The FDA is holding a public hearing on the use of fecal microbiota transfer (FMT) to treat a bacterial infection. Are they paving the way to hand FMT to Big Pharma? Action Alert!
The FDA announced a public meeting for November 4 of this year. The stated purpose of the meeting is to gather scientific information regarding the use of FMT to treat Clostridium difficile (C. diff) infections that are resistant to standard therapies. This follows the recent death of an immune-compromised patient who received FMT contaminated with drug-resistant E. coli. We fear that the FDA will use this tragedy to turn FMT into a drug, turning an inexpensive treatment into a pharmaceutical money maker.
We previously reported that the FDA is in the process of deciding how to regulate FMT. The agency can decide either to treat FMT as a drug, or more along the lines of donated organs or blood, which are covered under the Public Health Service Act (PHS). We argued that, as long as the safety of FMT can be ensured by regulation solely under PHS, this is the path the FDA must pursue to ensure that consumers can continue to access this treatment affordably.
It seems reasonable to assume that basic screening of fecal samples can ensure the safety of FMT. Donated blood, for example, is screened for a variety of infectious disease pathogens before it can be used by patients. A similar regimen should be devised for FMT to ensure that contaminated samples are not given to sick patients.
Given the FDA’s history, however, we fear that the agency will use this recent death to turn FMT into a drug. There are precedents for this: the agency has allowed a number of natural medicines, like CBD oil and l-glutamine, to be turned into expensive drugs.
The FDA acted similarly in its approach towards compounding pharmacies. Recall that Congress passed a law in 2013 after dozens of patients were killed by contaminated medicines from one compounding facility (to which the FDA had sent several warning letters but never followed up). The FDA took this opportunity to go beyond Congressional intent in an attempt to regulate compounding pharmacies out of existence. To justify these actions, the FDA has said that the safety and quality of compounded medicines cannot be guaranteed because they aren’t FDA approved.
Our fear is that the FDA will use similar logic to turn FMT into a drug. They will argue that the safety and efficacy of FMT can only be guaranteed through FDA drug approval, thus turning human poop into an expensive drug—never mind the fact that FDA approved drugs kill about 128,000 people a year and cause 1.9 million hospitalizations.
C.diff sickens 50,000 Americans each year and kills 30,000. FMT has an 80% success rate treating C. diff, with some patients requiring just a single dose. Beyond C. diff, there are vast applications for using FMT to treat illness. It is being studied for a wide variety of indications, including ulcerative colitis, Crohn’s Disease, Parkinson’s disease, multiple sclerosis, childhood regressive autism, metabolic disorders, diabetes, and others. FMT could lead to the next generation of medicines that utilize the trillions of microbes living within us to heal.
To protect FMT, we must tell the FDA not to turn it into a drug.
Action Alert! Write to the FDA, with a copy to Congress, urging the agency not to treat FMT like a drug. Please send your message immediately.
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Leave FMT alone!
I am a holistic journalist. I got a critical case of C-Diff from the antibiotics that I foolishly took for pneumonia. I was given several drugs, all of which did not heal the C-Diff, in fact they aggravated it. I finally resorted to one of my favorite, proven cures. I started with 6,000 mgs of Vitamin C which stopped the uncotrolllable diarrhea immediately! Then, I took olive leaf and colloidal silver for about a week with the addition of Vit C and was completely healed. My doctor was stunned. I suggest you pass this info on as a cure for this nightmare caused by antibiotics.
Please, do not let one tragedy become the reason to turn this into mountain. What needs to be done is screening samples, just like donated blood is. This fecal transplant does Save Lives; and my husband may need this life saving treatment. He’s being treated for C Diff since early April, 2019. It has come back 4 times already. The Specialist just took him off the antibiotics, and we all are praying it doesn’t come back, Again. If if does, the fecal transplant is his only hope. Please, don’t make this more expensive then it already is; and please, don’t kill my husband. Thank you for your time and understanding.
hope you read this reply> Nancy Ross says:
October 24, 2019 at 8:24 pm
I am a holistic journalist. I got a critical case of C-Diff from the antibiotics that I foolishly took for pneumonia. I was given several drugs, all of which did not heal the C-Diff, in fact they aggravated it. I finally resorted to one of my favorite, proven cures. I started with 6,000 mgs of Vitamin C which stopped the uncotrolllable diarrhea immediately! Then, I took olive leaf and colloidal silver for about a week with the addition of Vit C and was completely healed. My doctor was stunned. I suggest you pass this info on as a cure for this nightmare caused by antibiotics.
Hi Barb, Has your treatment for C – Diff continued to have been successful? If so, how much olive leaf and colloidal silver did you take? Thank you for publishing what you found helpful.
As long as the safety of FMT can be ensured by regulation solely under PHS, this is the path the FDA must pursue to ensure that consumers can continue to access this treatment affordably.
It seems reasonable to assume that basic screening of fecal samples can ensure the safety of FMT. Donated blood, for example, is screened for a variety of infectious disease pathogens before it can be used by patients. A similar regimen should be devised for FMT to ensure that contaminated samples are not given to sick patients.
Given the FDA’s history, however, I fear that the agency will use this recent death to turn FMT into a drug. There are precedents for this: the agency has allowed a number of natural medicines, like CBD oil and l-glutamine, to be turned into prohibitively expensive drugs.
The FDA acted similarly in its approach towards compounding pharmacies. Recall that Congress passed a law in 2013 after dozens of patients were killed by contaminated medicines from one compounding facility (to which the FDA had sent several warning letters but never followed up). The FDA took this opportunity to go beyond Congressional intent in an attempt to regulate compounding pharmacies out of existence. To justify these actions, the FDA has said that the safety and quality of compounded medicines cannot be guaranteed because they aren’t FDA approved.
Our fear is that the FDA will use similar logic to turn FMT into a drug by arguing that the safety and efficacy of FMT can only be guaranteed through FDA drug approval, thus turning human poop into a probibitively expensive drug—never mind the fact that FDA approved drugs kill about 128,000 people a year and cause 1.9 million hospitalizations.
C.diff sickens 50,000 Americans each year and kills 30,000. FMT has an 80% success rate treating C. diff, with some patients requiring just a single dose. Beyond C. diff, there are vast applications for using FMT to treat illness. It is being studied for a wide variety of indications, including ulcerative colitis, Crohn’s Disease, Parkinson’s disease, multiple sclerosis, childhood regressive autism, metabolic disorders, diabetes, and others. FMT could lead to the next generation of medicines that utilize the trillions of microbes living within us to heal.
To protect FMT, and to protect the health and financial accessibility interests of the patients that benefit from it, it is critical that the FDA not to turn it into a drug.
Cando merda tiver valor, os povres nacem sem cu
That’s horrible. Don’t you have a better way to make money?
Please do not treat FMT like a drug.
Please don’t make poop a big “Money-maker” for corporations.
FDA and Big Pharma are only another hypocritical example of greedy opportunism muscling out what they consider competition. FDA snd big pharma kill far more ppl with their drugs than the few exceptions In the alternative fields. Agreed NO ONE should get away with negligence and careless practices. But if they can wipe out a smaller compounding operation for a mistake should mean the the pharmaceutical companies should be wiped out when their products kill people.
Must the FDA steal every ingredient, every supplement, and in this case fecal matter in order to continue to do the bidding of Big Pharma who has the FDA bought and paid for?
DO NOT treat FMT like a drug
As a veterinarian for over 40 years, we have used Micro Biome Restorative Therapy which is Fecal Microbiota Transplantation FMT with nutritional support for the GI tract terrain .for over 8 years. We have done over 7,000 in dogs and cats at it saves lives and needs to be regulated with good screening of the donors but accessible to more and more animals. The cost should be reasonable and not only be used for GI issues but we are using it for other infections, allergies, kidney and liver issues, cancer and behavior.
We need to take care of our microbiome . We need quality donors and have people that are super donors able to help others without it becomeing a drug.
The FDA announced a public meeting for November 4 of this year. The stated purpose of the meeting is to gather scientific information regarding the use of FMT to treat Clostridium difficile (C. diff) infections that are resistant to standard therapies. This follows the recent death of an immune-compromised patient who received FMT contaminated with drug-resistant E. coli. We fear that the FDA will use this tragedy to turn FMT into a drug, turning an inexpensive treatment into a pharmaceutical money maker.
We previously reported that the FDA is in the process of deciding how to regulate FMT. The agency can decide either to treat FMT as a drug, or more along the lines of donated organs or blood, which are covered under the Public Health Service Act (PHS). We argued that, as long as the safety of FMT can be ensured by regulation solely under PHS, this is the path the FDA must pursue to ensure that consumers can continue to access this treatment affordably.
It seems reasonable to assume that basic screening of fecal samples can ensure the safety of FMT. Donated blood, for example, is screened for a variety of infectious disease pathogens before it can be used by patients. A similar regimen should be devised for FMT to ensure that contaminated samples are not given to sick patients.
Given the FDA’s history, however, we fear that the agency will use this recent death to turn FMT into a drug. There are precedents for this: the agency has allowed a number of natural medicines, like CBD oil and l-glutamine, to be turned into expensive drugs.
The FDA acted similarly in its approach towards compounding pharmacies. Recall that Congress passed a law in 2013 after dozens of patients were killed by contaminated medicines from one compounding facility (to which the FDA had sent several warning letters but never followed up). The FDA took this opportunity to go beyond Congressional intent in an attempt to regulate compounding pharmacies out of existence. To justify these actions, the FDA has said that the safety and quality of compounded medicines cannot be guaranteed because they aren’t FDA approved.
Our fear is that the FDA will use similar logic to turn FMT into a drug. They will argue that the safety and efficacy of FMT can only be guaranteed through FDA drug approval, thus turning human poop into an expensive drug—never mind the fact that FDA approved drugs kill about 128,000 people a year and cause 1.9 million hospitalizations.
C.diff sickens 50,000 Americans each year and kills 30,000. FMT has an 80% success rate treating C. diff, with some patients requiring just a single dose. Beyond C. diff, there are vast applications for using FMT to treat illness. It is being studied for a wide variety of indications, including ulcerative colitis, Crohn’s Disease, Parkinson’s disease, multiple sclerosis, childhood regressive autism, metabolic disorders, diabetes, and others. FMT could lead to the next generation of medicines that utilize the trillions of microbes living within us to heal.
To protect FMT, we must tell the FDA not to turn it into a drug.
I urge the FDA not to treat FMT like a drug.
FMT is not a drug. The pharmaceutical companies put not research money into it. Therefore, they do not need to make an exorbitant profit on it which is exactly what will happen if you consider it a drug. For once, look at the facts and don’t allow what should be inexpensive to become un-affordable to those who need it.
My mother has had c-diff for over a year! She is losing weight can’t sleep because she has to get up several times a night from accidents. She has exhausted all her antibiotic choices and her Doctor has recommended this FMT for her. Please keep the FDA and Big Pharma out of this.