A salute to "World Milksharing Week" September 24-30

"There is serious concern that some of these artificial recombinant DNA molecules could prove biologically hazardous.  One potential hazard in current experiments derives from the need to use a bacterium like E. coli to clone the recombinant DNA molecules and to amplify their number.  Strains of E. coli commonly reside in the human intestinal tract, and they are capable of exchanging genetic information with other types of bacteria, some of which are pathogenic to man.  Thus, new DNA elements introduced into E. coli might possibly become widely disseminated among human, bacterial, plant, or animal populations with unpredictable effects."
                                                The Paul Berg letter in "Science" 1974

Is this a hint of things to come, the darkening shadows being played out in our science fictionalized world?  Or did the Asilomar Conference in 1975 resolve this situation by letting the scientists themselves self-regulate the dangers of this new science.  Never before had scientists come together and proposed a year long moratorium on research.  But when that year long moratorium ended, did the hazards of genetic engineering subside?  Does self-regulation of such a science create safety or open the door to a variety of dangers.  Those dangers go unrecognized in a society in which the word genetic engineering is considered a dirty word.  Instead we talk about food products that were synthetically produced.  Not saying that dirty word in public means it doesn't exist.  No questions can be asked.  How can you question something that doesn't exist? 

Genetic engineering has its beginnings in the cellular manipulation of pathogens.  E. coli was often the pathogen of choice because it was considered a benign bacterium.  Some guidelines were put in place by the NIH in which some recombinant DNA experiments were prohibited.  But it seems that over time anyone critical of genetic engineering or its direction found themselves out of work.  Not surprising is the fact that industry jumped into this new science, particularly Monsanto.  Genetic engineering had broad applications not only in food technology but in the medical field.  Antibody testing (vaccination, drugs are other products) is one of the products of genetic engineering.  The fast sometimes erroneous results we get regarding the current disease-of-the-month is because our medical testing kits are based on genetic engineering.  Yes, you are positive for MRSA (or it could be HIV or Hepatitis C)...the new testing kit proves without a doubt that you are contagious and very sick.  Wait, two days later you aren't positive for MRSA.  How about your vitamin D levels--test kits are genetically engineered.  Funny, how everyone believes in the infallibility of the test.  They are told they are low in vitamin D.  How do they know this, the test kit tells them so.  Yes it was genetically engineered just for you!  Its always interesting to listen to conversations in doctors offices.  There is something magical about going to the doctor.  Its a religious experience because if the person in the white coat says that you have whatever disease because of test so and so, we believe.  Most of us never question our doctor, and would never consider questioning the test.  Well, your belief is based on the infallibility of genetic engineering, when your blood is tested for diseases.

I have a hard time believing that genetic engineering is infallible.  Or that scientists can self-regulate this science safely.  We are after all human not gods.  We make mistakes, even PhDs.  In fact I would say we learn more by our mistakes.  But our industry and our governments have placed their bets on the side of self-regulation.  The food industry in particular has an enormous impact on our health and well-being as well as our financial state.  Food is a necessity and it takes a big bite out of our budget on a weekly basis.  Infant formula is an expensive product.  Infants who are formula fed do not have immune protection.  They are more likely to get sick and be hospitalized unlike the breastfed infant.  So one needs to factor in not only the fact that the product is costly but it is also medically costly.

The recognition that infant formula is deficient in building immunity has created the need for creating a safer infant formula. Human milk research became the answer to creating a safer infant formula. Genetically engineering  human milk components in bacteria is believed to create a better infant formula. 

A recent patent application entitled, "Biosynthesis of Human Milk Oligosaccharides in Engineered Bacteria,"  by the company Glycosyn LLC has a long list of pathogens in which to create their "synthetic" human milk oligosaccharide.

"The invention described herein details the manipulation of genes and pathways within bacteria such as the enterobacterium Escherichia coli K12 (E. coli) or probiotic bacteria leading to high level synthesis of HMOS. A variety of bacterial species may be used in the oligosaccharide biosynthesis methods, for example Erwinia herbicola (Pantoea agglomerans), Citrobacter freundii, Pantoea citrea, Pectobacterium carotovorum, or Xanthomonas campestris. Bacteria of the genus Bacillus may also be used, including Bacillus subtilis, Bacillus licheniformis, Bacillus coagulans, Bacillus thermophilus, Bacillus laterosporus, Bacillus megaterium, Bacillus mycoides, Bacillus pumilus, Bacillus lentus, Bacillus cereus, and Bacillus circulans. Similarly, bacteria of the genera Lactobacillus and Lactococcus may be modified using the methods of this invention, including but not limited to Lactobacillus acidophilus, Lactobacillus salivarius, Lactobacillus plantarum, Lactobacillus helveticus, Lactobacillus delbrueckii, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus casei, Lactobacillus reuteri, Lactobacillus jensenii, and Lactococcus lactis. Streptococcus thermophiles and Proprionibacterium freudenreichii are also suitable bacterial species for the invention described herein. Also included as part of this invention are strains, modified as described here, from the genera Enterococcus (e.g., Enterococcus faecium and Enterococcus thermophiles), Bifidobacterium (e.g., Bifidobacterium longum, Bifidobacterium infantis, and Bifidobacterium bifidum), Sporolactobacillus spp., Micromomospora spp., Micrococcus spp., Rhodococcus spp., and Pseudomonas (e.g., Pseudomonas fluorescens and Pseudomonas aeruginosa). Bacteria comprising the characteristics described herein are cultured in the presence of lactose, and a fucosylated oligosaccharide is retrieved, either from the bacterium itself or from a culture supernatant of the bacterium. The fucosylated oligosaccharide is purified for use in therapeutic or nutritional products, or the bacteria are used directly in such products."





Pick a bacteria, any bacteria and we will create a human milk component that will make infant formula safer.  I noticed one of the bacterium listed is Bacillus cereus, a well known food poison.  So you and I must trust that using these pathogens is safe and the toxins that would normally be produced have been disabled.  This process of making human milk oligosaccharides in bacteria is not new.  I found a paper written in Glycobiology in 2002 entitled, "A new fermentation process allows large-scale production of human milk oligosaccharides by metabolically engineered bacteria."  So the process has been known for over a decade but I am wonder about how much studying has been done on the safety of this in regard to infant formula.   And then I wonder about this company, Glycosyn, that is based in Massachusetts whose advisory board includes some well known human milk researchers, David S. Newburg (who is on the editorial board of Breastfeeding Medicine and was on the HMBANA advisory board for almost a decade) and Ardythe L. Morrow.   Human milk research is connected to the infant formula industry because we seem to be obligated to use human milk components as the gold standard in which to create a better infant formula.  This science is using genetic engineering to create these substances for the infant formula industry.  




  
This week we celebrate World Milksharing Week.  I  salute the women who donate their milk.  They donate to help mothers feed their babies.  They help babies survive because of the wondrous properties of human milk.  My only wish would be that these mothers understand that some of their donations are about helping the infant formula industry make a better infant formula.  And maybe that is a good thing.  And then maybe it is not a good thing. My fear has been that we don't have a long-term safety record of this technology we are employing to create imitation human milk components.  Breastfeeding has a long-term track record.  It saved babies for thousands of years.  Designing baby milks based on human milk is a complement to the value of human milk.  After all it is considered the gold standard.  But fermenting and genetically manipulating bacteria to create our "synthetic" human milk components creates enormous questions of safety in my mind.  Why are we so willing to genetically engineer human milk rather than work to create a society that promotes and protects breastfeeding?
Copyright 2012 Valerie W. McClain
 

Sacred promise: a better infant formula next year

"Man does not weave this web of life.  He is merely a strand of it.  Whatever he does to the web, he does to himself."  Chief Seattle

"How can you buy or sell the sky, the warmth of the land?  The idea is strange to us.  If we do not own the freshness of the air and the sparkle of the water, how can you buy them?  Every part of earth is sacred to my people."  Chief Seattle

How smooth must be the language of the whites, when they can make right look like wrong, and wrong like right."  Black Hawk

The discovery of America was in reality a giant land grab by the White Man.  The American Indian suffered the consequences of a system that believed that land could be owned.  In fact a way of life was destroyed in order that the White Man could own property.  Likewise we are currently witnessing a greed that knows no boundaries.  But it is not ownership of land/property but ownership of cells, of DNA.  It is a molecular tag sale in which bacteria, viruses, fungi, human and animal cells, tissue are up for grabs.  Patent it, stake your claim, and monopolize life.  The infant formula industry has become part of this biotech industry.  They believe that the manipulation of our DNA can create a better, safer infant formula.   Imitating human milk has been the game for many years.  In the 70's the infant formula industry wrote about humanized infant formula.  A patent filed in 1970 by American Home Products (which became Wyeth, which became Pfizer, which became Nestle) stated, "Breast feeding of all infants for at least 6 months offers the best nutrition and greatest resistance to disease."  Patent # 3649295 entitled "Humanized Fat Compositions and infant formulas thereof"

Fifty years later we still have a public that hasn't a clue that breastfeeding inactivates pathogens and gives "the greatest resistance to disease."  Breastfeeding in many people's minds is just a life-style choice with some added benefits.  Those added benefits are constantly disputed in the press so the public is kept in the dark about the riskiness of infant formula and how breastfeeding safeguards an infant from disease.  There is constant talk about breastfeeding being the "preferred method of feeding" but that is coupled with statements that some moms can't or won't breastfeed.  Very little discussion goes into why moms can't or won't breastfeed.  Instead the talk is that moms have to have "choice."  And moms sure have a lot of choices when it comes to choosing an infant formula.  Every year there is something new or improved in the formulations.  Why?  Because the industry finds out that last year's new and improved doesn't work well or it actually made infants sicker or in fact killed them.  We are relieved to know that most babies don't die from infant formula in the USA, just a few. But the reality is we don't study this issue at all.  An industry might take offense to such an endeavor.  And heaven forbid we get that industry upset because after all they make billions of dollars a year.  And the US Government is invested in the making of infant formula.  Well, yes they do proclaim their belief in breastfeeding but you know moms can't or won't breastfeed.  So in the interest of those who can't or won't, we must make a better infant formula, better than human milk.  Funny how they never say better than breastfeeding, its always about human milk-the product.

Breastfeeding advocates believe in the improvement of infant formula.  Because who would be against it?  I am not against the improvement of infant formula.  I just don't think it can be done.  In fact this constant changing of infant formulations is questionable.  We now have formulas to make the baby's poop more like breastfed baby's poop, more like a breastfed baby's immune system, to prevent obesity, to prevent diarrhea, to prevent respiratory illnesses, to create better brains, better eyesight.  The list goes on and on and each year something new is added.  We have all these human milk researchers who are going to make infant formula just like human milk through genetic engineering.  No one questions the genetic engineering because that's our spiffy new science (actually its old it dates from 1970s).
So in reality each year, a new set of infants who are given infant formula become the guinea pigs to a science that we are just beginning to ask safety questions.  How do you disable the virulence of e.coli that is producing the enzyme that makes human milk oligosaccharides?  I learned the other day you irradiate it, use cobalt-60 and nuke it.  Doe irradiation work?  I don't know but I honestly don't like my food nuked.  But its okay to nuke food for babies cause it makes it safer.  Then when we genetically engineer cells to produce oils, probiotics, or other products; we monitor the situation by adding antibiotic resistance genes.  Those antibiotic resistant genes are ingested by the infant.  They use to believe that those genes were not absorbed by the intestines.  Whoops, a little mistake, we now know that isn't true.  The gut takes it into it's cells.  So now we have an individual that may develop antibiotic resistance to certain drugs used in genetic engineering.  Improvement?    Pass the probiotics, please, I like my bacteria well done.  Who is monitoring this?  The FDA?  Yeah, sure they are and I believe in the Easter Bunny, too.

Newest trend in improving infant formula.  Hazelnuts.  Do you know that hazelnut oil mimics the structure of mother's milk?   Let's try it cause we know that women won't or can't breastfeed.  Maybe next year it will be some other nut. Another new trend is a purified antibody called secretory immunoglobulin A.  That's still in the research phase.  Surely, it will have to be genetically engineered?  We will try that next year and see what happens, probably goes well with hazelnuts.

Does the public truly understand what is going on with infant formula?  Do breastfeeding advocates who advise other advocates to modify their supposedly extreme statements about infant formula, understand this engineering?   I doubt it.  Here's a patent for ya, enjoy it.  It's another new formulation of probiotics.  This is owned by Mead Johnson and called, "Probiotic infant products,"  patent #8137718 filed in 2008.

"As used herein, the terms 'mutant,' 'variant,' and 'genetically modified mutant' include a strain of Bifidobacteria whose genetic and/or phenotypic properties are altered compared to the parent strain."

"Genetic modification includes intorduction of exogenous and/or endogenous DNA sequences into the genome of a Bifidobacteria strain, for example by insertion into the genome of the bacterial strain by vectors including plasmid DNA, or bacteriophages."

This novel probiotics came from the feces of a 3 day old male breastfed infant.  I wonder if the mom of this baby knows that her baby's poop is a treasured product used by an infant formula company.  Wasn't it a French Queen during the French Revolution that said, "Let them eat cake,"  in response to the starving masses.  I can almost hear the new biotech slogans for this decade, "Let them eat poop--breastfed poop."  Here's to making a better infant formula this year!
Copyright 2012 Valerie W. McClain

 

Inventing Human Milk Oligosaccharides

"Furthermore, E. Coli is the primary bacterium used in genetic engineering.  Many new genes and combinations of genes were created and amplified and propagated in E. Coli, because the original bacterium was harmless.  In the process, genetic engineers have turned an original harmless bacterium into deadly pathogens."   Dr. Mae-Wan Ho
http://www.i-sis.org.uk/Genetic_Engineering_E_coli_Outbreak.php

Who would think that men could engineer a microbe that could make a human milk oligosaccharide?  But, yes, yes we can do this through metabolic engineering.  Say what?  Let's look at what Wikipedia says about metabolic engineering.

"Metabolic engineering is the practice of optimizing genetic and regulatory processes within cells to increase the cells' production of a certain substance."  
Metabolic engineering uses genetic engineering techniques. Various research papers state the use of various pathogens to create human milk oligosaccharides:  Escherichia coli (e. coli), Pichia pastoris, Agrobacterium sp. Corneybacterium ammoniagenes, and Corneybacterium glutamicum.  Yeah, quite the mouthful, not sure I can pronounce any of these pathogens except e.coli.

An interesting paper from the Journal of Biotechnology published in 2008 called, "Genetic engineering of Escherichia coli for the economical production of sialylated  oligosaccharides," by Nicolas Fierfort and Eric Samain states,

"Free sialylated oligosaccharides are found at high concentrations in human milk and are know to have both anti-infective and immunostimulating properties."

"The development of efficient systems for the enzymatic synthesis of sialylated oligosaccharides has been possible through the identification of bacterial sialytransferase genes which are well expressed in Escherichia coli and the design of multiple enzymatic systems for the synthesis of CMP-Neu5Ac."

But wait we have to redesign the system,

"Since the only E. coli strains that naturally produce CMP-Neu5Ac are pathogenic strains that cannot be used in biotechnological processes, a pathway for the synthesis of CMP-Neu5Ac had to be imported into E. coli strain K12 derivatives.."

Yes, restructure that e.coli and hopefully trust that our scientists can create pathways that disable the pathogenic tendencies of e.coli.  This study was about generating this particular human milk oligosaccharide at low cost for the food industry.  Scared.  Ya ought to be.

We have a company in Denmark, called Glycom that is using their "bench chemistry" to create human milk oligosaccharides.  I wonder if bench chemistry is another word for genetic engineering?  I presume that some of their bench chemistry will be placed in infant formulas.  Why because their outstanding partner is the Nestle Group with some of their BOD directors from Nestle.  I was amused to see that their CEO and Director, John Theroux, served as head of the European management consultants, Bain and Company (this company has been making the news in the US).  Not that his service is amusing, just that well "its a small world after all."

Actually my real interest in all this is, of course, a patent entitled, "Human milk oligosaccharides to promote growth of beneficial gut bacteria," patent # 8197872.  The inventors are David A. Mills, Carlito B. Lebrilla, Riccardo LoCascio, Milady Ninonuevo, J.Bruce German, and Samara Freeman.  I believe most of the inventors are from UC Davis, land of biotechnology.  The patent is owned by the Regents of the University of California.

In February 2012 Dr. David Mills of the Foods for Health Institute (UC Davis) received a Gates Foundation Grant.  This grant "will improve the health of infants in developing countries by building the scientific knowledge of how intestinal microbiota affect infant health and by developing probiotics uniquely protective against infection of the gastrointestinal system."

Other researchers at the Foods for Health Institute are Dr. German and Lebrilla.  The Food for Health Institute at UC Davis has quite a few partners.  The California Dairy Research Foundation, Nestle, Prolacta, DSM-maker of DHA/ARA, Abbott, Innovation Center of US Dairy, Unilever, Dairy Management Inc., etc.

Ah, the business of improving infant formula...through genetic engineering?  Is that what their patent is all about?  Yes, this particular patent is about a synthetic prebiotic composition.  Biotechnologist often use the word synthetic when what they really mean is genetically engineered.    Yet, in reading this patent one finds some confusing language.  Claim 1 states:  "A synthetic prebiotic composition comprising a first, second and third purified oligosaccharide each of which naturally occur in human breast milk."  Huh?  The prebiotic is synthetic but the oligosaccharides are derived/purified from breastmilk?  Some of the claims are prebiotics from a bovine milk protein, a soy protein, whey, soybean oil or starch.  One of their claims is for use in infant formula.

The patent does state that Human Milk Oligosaccharides of their invention can be derived from purified pooled human milk.  They describe how this separation can be done through centrifugation, fat removal, addition of ethanol and so forth.  And then they go on to describe other ways to obtain the oligosaccharides.  Frankly, the way it is described one would not know whether you were getting the real component or not.  Although the real component is purified through such a chemical process one could not possible believe it was the real human milk oligosaccharide.

The patent does describe not only prebiotic but probiotic formulations and specifically mentions Gerber--which is now owned by Nestle, and Carnation Good Start.  They do mention that their pooled milk--human milk was provided by the Mother's Milk Bank of San Jose, California and the Mothers Milk Bank of Austin Texas.  

So donor mothers, how does it feel to donate your milk in helping create a better infant formula? Yeah I know I am the only one appalled...obviously these mothers knew this was a possibility and they will be happy to know that some infant formula company is making a better infant formula.   Yeah, I know the improvement of infant formula is the moral imperative of all of us breastfeeding advocates.  Of course, I am a little uncomfortable with the profits these companies make but someone has to make the money.
Copyright 2012 Valerie W. McClain

Mutants, mama's milk, and probiotics

"With the broadening of patents to life forms, patents do not just regulate technology they regulate life.  They regulate economy.  They regulate basic needs."  
Vandana Shiva, "The Role of Patents in the Rise of Globalization"
http://www.inmotionmagazine.com/global/vshiva4_int.html#Anchor-16557

Bacteria is a life form.  And the biotech industry is certainly making, using and offering for sale mutant variations of bacteria for use in probiotics.  Where do we see probiotics?  Industry has found some creative uses for its "novel" probiotics:  in foods such as yogurts; supplements; infant formula; pharmaceuticals.  They are genetically modified, unless the company specifies organic on the label.  When these mutant bacteria are used in baby formulas, it would seem that there should be more stringent regulations in place.  Babies are one of our more vulnerable populations.  Their immune systems are not fully developed and if they are being formula fed they are even more vulnerable than the breastfed infant.  Yet it doesn't seem that our industry that plays and mutates bacteria for our foods has such regulations.  People seem unaware of how our probiotics are created.  Fermentation is an age-old tradition.  But we are living in a new age where novelty is the priority.  Fermentation is enhanced by creating genetic variations of bacteria.  So you don't believe that is happening?  Well let's take a peak at some patents.

Mead Johnson has a patent called, "Probiotic infant products,"  patent #8137718 that was filed in September of 2008.  The "technical problem solved to provide infant formulas and children nutritional products containing novel probiotics."  They state, "In another embodiment, the infant formula or children's nutritional product contains B. longum strain AH1205 or a mutant or variant therof.  The mutant maybe a genetically modified mutant..."

Filed in 2008, do you want to guess if its in baby formula?  Skeptical?  I know hard to believe.  Well here is another patent from a company well-known in the food industry called Chr.Hansen A/S of Denmark.  It's from a patent filed in April of 1999 called, "Food-grade cloning vectors and their use in lactic acid bacteria," patent number 7358083

"Presently used methods of stably maintaining (stabilising) vectors in a host cell include insertion of relatively large DNA sequences such e.g. antibiotic or bacteriocin resistance genes into the cell. In the art, such genes are also referred to as selection markers. However, it is well-known that the insertion of large DNA sequences involves the risk that other sequences are deleted from the vector. Furthermore, the use of resistance genes for maintaining the plasmid in the host cell implies that antibiotics or bacteriocins must be present in the cultivation medium. This is undesirable in the manufacturing of food and feed products. In addition, it is undesirable that live bacteria comprising antibiotic resistance genes are present in food products as such genes may be transferable to the indigenous gastro-intestinal microflora. "

As they say in the Space Industry, "Houston, we got a problem."  Hm...antibiotic resistant genes in food products are undesirable.  Yes, yes but we now have Nestle to the rescue.  Nestle (Nestec S.A.) filed a patent in August of 2007 called, "Genetic remodeling in Bifidobacterium,"  patent #8071353.  They had noticed a recently discovered problem with a commercially available strain, Bifidobacterium animalis subsp. lactis strain NCC2818, CNCMI-3446.   The strain was generally recognized as safe.  It carried a tetracycline resistance gene tetW.  Oops.  So now we are going to remodel that problem and hopefully solve that problem.  Hopefully we won't be creating more problems.

"Use of any bacterium that possess or has acquired antibiotic resistance in food processing or agricultural production poses a potential theoretical risk of transfer of the resistance fostering genes to other bacteria in the food, the gastrointestinal tract (GIT) of a person or animal after consumption of the food, or the environment at some point before or after consumption at some point before or after consumption."

Hopefully, when our genetic engineers play with bacteria and use it for food they disable any virulence of that bacteria.  They say they do but one might wonder since it took our scientists 20 years to find out that a strain that was recognized as generally safe carried a gene resistant to the antibiotic tetracycline.  And we wonder why our antibiotics don't work.  Blame it on the patients for always asking for antibiotics, or blame it on the massive cattle feed lots contaminating the environment  or perhaps we might consider that the food we are ingesting carries antibiotic resistant markers.  Hm...and we feel comfortable giving this to babies fed infant formula or babies that are breastfed.  You know sometimes when I wake up in the morning, I just wonder about the sanity of the world.  Lets play with bacteria, rearrange the genes, add antibiotic resistant genes, subtract antibiotic genes, and then feed it to babies.  Sometimes I wish I would wake up on Mars and join the LandRovers.  Then I could be a mutant LandRover and live happily everafter...
Copyright 2012 Valerie W. McClain

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.  
http://clinicaltrials.gov/show/NCT00810160

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

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
http://www.inmotionmagazine.com/shiva.html




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..."
http://www.glycom.com/About_us.asp

In January 2010 in Dairy reporter.com  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

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