than some entertainment of questionable social value. Extreme medicine, on the other hand, has the potential to improve all our lives and at the very least is a useful warning about what not to do. Yet, extreme sports are lauded, or at least treated as mostly your own business (we do put some regulations on boxing and race car driving), while extreme medicine is heavily regulated and socially frowned upon.

My attitude is the reverse. You want to risk your life climbing without ropes? Knock yourself out–but don’t expect any support from me. I won’t even watch Alex Honnold because I think that what he does is Russian roulette and I do not approve. But, you want to risk your life trying an unapproved medical treatment? Sir, I salute you. Give that man a Nobel prize.


C.diff is transmissible, but it commonly arises from use of broad-spectrum anti-biotics. They can usually knock it out of your system with Flagel, but not always. I knew a woman who had chronic c.diff for the last 7 years of her life.

Lots of recent research indicating the microbiota of the gut are extremely important for human health (including hints that good gut health is important for good mental health) and that broad spectrum antibiotics may CAUSE problems by messing up the gut.

Indeed. The disbiosis caused by antibiotics has been shown to weaken the blood-brain barrier (suggesting new avenues in Alzheimer's disease research), to cause gut leakage (which precipitates liver changes known to lead to liver cancer) and to cause the unusual patterns of SNPs that are also the hallmark of oral squamous cell cancer. "Bones" McCoy was right. The physicians of our era will in the future be remembered as being far more dangerous than barbers bearing mere leeches.

There's a lot of hype about how important and game-changing the microbiome is. It follows many hyped ideas/technologies in biology, e.g. the human genome project, epigenetics, stem cells, synthetic biology, etc. There's a lot of good work in those fields, but the media hype, and science hype at times, promises too much. I'm sure microbiome research will give us good, interesting results, but I'm skeptical that it will deliver what some of the news articles and research promise.

I completely agree. All except the part about Alex Honnold -- I'm convinced he'd be doing exactly what he is doing regardless of whether or not anybody was paying attention (except, perhaps, other climbers).

I'm not sure you can or should ban extreme sports. But it is important to understand that extreme medicine is something completely and legally different. The cardinal rule in medicine is "first do no harm". If in an attempt to cure/help you do harm then you are legally and morally responsible.

I think if the vocabulary had been available, the cardinal rule would have been "the expected value of the action you are taking should be positive." Expecting medicine to be Pareto optimal is unrealistic.

Who gets to decide that "first do no harm" is paramount?

You reach man, none of comparamours of under water fish, the straits or hollows of Jupiter's Sulphur, a rustic swallow, a creeping willow, the mercury rising again, living in another world.

If in an attempt to cure/help you do harm then you are legally and morally responsible.


Yes, in an act of selfless generosity,

I have agreed to collect my own poop

And offer it free to readers of this post.

But, alas, Alex has declined my shit,

Insisting that it must be sold as part of a shit exchange

Modeled after a for profit kidney exchange he dreams of.

Damn that FDA. People dying without access to good shit.

This sounds great sung to that "Heaven is a place on earth" song.

You have my permission to use the lyrics for non-commercial purposes. All other rights are reserved. Copyright Bill 2017

Spoken like a guy who doesn't need a kidney.

Yes, kidneys should go to the highest bidder.

People should be allowed to undertake a consensual exchange, yes. It isn't any of your business.

You are not familiar with the externalities from monetization. Good for you. What are your views on a distraught new mother selling her child, indentured servitude, buying child porn, or payment for sex (prostitution).

The libertarian position on those are: child selling is wrong (child cannot give consent), indentured servitude is ok (consenting adults), child porn is wrong (children cannot consent to making it), prostitution is very ok (that one is libertarianism 101)

Re: Child selling.

Are you sure of the libertarian position.
What if the mom deliberately created this new property in the hopes of selling it.

Are you saying she should be denied the opportunity of capturing the benefit of her own labor.

Indentured servitude is a free exchange, so why object? Just another example of the nanny state.

Child pornography: what if the child consented in exchange for a trip to Disneyland. What if it was a thirteen year old. A fifteen year old...where do you draw the line for consent. Just another example of nanny state interference.

And, from there, I guess, logically, we slip into prostitution.

Wouldn't child selling be more of a progressive thing? If you can kill them, you should be able to sell them.


Don't suggest this to Newt Gingrich who wanted to take children from parents and place them in foster care or up for adoption.

We have private prisons and laws which promote incarceration. The last thing you want are policies which favor adoption for money.

And Bill has reached a new low.

Blue tribe economics. All demand curve, no supply.

Or, maybe they assume the supply curve is a vertical line.

Or maybe the fear is an unequal distribution of kidneys. Better many die than some live. Since it's not fair.

Or it's okay, but only if it's a line and the price is time. Even if many more people die because it's illegal to pay.

I suppose it's just a left wing set of ethics: more deaths > mixing money and health.

Sacred and the profane and all that. Not any different than saudis letting girls burn to death rather than run outside of a burning building without their faces covered.

Sacred and the profane. I wish we could have a left wing that could drop the religious framework. It's 5000 years old and stupid, and we more than meet our quota from the idiot right wing.

No, Potato, just plain economics. Behavioral economics. Do some reading on the subject of taking transactions that are non-market (donating kidneys ala donor programs) and switching to a market system.

You do not advance an argument when you use the Fox News Left wing meme either. Grow up. Turn off the TV. Read.

Of course, what Tabarrok is encouraging is a form of human sacrifice. We do it with mice and monkeys, so why not with Mary?

Of course few people like him would consider this sacrifice, only the most desperate (read: poor, and african-american, which is why he thinks its ok). The comparison with extreme sports does not make much sense..

You think it is poor African Americans who are getting poop transplants?? I promise you 1000% that is not the case

human sacrifice? You asshole. C-diff is a really serious infection, and a hell of a lot more dangerous than even a completely random, unscreened fecal transplant

amusing to see auto racing listed as an extreme sport when racer all seem to feel the need to prove to outsiders that racing does make them athleats an is physically & mentally demanding. To call either boxing or auto racing an extreme sport seems odd -- MMA, sure; cliff climbing without safety lines, okay. That said the impact seems to be limited to the voluntary participants and, where they exist, audience.

In the case of medicine it's not always the case that the impact is as localized and more importantly in most cases the abilility to assess the risks more limited making the customer dependant on a specialist who may or may not have that person's best interest in mind. That would put extreme medicine in a different class than extreme sports.

This post was not carefully thought. Alex needs to realize that he went full "society value is more important than the individual freedom/happiness". Then realize that bull riding is an extreme sport, it's not only Alex Honnold or Evil's America.

But we're rational around here. Thus, let's ignore those two controversial things and focus on the central issue which is the FDA regulations on fecal transplants. The linked Nature article where scientists suggest to treat poop as a tissue instead of a drug is great. Then, you realize why regulations are needed: "Duff tries to remind everybody that donors need to be tested for infections first.". As example, every time an individual donates blood it is tested because there are no safe donors. A gastroenterologist is quoted later in the article saying that without careful screening this is a way to spread unknown illness.

Is this really about the FDA and government regulations? Is this not actually about the social status of doctors? They have a reputation (and incomes!) to maintain (do no harm and all that). Any loosening of constraints will likely bring in much more snake oil than legitimate experimental therapies. Could doctors maintain their vaunted status (and consequent incomes) under such conditions?

It's probably also about regulation bringing higher prices for the procedures and suppliers. It's not just government, it's driven by commercial suppliers and want-to-be commercial suppliers.

To understand why this needs to stay regulated until we know more about it, you only have to think back to the 1990's when bone marrow transplantation (BMT) became popular as a treatment for advanced breast cancer. BMT was already established as a treatment for some hematologic malignancies, so there was little restraint on its use for other things (for which its effectiveness was not proved.) There were big bucks to be made, a population of desperate patients eager to grasp at straws, and a health-care industry well prepared to market it aggressively. It spread rapidly, with desperate women appearing on morning TV shows to plead for their insurance companies to cover the huge cost.

There was, in fact, a National Cancer Institute sponsored clinical trial to test whether it actually worked. But the trial suffered from extremely slow recruitment, as women, convinced by the hype about it, declined to be randomized. They were so sure it worked. This went on for years, and eventually the NCI trial was completed. The results were dramatic: it didn't decrease breast cancer mortality. (At first there were some questions raised because in one site they seemed to get good results. An audit of the trial later discovered that those good results were actually based on falsified data.) Now, if getting a BMT were innocuous, one might say that fools will always be parted from their money and this would serve as a cautionary tale for future fools. But BMT is itself a life-threatening process. It involves obliterating the immune system, and then "rescuing" it with the BMT "just in time" to prevent death from overwhelming infection. Unfortunately, there is an appreciable mortality from the procedure (which was even higher back than then it is now.) I don't think anybody every kept statistics on how many women died from useless BMTs in that era.

The point is that innovative treatments are playing with fire. There is always a downside; there may or may not be an upside. Only a minority of what appear to be initially promising treatments actually prove effective when properly evaluated. So when dealing with a new treatment like fecal microbiota transplantation (FMT), the situation is somewhat like that of BMT and breast cancer. The treatment itself, though not nearly as dangerous as BMT, still carries an appreciable risk of inducing life-threatening consequences, though it may ultimately prove effective for a life-threatening and difficult-to-treat, but relatively uncommon condition.

I haven't done any calculations, but my instinct is that the number of people who will be harmed or killed by uncontrolled use of FMT pushed by eager providers on patients with limited understanding will exceed, perhaps greatly, the number of people who might avoidably suffer and die from C. diff. during the time it will take to properly assess its usefulness. So let's keep it restricted while we figure out whether, and under what circumstances, it works.

[Note: I am not familiar with the specific regulations the FDA has imposed on FMT: they have different tracks of varying stringency for different types of treatments. I am not expressing any opinion on these particular regulations, only on the notion that FMT should not be deregulated, and people allowed to take their chances with it, at this time.]

I know better than you. You would be better off if I made your medical decisions for you.

You probably would be. I know my plumber is better at making plumbing decisions than I am.

Marrow ablation followed by BMT used to run $800,000 at M.D. Anderson and many died of GVHD before anyone could tell if it worked. Poop on the other hand, even that of the highest quality, has historically been inexpensive.

Remember, the point of microbiota transplantation is to enhance your immune system. The point of BMT is to destroy it and replace it with another.

just curious, how does one determine the "quality" of fecal matter? Is there objective criteria?

Nestle and others are investing billions to find out.

There is a difference between what individuals may do and what an institution whose motto is first do no harm may ethically undertake, especially when funded by others and provided sanctions through licensing.

I look forward to the Unauthorized Poop Transplant Act of 2018.

Or consider the remarkable discovery of the interaction between commensal bacteria, checkpoint inhibitors and cancer. Or any of thousands of equally bizarre (but only because we've been doing biomedical science all wrong for so long) discoveries flowing from actually opening the black box and doing real experiments (e.g. the H. pylori story). The "mindless" null hypothesis ritual wasn't just a mistake. It was a way to control science. A way to control the accumulation and dissemination of knowledge. And its sudden collapse is probably the most important yet under-reported story of our time.

The FDA can stop you from buying some medicine you'd like to try but it can't stop you from ingesting bacteria that will happily make the very same molecule (e.g. serotonin) for you (for free). The FDA can refuse to approve a therapeutic regimen but you are free to swallow a poop pill teaming with microbes that will team up with your immune system to seek out and destroy intracellular pathogens that are working hard to turn you into a meat pie. You may soon even take a poop pill to control your high blood pressure:!po=0.359712

We're in the midst of a paradigm shift and as you point out it's one that will profoundly alter our masters' ability to control healthcare.

What is stopping the FDA from regulating "poop-pills"?

It's neither a food nor a drug/device. On the other hand, to exploit the poop-rush a number of companies like Seres Therapeutics are courting regulation (for the obvious reason) by testing mixtures of pure spores from various combinations of "good" bacterial communities and have also secured patents on their refined crap. Whichever company wins the race to tune the various microbiotas of the body will have done mankind a great service but once the secret is out of the bag/rectum it's hard to see how they'll make money (the bacteria being self-replicating) even if they follow the GMO crop seed model (are the Feds really going to prosecute someone for taking crap off their neighbor?)

"(are the Feds really going to prosecute someone for taking crap off their neighbour?)"

Neighbour 1: "What the hell are you doing in my bathroom?

Neighbour 2: "Aw, you always seem so sleek and happy. I just want some of your poop for transplantation."

Neighbour 1: "Well, okay. But just you. I don't care to supply everyone in the 'hood."

Neighbour 3: "Hey, sharing with him huh? But you won't share your poop with me? You will now. This handgun is loaded. I DEMAND your healthy gut microbes!"

Scaring the crap out of healthy people - a new mob business angle :) --- or is it a much older business angle?

The situation is not as dire as Alex makes it out to be. Of course I know well from past posts that the good economist seldom misses an opportunity to bash the FDA. A quick scan of the database that is maintained by the NIH using the term 'fecal transplant' shows that 227 trials are registered. These include studies that have concluded, are active but not recruiting new patients and those that are recruiting new patients. Many of them are/were for C. difficile but many other conditions are being studied.

"The FDA regulations on these procedures, however, keep them out of reach for most patients: Since 2013, the agency has banned doctors from doing fecal transplants on anything except C. diff."

So the procedure is not banned. Exactly what is being kept out of patients hands? If it's approved for c. diff then apply for it to be approved for other indications.

Again this sounds like TacoCopter....supposedly it's the regulations at fault but actually citing the regulation to blame seems beyond the author.

If you set out to give the quacks free reign, they'll mess it up for everybody.

When a photogenic patient dies after receiving Mystical Pete's Magical Snake-oil Infused Feces, there will be a panic and the government will crack down. All those promising trials that you cite as rapidly advancing the science will be shut down and we'll all lose out.

If the science is already advancing rapidly, let it.

Exactly. Doing the right thing in medicine MATTERS. It is so much easier to market a fake treatment than to actually make a real one. I think you can make the case for allowing for more potential harm to study participants to encourage more radical experimentation in regimented clinical trials, but what the OP is proposing is wildly reckless. It seems like he is saying that he is happy with people being given whatever quack 'medicine' they can be convinced will work, and his idea of experimentation seems to be more along the lines of 'give it a try' than 'carefully designed scientific study.'

I'm reminded of the quack cancer doctor who has been 'experimenting' with his ineffective treatment for 40 years ( ). Does the OP salute him for his experimentation and write off the deadly harm to patients as there own fault for believing him.

Transpoohsions have been around for several years now to replenish gut bacteria wiped out by antibiotics used to fight C. Difficile.

@Borjigid may be right about the potential for panic and government bureaucratic shutdown. We've seen such for other products. But what I wanted to mention is that this area of research only came to my attention in the past few months, and it holds a great deal of promise. That antibiotics wipe out gut bacteria has been known. That gut bacteria may play a significant and larger role is not known, but there is promising evidence that this is the case.

I'll just leave it here and walk away...

WTF is "extreme medicine"??? Can you give us examples? How is it different from snake oil or something I'd read about in a book by Kevin Trudeau? I can see the internet ads: "EXTREME MEDICINE - the life-saving remedies THEY don't want you to know about!"

I'm reminded to the sad sight of Steve McQueen spending his last days being injected with apricot pit extract and sheep fetuses, and being flushed with coffee enemas. I guess it didn't harm anybody else, so I suppose he had the right to die any way he wanted, pathetic and fraudulent as it was. But there are a lot of vaccine denies and autism kooks who consider themselves also brave practitioners of EXTREME MEDICINE! (TM), and their freedom to believe and practice nonsense does in fact affect the rest of us.

The solution to the problem of a fecal transplant being contaminated with a disease from the donor is for a patient to use their own microbiota.

If you're being prescribed a dose of antibiotics or if you're scheduled for a hospital admission where you might be given antibiotics to ward off an infection after surgery, you should collect a small, cherry-sized stool sample beforehand and freeze it in your freezer. If you catch C. difficile, you can repopulate your gut with the presumably healthy microbiota you had before the infection. This is an autologous fecal transplant and is analogous to an autologous blood transfusion.

Good concept. A -60C freezer would be far better and a home freezer will allow bacterial death.

For the medicine/sports question, the answer seems fairly straightforward: you generally do sport only to yourself, but medicine is by definition a service given to another. That makes it much more susceptible to regulation.
And I agree with the point made by several others above: it seems much easier to break a system that generates genuine medical advances than it is to maintain one.

Should doctors be excused from liability when 'extreme medicine' goes wrong? Doctors are risk averse because they may be liable for everything that goes wrong.

If you want to take the risk of an unproven medical procedure, fine. Doctors, however, have to operate within an incredibly trigger-happy legal system which does not tolerate risk.

It is ironic that the quacks of alternative medicine seem to be free of FDA control as they sell their holistic medicine and homeopathic nonsense. You have MD's telling people not to vaccinate their children on a normal schedule that is risking the lives of other children or injecting ozone into your blood with no clue about the chemistry of what they are doing. You have MD's making all sorts of scientifically false claims and even suggesting that an infinite dilution of an active ingredient is active. The FDA does nothing about this false "science" nonsense.

However, the FDA does have to power and desire to block fecal transplants even after it has been proven for at least one viable application. All other drugs for one use are free for MD's to utilize "off label".

However, the FDA does seem to be anal about the subject and is saying NO. They could have just looked at risk minimization issues like using sources that people have already been exposed to. Instead, they want specific bacteria strains and will be facing the problems associated with any bacteria strain that has a real interaction with the human as part of a gut microbiome. The nature of that interaction depends on the specific history of previous interactions between that species/strain and the host's immune system plus all the interactions between the FDA approved species/strain and the bacteria phages in the gut that could/will change some of the approved DNA and functions or just kill off that species making that approval irrelevant.

To complicate the issue, even more, is the observation that we can't even grow more than a few % ( about 7% or so) of the organisms that make up the human microbiome. We only know about them from their DNA and we have no idea what they do or how they interact with other species or how to even grow them. We also know that some bugs both make rats healthy and improve several health factors while increasing inflammation in the lower gut and the risk of colon cancer.

The risk of a fecal transplant from someone who you live with is very minimal as most of their bugs, your system has already seen and is immune to. Some of the bugs we can't grow may be relevant to gut health, but if we can't grow it can't be FDA approved.

The FDA has evolved into an organization that is doing more damage by delays that they are savings. We have to start asking the FDA: how many people did you kill today?

Your point about culturability is critical to this discussion. The idea that if you can't grow it in some sea weed - based medium then it doesn't exist lies at the heart of the US Surgeon General's claim 50 years ago that we'd conquered infectious diseases and had entered a new epidemiological transition in which the only important diseases were manmade/man-caused. There are no scientists so blind as those who refuse to see

Is the phrase "French kissing" considered cultural appropriation?

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