As Fecal Transplants Cure and Save Lives, FDA Classifies Poop as a Drug and Restricts It
Health Impact News
Back in January of this year (2013), we reported how the effective treatment of using fecal transplants was curing patients with Clostridium difficile (C. diff) with outstanding success. C. diff is a bacteria that is resistant to antibiotic treatment and has become epidemic in hospitals and nursing homes. A study published the New England Journal of Medicine, that made mainstream news back in January, showed how Fecal Microbiata Transplant (FMT) was curing C. diff at an incredible rate. FMT is therapy that puts fecal matter from a person with good gut flora directly into the colon of the sick person. It has literally saved people’s lives.
Many doctors around the world have been experimenting with this therapy for diseases other than C. diff, including bowel diseases such as Ulcerative Colitis and Crohn’s Disease. Some of the doctors that we quoted back in January who were utilizing this therapy in the U.S. were becoming concerned that the FDA might step and try to control this therapy, in spite of the fact that there are virtually no recorded major side effects, only testimonies to very dramatic healings.
Well unfortunately, that is exactly what the FDA did. Because doctors were using fecal matter from healthy people to cure C. diff and other diseases, it stepped in and declared fecal matter as a “drug.” Since it is a drug they have not approved, it 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), they 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.
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 – not even close!
Ever since mainstream medicine has decided that probiotic therapy is not only effective, but necessary in overcoming our society’s addiction to antibiotics, there has been increased interest in understanding what is referred to as the “microbiome.” While the best probiotic supplements currently on the market might have 20 to 30 strains of “friendly” bacteria, each person’s own collection of bacteria numbers in the trillions, and with what many researchers consider over 20,000 different species of bacteria.
So isolating and mapping specific bacteria to specific diseases is a huge undertaking, and modern medicine is attempting to do just that, similar to the genome project. As this microbiome research advances, expect new synthetic drugs on the market advertised as treating specific diseases and working similar to FMT, which of course cannot be patented.
With FMT, however, all the guesswork of trying to figure out which bacteria is effective in curing is bypassed by a simple procedure: take ALL of the microbiome from a healthy person via their feces, and transplant that into the sick person. It is nature’s ultimate “super probiotic.” It is simple, affordable, and effective. So simple, that there is a group of people on the Internet doing it at home now. And these are formerly very sick people who are now healthy, or on the road to recovery where they can function as “normal” people again.
This must make the pharmaceutical companies rage with jealousy! So of course the first step was to get the FDA to step in and stop doctors from doing this routinely, and put restrictions on it by classifying it as a drug.
The other step they are taking is securing funding for research so they can develop drugs that they hope will work in similar ways. Here is one announcement published on a drug industry website just a few days ago:
Janssen Biotech and Second Genome have entered into an agreement to focus on microbiome drug discovery, Second Genome announced in a press release. With the goal of advancing novel drug targets, the agreement is focused on therapeutic mechanisms in ulcerative colitis mediated by the bacterial ecosystem living within the human gut, referred to as the microbiome. Second Genome will apply its microbiome modulation discovery platform to characterize the role of bacterial populations in ulcerative colitis.
The microbiome is an emerging area of interest involving research, such as the National Institute of Health’s Human Microbiome Project, to evaluate the symbiotic relationship that bacteria have developed in the human body. “Foundational microbiome research over the past several years has demonstrated that alterations to the microbiome are central to the development of inflammation and metabolic disorders,” said Peter DiLaura, president and CEO at Second Genome, in the press release. (Full story here.)
So 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.
Will the government go after home FMT patients next? While many doctors are now prohibited from practicing FMT, many of them will still help their patients screen potential donors through laboratory tests so they can practice FMT at home safely. These home users of FMT are still a small group, but if they become so large that they take a dent out of the market of competing drugs, could the FDA start going after home FMT users as well?
One of the more popular blogs that gives people instructions on how to do FMT at home also has several testimonies recorded. It is run by Tracy Mac of Australia (outside the reach of the U.S. FDA): The Power of Poo. She has an active Facebook Group that is by invitation only to protect members’ privacy. She has links to how-to videos. There are many other recorded testimonies of FMT cures from home treatments found on the Internet, including this one who states:
I have not had a flare since then, nor am I taking any prescription immune-suppressing or anti-inflammatory drugs, herbal supplements or pro-biotic,s nor am I on a highly restricted diet like Gluten-Free or the Specific Carbohydrate Diet (SCD).
But don’t think all the evidence of FMT is purely anecdotal. There is plenty of published research in this area now, and the therapy is nothing new. There is documentation that the therapy is at least 1,700 years old in Chinese Traditional Medicine!
The range of illnesses and diseases that FMT can prove beneficial is almost limitless, as modern research reconfirms that most of our physical health begins in the gut, with our micro flora and our own “micorbiome.” While most of the experience and research in modern times has focused on C. diff and bowel diseases, here is a partial list of illnesses that FMT has also been used for, or could potentially be used for:
- drug-resistant bacterial infections (Clostridium difficile and many others)
- inflammatory bowel disease (IBD)
- irritable bowel syndrome (IBS)
- Ulcerative Colitis
- Crohn’s Disease
- chronic constipation
- chronic fatigue syndrome
- neurological diseases such as Parkinson’s
- mental disease (see also: Changing gut bacteria through diet affects brain function, UCLA study shows)
- food poisoning
- metabolic syndrome
- autoimmune diseases
The only thing probably holding back this simple, natural and ineffective treatment from being used by more people is the “ick” factor. But, if you are one of the many thousands of people suffering from bowel diseases that makes life almost unbearable, the hope for a better life is a great trade-off for the uncomfortable feelings of using someone else’s poop.
I don’t know how the FDA can get away regulating your fecal material as a drug, and I hope some doctor will defy their tyrannical authority and challenge them in court. For those who don’t have healthy family members who can function as donors, a good donor screening program is essential for this therapy to reach its potential of healing so many people.
Copyright 2013 – Health Impact News – Permission to republish according to Creative Common Standards permitted.
UPDATE: On June 17 the FDA released an announcement stating they will not require doctors to follow the full IND procedure as a requirement to administer FMT. But they are still claiming it is an unapproved drug.
by Attorney Jonathan Emord