FDA steps in it: Classifies poop as a drug and restricts fecal transplants

June 17, 2013

fda classifies poop as a drug photo by Health Impact NewsBack in March we did a Monday Musing post called “Would you take this crap if your life depended on it?”  about how “poop transplants” are an effective way to treat people with a type of intestinal bacteria infection.

Basically researchers transplant fecal matter from healthy people into the colons of people infected with the notoriously hard-to-treat Clostridium difficile (klos-TRID-e-uhm dif-uh-SEEL) bacteria (a.k.a. C. diff), which causes severe, watery diarrhea. They found that 46 out of 49 patients got better within a week of the enema treatment (a.k.a. Fecal Microbiata Transplant or FMT.)

Well … according to Health Impact News, the FDA has literally stepped in and has now declared fecal matter as a “drug.” And, since it is a drug they have not approved, it’s now officially in Phase 1 of the drug research and approval process, a process that can take many years.

In a letter from the FDA to the American Gastroenterological Association (AGA), FDA stated that FMT is not to be used by physicians, other than in life saving situations subject to a formal IND (Investigational New Drug) application.

Health Impact News writes…

“So why would the FDA make the ridiculous claim that someone’s healthy poop is a drug, and start regulating a safe therapy that has saved so many lives, cured so many with bowel diseases, and has virtually no recorded adverse effects? It is far more effective and far more safe than drugs used for the same conditions!  … While doctors, published research, and home users have already successfully used FMT therapy with miraculous results, our government agencies are spending our tax dollars to restrict this simple and inexpensive therapy so that drug companies can develop patented and profitable drugs instead.

Yes … the thought of taking someone else’s poop has an “ick” factor and many people have probably never even considered (or are aware of) FMT. But now many sufferers will have to live with the uncomfortable and excruciating pain of bowel diseases or take prescription drugs with potential side effects since the FDA is restricting FMT therapy.

Read the full article on Health Impact News  and learn more about about poop transplants at MyHealthNewsDaily.com and LiveScience.com

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Would you take this crap if your life depended on it?

March 4, 2013

Have you ever said or thought “I won’t take any crap from you”..?

Well … here’s a different twist on that logic. Did you know recent studies show “poop transplants” are an effective way to treat people with one type of intestinal bacteria infection?

Researchers transplanted fecal matter from healthy people into the colons of people infected with the notoriously hard-to-treat Clostridium difficile (klos-TRID-e-uhm dif-uh-SEEL) bacteria (a.k.a. C. diff), which causes severe, watery diarrhea.

The researchers found that 46 out of 49 patients got better within a week of the enema treatment.

And according to LiveScience.com, scientists have created a fake feces — a “super-probiotic” named RePOOPulate — that could be a safer alternative to the real poop transplants.

“C. diff is a serious infection — people die from this. With this treatment, the cure rate is close to 100 percent,” said study researcher Dr. Mayur Ramesh, an infectious disease physician at Henry Ford Hospital in Detroit.

According to USA Today, C. diff is linked to more than 30,000 deaths a year in the United States — about twice federal estimates and rivaling the 32,000 killed in traffic accidents. And it sickens almost 500,000 Americans a year.

Also, one out of five people who get the infection will get it again, and recurrences can be more severe or deadly.

Unfortunately C. diff spores can survive on most surfaces for months and most hospital cleaners won’t kill it, but a solution of bleach and water could. Also, alcohol-based hand sanitizers used in many health facilities do not work against C. diff … so staff, patients and visitors must wash hands with soap and water frequently to reduce spreading the infection.

Read more about poop transplants at MyHealthNewsDaily.com and Live Science

And learn more about C. diff from the CDC  or Mayo Clinic

And finally … try not to take any crap from anybody … unless you need to for health reasons.

Have a great week! 🙂 j & B


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