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The Most Effective Probiotic is Free but the FDA Wants to Ban It

Stool sample jar on blue

by John P. Thomas
Health Impact News

The therapeutic use of human poop has proven to be more effective than very expensive pharmaceutical drugs for certain diseases. Fecal Microbiota Transplants (FMT) are a less expensive and more effective treatment for many common diseases, yet the FDA is limiting the use of this therapy to a single condition. Further limitations have been recently proposed by the FDA, which will make it even more difficult for people to receive this life saving therapy.

Fecal Microbiota Transplant therapy involves transplanting stool from a healthy person into the digestive system of an unhealthy person to cure specific diseases. FMT is helpful because the poop from a healthy person contains bacteria that is needed by the person who is sick.

FMT has been successfully used for: drug-resistant bacterial infections such as Clostridium Difficile, Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Ulcerative Colitis, Crohn’s Disease, chronic constipation, Chronic Fatigue Syndrome (CFS), obesity, type II diabetes, Autism, Parkinson’s, mental disease, food poisoning, Malaria, Metabolic Syndrome, autoimmune diseases, and allergies.

The natural combination of bacteria in healthy human poop is the perfect health promoting probiotic. The transplant restores the damaged internal microbial environment, which helps people heal.

The threat to annual drug company profits could be measured in the many billions of dollars of income per year if doctors were free to use fecal microbiota transplants for treating the above list of diseases.

Fecal Transplants Cure Disease – FDA Declares it a Drug so They Can Control it

The biggest problem, from the point of view of drug makers, is that fecal transplants do more than just manage disease, they can actually cure disease and bypass the need for pharmaceutical drugs. In response to physicians who were beginning to experiment with using FMT for a wide range of health conditions, the FDA declared that poop from healthy people is a drug, and therefore can only be used for medical purposes according to the criteria that the FDA establishes. At this point, the FDA only permits physicians to use FMT with patients who have failed to respond to conventional antibiotic treatment for C Diff. Thus, first a doctor must use expensive antibiotics, which are commonly ineffective for C Diff, before trying the inexpensive fecal transplant treatment, even though FMT has a much higher rate of success.

Poop is now treated as a drug by the FDA and is officially in stage one of its Investigational New Drug application process. This means that physicians are not able to use fecal transplants for treating any condition other than C Diff until the FDA approves it for research with other diseases. Such approval is probably going to be slow to appear, because the FDA will give plenty of time for the drug companies to pursue their agenda, which is to isolate specific microbial strains in human feces, which they will put into pills and will sell as high cost prescription probiotic medications. It is not possible to patent poop, but they will try to patent certain formulas of microbes and market them for exorbitant prices as they do with their other products.

The FDA Wants to Ban Stool Donor Banks

The restrictions on performing fecal transplants may be getting tighter in the near future. In March of 2014, the FDA issued a draft instructions paper which would limit the source of fecal material that can be used in transplants. A few courageous individuals have set up laboratories for disseminating high-quality parasite-free bottles of fecal material that is ready for transplanting. The new instructions indicate that fecal material could only be provided by a person that is known to the patient or his physician, and the patient’s physician must be the one who manages the testing of the stool. The effect of this proposed instruction is to eliminate stool banks which would do the work of obtaining and screening/testing stool for transplanting. This would prevent doctors and patients from having a safe supply of suitable material available for immediate use. [1]

Why is the FDA trying to restrict such a basic procedure that is saving so many lives?

The answer may lie in the Human Microbiome Project, and the lucrative probiotic pharmaceutical market that is seen by drug makers as potentially one of the largest money-making opportunities of the future. The age of antibiotic pharmaceutical products is coming to an end, as antibiotic resistant pathogens have now rendered many of these drugs useless. Probiotic drugs offer a huge potential for the future, as the market for antibiotic resistant diseases is staggering.

Human Microbiome Project 

The National Institutes of Health launched the Human Microbiome Project in 2007 with a grant of 175 million dollars. Funding was distributed to 80 institutions around the United States for the purpose of analyzing the human microbiome to determine its role in health and disease.

The goal was to define a healthy human microbiome. The 300 healthy adult volunteers that researchers recruited for this project were not obese, not on medications, and did not have any chronic health problems or diseases; even minor gum disease was enough to exclude a subject from the study. Samples were collected from the skin, mouth, nose, stool, and vagina of volunteers. 100,000 samples were collected and analyzed over a one year period. [2]

Developing drugs to treat the human microbiome is no easy task, however. 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 when funding was exhausted on the original Human Microbiome Project, another plan to develop drugs was created.

American Gut Project

The “American Gut” project has picked up where the initial NIH study left off. Researchers are now hoping to examine the microbial populations located in and on the bodies of people around the world. They are gathering raw data to look for patterns between the samples they analyzed and the diseases and diets of people who participate in the on-going research. Anyone may participate in the American Gut project by making a donation of $99 – $25,000 to the project. In response, people can receive a kit for submitting specimens for various levels of analysis. As of May 9, 2014, 9,000 people have donated $502,00 to support the research.

According to the American Gut website, 100% of the donations go to the Biofrontiers Institute at the University of Colorado-Boulder and the Earth Microbiome Project at the University of Chicago.

The website states:

Please note this is a pure science project, not a fee-for-service business. Aside from one person, the dozens of people working on this project volunteer their time and scientific expertise.

Data from American Gut will be open source and be included as part of the Earth Microbiome Project (EMP), which is a massively collaborative international study aimed at systematically characterizing microbial life on earth. … The open source nature of our project is important because data should be free, the only way to make best use of data from massive studies is to give it to the world and see what they can do with it. … This is Citizen Science 101 and we need your help! [3]

The senior scientist on the American Gut project is Dr. Rob Knight from the Knight Lab at the University of Colorado-Boulder. He describes the grand vision:

We are trying to extend these techniques to personalized medicine with application to conditions including obesity, malnutrition, and Crohn’s disease. Our goal is to develop a predictive model that will allow us to test the effects of different treatments on an individual patient’s microbiota: for example, in our study populations in developing nations for the malnutrition project, a particular child might have a pathogen that blocks nutrient uptake that we could treat, might lack a normal gut symbiont that we could supply, or there might simply be a mismatch between what that child can metabolize and what he or she is eating. Our dream is to use the decreasing cost of DNA sequencing to bring the benefits of personalized medicine to slums and refugee camps. [4]

The agenda to conduct worldwide research and to make it free of charge to all the people of the world sounds admirable. The project is being marketed on a powerful altruistic mission statement. Who could possibly object to helping the poorest and sickest people of the world?

In thinking about this project, one might wonder who will reap the greatest benefit. Will it be the poorest and sickest people of the world who benefit, or will it be the pharmaceutical companies who are getting the benefit of free research? It is true that data from the project will be open source and potentially available to all researchers. But, it will be the drug companies that line up to mine the data, so they can create patentable formulas of human microbiota which they can market.

Over a half million dollars has been raised for research thus far. Given the totally positive coverage of this project in the media, the donations are likely to continue pouring in. It all sounds very interesting and even exciting, but we must remember that human microbiota transplants are already successfully curing diseases. None of this research is needed to make FMT more effective. All that is needed is for the FDA to remove the restrictions on using fecal transplants. The point of this massive research project is to create a new generation of products for the pharmaceutical industry. It is not to make human fecal microbiota transplants more effective.

Poop is the Universal Probiotic – Drugs Not Needed!

It is not necessary to refine and isolate specific microbes from human feces to create a special probiotic, because the microbes are designed to work together. The maximum benefit is already present in the natural form of fecal material.

Whole and natural stool has proven to be highly effective for treating C Difficile diarrhea. C Diff is a life threatening disease, which kills over 14,000 people each year. It is a disease that primarily affects elderly people age 65 or older. It contributes to situations of wasting, where elderly people steadily lose weight and grow more and more frail. In some cases death is quick if there are complicating health conditions. [5]

Let’s Look at How Well Whole and Natural poop Works for Extreme Cases of C Diff

Dr. Lawrence Brandt, a gastroenterologist from New York, reported the results of using fecal microbial transplant therapy at the annual scientific conference of the American College of Gastroenterology. He, together with physicians from Washington State, California, Oklahoma, Rhode Island, and New York, treated nearly 100 patients with resistant Clostridium Difficile Colitis.

These were people that had at least two episodes of recurrent C Dif. Patients had been treated with conventional antibiotic treatments, which failed to resolve the condition. Patients had symptoms of C Diff for an average of 11 months prior to receiving the fecal transplant. More than half the patients experience a cure, with the complete alleviation of symptoms in 3 days or less after the transplant. Some patients experience a cure within a few hours. The vast majority of patients had a complete cure in less than 6 days after suffering for nearly a year.

The key point is that relief of symptoms was prompt. The second key point is 91% of people were free of symptoms for at least 2 months. The remaining 9% of patients, who did not experience a relief from symptoms, were then given either a second fecal transplant or antibiotic therapy. The second transplant worked for many patients and the antibiotics worked for others. It was believed that the previously ineffective antibiotics suddenly worked for these patients, because the microbial terrain in the intestine had been changed to a more normal population of microbes. The total cure rate for all groups was 98.3%. [6]

Drug Costs Continue to Increase While the cost of Poop Remains Free

The cost of conventional treatment for C Diff continues to skyrocket despite the availability of the highly effective and inexpensive FMT treatment which could easily replace the use of antibiotics in most cases.

A 2014 study compared the cost/benefit of using conventional antibiotic treatment for C Diff to the use of fecal transplants. Researchers reported,

Clostridium Difficile infection (CDI) is an important cause of morbidity and healthcare costs, and is characterized by high rates of disease recurrence. … The aim of this study was to analyze the cost effectiveness of competing strategies for recurrent CDI. We constructed a decision-analytic model comparing 4 treatment strategies for first-line treatment of recurrent CDI in a population with a median age of 65 years: metronidazole, vancomycin, fidaxomicin, and fecal microbiota transplant (FMT). …On sensitivity analysis, FMT colonoscopy remained the most cost-effective strategy at cure rates >88.4% and CDI recurrence rates <14.9%. … We demonstrate that FMT colonoscopy is the most cost-effective initial strategy for management of recurrent CDI. [7]

In other words, the best and the least expensive strategy is to do FMT when a person is first diagnosed with C Diff. This is bad news for the drug companies. This is why the FDA is protecting the interest of drug companies by requiring that doctors use antibiotics first and then use fecal transplants when the antibiotics don’t work, which is quite often. Long term unsuccessfully treated C Diff is painful, disabling, and life threatening, but doctors are being prevented from using a natural therapy that has proven to offer quick and inexpensive results, while patients suffer through antibiotic treatment.

If you have witnessed anyone who has had C Diff, then you know that there is suffering involved for those who do not respond to antibiotic treatment. There is also suffering involved for those who go through several rounds of antibiotic treatment even if it ultimately arrests the infection for a while before it returns again.

The Cost of Conventional C Diff Therapy is staggering

Let’s take a look at the financial costs of treating C diff by means of conventional therapy. A 2003 study examined the costs related to the hospital treatment of 439 patients with Clostridium Difficile– associated disease (CDAD).  Patients were admitted to Barnes-Jewish Hospital, a tertiary care hospital in St. Louis, Missouri, for non-surgical reasons during 2003. Several methods of statistical analysis were used to compare the cost of treating patients with C Diff as compared to treating patients with similar health conditions who did not have C Diff. Antibiotic treatment for C Diff would have been the standard treatment used at that time.

Researchers found that the specific costs associated with the treatment of C Diff and associated diseases added $2,454 to $2,950 to the cost of the hospital stay when compared to patients with similar health conditions without C diff. Hospital costs associated with C Diff were 41% to 33% higher per hospital visit.

When these costs were multiplied by the 439 CDAD admissions, the cost of conventional treatment for C Diff in 2003 at this hospital was estimated to be between $1,077,306 and $1,422,360.

Researchers further found that there were 178,000 discharges from short-stay hospitals in the United States during 2003. Based on the treatment cost at the St. Louis hospital, it was estimated that the national attributable costs of treating CDAD in 2003 were $436– $580 million. The long-term costs of CDAD may be even greater. When multiplied by the estimate of other researchers, (McDonald et al.), the estimated attributable 180-day costs of CDAD cases in the United States in 2003 were $897 million— $1.3 billion.[8]

Treating C Diff is Big Business

Based on these numbers, treating C Diff is big business and it is getting bigger. It represents a large income stream for pharmaceutical companies and hospitals. The income stream has grown even larger over the past 10 years.

In a report prepared for the American Academy of Family Physicians, we learn that,

According to the March 9 MMWR Vital Signs report, which analyzed population-based surveillance data from the CDC’s Emerging Infections Program and other sources, hospital stays directly tied to CDIs tripled in the past decade and the number of hospitalized patients with any CDI discharge diagnosis more than doubled — from about 139,000 to 336,600. [9]

Conclusion

The great news and the great promise that we are now seeing from Fecal Microbiota Transplants are the cures that are being realized by people with a wide variety of health conditions. The success for C Diff cannot be denied. Even the FDA and the CDC acknowledge this fact. What is concerning the FDA and the pharmaceutical manufacturers is that Fecal Transplants are showing promise as effective treatments for many other diseases. These include: inflammatory bowel disease, obesity, diabetes mellitus and atopic disorders, just to name a few. [10]

Even though the FDA has clamped down on the use of FMT to protect the profitability of pharmaceutical companies, the research is continuing in other countries. Many people could benefit from FMT in the United States for a variety of diseases. Some people are using their remaining health freedom to learn about how to do their own fecal transplants.

Fortunately, there is an excellent comprehensive online resource located outside of the United States, which provides an amazing amount of “how to” information for those who wish to use FMT. There is information about how to work with your doctor and how to do home FMT in situations where a doctor is unable or unwilling to help. There are instructions for selecting donors and for using the therapy. The Frequently Asked Questions section is well worth reading. The web site is called “Power of Poop.” They also have a private Facebook page for those who wish to be in contact with other people who are using this therapy. http://thepowerofpoop.com/ [1]

References

[1] “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium Difficile Infection Not Responsive to Standard Therapies,” March 2014. http://www.regulations.gov/#!documentDetail;D=FDA-2013-D-0811-0003 [2]

[2] “The Human Microbiome Project – Department of Molecular Virology and Microbiology – Baylor College of Medicine, Houston, Texas,” Retrieved 5/9/14.

[3] American Gut by Human Food Project, Retrieved 5/9/14. http://humanfoodproject.com/americangut/ [3]

[4] “Rob Knight, PhD, Research Abstract,“ HHMI.org, Retrieved 5/9/14. http://www.hhmi.org/research/microbial-ecology-and-human-microbiome [4]

[5] (Comprehensive website on all aspects of fecal transplants), Promoting safe accessible fecal transplant for all who need it – The Power of Poop. http://thepowerofpoop.com/ [1]

[6] “Fecal Microbiota Transplant Study Part I,” Dr. Lawrence Brandt M.D., Recorded at the annual scientific conference of the American College of Gastroenterology and uploaded to YouTube on Jan 11, 2012. http://www.youtube.com/watch?v=JRZxOU1x71c [5]

[7] “Cost-effectiveness of Competing Strategies for Management of Recurrent Clostridium Difficile Infection: A Decision Analysis,” Clin Infect Dis. Mar 31, 2014, PMID: 24692533.

[8] “Short- and Long-Term Attributable Costs of Clostridium Difficile-Associated Disease in Nonsurgical Inpatients,” Oxford Journals, 2003, Vol. 43 Issue 4 Pp. 497-504. http://cid.oxfordjournals.org/content/46/4/497.full [6]

[9] “Clostridium Difficile Infection Incidence, Costs Reach Historic High,” Lisa Curran, American Academy of Family Physicians, April 30, 2012. http://www.aafp.org/news/health-of-the-public/20120430community-onsetcdi.html [7]

[10] “The gut microbiota in sickness and health,” Ned Tijdschr Geneeskd. 2014, PMID: 24780568 https://www.bcm.edu/departments/molecular-virology-and-microbiology/microbiome [8]

 

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