Thursday, July 26, 2012

Protecting Breastfeeding from the Human Milk Industry

"The 10,000 years of human expertise in feeding us is a women's expertise."
                                            Vandana Shiva-"Seeds of Resistance"
                                            from the International Museum of Women

Vandana Shiva was writing about women as seed experts, "the biodiversity conservers of the world."  Reading about the preservation of seeds, of the need for biodiversity in our crops, I find that instead of thinking about seeds I am thinking about breastfeeding.  The survival of humanity for thousands of years depended upon breastfeeding.  It was dependent upon the knowledge of breastfeeding being passed from one generation to the next.  It was dependent upon the diversity of human milk.  Breastmilk, unlike formula, is not just species specific, but genetically specific for each infant.   The survival of the infant is dependent on the closeness of the mother.  Her milk producing antibodies specific to their shared environment.

Fast forward to our biotech society that believes in separation of mother and infant and that it doesn't really matter what you feed the baby.  All we need is clean water, antibiotics, and available health care facilities and providers and babies will survive.  And most do survive in our biotech society but we might question whether infant's have optimum health.  We do not consider that for 1000s of years,  infants were biologically programed to be close to their mothers and feed at their breasts.

And now we are entering an era where improvement of infant formula will be based on actual human milk components.  I realize there will be people who think this is a great thing, a safe thing for infants.  And maybe that is so.  But the real issue breastfeeding advocates need to ask themselves is how will this protect, promote, and preserve breastfeeding?  How does homogenization of human milk into infant formula safeguard the biological diversity of breastmilk?  Yes, I hear the voices of industry:  some babies cannot breastfeed, some mothers cannot produce enough milk, and some mothers do not want to breastfeed.  We must have a billion dollar industry to save those babies.  Seems like a hell of a lot of babies need saving to support a billion dollar industry.  And adding real human milk components, is only going to add to the cost of infant formula.  What babies are we saving?  Certainly not the babies who are born into poverty?  Not the babies whose parents cannot afford expensive infant formula.  And how do we ethically justify the use of free donor milk to aid a billion dollar industry?  

I hear the little doubters in the room.  This isn't happening.  We are not seeing the merging of the infant formula industry with a human milk industry. Let me see, let's take a look at the clinical trial called, "The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants,"  ClinicalTrials government identifier NCT00810160.  The study start date was June of 2009 sponsored by University of California, Davis and the collaborators are Eunice Kennedy Shriver National Institue of Child Health and Human Services.  Some babies will get Prolact Plus mixed with formula, this group is labeled Permeate (remember Prolacta's patent application for human milk permeate?).  This is a Prolacta product.  Other babies will get a galacto-oligosaccharide supplement, and some babies will get either Bifidobacterium infantis or animalis.

I have no information on the results but I presume that since Abbott has made those 7 applications on human milk oligosaccharides that they may have been very promising. Premature babies are usually the first to get new additions to infant formula.  It was certainly the case with Martek's DHA/ARA.  So one must presume that the next step would be all babies.

Prolacta was started by Elena Medo in California.  Lately, I have not seen her name mentioned among the executives of the company.  Many of those executives were previously employed by Baxter.  So I started trying to find out what happened.  I found a little information.  She is now the CEO of a company called Neolac, Inc. based in Murrieta, California.  At the Manta website it states that Neolac is a private company categorized under Fluid Milk.  Interesting.  But not as interesting as her new invention patent at the World Intellectual Property website.  Her company Neolac has a patent application WO/2012/030764 entitled, "Human Milk Preparation."  So I guess Neolac isn't a company based on cow's milk.  It's really weird writing this.  We have a fluid milk industry and its made up of women donating their milk to save all those little NICU babies.   Science fiction coming alive to a place near you.  Obviously, the US is way ahead of the game of monopolies and using women for greater gain.   I am shaking my head and wondering when will breastfeeding advocates stop imploring women to donate their milk and at the very least question what is going on?  I guess when hell freezes over.
Copyright 2012 Valerie W. McClain

Sunday, July 22, 2012

The infant formula industry merges with the human milk industry

"Contemporary patents on life seem to be of a similar quality. They are pieces of paper issued by patent offices of the world that basically are telling corporations that if there's knowledge or living material, plants, seeds, medicines which the white man has not known about before, claim it on our behalf, and make profits out of it.
That then has become the basis of phenomena that we call biopiracy, where seeds such as the Basmati seed, the aromatic rice from India, which we have grown for centuries, right in my valley is being claimed as novel invention by RiceTec.
Neem, which we have used for millennia for pest control, for medicine, which is documented in every one of our texts, which my grandmother and mother have used for everyday functions in the home, for protecting grain, for protecting silks and woolens, for pest control, is treated as invention held by Grace, the chemical company."
                                                        Interview of Dr. Vandana Shiva of India

Human milk components (lactoferrin, lysozyme, bile salt-stimulated lipase, HMFG, the oligosaccharides) , like the Basmati seed and Neem, are being patented.  We are witnessing the merger of interests between the infant formula industry and the milk banking industry.  Biopiracy of human milk is entering a new era.  The interests of two companies, Abbott Nutrition and Prolacta Bioscience merged 2-3 years ago with a co-promotion arrangement.  Abbott would help Prolacta advertise their NICU products made from human milk.  But was there more to this deal then was publicly stated?

Why has Abbott applied for 7 patents for infant formula that contain human milk oligosaccharides to be used for preterm and term infants, toddlers and children?  All 7 patent applications (there could be more) are dated December  22, 2011.  Those applications are: Human Milk Oligosaccarides to promote growth of beneficial bacteria (application # 20120171165), Methods for reducing the incidence of oxidative stress using human milk oligosaccharides, vitamin C and anit-inflammatory agents (application # 2012172307), Methods for decreasing the incidence of necrotizing enterocolitis in infants, toddlers, or children using human milk oligosaccharides (application # 20120172319), Nutritional formulations including human milk oligosaccharides and antioxidants and uses thereof (application # 20120172327), Human milk oligosaccharides for modulating inflammation (application # 20120172330), Methods of using human milk oligosaccharides for improving airway respiratory health (application # 20120172331), and Nutritional compositions comprising human milk oligosaccharides and nucleotides and uses thereof for treating and/or preventing enteric viral infection (application 20120184503).  These patents are about adding the real component not that which is genetically engineered.  

Glycom in Denmark is one company that is using its experience in carbohydate technology to develop HMOs (human milk oligosaccharides).  They are synthetically producing the HMOs, probably genetically engineering them. This company states, "HMOs are the 3rd largest component of mother's milk and are attributed with many of its wonderful health effects.  Until now study of these natural biopharmaceuticals has been limited and commercialization has been blocked by lack of available material and high costs..."

In January 2010 in Dairy  the headline reads, "Danes unite to mine infant formula prebiotics."   Two  European formula companies, "Danisco and Arla were taking part  in a C2.5m+ business/academia research project to isolate and develop some of the oligosaccharides naturally present in human breast milk for use in infant formulas."

The infant formula industry is working on obtaining a synthetic (GMO) human milk oligosaccharides to improve infant formula.  But it seems that Abbott is interested in the real thing. And through their "partnership with Prolacta," they may have access to the real thing.

In December 2009 Prolacta filed for a patent called, "Human milk permeate compositions and methods of making and using same," patent application # 20110256233.  The abstract says, "This disclosure features human milk permeates and compositions containing the same obtained from fractionated whole milk.  The oligosaccharide rich permeate and permeate compositions of the present invention are useful as nutritional supplements for pre-term and full term infants, for establishing or maintaining gut flora and for treating the symptoms of inflammatory bowel disease,"

I find myself wondering when will the breastfeeding community wake up.  The world has changed.  The merger of interests between the infant formula industry and the human milk industry should be a very late wake up call to breastfeeding advocates around the world.  Should we wonder why the WHO Code does not work in the USA?  This is biopiracy.  The tradition of breastfeeding (not human milk feeding) is being spirited away by corporate values of ownership.

Like our seeds, freely flowing clean water, our earth;  breastfeeding is about the survival of humanity.  Corporations are about ownership, monopolies, and profit.  Our society has chosen profit over survival.  It's another sad day for Mother Earth.
Copyright 2012 Valerie W. McClain

Thursday, July 19, 2012

World Breastfeeding Week: Understanding the Past--Planning the Future


     I wrote the following to the NY Times Op-Ed department.  It wasn't published but I thought I'd share it with my readers.  The NY Times has a habit of publishing what I consider to be slanted articles on breastfeeding, like the recent opinion piece called, "Milk Wars."   The article sounds like the fearless formula blog.  How times have changed since I was a breastfeeding mother.  Back 30 years ago, breastfeeding did not get much if any support from the medical community.  Weaning was always the solution to any problem a mom might have while breastfeeding.  Have a headache? Must be because you are breastfeeding.  Broke your leg?  You need to wean the baby.  Having mother-in-law problems? Wean the baby.  Despite the growing body of knowledge about breastfeeding, weaning is still the solution.  How far have we really come in 30 years?

Here's the op-ed piece written for the NY Times:

     Every year prior to World Breastfeeding Week (August 1-7), media coverage of infant feeding seems slanted against breastfeeding.  As a long-time breastfeeding advocate, researcher on human milk component patents, and retired International Board Certified Lactation Consultant, I believe these articles are a distortion of reality.  The common theme seems to be about making women feel comfortable about their choice of infant formula.  The long-term and short-term risks of infant formula are not addressed.  Breastfeeding benefits are described in such a manner as to be perceived as enormous burdens.  We start to question whether breastfeeding is an important health care issue.  Or is it just a life-style choice whose promotion is making formula feeders feel guilty?
     In September of 1992, the Swedish newspaper, Dagens Nyheter had a photo of an infant at the breast with the caption, “Patent on Life:  Sweden must act to stop the patenting of a gene-manipulated woman, demanded patent lawyer Anders Hagman.”  The Green Party of Europe had learned about this pending patent application to the European Patent Office and mounted a campaign to have it rejected.  The description of this patent was that this was a patent on humans in order to gain monopoly rights to the production of drugs in women’s breasts.  This patent became known as the “Pharm Woman Patent.”  The patent was rejected by the European Patent Office.  But unknown to the public, the US Patent Office had already accepted and published this patent in 1990.  It was entitled, “Lactoferrin as a dietary ingredient promoting the growth of the gastrointestinal tract,” and owned by Baylor College of Medicine.  The source of their claim was on human and bovine lactoferrin.  Cow’s make little to no lactoferrin.  But human milk has substantial amounts of lactoferrin compared to cow’s milk.    “This present invention is based upon the discovery that milk lactoferrin as a dietary ingredient promotes the growth of the gastrointestinal tract when added to infant formula or given separately from the formula and thus reduces the occurrence of chronic diarrhea and may assist in the management of short-gut syndrome and avoids at least to some extent, chronic intractable diarrhea of the infant.”
     Baylor College of Medicine believed that lactoferrin, derived from human milk, could be used in infant formula to prevent the risk of diarrhea.  Studies in the 1980’s showed that formula-fed infants in industrialized nations had a 3-4 fold risk of diarrhea.  The inventors from Baylor also believed that short-gut syndrome was caused by a lack of human milk lactoferrin.  This was the beginning of patenting on human milk components.    There are over 2000 human milk component patents and filed patent applications at the US Patent & Trademark Office.  Human milk components, mostly their gene constructs, are being used or will be used to protect and treat not only infants but adults from a wide variety of pathogens.  Human lactoferrin is considered by some pharmaceutical companies to be an antibiotic.  Other human milk components are considered to be probiotic and prebiotic, a treatment in wound healing and cancer, and as a source of stem cells.  The infant formula industry in some countries has been adding lactoferrin to their products to better protect infants.  The infant formula, supplement, and food industries have been using the genetically engineered sugars from human milk as a prebiotic and probiotic.
     Patenting human milk components, mostly their gene constructs to make a safer infant formula tells us that the industry knows and is trying to prevent the risks of infant formula.  Pharmaceutical companies want to use those components as a source for drugs to save people from disease and cancers.  The food industry makes claims of health based on the goodness of prebiotics and probiotics, which are components of human milk. Yet, publicly we are still debating the issue of infant feeding as if breastfeeding is a lifestyle choice.  Meanwhile industry and institutions are making claims on what is produced in the human mammary gland.  Why is our society willing to own, monopolize, and commercialize human milk components?  Yet, reluctant to recognize that breastfeeding is an important health care issue? 
Copyright 2012 Valerie W. McClain