Tuesday, December 30, 2014

The Commercialization of Human Milk

"Human milk is not a uniform body fluid, instead, it is a secretion from the mammary gland of constant changing composition.  In nature, the composition of human milk changes not only from day to day, but also throughout the course of a single day.  While the reasons and outcome of these changes are not fully understood, it is intuitive to believe that these changes benefit the species and that substantial advantages may be gained for the infant who is provided an opportunity to reap the benefits of a modified formulation of 100% human milk."--PATENT #7914822 "Method of producing nutritional products from human milk tissue and compositions thereof," invented by Elena Medo, owned by Prolacta Bioscience  http://patft.uspto.gov/

Prolacta Bioscience was founded in 1999 by Elena Medo, an inventor, and entrepreneur.  Over the past decade she has raised $33 million for 3 start-up companies:  Prolacta Bioscience (manufacturer of standardized human milk products), Neolac (dba Medolac Labs--a milk bank owned and controlled by qualified milk donors, Mother's Milk Cooperative, which has created a human milk product that is in a 4oz foil pouch with a shelf life of 3 years and can be stored at room temperature), and North American Instruments which has developed the Calais Human Milk Analyzer which uses infrared spectroscopy to analyse human milk http://www.calaisanalyzer.com/about-us.html

Elena Medo is a listed inventor to at least 9 US patents (two are patents on a breast pumps-and she is the only listed inventor/owner).  The other 7 US patents are owned by Prolacta Bioscience and about methods of testing human milk, compositions of human milk and/or compositions of human lipids.  She also is a listed inventor to 6 US patent applications (not yet patented) on human milk compositions and/or testing of human milk owned by Prolacta Bioscience.  She started two more companies in 2009:  Neolac, Inc. (DBA-Doing Business As-Medolac) and North American Instruments.  She also is the only listed inventor to a WIPO (World Intellectual Property Organization) patent application entitled, "Human Milk Preparation" filed in 2011 and owned by her company, Neolac, Inc.  

The name Neolac has generated a lot of confusion because it is also the name of a brand of infant formula made by a company, Neolac Nutrition B.V. of the Netherlands, part of the Ausnutria Hyproca Dairy Group.  There is also a Neolac Nutrition in Shanghi China, which sells Neolac infant formula.  Medolac/Neolac of the USA in their website states that they are, "in no way affiliated with the Neolac infant formula company in the Netherlands."  Although there is another unusal similarity between Medolac and the Dutch infant formula company.  The history of the Netherland's infant formula company includes a co-operative (a group of farmers in 1910 created a co-operative and owned the company for some years).  Medolac is supported by its Mother's Milk Cooperative.

 Of interest to some readers is that the name Neolac, as a trademark has been disputed in the past.  In 1988 in the Philippines. Nestle filed a notice of opposition to the trademark, NEOLAC, filed by a company called Nutritional Dietetic Corporation for their infant formula named, NEOLAC.  Nestle believed it was "confusingly similar to their trademarked product, NESLAC."  http://onlineservices.ipophil.gov.ph/ipcaselibrary/ipcasepdf/IPC3076.pdf  

All rather confusing but obvious that the dairy/infant formula/human milk industries like the name, Neolac.  And so when it comes to selling products of similar names, it can become a legal nightmare for companies, if someone disputes the ownership of a trademark.  Neolac is a trademark owned by Ausnutria Hyproca B.V. of the Netherlands (2009-Word, 2012-Figurative).  There is no US trademark for Neolac.  Medolac is a US trademark, filed in 2013, and owned by Neolac, Inc. USA.

In the patent owned by Prolacta Bioscience and invented by Elena Medo, she describes that human milk is not a uniform body fluid (quote from the patent quoted above, #7914822).  She believes that these changes are not understood but benefit the species.  Yet her patent also states, "Accordingly it would be desirable to provide a standardized source of human milk that can be modified to reflect the various stages of lactation and various immune responses."  


"It is at the core of the present invention to utilize such human milk constituents, in their processed form, in such a sequential fashion as to provoke the same type of chain reaction in the body.  With this concept the pairing of the processed milk tissue with the sequential and differentiated delivery methods, patients may enjoy a new type of preventative and therapeutic medicine."

This patent states that the human milk constituents will be in a processed form.  What research do we have that shows that there is an equivalency between unprocessed and processed human milk consitutents?  We know that processing of human milk changes some of the components of human milk.  Dr. Ruth Lawrence states in a paper published by Acta POdiatr in 1999, entitled, "Storage of human milk and the influence of procedures on immunological components of human milk," She states,

"The potential for alteration of the constituents begins with the mode of collection and the nature of the collecting and storage vessel.  The temperature for storage, i.e. room temperature, refrigeration or freezing, and pasteurization or sterilization have an impact."

and she also states

"The nutrient value of human milk is essentially unchanged, but the immunological properties are reduced by various storage techniques."

Medela, well-known breast pump manufacturer, in their literature for a product called, Calesca ( a waterless, warming device for human mik, designed for NICUs) states:

"...the handling of human milk may compromise its bioactivity and practices must therefore be carefully optimised.  Various human milk components show very different sensitivity.  Proteins and vitamins are among the most sensitive consituents, whereas carbohydrates and most fats are much more stable."

The pasteurization of milk does destroy pathogens in the milk but it is also destructive of vitamins, beneficial bacteria (probiotics), and enzymes.  Pasteurization does increase the shelf-life of milk, making it easier to mass-market a product.

In some of the Prolacta patents the processing of human milk is described for various standardized formulations of human milk.  In general and from my understanding, donor milk is pooled, screened for viruses, filtered, ultrafiltered--water is filtered out of the milk, called permeate, then the watery milk called permeate is added back in, cream from another batch of milk may be added, then the composition can be frozen and thawed out later for futher processing, minerals are added (and/or vitamins), then pasteurized at 63 degrees C. for minimum of 30 minutes, cooled to 2-8 degrees C., samples taken for nutritional and bioburden analysis, and finally product packaged and shipped.

It appears to me to be a lot of processing, which creates in my mind the question of how equivalent are these standardized human milk formulations to the milk that a baby receives from breastfeeding?  How equivalent to the donor milk provided by the non-profit milk banks, which is pasteurized without additives?  Where are the scientific studies to show that the methods used by Prolacta (and Medolac with its 3 year shelf-life product) to create a standardized human milk product are based on clear facts?  We seem to be investing in products rather than breastfeeding.  What is our knowledge base regarding preterm infants ability to breastfeed?  Are preterm infants given the earliest possible opportunity to breastfeed?  Or will we presume because we have these human milk products that breastfeeding is not a necessity?  And will we continue to presume like the mantra brought to you by the infant formula industry that some women don't want to or can't breastfeed?  Is that a truth or a self-forfilling prophecy?  Will these products that are only created for preterm babies eventually be marketed to mothers whose babies are full term?  How else can profits be made unless one expands the market?  

The commercialization of infant formula happened in the late 19th century and expanded in the 20th century.  Commercialization took place because of a number of inventions.  Milking machines became more and more efficient.  Although some physicians in the 19th century were alarmed by the abandonment of milking by hand.

"L.B. Arnold, secretary of the American Dairyman's Association wrote about the great value of hand milking in the development of the bovine udder and warned against resorting to machine milking." http://www.americanartifacts.com/smma/milker/milker.htm

Likewise in the 21st century, some lactation professionals, remind us of the great value of hand expression over breast pumps.  Yet it seems the widespread use of breast pumps by breastfeeding mothers, has devalued and limited the use of hand expression.  Is the growing use of breast pumps rather than breastfeeding in the USA facilitating the growth of a human milk industry? 

Aren't the standardized human milk products and its rationales, similar to the history of the infant formula industry?  Author Rima D Apple in her book, "Mothers and Medicine:  A Social History of Infant feeding 1890-1950," writes,  

"Once their research had disclosed the variable nature of breast milk, some physicians promoted artificial feeding with a food compounded of known ingredients in preference to the uncertainty of maternal nursing."

Despite our greater scientific understanding of human milk, we like our forebears of the 19th century are deeply uncertain about breastfeeding.  The medical and scientific communities are still leery of breastfeeding, particularly for the preterm infant.  Anything that cannot be quantified, standardized is pure mystery and somewhat dangerous. Perhaps it is the ideology that women cannot be trusted to provide for their infants and that only industry should be trusted.
Rima D. Apple writes in her book, "Mothers and Medicine,
"Believing that breast milk was the best food, but that in actuality 'the ideal breast milk is rare,'"

"As infant feeding became the keystone of the emerging specialty of pediatrics in the twentieth century, the manufacture of infant food became a lucrative industry.  More and more mothers reported difficulty in nursing their babies."

Deja vu?   The 21st century seems stuck by the same infant feeding ideology as the 19th century. What is possible?  Breastfeeding?  Should we let women control how their infants are fed?  Or should we let the scientific/medical community lead by industry, control the feeding of infants?  Is controlling and patenting a natural resource, like human milk, about wisdom or scientific truths?  Or is it about finding gold in them there hills?

Copyright 2014 Valerie W. McClain

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." http://summaries.cochrane.org/CD005496/NEONATAL_probiotics-for-prevention-of-necrotizing-enterocolitis-in-preterm-infants

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