When Poop Becomes a "Drug," Docs Better Watch How They Speak to the FDA

There appears to be a little hangup in all the good news about poop helping cure intestinal infections. You see, when you discover that something, anything, acts as a cure for disease, well, that something becomes, in the parlance of the U.S. Food and Drug Administration, a “drug.” 

 

And as a drug, that something must go through a strict approval process. All kinds of testing and forms to fill out. Can take years. Except the doctors using poop to eradicate recurring infections of Clostridium difficile bacteria don’t have years. They have patients who need the treatment now. 

 

The New York Times article reporting on the research results (which is the most emailed article at the NY Times, by the way) noted at one point:“Dr. Lawrence J. Brandt, a professor at the Albert Einstein College of Medicine in New York, said that the Food and Drug Administration had recently begun to regard stool used for transplant as a drug, and to require doctors administering it to apply for permission, something that he said could hinder treatment.”

 

Now, I can understand that Dr. Brandt might become impatient with the FDA and its rules. It has used those rules to require food sellers to remove information from the Internet in which they even hint that certain foods can relieve certain medical conditions and thereby improve health. So if food can be considered a drug, why not poop? 

 

So here’s some advice for Dr. Brandt to deal with his impatience: 

 

*Try not to lash out at the FDA. If they hold up your treatment, definitely don’t say, “You guys are full of shit!” Instead, try the soothing-voice approach, as in, “You guys are sooooo full of shit.” 

 

*Try not to threaten the guys and gals at the FDA. Definitely don’t tell them, “You guys better move it, or the shit is going to hit the fan!” Rather, say something that might be appealing, given the new status of poop, like, “The sooner you guys approve this, the sooner we can all bathe in the shit that is going to fly around here.” 

 

*Keep a lid on the personal accusations. You might be tempted to tell one or the other FDA operative, “You guys really have you heads up your asses.” Temper it a bit. Something more positive, like, “Hey, try sticking your head up your ass, you may find some of the meds I need.” 

 

*Don’t question the FDA commitment to improving health. When an official talks about how the approval process “takes time,” don’t get accusatory, as in, “You guys don’t give a shit about whether people suffer.” Give him or her an incentive. “Next time you shit, think about how you could be helping people.” 

 

You see, it doesn’t have to be adversarial. Dealing with the FDA can be smooth and easy. No shit. 

Deborah - Pacifica's picture

Oh my gosh, David, I've got to say this has got to be one of the most humorous article To date! Love the list of Dr. Brandt's advice that you included. Despite the humorous side of a serious medical issue, as usual, you bring home the point of how disingenuous the FDA is. I keep praying that someone will pass some sort of restraint on the FDA with regards to ancient healing practices that have been around for eons! Those practices did not need an agency to verify that they healed a person & those same practices today still does not need them. The FDA needs to butt (yes, pun intended) out of these practices!

Smooth and easy, just like a bowel movement should be. =8-o

I sure wish the shit would hurry up and hit the fan with the fda because they desperately need to be dismantled. I'll bet there isn't one live brain cell around the place. If there is, no one is using it.

I have a question: IF the drug companies/manufacturers are no longer liable for adverse reactions or the resulting damage from the reaction, why do drugs have to be controlled? I mean, it's like they can put anything - ANYTHING - into these pills and potions and yet the fda *approves* it. That simply doesn't make sense.

The answer is that (corporate) control is the goal. That's why all regulation is promulgated, and all legislation written, to maximize government discretionary power, while granting corporations every kind of special right and absolving them of all responsibility.

The idea is to place corporations above the law in principle, and give government total flexibility to enforce laws and regulations only in ways which benefit corporations and assault dissenters from corporate domination and challengers to it.

That's why drugs, for example, are "controlled" at FDA discretion - what's really to be controlled isn't drugs but any threat to the power of Big Drug. The same is true of the Food Control Act and its accompanying regime of the food police. The goal is to strangle the Community Food movement in its cradle.

I think I might have found another reason why the "control" of drugs is important to the benefit of our gubment AND to bigPHRma. They are just going to make damn sure they get us coming and going.

http://washingtonexaminer.com/tax-on-flu-vaccines-helps-fund-national-de...

Making us pay for our own slow demise, too boot. Now that's slick. Gotta hand it to those doods in WADC, they're a bunch of underrated treasures, aren't they?

Well, don't let yourself be misdirected by the "national debt" scam, which is a meaningless number.

The most interesting and disgusting, and typical, thing here is how the government taxes customers to cover the corporations' legal risks, and how those risks are transferred from the corporations to this fund. That's typical corporatism, and a good example of how the corporate state functions: Nominal government transfers power from itself to the corporations it creates, while transferring all liabilities from the corporations to itself.

The intended end result: Corporations have 100% of the power and license, zero risks or responsibilities, governments (still nominally "democratic" and "accountable") function only as propaganda disseminator, corporate welfare bagman, and thug. The people are completely dispossessed and dominated. This is how corporate totalitarianism is being constructed before our eyes.

There is no national debt, not really. Just ask Krugman who thinks we should just mint a trillion dollar coin and poof our problems are gone. Yes, the idiots are clever.

All the small agencies were designed to cover up the short-comings of the corporate world. What a great place to stash and lose money, huh. Very clever indeed.

But a tax to help us kill ourselves with unwanted, unnecessary, unproven, untested, unscientific vax?

Yes, we must understand that taxes are fiscally unnecessary, but are only for purposes of fiscal propaganda and social control. As we've seen in Texas and elsewhere, the goal is to force as many vaccines as possible upon the people. The purpose of this is corporate profit and to force people into the corporate medicine system. Tying dedicated taxes to particular vaccines is meant to generate racket alliances (now the weapons rackets have an interest in vaccination) and build legislator support for coercive legislation.

As for the "debt", if a society wants to have centralized money at all, then a government can directly issue enough money to lubricate the productive capacity of the real economy. That's what the 19th century Populist farmer movement demanded, with the greenbacker planks of its platform. Needless to say, the exact opposite has since been done, and we've seen the devastating results. (Direct money issue would of course be best for farmers and worst for banks; it's a testament to modern insanity that among farmers today one's most likely to hear them suicidally parroting Wall Street's lies about money.)

churchlanefarm's picture

They regulate drugs such as antibiotics in order to kill microorganisms, now they want to classify and regulate shit as a drug because doctors are scurrying two use it in order to offset the effect of those same above antibiotics!?

Thanks for pointing out the lighter side of this autocratic insanity David.

Ken

Ora Moose's picture

I just had a great idea for a new business: Shit banks! Kinda like sperm banks but without the risk of babies... Now if there was a way that you could actually prove that your shit is the best around, you could become a "shit stud" and make a killing. Wait, that's the wrong word for earning a living, unless you are into antibiotics. And maybe you could get free asswipes for life, but strictly organic of course.

I wonder if the diet of a "shit stud" would play a large role in effectiveness, anyone know?

Ora Moose's picture

Once again logic, truth, ethics and integrity in medical science somehow got trumped, according to this NYT article. How can anyone rationalize that "The study was originally meant to include more patients, but it had to be cut short because the antibiotic groups were faring so poorly compared with the transplant patients that it was *considered unethical* to continue." It sure seems to me, it is a hell of a lot more unethical to stop when the results show that something actually works, no?

The truth is out there, and sometimes it just gets squashed but in this case I wonder, by whom? Wait, I just found a clue in the last paragraph: "Eventually, he said, if researchers can determine which bacteria are crucial, it should become possible to create products containing them, and to spare everyone the unpleasantness of dealing with stool specimens." Researchers need work too you know, even when not much of it is needed.

In other words, if something so simple and cheap works, we must regulate it to a stop until we can distill it and make an artificial expensive and controlled alternative that can be highly profitable and "less unpleasant."

You wouldn't want all those poor multibillion pharmaceutical corporations to go hungry now, would you?

Ora Moose's picture

One last thing: The FDA should not be allowed to get a stool at this table, or eventually maybe we'll end up getting arrested for pooping outside their jurisdiction.

[quote from Ora's post above]: "In other words, if something so simple and cheap works, we must regulate it to a stop until we can distill it and make an artificial expensive and controlled alternative that can be highly profitable and "less unpleasant." "[end of quote]

There already is a "less unpleasant" version. It's called a probiotic, and although it will take longer to do the job, it will work, no matter which end it goes into. After all, all poop has different microorganisms depending on the source of the poop so there are no guarantees even if *testing* is done. I prefer to use foods such as kefir or yogurt or homemade sauerkraut or pickles or horseradish - any combination of those and many, many other fermented, probiotic rich foods. Of course, no doctor is going to recommend those simple solutions when he can recommend surgery and drugs. That's a given. Then, too, doctors are forced by insurance companies to cut costs by prescribing a “one-size-fits-all” treatment whenever possible. Many of the symptoms of C. difficile are identical to the side effects of the antibiotic drugs. And GP's can be inexperienced with C. diff diagnosis and treatment. Misdiagnosis is common. Because most antibiotics can make C. diff worse, you need to be very careful about the use of antibiotics if you have a C. diff. infection.

Most doctors don’t know the first thing about natural medicine because they are never taught about it in medical school. In fact, most of them will discourage the use of natural medicine, even though they know nothing about it. The sad thing is, they don't want to know be

[quote from Ora's post above]: "In other words, if something so simple and cheap works, we must regulate it to a stop until we can distill it and make an artificial expensive and controlled alternative that can be highly profitable and "less unpleasant." "[end of quote]

There already is a "less unpleasant" version. It's called a probiotic, and although it will take longer to do the job, it will work, no matter which end it goes into. After all, all poop has different microorganisms depending on the source of the poop so there are no guarantees even if *testing* is done. I prefer to use foods such as kefir or yogurt or homemade sauerkraut or pickles or horseradish - any combination of those and many, many other fermented, probiotic rich foods. Of course, no doctor is going to recommend those simple solutions when he can recommend surgery and drugs. That's a given. Then, too, doctors are forced by insurance companies to cut costs by prescribing a “one-size-fits-all” treatment whenever possible. Many of the symptoms of C. difficile are identical to the side effects of the antibiotic drugs. And GP's can be inexperienced with C. diff diagnosis and treatment. Misdiagnosis is common. Because most antibiotics can make C. diff worse, you need to be very careful about the use of antibiotics if you have a C. diff. infection.

Most doctors don’t know the first thing about natural medicine because they are never taught about it in medical school. In fact, most of them will discourage the use of natural medicine, even though they know nothing about it. The sad thing is, they don't want to know be

Ratz . . . I hit the "post" button by accident. Doctors don't want to know much about natural medicines because it's a whole 'nother field they'd have to study. In a way, I can see their point, but then again they should want to know what works, right?

Simplicity, add a bit of class--be open---polite-- inviting----perhaps;

"Mi caca su caca."

ingvar's picture

David.

Sylvia Gibson's picture

Ora, will the shit banks be organic?
David, great post!

Sylvia Gibson's picture
mark mcafee's picture

I am critical of Aajonus's cult like style. Critical of medical advice being retrieved by speaking to animals. Critical of his weird concepts of sex. I am not critical of his basic nutritional concept which advocates a whole and unprocessed diet. Just this last week, one of his patients contacted OPDC saying that Aajonus claims that OPDC raw milk.....is not really raw....because OPDC freezes all of our raw milk. This is twisted and a blatant and outrageous lie... That is why I am critical of Aajonus. He could be a revered and respected healer.....instead he is a confusing self appointed cult quack. In 2003 OPDC fulfilled special requests from Aajonus for containers of fresh manure to be consumed on his food. He explained that he needed this as a powerful medicine. I had no problem with this....it is the additional garbage that I challenge.

I hope that the FDA sticks its nose into the wild and unknown samples of diverse probiotic human fecal matter. It will drive them crazy. All science at the FDA is based on strict "standards of identity". Human fecal samples lay far outside of any definable known standards. They are each special and different....

If the FDA ventures into this realm....raw milk acknowledgement as a medical food is close at hand. The FDA criticism that raw milk contains some fecal type bacteria would then be less villianized. In fact that could be the very basis of some of its medical value.

Add to all of this the pending primate studies being performed at certain CA Universities showing how raw milk cures Crohns.....and the FDA will be in a shake up. Its bias will be clearly exposed. The NIH will follow close behind by connecting the dots and it will be a brave new world. Evolution takes time and it takes persistence. The truth is the truth.

I agree with your assessment of Vonderplanitz, Mark. I've been doing some checking and although, as you say, some of his nutritional information is ok, the rest of his stuff seems almost quacky and cultish and would sound especially so to newbies and *agency nerds* who relish the idea of knowing nothing about health or nutrition, and yet are the ones making those decisions. Say what he will, I don't think the idea of putting pure poop on our food is going to appeal to the masses. Too much ick factor. Especially since we have choices of other probiotics. Perfect? Maybe not, but foods as probiotics are about as close as most of us are going to get. As long as they are quality in nature and not store-bought-full-of-sugar yogurts or heated/cooked sauerkraut and such, most folks will stick with these.

Raw milk needs to be classified as a "medical" food, but it's probably not "close at hand". Whenever people with mindsets like those who read here and are fans of raw milk are certain that the truth will soon become widely known, we are disappointed when the fda drops the ball, and they always do. Positive, truthful science and testing and whatever else they think is important, suddenly becomes unimportant when it involves real foods. And they understand poop (as compost) even less, it would seem. But I agree that fecal matter in raw milk is not the gargantuan issue it's made out to be, even though that seems to be where the focus lies with some folks. If that were the truth and the whole truth, generations of people would not have lived to homestead in the 1800's because they had very unsanitary conditions and would all have died if a little poop in their milk or on their veggies was such a terrible thing. Ick factor, yes, villian it's made out to be, no.

mark mcafee's picture

Let me apologize to all of the good people of the world that have gained intellegence by speaking with Coyotes and rabits just like Aajunus. There is room for all of us.....I just have a hard time with listening to Coyotes and rabits.

I guess I do not have the cultish skills required to hear what they say. When I hear coyotes yiping at night and trying to eat my calves...I shoot the bastards with a .223

Sorry to all the evolved souls. I love my calves.

Mark

Mark,

We have plenty of coyotes where I live.They don't ever bother the calves. Maybe because when they are small the calves stay with their mothers and the cows all have their horns.Coyotes are smart enough to stay a safe distance from a mother cow with horns.We also have plenty of wildlife like rabbits and turkeys that the coyotes can hunt. We love our calves and our coyotes.They are all part of the diversity here that makes the place healthy and sustainable.

miguel

churchlanefarm's picture

There are plenty of coyotes and a healthy population of wolves where I live just north of Algonquin Park. They will usually keep a wide berth between themselves and a herd of cows, heaven forbid if a herd of cows should happen to surround one of these predators. A lone cow on the other hand, that segregates herself from the herd to have its calf is vulnerable and a pack of hungry coyotes in particular, who are not as shy as wolves, will take advantage of this in order to disorientate the cow and snatch the calf. For the most part however these predators pose little threat to cattle unless there is a shortage of mice and wild game. An unprotected flock of sheep or turkeys on the other hand is a different story. Coyotes have been known to tear through the chicken wire in order to get into the coop and once in they can quickly make short work of your turkeys.
I have never had to shoot a wolf.
Ken

mark mcafee's picture

Coyotes ( dumpster divers ) are part of our ecosystem as well. Our neighbors have CAFO chicken systems and the dead chickens thrown into their dumpsters are their food. Fresh placentas and pasture gophers make a well balanced diet.

I must admit...I have not been able to hit a coyote in years. I scare them off with a super high powered light. When my 4 million candle power system hits them...they are gone. We do find pieces of dead calves that are not well protected when they stay with their moms out in the pastures.

All part of nature.

Sylvia Gibson's picture

Don't the farm dogs keep the coyotes away? I have a friend with a couple of Great Pyrenees' that she says keeps the critters away. Beautiful dogs, but they tend to bark at night.

Dave Milano's picture

Here in the mid-Atlantic mountains there are occasional roving bands of coyotes, along with more ubiquitous smaller predators like bobcats and fox.

One season we lost almost our entire flock of chickens over a short two weeks to a couple of bobcats, then lost our replacement flock. At that point I moved the chicken house down to the cow pasture, and have not lost a single chicken since. Often the chickens follow the cows as they graze, picking up jostled bugs while enjoying the protective services. Just yesterday I watched a large fox ambling through the pasture just 20 yards from a group of chickens who were standing in the snow with our cows---no sane fox would go near them. Similarly, it’s not uncommon to see chickens scurrying to our cows’ free-stall when a hawk is spotted.

Farming and fences are neither fully natural nor anathema to nature. As always, working with is easier and better than fighting with.

Sylvia Gibson's picture

Learning to work with Nature can be a challenge when various information/instructions are tossed at you. It can be overwhelming. There's so much to learn.

http://www.washingtontimes.com/news/2013/jan/22/pay-attention-adhd-diagn...

Just as Autism has grossly increased, so has ADHD... oh I see, the drug companies make big $$$ with Ritalin and other drugs.

http://www.medpagetoday.com/PrimaryCare/GeneralPrimaryCare/36951

Poison is poison no matter what form it comes in.

Sylvia Gibson's picture

http://gma.yahoo.com/exclusive-group-finds-more-fake-food-ingredients-09...

"Milk, honey, coffee and syrup are also listed by the USP as being highly adulterated products. "

And the lies continue...

Sylvia Gibson's picture

http://abcnews.go.com/Health/moo-man-premieres-sundance-celebrating-heal...

2nd video accuses raw milk causing GBS, wonder if he had a flu shot?

Sylvia Gibson's picture