Saturday, December 6, 2014

Probiotics: manufacturing health and holism or manufactured claims?

"Despite conflicting clinical trials, highly variable products, and lack of FDA approval, probiotic supplements containing Lactobacillus and/or Bifidobacterium species have been increasingly used in neonatal intensive care units to prevent death due to necrotizing enterocolitis (NEC), a disease of premature infants where the intestinal wall becomes inflamed and bacteria invade the bowel wall."
--Forbes, "Children's Probiotic Supplement Contaminated with Disease-Causing Fungus," by David Kroll, 11/18/2014

A very premature infant died from gastrointestinal mucormycosis.  The cause of this infection was determined to be from a fungus called Rhizopus oryzae, which had contaminated a product called ABC Dophilus Powder, distributed by Solgar Inc. of Leonia, New Jersey.  Three lots of this product were believed to be contaminated with the fungus.  The product is distributed in 29 states in the USA, as well as Puerto Rico.  Internationally, it is sold in the UK and Israel.  It is a product that has been available through the internet.

Probiotics have in recent years been promoted for use in the prevention of NEC (necrotizing enterocolitis), in preterm infants.  What is the medical evidence for use of probiotics in the preterm infant?  A recent Cochrane Summary of the evidence states, "There is insufficient data with regard to the benefits and potential adverse effects in the most at risk infants weighing less than 1000 grams at birth."

Probiotics seem to have side effects that often are not discussed widely.  Side effects noted in adults as well as children.  Some studies have shown an increased sensitivity to allergies, in the Dutch Pancreatitis Study Group the death rates of those treated with probiotics increased, and it has been known to cause lactobacillus septicaemia in immune-compromised patients.

What interests me is that my research on patents and human milk components,  found a number of patents and patent applications that used various human milk components (human lactoferrin, Human Milk Oligosaccharides for example) to prevent and treat NEC in preterm infants.  A Cochrane Summary on studies of the use of formula milk versus donor breast milk states, "This review of nine randomized controlled trials suggests that feeding formula increases short-term growth rates, but is associated with a higher risk of developing the severe gut disorder called 'necrotizing enterocolitis.'"

The American Academy of Pediatrics states in their policy statements in the document "Breastfeeding and the Use of Human Milk" dated 2012, "Meta-analysis of 4 randomized clinical trials performed over the period 1983 to 2005 support the conclusion that feeding infants human milk is associated with a significant reduction (58%) in the incidence of necrotizing enterocolitis (NEC).  A more recent study of preterm infants fed an exclusive human milk diet compared with those fed human milk supplemented with cow-milk-based infant formula products noted a 77% reduction in NEC." 

It appears that we have medical evidence that human milk/breastfeeding protects against NEC, particularly exclusive human milk feeding/breastfeeding.  What is the basis for using probiotics in preterm infants?  We have insufficient data.  So why are NICUs (Neonatal Intensive Care Units) using probiotics?  And how many NICUs are encouraging exclusive human milk feeding/breastfeeding in their NICUs?  

One of the fascinating facts I recently learned about probiotics is that of a scientist named Henry Tissier of the Pasteur Institute in France in the 1900's.  He isolated a microorganism from the intestinal flora of breastfed infants, called Bifidobacterium.  Throughout his life he promoted the therapeutic use of this bacterium to prevent diarrhea.  (breastfed infants are protected against diarrhea).  Thus it is rather ironic in my opinion to give a breastfed infant a product off the shelf that has Bifidobacterium because breastfeeding provides this protective bacterium.  We now consider Bifidobacterium a probiotic ("for life") and it is being added to all kinds of products:  infant formula, yogurts, cereal, sports drinks, cereal, nutritional bars, etc.  Some how consumers now believe that adding probiotics to their foods somehow makes it healthier.  Yet consumers and medical professionals have very different feelings about human milk and its components.  The medical evidence for these probiotic products are not confirmed by studies.  We have a confusion regarding what probiotic bacterial strain is really in these products.  How do these substances survive packaging?  And some experts are concerned that some bacterial strains are toxic to humans.  In the USA we have no governmental regulation regarding labeling of those probiotics that are genetically engineered.  

Frightening is the fact that the Rhizopus oryaze is used by food manufacturers to create lactic acid (which is used to create probiotics).  And this fungus can be genetically engineered.  A patent  (# 6849444) filed in 2002 and owned by Archer Daniels Midland Company (a well-known food company) entitled, "Strains of Rhizopus oryzae and uses thereof," states the following:

"The strains of the invention are temperature-resistant and convert a carbon source to lactic acid at high temperatures."  and, "If desired, a Rhizopus strain of the invention can be transformed with a genetically engineered vector to express a coding sequence."

So I wonder about the contamination of a product with Rhizopus oryaze.  Is this a simple case of contamination of probiotic product? Or a result of the use of this fungus in the genetic engineering of lactic acid cultures?  What do we really know, as consumers, about the products we buy that are considered foods or supplements?  And why are hospitals using these products without clear medical evidence?  Particularly when it appears to me that we have clear evidence that exclusive human milk feeding or breastfeeding, is protective against NEC.  Human milk/breastfeeding contain what we now call probiotics.  This has been known since the early 1900s.  The food and supplement industries are basing their probiotic products on the studies of human milk bacterium.  These industries are creating these products through the use of synthetic materials and/or gene technology.  Consumers have become part of a experiment that enriches industry without being fully informed of the risks. 
Copyright 2014 Valerie W. McClain



  1. Speaking of Oligosaccharides...

  2. There are oligosaccharides and then there are human milk oligosaccharides (HMOs). Medolac is one of two for-profit "milk banks" in the USA, part of a growing human milk industry specializing in the sale of "standardized" human milk products. Of interest to readers might be the fact that Medolac has no US patents or applications. But Prolacta has many US patents and applications. One US patent application is on Human Milk Oligosaccharides derived from donor milks--although should we call it donor milk since donors are now being paid for their donations by both companies?