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Next Medical Breakthrough: Fecal Transplants (1 Viewer)

Sarnoff

Footballguy
http://www.slate.com/id/2282768/pagenum/all/

The Enema of Your Enemy is Your Friend
Fecal transplants could be a cheap and effective treatment for gastrointestinal disorders.
By Emily P. Walker Posted Thursday, Jan. 27, 2011, at 4:26 PM ET

One day in 2008, Ruth, a Long Island teacher, walked into her doctor's office with a container of a relative's feces, lay down, and had her doctor pump the stool inside her. Ruth had been suffering for nearly two years with an intestinal infection called Clostridium difficile, which caused her to suffer from excruciating diarrhea. She had lost 20 pounds. Her hair was falling out. Friends asked if she had cancer.

Then she met Lawrence Brandt, a gastroenterologist in the Bronx who believed he had developed a procedure to cure people of recurrent c. diff infections: fecal transplant. Brandt has been inserting feces into his patients for a decade now and claims to be solving their problems nearly 100 percent of the time. If his method really works—and he's not the only doctor who believes that it does—then we may have found a viable, if weird, solution to a serious problem. C. diff infects 250,000 Americans each year and killed more than 20,000 from 1999 to 2004. (Researchers estimate that 13 out of every 1,000 patients admitted to a hospital will pick up the bug.) Antibiotics will always be the first response to such infections, but when those fail, a fecal transplant could be the next step. For Ruth, at least, the procedure was a godsend. "I'm cured," she said. "Period. End of story. Cured."

Here's the basic idea. People suffering from the hardy C. diff bacteria are generally prescribed a powerful antibiotic. Problem is, the drugs don't just kill the invaders; they also wipe out much of the beneficial bacteria in the gut. With these "good" microorganisms out of the way, any C. diff stragglers have a much easier time regrouping for a second bout of illness. If there were some way to respawn the beneficial bacteria in the intestines, such re-infections could be warded off. Some people, like Ruth, turn to expensive probiotic supplements. (At one point she was spending $350 on them every week.) But in certain cases, a patient who has lost nearly all of her good bacteria will find it nearly impossible to get them back. A fecal transplant seems to work as a sort of mega-probiotic, allowing doctors to repopulate a patient's intestines with the appropriate microorganisms by placing a robust sample directly into her gut.

Doctors recommend that the fecal donor be someone close to the patient—a family member, perhaps, or a spouse. Scientists reason that when people live in close quarters, they are exposed to similar bacteria—good and bad—and are likely to have had a similar set of bacteria living in their guts before anyone got sick.

The donor takes a stool softener the night before and then gives a full morning bowel movement to the recipient, who takes it to a doctor for screening. It's important to make sure that the sample doesn't contain any parasites or other pathogens, such as hepatitis, salmonella, or HIV. Once the transplant material has been cleared, the doctor mixes it with saline to make about a pint of liquid with the consistency of a milkshake. This is pumped into the patient's colon using a colonoscope or endoscope, or siphoned into the stomach via a nasogastric tube. (The latter method is considered more dangerous, since there's a chance feces will end up in the lungs. Colonoscopies carry their own risk of bowel perforation.)

And then there's the do-it-yourself crowd. All you need is a bottle of saline, a 2-quart enema bag, and one standard kitchen blender. Mike Silverman, a University of Toronto physician who wrote up a guide to homespun fecal transplants for the journal Clinical Gastroenterology and Hepatology, says it's entirely safe to do the procedure this way, provided that a doctor gets involved at some point to screen the donor sample. He felt he needed to draw up the instructions because administrators at his hospital wouldn't allow their doctors to perform a procedure that hasn't been validated in a large, peer-reviewed study.

It's true there's been no major clinical trial of fecal transplants, but the procedure appears in the medical literature at least as far back as 1958. That's when a Denver-based surgeon named Ben Eiseman performed four of the procedures to rid patients of a form of colitis thought to be caused by C. diff. His plan was to administer "normal feces into the colon of patients with the disease," so as to "re-establish the balance of nature." Three of his four patients were near death before the fecal enema. After, they recovered. This small experiment suggested a "simple yet rational therapeutic method," Eiseman and his colleagues wrote, that deserved careful evaluation.

Now we're beginning to see some more extensive studies. Mark Mellow, a gastroenterologist at INTEGRIS Health in Oklahoma City, recently presented a paper showing that 15 out of 16 C. diff patients whom he'd provided with a fecal transplant remained disease-free after five months. Several other papers presented at the meeting showed similar positive effects, and in every case, symptoms disappeared almost immediately after the transplant.

Still, the evidence supporting fecal transplant comprises just about 20 published case reports involving about 200 patients. Until a large-scale, randomized trial is published in a big-name medical journal, most doctors will likely follow the example of the University of Toronto and hold off on performing the transplant. Indeed, relatively few gastroenterologists have even tried it. Colleen Kelly, a gastroenterologist at Women & Infants Hospital of Rhode Island, surveyed 72 gastroenterologists at a recent international medical meeting and found that only seven had performed the procedure. Nearly half said they'd be willing to perform a transplant on a sick patient, but the rest said they weren't ready yet. "I really think in another couple of years, it's going to be something that everyone's doing," said Kelly, who has performed the operation 22 times herself.

Infectious-disease experts are a little more tempered in their enthusiasm. According to Vincent Young of the University of Michigan, the data look promising but he wouldn't perform a fecal transplant himself because there are too many unknowns about what bad things might be lurking in a stool sample. William Schaffner, president of the National Foundation for Infectious Diseases, warned that the procedure is still in its early days and not yet ready for prime time. (The American College of Gastroenterology, for its part, has no official position on fecal transplants.)

But the true believers have even bigger plans. They hope fecal transplants might be used to treat other gut-related conditions, such as ulcerative colitis and even obesity. Some very overweight people, for example, are thought to have more of a certain type of bacteria in their intestines, which causes them extract extra calories from complex carbohydrates. With this in mind, researchers found that fat mice would lose weight if transplanted with feces from thin ones. Later, a team of Dutch researchers tried the same approach in humans: No one lost weight, but the fecal recipients did show a significant improvement in their ability to regulate insulin. (That study is under review and should be published in the next few months.)

For all its promise, it's unlikely fecal transplants will take off any time soon. Not because patients are grossed out by the procedure—in fact, doctors say that long-standing sufferers from C. diff are eager to have it done—but because there's so little funding for large-scale clinical trials. Drug or medical-device companies usually foot the bill for such research, but in the case of a natural, patent-free treatment like this, no company stands to turn a major profit. If anything, fecal transplants would end up costing the pharmaceutical companies money: A single pill of vancomycin—one of two antibiotics used to treat C. diff—costs about $55, and the average dose is four pills daily over a two-week stretch. A glass of ####, on the other hand, costs very little. That doesn't mean we'll never get the much-needed data: Lawrence Brandt, the gastroenterologist in the Bronx, is applying for a grant with the National Institutes of Health for a small, double-blind, controlled study. He says he'll need about 40 patients, and he's hoping to get started right away.
 
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I just had to fight off my gag reflex after imagining the procedure.

 
Last edited by a moderator:
http://www.slate.com/id/2282768/pagenum/all/

The Enema of Your Enemy is Your Friend

Fecal transplants could be a cheap and effective treatment for gastrointestinal disorders.

By Emily P. Walker Posted Thursday, Jan. 27, 2011, at 4:26 PM ET

One day in 2008, Ruth, a Long Island teacher, walked into her doctor's office with a container of a relative's feces, lay down, and had her doctor pump the stool inside her. Ruth had been suffering for nearly two years with an intestinal infection called Clostridium difficile, which caused her to suffer from excruciating diarrhea. She had lost 20 pounds. Her hair was falling out. Friends asked if she had cancer.

Then she met Lawrence Brandt, a gastroenterologist in the Bronx who believed he had developed a procedure to cure people of recurrent c. diff infections: fecal transplant. Brandt has been inserting feces into his patients for a decade now and claims to be solving their problems nearly 100 percent of the time. If his method really works—and he's not the only doctor who believes that it does—then we may have found a viable, if weird, solution to a serious problem. C. diff infects 250,000 Americans each year and killed more than 20,000 from 1999 to 2004. (Researchers estimate that 13 out of every 1,000 patients admitted to a hospital will pick up the bug.) Antibiotics will always be the first response to such infections, but when those fail, a fecal transplant could be the next step. For Ruth, at least, the procedure was a godsend. "I'm cured," she said. "Period. End of story. Cured."

Here's the basic idea. People suffering from the hardy C. diff bacteria are generally prescribed a powerful antibiotic. Problem is, the drugs don't just kill the invaders; they also wipe out much of the beneficial bacteria in the gut. With these "good" microorganisms out of the way, any C. diff stragglers have a much easier time regrouping for a second bout of illness. If there were some way to respawn the beneficial bacteria in the intestines, such re-infections could be warded off. Some people, like Ruth, turn to expensive probiotic supplements. (At one point she was spending $350 on them every week.) But in certain cases, a patient who has lost nearly all of her good bacteria will find it nearly impossible to get them back. A fecal transplant seems to work as a sort of mega-probiotic, allowing doctors to repopulate a patient's intestines with the appropriate microorganisms by placing a robust sample directly into her gut.

Doctors recommend that the fecal donor be someone close to the patient—a family member, perhaps, or a spouse. Scientists reason that when people live in close quarters, they are exposed to similar bacteria—good and bad—and are likely to have had a similar set of bacteria living in their guts before anyone got sick.

The donor takes a stool softener the night before and then gives a full morning bowel movement to the recipient, who takes it to a doctor for screening. It's important to make sure that the sample doesn't contain any parasites or other pathogens, such as hepatitis, salmonella, or HIV. Once the transplant material has been cleared, the doctor mixes it with saline to make about a pint of liquid with the consistency of a milkshake. This is pumped into the patient's colon using a colonoscope or endoscope, or siphoned into the stomach via a nasogastric tube. (The latter method is considered more dangerous, since there's a chance feces will end up in the lungs. Colonoscopies carry their own risk of bowel perforation.)

And then there's the do-it-yourself crowd. All you need is a bottle of saline, a 2-quart enema bag, and one standard kitchen blender. Mike Silverman, a University of Toronto physician who wrote up a guide to homespun fecal transplants for the journal Clinical Gastroenterology and Hepatology, says it's entirely safe to do the procedure this way, provided that a doctor gets involved at some point to screen the donor sample. He felt he needed to draw up the instructions because administrators at his hospital wouldn't allow their doctors to perform a procedure that hasn't been validated in a large, peer-reviewed study.

It's true there's been no major clinical trial of fecal transplants, but the procedure appears in the medical literature at least as far back as 1958. That's when a Denver-based surgeon named Ben Eiseman performed four of the procedures to rid patients of a form of colitis thought to be caused by C. diff. His plan was to administer "normal feces into the colon of patients with the disease," so as to "re-establish the balance of nature." Three of his four patients were near death before the fecal enema. After, they recovered. This small experiment suggested a "simple yet rational therapeutic method," Eiseman and his colleagues wrote, that deserved careful evaluation.

Now we're beginning to see some more extensive studies. Mark Mellow, a gastroenterologist at INTEGRIS Health in Oklahoma City, recently presented a paper showing that 15 out of 16 C. diff patients whom he'd provided with a fecal transplant remained disease-free after five months. Several other papers presented at the meeting showed similar positive effects, and in every case, symptoms disappeared almost immediately after the transplant.

Still, the evidence supporting fecal transplant comprises just about 20 published case reports involving about 200 patients. Until a large-scale, randomized trial is published in a big-name medical journal, most doctors will likely follow the example of the University of Toronto and hold off on performing the transplant. Indeed, relatively few gastroenterologists have even tried it. Colleen Kelly, a gastroenterologist at Women & Infants Hospital of Rhode Island, surveyed 72 gastroenterologists at a recent international medical meeting and found that only seven had performed the procedure. Nearly half said they'd be willing to perform a transplant on a sick patient, but the rest said they weren't ready yet. "I really think in another couple of years, it's going to be something that everyone's doing," said Kelly, who has performed the operation 22 times herself.

Infectious-disease experts are a little more tempered in their enthusiasm. According to Vincent Young of the University of Michigan, the data look promising but he wouldn't perform a fecal transplant himself because there are too many unknowns about what bad things might be lurking in a stool sample. William Schaffner, president of the National Foundation for Infectious Diseases, warned that the procedure is still in its early days and not yet ready for prime time. (The American College of Gastroenterology, for its part, has no official position on fecal transplants.)

But the true believers have even bigger plans. They hope fecal transplants might be used to treat other gut-related conditions, such as ulcerative colitis and even obesity. Some very overweight people, for example, are thought to have more of a certain type of bacteria in their intestines, which causes them extract extra calories from complex carbohydrates. With this in mind, researchers found that fat mice would lose weight if transplanted with feces from thin ones. Later, a team of Dutch researchers tried the same approach in humans: No one lost weight, but the fecal recipients did show a significant improvement in their ability to regulate insulin. (That study is under review and should be published in the next few months.)

For all its promise, it's unlikely fecal transplants will take off any time soon. Not because patients are grossed out by the procedure—in fact, doctors say that long-standing sufferers from C. diff are eager to have it done—but because there's so little funding for large-scale clinical trials. Drug or medical-device companies usually foot the bill for such research, but in the case of a natural, patent-free treatment like this, no company stands to turn a major profit. If anything, fecal transplants would end up costing the pharmaceutical companies money: A single pill of vancomycin—one of two antibiotics used to treat C. diff—costs about $55, and the average dose is four pills daily over a two-week stretch. A glass of ####, on the other hand, costs very little. That doesn't mean we'll never get the much-needed data: Lawrence Brandt, the gastroenterologist in the Bronx, is applying for a grant with the National Institutes of Health for a small, double-blind, controlled study. He says he'll need about 40 patients, and he's hoping to get started right away.
If anything, fecal transplants would end up costing the pharmaceutical companies money: A single pill of vancomycin—one of two antibiotics used to treat C. diff—costs about $55, and the average dose is four pills daily over a two-week stretch. A glass of ####, on the other hand, costs very little.

:yes:

 
Just asked my lady if she'd be ok with doing this for me and she said she didn't give a crap and then left for work. Now I gotta wait until she gets home for clarification.

 
Hm. This is one area where I'm hoping the medical advance doesn't involve a "break through".

 
My brother has a gastrointestinal disorder, so I forwarded him the link and told him if he needed a donor, I'm there for him.

 
http://www.slate.com/id/2282768/pagenum/all/

The Enema of Your Enemy is Your Friend

Fecal transplants could be a cheap and effective treatment for gastrointestinal disorders.

By Emily P. Walker Posted Thursday, Jan. 27, 2011, at 4:26 PM ET

One day in 2008, Ruth, a Long Island teacher, walked into her doctor's office with a container of a relative's feces, lay down, and had her doctor pump the stool inside her. Ruth had been suffering for nearly two years with an intestinal infection called Clostridium difficile, which caused her to suffer from excruciating diarrhea. She had lost 20 pounds. Her hair was falling out. Friends asked if she had cancer.

Then she met Lawrence Brandt, a gastroenterologist in the Bronx who believed he had developed a procedure to cure people of recurrent c. diff infections: fecal transplant. Brandt has been inserting feces into his patients for a decade now and claims to be solving their problems nearly 100 percent of the time. If his method really works—and he's not the only doctor who believes that it does—then we may have found a viable, if weird, solution to a serious problem. C. diff infects 250,000 Americans each year and killed more than 20,000 from 1999 to 2004. (Researchers estimate that 13 out of every 1,000 patients admitted to a hospital will pick up the bug.) Antibiotics will always be the first response to such infections, but when those fail, a fecal transplant could be the next step. For Ruth, at least, the procedure was a godsend. "I'm cured," she said. "Period. End of story. Cured."

Here's the basic idea. People suffering from the hardy C. diff bacteria are generally prescribed a powerful antibiotic. Problem is, the drugs don't just kill the invaders; they also wipe out much of the beneficial bacteria in the gut. With these "good" microorganisms out of the way, any C. diff stragglers have a much easier time regrouping for a second bout of illness. If there were some way to respawn the beneficial bacteria in the intestines, such re-infections could be warded off. Some people, like Ruth, turn to expensive probiotic supplements. (At one point she was spending $350 on them every week.) But in certain cases, a patient who has lost nearly all of her good bacteria will find it nearly impossible to get them back. A fecal transplant seems to work as a sort of mega-probiotic, allowing doctors to repopulate a patient's intestines with the appropriate microorganisms by placing a robust sample directly into her gut.

Doctors recommend that the fecal donor be someone close to the patient—a family member, perhaps, or a spouse. Scientists reason that when people live in close quarters, they are exposed to similar bacteria—good and bad—and are likely to have had a similar set of bacteria living in their guts before anyone got sick.

The donor takes a stool softener the night before and then gives a full morning bowel movement to the recipient, who takes it to a doctor for screening. It's important to make sure that the sample doesn't contain any parasites or other pathogens, such as hepatitis, salmonella, or HIV. Once the transplant material has been cleared, the doctor mixes it with saline to make about a pint of liquid with the consistency of a milkshake. This is pumped into the patient's colon using a colonoscope or endoscope, or siphoned into the stomach via a nasogastric tube. (The latter method is considered more dangerous, since there's a chance feces will end up in the lungs. Colonoscopies carry their own risk of bowel perforation.)

And then there's the do-it-yourself crowd. All you need is a bottle of saline, a 2-quart enema bag, and one standard kitchen blender. Mike Silverman, a University of Toronto physician who wrote up a guide to homespun fecal transplants for the journal Clinical Gastroenterology and Hepatology, says it's entirely safe to do the procedure this way, provided that a doctor gets involved at some point to screen the donor sample. He felt he needed to draw up the instructions because administrators at his hospital wouldn't allow their doctors to perform a procedure that hasn't been validated in a large, peer-reviewed study.

It's true there's been no major clinical trial of fecal transplants, but the procedure appears in the medical literature at least as far back as 1958. That's when a Denver-based surgeon named Ben Eiseman performed four of the procedures to rid patients of a form of colitis thought to be caused by C. diff. His plan was to administer "normal feces into the colon of patients with the disease," so as to "re-establish the balance of nature." Three of his four patients were near death before the fecal enema. After, they recovered. This small experiment suggested a "simple yet rational therapeutic method," Eiseman and his colleagues wrote, that deserved careful evaluation.

Now we're beginning to see some more extensive studies. Mark Mellow, a gastroenterologist at INTEGRIS Health in Oklahoma City, recently presented a paper showing that 15 out of 16 C. diff patients whom he'd provided with a fecal transplant remained disease-free after five months. Several other papers presented at the meeting showed similar positive effects, and in every case, symptoms disappeared almost immediately after the transplant.

Still, the evidence supporting fecal transplant comprises just about 20 published case reports involving about 200 patients. Until a large-scale, randomized trial is published in a big-name medical journal, most doctors will likely follow the example of the University of Toronto and hold off on performing the transplant. Indeed, relatively few gastroenterologists have even tried it. Colleen Kelly, a gastroenterologist at Women & Infants Hospital of Rhode Island, surveyed 72 gastroenterologists at a recent international medical meeting and found that only seven had performed the procedure. Nearly half said they'd be willing to perform a transplant on a sick patient, but the rest said they weren't ready yet. "I really think in another couple of years, it's going to be something that everyone's doing," said Kelly, who has performed the operation 22 times herself.

Infectious-disease experts are a little more tempered in their enthusiasm. According to Vincent Young of the University of Michigan, the data look promising but he wouldn't perform a fecal transplant himself because there are too many unknowns about what bad things might be lurking in a stool sample. William Schaffner, president of the National Foundation for Infectious Diseases, warned that the procedure is still in its early days and not yet ready for prime time. (The American College of Gastroenterology, for its part, has no official position on fecal transplants.)

But the true believers have even bigger plans. They hope fecal transplants might be used to treat other gut-related conditions, such as ulcerative colitis and even obesity. Some very overweight people, for example, are thought to have more of a certain type of bacteria in their intestines, which causes them extract extra calories from complex carbohydrates. With this in mind, researchers found that fat mice would lose weight if transplanted with feces from thin ones. Later, a team of Dutch researchers tried the same approach in humans: No one lost weight, but the fecal recipients did show a significant improvement in their ability to regulate insulin. (That study is under review and should be published in the next few months.)

For all its promise, it's unlikely fecal transplants will take off any time soon. Not because patients are grossed out by the procedure—in fact, doctors say that long-standing sufferers from C. diff are eager to have it done—but because there's so little funding for large-scale clinical trials. Drug or medical-device companies usually foot the bill for such research, but in the case of a natural, patent-free treatment like this, no company stands to turn a major profit. If anything, fecal transplants would end up costing the pharmaceutical companies money: A single pill of vancomycin—one of two antibiotics used to treat C. diff—costs about $55, and the average dose is four pills daily over a two-week stretch. A glass of ####, on the other hand, costs very little. That doesn't mean we'll never get the much-needed data: Lawrence Brandt, the gastroenterologist in the Bronx, is applying for a grant with the National Institutes of Health for a small, double-blind, controlled study. He says he'll need about 40 patients, and he's hoping to get started right away.
If anything, fecal transplants would end up costing the pharmaceutical companies money: A single pill of vancomycin—one of two antibiotics used to treat C. diff—costs about $55, and the average dose is four pills daily over a two-week stretch. A glass of ####, on the other hand, costs very little.

:football:
The kitchen blender part is what got me. Somebody would probably just clean it and sell it at their next garage sale.

 
I just had to fight off my gag reflex after imagining the procedure.
I know what you mean. I'm still not brave enough to click this link:

And then there's the do-it-yourself crowd. All you need is a bottle of saline, a 2-quart enema bag, and one standard kitchen blender. Mike Silverman, a University of Toronto physician who wrote up a guide to homespun fecal transplants for the journal Clinical Gastroenterology and Hepatology
 
Not 5 minutes ago I was reminded just how full of #### I am. Is there a study I can volunteer for?

 
Sounds like something Cartman would invent.

[Cartman]"Kyle, I swear if I crap in your mouth it will make you feel better"[/Cartman]

 
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So the peeps in all the scat pr0ns i watch must be immune to this condition. What a career choice benefit!

 
I'd like to invent a product that gel-coated your poop inside...packaged it up like a Tylenol gel-cap. Then you could poop it out nice and clean...even remove it while driving, toss it out the window. Poop 'n' toss.

 
I'd like to invent a product that gel-coated your poop inside...packaged it up like a Tylenol gel-cap. Then you could poop it out nice and clean...even remove it while driving, toss it out the window. Poop 'n' toss.
This just happened. But kind of in reverse to what you were saying:

http://jezebel.com/seriously-poop-pills-just-might-save-your-life-with-p-1441270671

Seriously, Poop Pills Just Might Save Your Life (With Poop!)

Ohhhhhh my GOD, I will never ever ever in my life get tired of stories where doctors use poop as medicine. EVER. Because, you see, it's poop (which is stinky stuff that comes out of your butt*), and then doctors (who are very serious science grown-ups) have to touch the poop with doctory gravitas, and then they turn the poop into a magic potion called medicine, and then, WITH A STRAIGHT FACE, they put someone else's poop-medicine back into your body. And it cures you. POOP!!! Poop is a hero!

Yep, in addition to being super duper hilarious, the therapeutic application of feces is a revolutionary medical development that has the potential to save fourteen-thousands of lives. Patients suffering from C. diff (a potentially deadly bacterial infection that you might remember from the time it started devouring Tig Notaro's intestines at the worst possible moment) have seen amazing results from fecal transplants administered either through an enema or a nasal tube. But, to spare patients that unpleasantness, doctors are working on a way to deliver the processed fecal bacteria in pill form. It's not perfect (patients have to swallow 34 poop pills in 15 minutes), but it's working!

Via Salon:

In a clinical trial carried out in Canada, researchers announced, 32 patients with recurring C. diff infections were successfully treated will pills containing donated fecal matter, broken down to its bacterial components.

The patients had to quickly swallow up to 34 pills in a 15-minute period. Not one threw up, according to the researchers. And while taking the pills with the knowledge of what was in them may not have been the most pleasant experience, it’s an improvement from previous transplant procedures, which include enemas, tubes placed directly into the colon or nasal tubes.

...In a statement, researcher Thomas Louie said, ”Many people might find the idea of fecal transplantation off-putting, but those with recurrent infection are thankful to have a treatment that works.”

C. diff affects an estimated 250,o00 people per year, and kills around 14,000. So far, the success rate of fecal transplants is 90%. Because POOP IS BOSS.

So basically, this is the best win-win-win ever. Present and future C. diff-sufferers get to not die of C. diff, feces gets a major PR boost, and I get to keep making this face every time a new poop transplant story comes out:

ku-medium.gif


The world is a beautiful and just place.
If you can swallow 34 pills filled with turds in 15 minutes, it could cure you!

 
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Scientific American: Hey FDA, Poop Is Not a Drug

Imagine if in the 1960s surgeons like Christiaan Barnard or Norman Shumway had had to use the same rules that govern the development and testing of pharmaceutical medications when they were teaching the rest of the world how to transplant hearts from the recently deceased into their patients. The idea is absurd on the face of it. For starters, hearts do not come in standard sizes. Nor do all transplanted organs have the same “shelf life” the way different lots of properly manufactured drugs do.

So why does the U.S. Food and Drug Administration (FDA) regulate fecal transplants the same way that it does medications? That’s the question that Mark B. Smith, Colleen Kelly and Eric Alm ask in the current issue of Nature (which is owned by the same company as Scientific American).

Fecal transplants have become increasingly important over the past few years as a way of basically taking the healthy gut bacteria out of one person and putting them in another person whose own gut bacteria are deficient in some way. (To learn more about this process and its benefits, check out Maryn McKenna’s article “Swapping Germs” in the December 2011 issue of Scientific American)

Instead, Smith and colleagues argue that fecal transplants should be regulated by their own set of safety rules–in much the same way that organs and other tissue products (pig valves, corneas, cartilage, blood, etc.) are.

Currently, the FDA has given fecal transplants a kind of waiver from some of the stricter rules that govern the development and testing of medications. But that’s only as long as the treatment is used strictly for C. difficile infections, which cause debilitating gastrointestinal problems and are not otherwise easily curable. Many physicians and patients would like to know if the therapy could be made to work for other bowel problems–such as Crohn’s disease.

But the stricter FDA rules would make it harder to test fecal transplants for no good reason. Regulating fecal transplants like other tissue products would still keep patients safe, the authors argue. And it would undoubtedly keep the cost of treatment lower than would otherwise be possible if some large company with deep pockets had to undertake the sorts of tests that would need to be done to approve fecal transplants as if they were drugs. After all, if there’s something we have a lot of in this world, it’s poop.



About the Author: Christine Gorman is the editor in charge of health and medicine features for SCIENTIFIC AMERICAN. Follow on Twitter @cgorman.
 

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