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

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