WHY is FMT (Fecal Microbiota Transplantation) as a remedy for c. difficile related colitis ‘banned’ in the USA and encouraged in Europe?

 

ANSWER: Because it’s cheap as shit and Pfizer and other drug companies stand to make literally BILLIONS on a vaccine for “d. cifficile infections” (THE REALITY IS that rather that c.difficile being a ‘pathogen’ it is a microbe that proliferates under conditions of imbalance in the microbial assemblage in the gut).  A widespread acceptance of FMT as in Europe, will negate BILLIONS in projected pharmaceutical company revenues.

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c. diff causes about half a million infections and 25,000 deaths in the U.S. each year

While the FMT (stool transplant) treatment is close to 100 percent effective as a cure for c. difficile related colitis, it is not allowed in the U.S. unless one has had 3 or more recurrent bouts of this imbalance in the intestinal microbial assemblage.

WONDER WHY FMT IS NOT THE GENERAL REMEDIAL APPROACH FOR C. DIFFICILE?

“Back in May, a Moody’s report predicted the vaccine being developed for c. difficile infections would launch in 2021 and generate peak sales of $300 million.

But Barclays analyst Carter Gould thinks the vaccine has more promise than that. Along with Pfizer’s 20-valent pneumococcal vaccine, the candidate has “the potential to drive an inflection in growth across the vaccines business which provides a durable revenue contribution,”

— Gould’s team (Sanofi) sees the vaccine as a “high risk/high reward opportunity,” and predicts it could generate $2 billion by 2030″.

 

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THE KEY POINTS ON WHAT IS GOING ON HERE CAN BE GLEANED FROM JUXTAPOSING THE FOLLOWING THREE ARTICLES (The URL’s, Article titles and a short extract from each of the three are included below).

THE “STORY’ IN BRIEF HAS CONFLICTING ASPECTS, labelled A, B and C.

 

(A) THERE IS A NATURAL REMEDY TO RESOLVE c. difficile ‘infections’ (imbalances in the microbial assemblage in the gut) WHICH IS TO RESTORE THE NATURAL BALANCE IN THE MICROBIAL ASSEMBLAGE IN THE GUT.  That re balancing is what FMT achieves.  This was known in Chinese medicine but it is ‘foreign’ to WESTERN MEDICINE which is ALLOPATHIC (oriented to eliminating pathogens) while Chinese medicine orients to the restoring of natural balance, which was also the orientation of EARLY WESTERN “HYGIEAN ” MEDICINE as conceivved by Hippocartes, which was overtaken, in the WEST, by AESCULAPIAN medicine oriented to the ELIMINATING OF PATHOGENS (Western Justice ‘went the same way’, fuelled by BINARY LOGIC as in GOOD versus EVIL which we have applied to both MEDICINE and SOCIETY. (ref. https://goodshare.org/wp/copy-of-dr-robert-herwicks-the-limitations-of-medical-science-in-the-solution-of-social-problems/ 

THE OLD CHINESE METHOD of RE-BALANCING the microbial assemblage in the gut WORKS because the problem is imbalance in the gut and NOT “THE ATTACK OF PATHOGENS”.  ‘C. DIIFICINE IS NOT AN ATTACKING PATHOGEN, that is just the simplistic BINARY LOGIC based model of EVIL versus GOOD which one tries to resolve by ELIMINATING THE EVIL as in classic ALLOPATHIC WESTERN MEDICINE.

This RE-BALANCING story is being told here;

https://www.health.harvard.edu/blog/stool-transplants-are-now-standard-of-care-for-recurrent-c-difficile-infections-2019050916576

Harvard Health Blog

Stool transplants are now standard of care for recurrent C. difficile infections

Published: May 09, 2019

Author: Jessica Allegretti, MD, MPH, Contributor

Fecal microbiota transplantation (FMT), also known as stool transplantation, is a procedure in which stool from a healthy donor is placed into the gut of a patient in order to treat a certain disease. FMT is not a new concept, but in the last six years it has become a standard-of-care therapy for the treatment of recurrent Clostridium difficile infection (CDI).

Treating infection with C. difficile

Clostridium difficile (C. diff) is a bacterium that is ever-present in our environment. Many people have C. diff in their bodies without issue; it is not the bacteria itself that makes you sick. However, under certain conditions, the bacteria release toxins, and it is the toxin that causes disease. A person with a CDI may experience watery diarrhea and abdominal cramping. In severe cases, infection can cause dehydration, require hospitalization, and be life-threatening.

The main risk factor for CDI is taking antibiotics, which is why doctors discourage unnecessary antibiotic use. Ironically, first-line treatment for CDI is also antibiotics. About 20% of people treated with antibiotics will develop recurrent infections, and the best way of clearing recurrent CDI is with FMT. This is supported by several guidelines. The reason why FMT works so well is largely unknown, but generally speaking it restores important helpful bacteria that help protect against CDI.

But while supported by guidelines, FMT is still considered investigational and is not currently FDA-approved. However, FMT can be performed for clinical care to treat recurrent CDI (typically defined as three or more confirmed episodes), or CDI that does not respond to other treatments. An FMT for any other indication can only be performed in the setting of a clinical trial.

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(B) The FMT rebalancing method WORKS but it just doesn’t fit into the usual models so it remains RESTRICTED in the U.S.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6510370/

Discrete classification of FMT is challenging because FMT meets requirements for multiple product classes. The FDA Center for Biologic Evaluation and Research has labeled FMT as a drug because donor feces must be modified before going into patients. In Canada, FMT is classified as a new biologic drug and requires an approved Clinical Trial Application to be used. The European National Institute of Health and Care Excellence has advised that FMT is safe and effective—making FMT more accessible in Europe than in the United States.

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(C) FOR THE PHARMACEUTICAL INDUSTRY, THE ECONOMICS OF VACCINE DEVELOPMENT FOR c. difficile “infections” are HUGE!

https://www.fiercepharma.com/special-report/pfizer-pf-06425090

 

Special Reports

Pfizer, C. diff

by Eric Sagonowsky | Sep 29, 2020 3:00am

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Pfizer, PF-06425090
Disease: Clostridium difficile

Pfizer’s 20-valent pneumococcal vaccine has generated considerable attention from analysts and market watchers, but at the same time, the company is advancing a C. difficile vaccine that would be the first immunization against the infection if approved.

The vaccine candidate, called PF-06425090, entered phase 3 testing in 2017. The late-stage study for the shot is expected to read out “later this year,” CEO Albert Bourla said on a July conference call.

It’s intended to help prevent C. diff infections, which often occur in hospitals or long-term care facilities, by triggering an antibody response to the two leading disease-causing toxins from the bacteria.

Back in May, a Moody’s report predicted the vaccine would launch in 2021 and generate peak sales of $300 million.

But Barclays analyst Carter Gould thinks the vaccine has more promise than that. Along with Pfizer’s 20-valent pneumococcal vaccine, the candidate has “the potential to drive an inflection in growth across the vaccines business which provides a durable revenue contribution,” Gould wrote in a February note to clients. Given past failures in the field, he said it’s “understandable” that some analysts are ignoring the candidate.

But C. diff causes about half a million infections and 25,000 deaths in the U.S. each year, he wrote, and the market is currently wide open. Sanofi previously had a late-stage candidate, but it abandoned the program after a big trial flop.

RELATED: After a phase 3 flop, Sanofi cans its C. diff vaccine hopes

The market opportunity is “quite large,” Gould wrote, as millions of patients are either hospitalized for long periods or are on antibiotics each year. Plus, around 15 million patients have severe comorbidities. The company would need to build the market in part through strong data to score a recommendation from CDC vaccine experts, he noted. Gould’s team sees the vaccine as a “high risk/high reward opportunity,” and predicts it could generate $2 billion by 2030.

Aside from Pfizer, Valneva also has a C. diff vaccine candidate, VLA84, that’s completed a phase 2 study. The company is seeking a partner to conduct phase 3 testing.

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