FEARING THE TRUTH

"As long as the people don't fear the truth, there is hope.  For once they fear it, the one who tells it doesn't stand a chance.  And today, truth is still beautiful but so frightening."  --Alice Walker, poet and author

How should one feel, when someone on Facebook describes your writing as "fake news?"  After 2 decades of writing about human milk patents, it is rather insulting to have that Trumpian slogan thrown my way.  I find the anger boiling up inside, and then I find the humor in it.  What does one expect in this world in which people cannot speak the truth?  Where up is down, and down is up? Where truth is fiction and fiction is truth?  A confirmation hearing of a supreme court justice becomes a sad revelation of what white men in power think about women.  Where a President can encourage a Custom and Border Protection Commissioner to break the law with an offer of a presidential pardon.  Where one can name a genetically engineered substance a Human Milk Oligosaccharide and call its addition an improved infant formula. 

Facebook is supposedly on the hunt to root out "fake news" by kicking those who distribute fake news off their social media platform.  But who defines fake news?  Is this a newest Facebook mea culpa to allowing Cambridge Analytica access to Facebook data?

"Cambridge Analytica, a political data firm hired by President Trump's 2016 election campaign, gained access to private information on more than 50 million Facebook users." NY Times 3/19/18, "Facebook and Cambridge Analytica:  What You Need to Know as Fallout Widens," by Kevin Granville
https://www.nytimes.com/2018/03/19/technology/facebook-cambridge-analytica-explained.html 

I cracked up laughing when lists of newspapers and media outlets that are not fake news made the rounds of Facebook.  The person or organization that determines who and who is not fake news is never questioned for bias or suspect motivation.  Fox News calls CNN fake news and CNN calls Fox fake news. Fake news determination has become which political side of the fence the accuser stands.  News, knowledge should always be questioned. 

How many people whose political, medical, or scientific viewpoints are different from the consensus of the mob will be denied access to social media platforms?  Does truth reside on one side or the "other?"  We seem to be living in a time where lies surround us, sheltering us from reality.  And do we really want to see the reality?  Should we presume that one newspaper, one corporation or dozens of corporations, one political party, one elected official, or dozens own the truth of a given situation?  

For example, what is the truth regarding the following situation?

Lars Bode is the Director of the Larsson-Rosenquist Foundation Mother-Milk-Infant Center of Research Excellence (MoMI Core) and is also been appointed as the Larsson-Rosenquist Foundation Chair of Collaborative Human Milk Research at University of California (UC)-San Diego.   UC-San Diego received $10.5 million from the Larsson-Rosenquist Foundation for seed funding of the Mother-Milk Infant Center of Research and for the Chair of Collaborative Human Milk Research.  Some of this funding was also used to establish the Mother's Milk Bank of San Diego. The co-founders of this milk bank have had financial relationships with Medela. This milk bank has also partnered with the Mother's Milk Bank of Austin, a HMBANA milk bank and the Mother's Milk Bank of San Jose.

https://ucsdnews.ucsd.edu/index.php/feature/gift_to_uc_san_diego_will_establish_san_diegos_first_mothers_milk_bank

https://ucsdnews.ucsd.edu/index.php/feature/unraveling_the_complexity_of_mothers_milk?utm_campaign=thisweek&utm_medium=email&utm_source=tw-2017-01-12 

Lars Bode is also a listed inventor to a number of patents regarding Human Milk Oligosaccharides.  One US patent # 9675649 is entitled, "Disialyllacto-N-tetraose or variants, isomers, analogs and derivatives thereof to prevent or inhibit bowel disease."  Disialyllacto-N-tetraose (DSLNT) is a Human Milk Oligosaccharide.  He is the only inventor named on the patent which is owned by the Regents of the University of California.  There is also a World patent application 2012106665 with the identical title, inventor and owner.

According to the Patent it will be used, "In one embodiment, the formulation of the invention is an enteral formulation.  Enteral formulations of the invention may be embodied in an infant formula, breast milk, water, juices, or baby food.  Additional, enteral formulations of the invention may be embodied in a nutritional supplement."

and

"In another embodiment, the formulation of the invention is used to supplement or fortify the mother's own milk or human donor milk (human milk fortifier) with DSLNT and/or its derivatives, isomers, analogs.  Commercial pasteurized human donor milk may be obtained from Prolacta Bioscience (Monrovia, Calif.) under the name Prolact+ H.sup.2MF such as Prolact+4.RTM., Prolact+6.RTM., Prolact+8.RTM., and Prolact+10.RTM..."

The patent states that this particular HMO could be added to water or juices.  It was filed in 2012.

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2012106665&recNum=71&docAn=US2012023866&queryString=((num&

Meanwhile on the East Coast of the USA, Glycosyn was co-founded by David S. Newburg.  Glycosyn will be manufacturing HMOs from an e.coli genetically engineered and is partnered with the European infant formula company FrieslandCampina.  David S. Newburg is on the Research Advisory Board of the Mother's Milk Bank NE and also on the BOD of HMBANA.  Newburg is a listed co-inventor to a number of patents regarding Human Milk Oligosaccharides.

 https://patents.justia.com/inventor/david-s-newburg

 http://www.glycosyninc.com/david-s.-newburg-phd-chairman,69.html

Should we be concerned about genetically engineered Human Milk Oligosaccharides being added to new and "improved" infant formulas?  Should we be concerned about the connections between researchers, milk banks (both for-profit and HMBANA non-profits) and the infant formula industry?  Should we close our eyes and ears and bury our heads in the sand regarding the influence of the Larsson-Rosenquist Family Foundation by its funding of research in various universities around the globe?  The list of universities includes Yale University, University of Oxford, University of Zurich, Universityof Perth (Australia), University of Western Australia, and in Shanghi, China both Fundan and Tongji Universities.  Even PATH, a global health non-profit, was the recipient of fund of $1.2 million from this Foundation to increase access to human milk.
https://www.path.org/media-center/path-welcomes-us12-million-grant-from-the-family-larsson-rosenquist-foundation-to-increase-access-to-lifesaving-human-milk/

Human milk or human milk-like substances seems to be the priority not breastfeeding.  How many milk banks around the globe do we need?  Having more milk banks is financially advantageous to the milk banks themselves and breast pump companies.  Will more women using breast pumps increase breastfeeding?  How will this push effect the world environmentally?  Will more babies be bottlefed human milk rather than breastfed?  As an LC I have seen more women using breast pumps but having less breastfeeding success.  Will academic research that is paid for by a foundation with ties to Medela increase breastfeeding?  Will we accept infant formulas with imitation mutant human milk ingredients ( we already accept the HMOs in infant formula)  Or better yet will we accept "donor" milks designed by an industry that has products to sell?  Will we accept donor milks that have added ingredients because academic research funded by a Foundation tied to a pump company believes they can make a better human milk than a woman?  Research papers are now coming out questioning the protective properties of human milk in regard to allergies.  Researchers will design and improve upon human milk.  When academic research depends on creating products and/or creating new companies, it appears to create a distorted science. Instead of recognizing the value of exclusive breastfeeding in the first 6 months of a baby's life, it's hell bent on providing a product.  A social-political problem of lack of support of exclusive breastfeeding is answered with a product, a patent, and a profit.

I know that some breastfeeding advocates believe that the Larsson-Rosenquist Family Foundation is a separate organization with no connections to Medela.  I have read several websites dated from 2013-2015 that state that the Larsson-Rosenquist Family Foundation owns Medela.  Medela in this 2013 states, 

"About Medela

Founded in 1961 by Olle Larsson and headquartered in the Canton of Zug, Switzerland, Medela is owned by the Larsson-Rosenquist Family Foundation and continues to grow under the leadership of the Larsson family."http://www.medelabreastfeedingus.com/media-center/238/medela-completes-acquisition-of-acacia-enteral-feeding-division  

In an article dated 2/23/18 regarding The Larsson-Rosenquist Family Foundation' s gift of CHF (Swiss Franc) 10 million to the University of Zurich to create  new research fund for child and youth development with a focus on breastfeeding and a new professorship.   Anders Staatsmonster Maarkus Müller states, "If you also know that lender is connected to a company for breastfeeding accessories is, in my view, that is toxic for the reputation of a university."  and, "The public will never get rid of the impression that there are other interests at stake."
https://tech2.org/switzerland/why-the-economy-is-suddenly-interested-in-breastfeeding-news-zurich-city-of-zurich/

I always thought it interesting how some people quickly understood that patenting of human milk components has a real dark side.  And some people seemed to live in utter denial of the implications.  The connections between some milk banks, the infant formula industry and academic research is troubling.  We are living in troubling times.  Is it fear of the truth or some other reason that we do not question the direction our corporate world is taking us?
Copyright Valerie W. McClain

 

 

Blueberries & Breastfeeding

"Industry and some government sources claim that GM [Genetically Modified] foods are strictly regulated.  But GM food regulatory systems world wide vary from voluntary industry self-regulation (in the US) to weak (in Europe).  None are adequate to protect consumer's health.  All rely on safety testing done by the company that wishes to commercialize the genetically modified organism (GMO) in question."  --GMO Myths & Truths, by John Fagan, PhD et al., 2nd ed. 2014
https://livingnongmo.org/wp-content/uploads/2014/11/GMO-Myths-and-Truths-edition2.pdf 

Blueberries, love blueberries.  I remember spending time on a dairy farm when I was 9 or 10 years old.  It was the 1950's, and we, kids roamed about rather freely in comparison to today's children.  The family I was staying with had 6 kids, mostly boys and one girl close to my age.  I enjoyed the chaos of so many children in one old farm house.  Warm milk straight from the cow was served on the table and it seemed like the boys were always wrestling and their mom was always yelling some child's name.  The girl and I had become great buddies and one morning her mother handed us two steel buckets and said go pick some blueberries.  Sounded like a great adventure to me but obviously a ho-hum experience for my new best buddy.  We had to go through the pasture and run around cows and the manure paddies.  And then up the side of what I thought was a mountain (probably a hill).  My friend knew the way and we found the blueberry patch.  So we set about filling up the pails but, of course, I started eating them:  one for the pail, two for me.  My friend seemed to be of the same mind, consequently the pails never seemed to fill up.  Then we were about stuffed with blueberries and tired of this job of filling a pail that never filled up;  when we heard rustling noises coming from the bushes.  My girlfriend yelled, "Bear!"  And the 2 of us ran down the mountain.  We told her mother that we would have filled up the pails, except for the bear.  Blame it on the bear, yet I believe our berry-blue smiles gave it away that we had been eating most of the berries.  No blueberry pies for the family tonight.  I really don't know if there was a bear in the bushes.  

When I look at blueberries in the grocery store, I think of the blueberries on that mountain.  Delicious and free, nature's bounty, and with the added bonus of a real adventure!  Yesterday I stared at the blueberries in small plastic box in the grocery store.  Not too many blueberries in the little plastic box and the cost of $4 seemed way too high.  I looked at the label.  They were blueberries from Peru, South America.  Nope, I didn't want to eat blueberries from Peru, I wanted blueberries from my little mountain in my childhood.  Nature gives freely by season and locale.   Our 21st civilization has made food into a commodity that is grown thousands of miles away, under unknown conditions.  It's costly and out of season for our locale and has no taste.  And yes, no adventure to remember it by.  

And what does this have to do with breastfeeding or infant formula?  Breastfeeding like the blueberries on my little mountain in my childhood, is free and not part of the global infant formula market.  Meaning breastfeeding does not require a huge carbon footprint.  How many miles does that can of formula travel to get on that grocery store shelf?  How many months, years does it sit on the shelf waiting to be bought?  Who manufactured it?  What water was used to process it?  What packaging was used to store it?  What are the ingredients? How can a processed food compete with something that is fresh, that varies over time, no packaging needed, and is free? Breastfeeding always provides a fresh food that varies from day to day, hour by hour and is free.  

But we live in a world that places enormous obstacles in front of women to breastfeed.  And we have enormous obstacles in front of us to eat fresh, nutritious foods.  The consequences of global food industries is that they have helped create food deserts, where only packaged foods and sugared, energy drinks exist in local stores.  Advertising increases the visibility of packaged, convenience foods.  Likewise advertising does the same thing with infant formula.  Many people have never tasted freshly picked broccoli from the garden.  If they buy broccoli in the store it is tasteless and rubbery, direct from the garden it is sweet and crisp, a very different experience.  Likewise breastfeeding is a whole different taste and tactile experience for babies compared to infant formula.

One of the interesting comments I have gotten from various people who live in other countries regarding my posts on patents on human milk components and particularly in regard to genetic engineering of ingredients in infant formula; is their belief that patenting of human milk components  and genetic engineering of infant formula is only happening in the USA.  Yet the truth of the matter is that the same patents in the US Patent Office are also in various countries around the world as well as the World Patent Office.  What is happening in the US regarding patenting of human milk components is not isolated to just the USA.

For example a new company in the USA, called Evolve Biosystems has 4 patent applications at the US Patent & Trademark Office. (patent applications #20170304375, #20180078589, #20180104157, #20180267037) Evolve Biosystems is marketing a product called Evivo, a probiotic (activated Bifidobacteria infantis) to be mixed with breast milk and given to babies to improve their gut health.  Interestingly David Kyle, a patent inventor and co-founder of Martek Biosciences, which manufactured DHA from algae (genetically engineered) and ARA fungi (genetically engineered) for infant formulas is Chairman of the Board and Chief Scientific Officer of Evolve.
https://www.evolvebiosystems.com/human-health

This isn't their only patent applications.  They also have a World Intellectual Property Organization patent application, European Patent Office application, Canadian patent application, Australian patent application, and Singapore patent application.  Thus the idea of meddling with breast milk to improve it will go world-wide.  And what will be the advertising?  And what is the science behind believing that breast milk needs improvement?  And how many mothers will no longer exclusively breastfeed so that they can add this probiotic (that is already in breast milk).  This probiotic will be used with specific HMOs.  Thus this product is joined with the promotion and commercialization of HMOs
 https://patents.google.com/patent/WO2017156550A1/en

The global nature of the human milk and infant formula industries;  and the power of internet advertising and social media will create a combined infant food industry that will be difficult to stop.  Genetic engineering is the way in which these products are being manufactured.  Hopefully more people will educate themselves about the risks of genetic engineering.  Or at least read the article on GMO Myths & Truths mentioned at the beginning of this post.
Copyright 2019 Valerie W. McClain

Part 2 continued-What's in a Name?

"..one of the necessary accompaniments of capitalism in a democracy is political corruption;  and one of the consequences of civic administration by ignorant and vicious politicians, is preventable diseases kill off half our population.  And even if science were allowed to try;  it could do little, because the majority of human beings are not yet human beings at all, but simply machines for the creating of wealth for others."  --Upton Sinclair, The Jungle

The authors of the study in Nutrients (discussed on previous page) state that clinical trials so far show limited data, not conclusive, and lack of coherent results.  But then they state that placing more HMOs in formula "could" result in evidence of benefit?  What?  Reading to the end of this study has a section called, "Author contributions," in which we learn that many of the authors have in the past been funded by various infant formula companies (several authors being on the board of advisors to Nestle Nutrition Institute).  Yet they all declare no conflict of interest.

Strange how easily one can add novel ingredients (genetically engineered) to infant formula.  And despite clinical trials lacking coherent results, there is no concern by researchers or governmental organizations that maybe this experimental infant formula should not be on the market until we have more data.  Where is the precautionary principle regarding adding ingredients to infant formula that have never existed before?

"The Precautionary Principle is a strategy to cope with possible risks where scientific understanding is yet incomplete, such as risks of nano technology, genetically modified organisms, and systemic insecticides."
http://www.precautionaryprinciple.eu/

Babies are the guinea pigs and women the handmaidens, when giant corporate industries play God.  Breastfeeding is a biodiverse system that impacts the health and well being of babies, children, and women.  It is a system that not only protects the future but protects the environment (little to no plastic trash and less dependency on the dairy industry).  Industry claims that by gene manipulation one can create the same safety that breastfeeding has created for thousands of years, and that the product made in a petri dish is identical to what is made in the human breast.  Such thinking is insanity and a civilization cannot survive with this kind of mindset.
Copyright 2019 Valerie W. McClain

PART TWO" WHAT's IN A NAME?

"But there is a 'creation myth' that is blind to both, nature's creativity and biodiversity as well as to women's creativity, intelligence and knowledge.  According to this 'creation myth' of capitalist patriarchy, rich and powerful men are the 'creators.'  They can own life through patents and intellectual property.  They can tinker with nature's complex evolution over milennia and claim their trivial yet destructive acts of gene manipulation as 'creating,' life, food and nutrition." --Vandana Shiva, at Common Dreams, "Tackling Monocultures of the Mind"

https://www.commondreams.org/views/2013/04/24/tackling-monoculture-mind



Manipulating genes, the tinkering of life at the molecular level, is based on a level of arrogance.  A shotgun approach to fixing biological problems.  Blasting through cellular matter, grabbing a gene of interest, and replacing it with another gene:  is coupled with the belief that such manipulation has only one specific consequence.  The web of life, its complexity is discounted.   We have a brand new Human Milk Oligosaccharide (HMO) industry, which is part of the infant formula industry.  

 https://www.prnewswire.com/news-releases/human-milk-oligosaccharides-market-worth-usd-170-4-million-by-2024-hexa-research-832644513.html



It has found a way to harness a specific bacteria (e.coli in most cases) to create a Human Milk Oligosaccharide.  And companies have the audacity to tell the US FDA that this manipulated product is identical to the real HMOs found in human breast milk.  It's safety is assured based on the safety of breastfeeding.  And the US FDA had no questions regarding these statements. 



Glycom's FDA GRAS #650 statement on the history of safe consumption regarding their 2'-FL oligosaccharide for use in baby formulas/food, etc.  This particular 2'-FL is manufactured by fermentation with E. coli K-12 SCR6 genetically engineered by 7 modifications and using antibiotic resistance genes ampR (ampicillin) and tetR (tetracycline).


"2'-FL is one of the naturally occurring fucosylated milk oligosaccharides present in some mammalian milks (Urashima et al., 2002;  Castanys-Muñoz et al., 2013), with markedly highest concentrations of 2'-FL occurring in milk from lactating women (Kuhn et al., 1955).  2'-FL therefore has an established history of safe consumption by infants consuming human milk." (page 32)

https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm513832.pdf


On page 34 of the FDA GRAS #650 pdf document under toxicological studies, they state that safety is based on published studies showing, "the corresponding history of safe consumption of 2'-FL by breast feeding infants."



Safety is based on the breastfeeding infant?  One of Glycom's patents, patent #9902984, entitled "Fermentative production of oligosaccharides."



"In this invention, the term "genetically modified cell" preferably means
a cell in which at least one DNA sequence has been added to, deleted
from or changed in its genome, so that the has a changed phenotype.
This change in phenotype alters
the characteristics of the genetically modified cell from that of the
wild type cell. Thus, the genetically modified cell can perform at
least an additional chemical transformation, when cultured or fermented,
due to the added or changed DNA that
encodes the expression of at least one enzyme not found in the wild type
cell, or the genetically modified cell cannot perform a chemical
transformation due to the deleted, added or changed DNA that encodes the
expression of an enzyme found in the wild
type cell. The genetically modified cell can be produced by well-known,
conventional genetic engineering techniques. The genetically modified
cell can be bacteria or a yeast but preferably is a bacterium.
Preferred bacteria include Escherichia coli,
Bacillus spp. (e.g. Bacillus subtilis), Campylobacter pylori,
Helicobacter pylori, Agrobacterium tumefaciens, Staphylococcus aureus,
Thermophilus aquaticus, Azorhizobium caulinodans, Rhizobium
leguminosarum, Neisseria gonorrhoeae, Neisseria meningitis,
Lactobacillus spp., Lactococcus spp., Enterococcus spp., Bifidobacterium
spp., Sporolactobacillus spp., Micromomospora spp., Micrococcus spp.,
Rhodococcus spp., Pseudomonas, particularly E. coli."

Where is the public outcry over an industry using the safety of breastfeeding to declare that a product that made in a laboratory using e.coli is identical to the component made in a woman's breast?  Is the public even aware of what this new industry claims to government officials?  Genetic engineering?  What is that?  In our food?  No can't be.  And genetic engineering in baby formula?  No can't be. 


As I understand the research, the number of Human Milk Oligosaccharides (HMOs, the real component not the manufactured) is guessed at from as low as 100-500 different HMOs.  No two lactating women have identical HMOs, and each woman has HMOs that vary over time.  For example, about 70% of women have the 2'-FL HMO.  This component seems dependent upon a woman's blood type.  Thus providing all formula fed infants with 2'-FL seems to be irrational without understanding the possible ramifications that might occur to infants who, if breastfed would never ingest this component.  Lars Bode's research paper, "Human milk oligosaccharides:  Every baby needs a sugar mama."

https://academic.oup.com/glycob/article/22/9/1147/1988076 



Human milk is not only species specific, it is individually specific.  Thus duplication is impossible on a basic level, because no manufacturer will have time, the money, the resources to duplicate that individuality.  Mass production of food means that there are major losses in nutrients.  And this is not the only issue.  In order to preserve shelf life in manufactured foods, additives are used so that the can or plastic tubs/bottles of infant formula can sit on the store shelf for 24-36 months.  It is a lifeless product unlike human milk that is alive.  The ability to duplicate human milk components by genetic engineering or any other method is a myth.





What about clinical trials of infant formula with HMOs, showing the safety of these novel ingredients?  The research paper in Nutrients in September of 2018 entitled, "Human Milk Oligosaccharides:  2'-Fucosyllactose (2-FL) and Lacto-N-Neotetraose (LNnT) in Infant Formula," states:



"Today, the amount of data available on HMO supplementation in infant
formula from clinical trials in infants is still limited. More data are
definitely needed. According to the data from the few studies,
differences in clinical outcome of supplemented vs. non-supplemented
formula are not yet conclusive [72,73,74,75,76].
The different primary outcomes of the different trials contribute to a
lack of coherent results. The cost-benefit ratio also needs further
evaluation. In addition, the optimal concentration of HMO added needs
further adjustment. And of course, there is the fact that only one or
two HMOs are added to infant formula, while mother’s milk contains 200
different oligosaccharides. Supplementation with more HMOs could result
in further evidence of benefit."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6164445/

WHAT'S IN A NAME? HUMAN MILK OLIGOSACCHARIDES FOR SALE

"But if thought corrupts language, language can also corrupt thought."
                                        --George Orwell, 1984

Words can be used to clarify human reality or they can be used to deceive our understanding of that reality.  Words sell products but they also sell ideas.  Advertising and marketing strategists use language to influence people's buying habits.

The infant formula industry is now advertising a new added ingredient to infant formula, which they name, Human Milk Oligosaccharide (HMO).  On the label of Abbott Nutrition's Similac infant formula with this added ingredient, they state in tiny, tiny, print, "Not from human milk."  Gerber (owned by Nestlé) on its formula with an added HMO makes the same statement that is also in tiny, tiny print.  An ingredient is named a Human Milk Oligosaccharide but it is not from human milk.  It reminds me of George Orwell's novel, 1984, in which "War is Peace," "Freedom is Slavery."  Or how the US War Department in 1947 became the Department of Defense.  Or how the military uses the term collateral damage rather than civilian casualties.  It is the corruption of language, what some people call double think.   It becomes the ultimate paradox to simultaneously hold two contradictory beliefs as correct.  A human milk component that is not a human milk component.  The truth gets lost in the contradiction.

According to the Codex Alimentarius, in the guidance of infant formula labeling,

9.6.3 "The terms 'humanized,' 'maternalized,'  or other similar terms shall not be used."   
http://www.fao.org/input/download/standards/288/CXS_072e_2015.pdf

In 2017 Mead Johnson challenged a number of claims made by Abbott Nutrition in its advertising of HMOs in its formulas to the National Advertising Division (NAD, part of the Council for the Better Business Bureau).

"The National Advertising Division has determined that '2'-FL human milk oligosaccharide,' a claim made by Abbott Nutrition in advertising for its Similac Pro-Advance and Pro-Sensitive infant formulas, doesn't convey a misleading message, as long as the advertiser makes the necessary disclosure, 'not from human milk,' easier for consumers to notice, read and understand."
http://www.asrcreviews.org/nad-finds-abbott-can-support-certain-claims-for-infant-formula-with-new-ingredient-but-only-when-disclosing-that-ingredient-is-not-from-human-milk/

The National Advertising Division has supposedly fore-filled its obligation to help industry to self-regulate its advertising.  After this decision in 2017, I do not think that Abbott's and Gerber's infant formula labels are any more enlightening to consumers. Self-regulation by industry is a joke, another version of double thinking.  It's like the analogy of the fox guarding the hen house.

A number of companies manufacture HMOs for the infant formula industry:  Glycom, Jennewein, Inbiose, Elicity, ZuChem, Medolac, Glycosyn.  Recently BASF announced a two-year collaboration with UC Davis regarding human milk oligosaccharides.  
https://www.basf.com/us/en/media/news-releases/2018/07/P-US-18-080.html

Glycom, a Danish biotech company, is owned by its founders, Nestlé, and other individuals.  https://www.glycom.com/about/who-we-are/

Glycom was the first company to apply for FDA GRAS for an HMO, named 2'-O-fucosyllactose (FDA GRAS #546), considered the most abundant HMO in human milk.  Yet this component is not in every woman's breast milk.  Lars Bode, human milk researcher at UC San Diego, has described human milk oligosaccharides in an article in 2012 in Glycobiology entitled, Human Milk Oligosacharides:  Every baby needs a sugar mama,

"Human milk oligosaccharides (HMOs) are a family of structurally diverse unconjugated glycans that are highly abundant in and unique to human milk."

and

"Oligosaccharide amount and composition vary between women and over the course of lactation." 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3406618/

How does one duplicate something that is unique, that varies from person to person, and individually varies over time?  Glycom states in its letter to the FDA,


"...the 2'FL manufactured by Glycom is chemically and structurally fully identical to the 2'-FL that is present in human milk.  Glycom's 2'-FL is therefore referred to as a human identical milk oligosaccharide."  FDA GRAS #546
http://wayback.archive-it.org/7993/20171031041609/https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/UCM427768.pdf

In a Glycom patent #9012625 they describe the various methods that have been used to manufacture HMOs:  isolation technology, chemical, enzymatic which uses enzymes produced in genetically modified organisms, and various biotech methods which would likely encompass genetic engineering.  All have various drawbacks.  Glycom in that particular patent describes a crystallization method that appears to be the basis for their FDA GRAS #546.

But in a later Glycom patent (#9896470) dated in 2013 called, "Enhancing the stability and purity and increasing the bioavailability of human milk oligosaccharides or precursors or blends thereof," they discuss that the crystalline process is still contaminated with small residues:  toulene and protic solvents.  And they mention in this patent that, "crystalline HMOs are relatively unstable when stored for extended periods without refrigeration."

Glycom received FDA GRAS for another 2'-O-fucosyllactose (#650) in which they use fermentation and genetic engineering techniques with the bacteria, Escherichia coli (E.coli) K-12SCR6, to produce the 2'FL HMO for infant formula.

"As discussed, 2'-FL produced by fermentation with Escherichia coli (E. coli) K12 SCR6 is chemically and structually identical to the 2'-FL produced by chemical synthesis methods described in GRN 546 and to 2'-FL that is present in human breast milk as confirmed by ¹H- and 2D-NMR spectroscopy, mass spectrometry and x-ray crystallography."
https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm513832.pdf

Glycom states in patent #9234225 entitled, "Method for generating human milk oligosaccharides (HMOs) or precursors thereof," in 2013
"The large variety of oligosaccharides in human milk and colostrum and the difference to other species, however, makes it difficult to prepare suitable replacements in foods, particularly in infant food formulae, which display at least part of the entire spectrum of human milk oligosaccharides. Furthermore, their recognized importance in the maturation of the immune system and their prognostic use as immunomodulators underlines their importance as a possible immunomodulator."

The infant formula industry has decided to name a novel ingredient they are adding to infant formula, calling that ingredient a Human Milk Oligosaccharide.  The US FDA in the GRAS process does not question this name.  And it has no questions regarding statements by companies that manufacture HMOs in which they declare their product to be exactly identical to the real HMO.  Substantial equivalence has been the FDA's view of novel/genetically engineered ingredients.  The understanding was that genetic engineering does not exactly duplicate the natural ingredient.  It seems that this FDA policy has now changed and the FDA accepts a company's belief that their genetically engineered product is identical to the natural component in human milk.

FDA GRAS #650 by Glycom in which the FDA had no questions,  

"2'FL produced by fermentation with Escherichia coli (E. coli) K-12 SCR6 is chemically and structurally identical to the 2'-FL produced from Glycom's chemical synthesis methods as described in GRN 546, and to 2'FL that is present in human breast milk..."
https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm513832.pdf

In the USA both Abbott Nutrition and Gerber (Nestlé), have added  a so-called Human Milk Oligosaccharide (HMO) to some of their formulas. Abbott has Similac Pro-Total Comfort™, Similac Pro-Advance™ and Similac Pro-Sensitive™, "closer to breast milk than ever before."  Gerber has Good Start® Gentle HM-O, "closest formula to breast milk." Close, closer, closest:  who should we believe? 


The challenge to human milk researchers who are funded by industry is to create and imitate a component of human milk so that infant formula is more like real human milk. It's a tall order creating a substance that is unique and diverse.  There are some 200 different HMOs in a woman's breast milk.  Although the number of different HMOs seems to not really be known.  Some papers state that there are over 100 different HMOs, some say over 200 HMOs, and some state over 500.

Why does the infant formula industry try to imitiate human milk components? It would appear that the Federal United States Code definition of infant formula may be the reason why the industry studies human milk and tries to simulate it.


" The term 'infant formula' means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk."
--from 21 U.S.C. §321 (z), United States Code

So we are now suppose to believe that industry can chemically and structurally duplicate a human milk component?  A process that uses various toxic solvents to extract the substance.  And this particular substance is identical to a genetically engineered and fermented bacteria?  So all 3 substances are supposedly identical and named a Human Milk Oligosaccharide?  What will parents believe about our newest infant formula?  Will they believe that what is made in a factory lab is exactly identical to what nature makes?  Since the FDA has no questions regarding these statements, then it would seem the FDA believes that genetic engineering is an exact science that duplicates nature.  The human mammary gland is quite amazing but I don't think it needs toxic solvents like toulene to produce an HMO.  Nor can I imagine that the human mammary gland uses E. coli to produce an HMO. So how can the real human milk component be identical to the manufactured?

As disturbing as this is, what seems little noticed is that Medolac, a for-profit milk bank is listed as a manufacturer of HMOs.  Prolacta Bioscience, another for-profit milk bank, has a US patent and World Organization Patent on Human Milk Permeate which contains human milk oligosaccharides.  In patent #8927027, they state,

"The present inventors have found that, surprisingly, permeate (which had been thought to be a waste product lacking significant nutritional value) contains high biologically active content, including human oligosaccharides. Because the starting material, from which permeate is obtained, is pooled human milk, permeate can contain more discrete molecular forms or types of oligosaccharides than individual mother's milk.

The permeate can be added to non-human or human milk to increase its nutritional value. For example, the permeate can be added to human milk fortifiers and standardized milk compositions described in application U.S. Ser. No. 11/947,580, filed on Nov. 29, 2007, the contents of which are incorporated herein by reference in their entirety. The permeate can also be added to non-human milk formula, e.g., bovine milk formulations or mixtures of human and non-human milk formulations."
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8927027.PN.&OS=PN/8927027&RS=PN/8927027

It would appear that a human milk oligosaccharide should have a clear definition so that consumers know what is contained in baby formulas.  It is possible that at some future time the real HMO from donated human milk may become part of the composition of infant formula. Prolacta and Medolac appear to be moving in that direction.  Of course, a pasteurized HMO from donor milk that stores for months, cannot be considered equivalent to the HMOs a mom provides when she is breastfeeding.  For after all, HMOs are genetically specific for each mom and vary over time.  If a genetically engineered bacteria or an extracted crystallized version with added solvents is considered equivalent to an HMO made in the mammary gland, then maybe we should consider that we are living in a Orwellian nightmare.
Copyright 2018 Valerie W. McClain
 







 


        

PALM OIL'S ENVIRONMENTAL IMPACT, A REFLECTION OF INFANT FEEDING CHOICES

"The expansion of Palm Oil plantations are the primary reason for the destruction of the rain forests of Indonesia.  The expansion of GMO soya plantations is a major reason for the destruction of the Amazon rain forests and cerrado, in Brazil and Argentina." --Vandana Shiva, "Gandhi's Ghani," 2/16/16
https://english.mathrubhumi.com/news/columns/vandana-shiva/gandhi-s-ghani-english-news-1.869038

When I was 5 or 6 years old I had vivid dreams of walking down a path in a jungle.  The dreams were colorful:  bright greens, deep reds and yellows.  I walked a path in which the vegetation was over-run by heart-shaped vines.  Born in Northern Ontario, Canada in the fifties, my family did not have a TV until we moved to the US, when I was 6 years old.  It was a black and white small screened TV. Color TV did not exist; or if it did, my family could not afford to buy one.  My father took my brother, me, and quite a few neighborhood children to the store to buy the TV.  What an adventure, riding in the car that was packed with excited kids and a TV.  I am not sure how my Dad survived that adventure.  I think he bought all us kids ice cream cones to shut us up!

When I moved to Florida in my adulthood, I noticed this particular heart-shaped plant that is considered an invasive plant in our landscape.  It's called an air potato (Dioscorea bulbifera) and snakes counter-clockwise around plants, shrubs, and trees producing various sized brown potato-like seeds that drop to the ground that reseeds into more air potato vines. According to some experts air potato plants grow 8 inches a day!  I have spent hours pulling out the vines because it grows and reproduces exponentially like in some horror flick.  Yet I do not hate this invasive heart-shaped plant but am fascinated by the patterns it makes upon the landscape.  The curious thing is that those bright green heart-shaped leaves are the very same leaves I saw as a child in my dreams.  Now I am living in a landscape that I dreamed about in my childhood. 

Living in Florida I have gotten an appreciation for plant life in a sub-tropical climate.  Rain forests fascinate me, although I have never actually stepped foot in a rain forest.  I can imagine it because I have watched you tube videos on  rain forests. But I don't know the rain forest like indigenous tribes know their forest.  I don't live in it.  Yet having lived in Florida for 40 years, I have seen the destruction of our subtropical forests.  A company had bought land near my town and basically cut down almost all the trees.  Burnt the trees which started a huge fire that the firefighters had to get under control.  I passed by the area and watched a gopher turtle (endangered species) hurrying across the scarred and burnt landscape.  How many gopher turtles made it out of there safely?  What was the reason for destroying all the trees?  Months later, the property sits there bare, life interrupted.  Not a rain forest, just another section of Florida environment destroyed to make room for more stores or car dealerships.  The heavy rainfalls we have had this summer and fall have made the property into mini-lakes.  Paving it over and building on it will surely cause flooding? Flooding will have an economic impact to the area.  The loss of trees will increase warming trends.  The loss of habit for various animals, many already endangered, increases the risk of extinction. 

The inter-connections between human economic activities, the environment, and the future of life on this planet need to be considered.  If one lives indoors all the time, then the outdoor environment is often not even considered. Eating manufactured, "convenience" foods without understanding how it is produced and the real costs of factory farming to the land and to human health is creating death and destruction to many plant and animal species.  Eventually if we continue unconscious thinking, humanity will also disappear from this planet.  The suffering this causes is not yet fully acknowledged.

PALM OIL 

                              Iceland's banned TV commercial

Our food choices impact not only the economics of nations but also the environment of nations. The choice to not breastfeed and use infant formula is also a choice that impacts the environment.  Palm oil is one of the fats used to make infant formula more like human milk.  A 1980's infant formula patent owned by the Bristol-Myers Company (which owned Mead Johnson at that time, now owned by Reckitt Benckiser) stated,

"Vegetable oil mixtures are prepared containing from 20-50% by weight of palm oil and quantities of lauric acid oils, oleic acid oils, and linoleic acid oils needed to provide proportions of oleic, palmitic, and linoleic triglycerides similar to proportions in human milk." 
US patent #4282265, entitled, "Fat Compositions for infant formulas." 1980.

Thirty-five years later a Mead Johnson patent states,

"In some embodiments, the fat or lipid source comprises from about 10% to about 35% palm oil per the total amount of fat or lipid."
US Patent #10,034,937 entitled, "Synergistic nutritional compositions and uses thereof," 2015.

There is about 200 US patents that discuss palm oil use in baby formulas or list it as an ingredient.  The following US patent filed in 2006 by a company called, Enzymotec Ltd. of Israel (manufactures Infat for use in baby formulas, "a SN2  palmitate ingredient that mimics the fat structure and properties of human milk fat.")  https://enzymotec.com/infat/

Their 2006 US Patent states,

"Thus in accordance with this aspect of the invention there are provided a process and triglyceride compositions employed therein, wherein the triglycerides are blends of palm stearin interesterified with palm oil, palm stearin interesterified with rapeseed oil, and the like."
US Patent #9332771 entitled, "Human milk fat substitutes," 2006.

In 38 years the infant formula industry is still using palm oils in their baby formulas.  And they still seem to think that palm oils can imitate human milk fats.  New and improved?  Not sure that we can call their technology new or improved, when they are still stuck on thinking a palm tree equals a human mammary gland.

The choice to use infant formula is due primarily because the infant formula industry and its suppliers influence governments and medical educational institutions and their facilities  Most of the obstacles women see regarding breastfeeding has a lot to do with pressures that women have little control over:  corporations that refuse to give women maternity leave or family leave after the birth of their babies.  Advertisements influence families and women to believe that the choice to use infant formula is a choice that has no health ramifications to mothers and babies.  And the environmental cost is never ever mentioned.  Many women make a choice to formula feed because of personal circumstances never realizing that their choice was not a personal choice but a choice orchestrated by mighty big corporations who prefer their profits over the safety of mothers and babies and ultimately prefer to degrade environments rather than take responsibility for destroying our mother earth, the only planet that supports human life.  Most of us will not be able to financially take the space ship to Mars or wherever. And most of us would not want to live on another planet unless...we have no other option in order to survive. 
Copyright 2018 Valerie W. McClain

BREASTFEEDING A DIVERSE AND SACRED GIFT

"In the time of the sacred sites and the crashing of ecosytems and worlds, it may be worth not making a commodity out of all that is revered."
                                                            --Winona LaDuke

"I saw some women had written that the cloning of Dolly* was wonderful since it showed that women could have children without men.  They didn't even understand that this was the ultimate ownership of women, of embryos, of eggs, of bodies by a few men with capital and control techniques; that it wasn't freedom from men but control by men."--Vandana Shiva

The Earth, Mother of us all, sends her message in hurricanes of wind and rain, flooding and devastation.  We are just like the ants floating in the flood waters, surviving by sheer will power or dying from exhaustion.  We are circling the storm drains of life, believing that somehow we will be rescued.  Passive to the storms created by mankind, we believe that someone or some government will rescue us.  But it appears that we are just ants to a government of ghosts from the past.  Their incompetence and ignorance means that the life boats are reserved for them and you are on your own.  

Survival?  How does one survive when the life boat you are on is filled with a flickering screen of constant entertainment.  The struggles in life muted or distorted by a Hollywood version of life or a social media version of community.  And then there is the constant background drone of trump, trump, trump.  A day without Trump and his trumpets would be heaven on earth.  Every day becomes a schizophrenic nightmare of media messages of idiocy.  At what point will the people say let's get off this train of incompetence, nastiness, and lunacy?  

I went to a library, to sooth my soul.  Escaping into the stacks of books, of quiet reflection and peace.  I found a book I wanted to read, Braiding Sweetgrass, by Robin Wall Kimmerer, a botanist and a Potawatomi woman.  And I lost myself in reading about the sacred and medicinal plants, indigenous knowledge of life on earth, and the principle of reciprocity in nature.

She writes in the chapter called, The Consolation of Water Lilies:

"I remember my babies at the breast, the first feeding, the long deep suck that drew up from my innermost well, which was filled and filled again, by the look that passed between us, the reciprocity of mother and child."

and

"We are showered every day with gifts, but they are not meant for us to keep.  Their life is in their movement, the inhale and the exhale of our shared breath.  Our work and our joy is to pass along the gift and to trust that what we put out into the universe will always come back."

Kimmerer's book, her observations danced around in my head and reminded me of my own observations of breastfeeding mothers and babies. Seeing the struggles of mothers to breastfeed in our society, reminded me of how isolated women are from nature and how artificial our world has become.  

Human being learn by imitation, what we see and hear becomes our reality
Modern observations of life are in many cases governed by the media.  In TV and Movie lands, life is seen through a mostly white male-dominated, corporate viewpoint. Solutions to problems involve buying certain products.  Breastfeeding problems?  Buy this or that breast pump, infant formula, pacifiers, bottles that mimic breastfeeding.  Solutions in our fast-paced world must be resolved quickly or else we go onto a newer better product to resolve a problem.  Having a baby in our consumer-driven world, means buying lots of things.  The problem with all these things is that these things don't necessarily make breastfeeding easier and often make things worse.  

Time spent using and/or cleaning breast pumps, bottles, and pacifiers is time and attention given to things.  Time taken away from the baby.  Time taken away from breastfeeding.  How did we learn to walk, when we were babies?  Babies are totally focused on learning that skill, so simple once you learn it but an investment in time measured in days and hours.  The baby never gives up, that drive and intensity is amazing to watch.  Babies are fearless in learning to get up, balance their body, push off, and reach out into space.  They watch you do it and they absolutely know they can do it, too.  As they wobble and fall down numerous times, they are comforted by their families, cheered on to continue to learn to do what comes so natural to all of us.  Many of us have forgotten that energy, that drive, that runs through our bodies as we learn a new physical skill.  Breastfeeding often requires that intensity of physical learning.  But moms often trade that learning time with baby for taking care of things.

What causes some adults to feel defeated quickly and others to continue forward despite the obstacles?  What is the reason why some women do not believe in themselves and their ability to breastfeed?  What is the thought process of mothers who seem helpless, when faced with breastfeeding difficulties?  As a lactation consultant, I met some mothers who were defeated, depressed by life and learning to breastfeed was just one more impossible task.  I also met some mothers who overcame difficulties that would defeat most people.  And some mothers who breastfed with ease.

Babies learn to walk at various ages, some are early and some are late bloomers.  But the interest and intensity in learning to walk is very much present.  They don't harbor doubt or helplessness but neither do babies have years of so-called experts telling them what and how to think.  They just see what they want to do because everyone around them is doing it.  And they don't depend on the Baby Walking Consultant or their doctor for a diagram of how their legs work, parts and function of legs, and crutches to rent to help them walk.  Babies usually have their families, who cheer-lead their efforts to walk, who pick them up when they fall. The breastfeeding mother may have few people or family members who delight in her learning to breastfeed. 

Breastfeeding is natural.  But we don't live in the natural world.  Most of us live in buildings that are temperature controlled.  We have cool air when its hot outside and warm air when its cold outside.  If we go outside, we must adjust to a vastly different temperature than our indoor temperature.  We wear clothes on our bodies, babies have to adjust to having diapers and clothes.  The skin is our largest sense organ.  In artificial environments such as ours, we have comfort without the challenge and sensation of temperature, wind, rain, and snow.  Women cover their breasts with bras and shirts, and men can go bare-chested at the beach or outdoors.  But women rarely do so without public complaint.  Breastfeeding in public, where skin-to-skin contact is required, creates unease among many people.  That discomfort at the idea or actual breastfeeding by mothers in public, creates an obstacle for some mothers that they cannot overcome.

It is no surprise that our society is becoming more and more trapped by its artificial facade.  If one is born into a world of artificial things that never challenge our bodies or our thinking, then breastfeeding appears to be this rather antiquated and unnecessary behavior.  Some women and men believe that female liberation is to have women behave more like men.  Therefore breastfeeding is unnecessary because anyone can feed a baby--even men.  Chestfeeding is the newest lingo.  Tinker with a few hormones and men can now breastfeed.  I read that the only problem is that men's boobs may get larger. 

Nature and nurture is being challenged by scientific-industrial interests.  Human milk is being standardized to fit a male-dominated society in which the belief is that some women can't or won't breastfeed.  No one questions why some women won't breastfeed.  Yet some men seem to be eager to take over that female biology by chestfeeding.  No one asks how many women can't breastfeed.  

Instead of considering breastfeeding to be a sacred gift of mothers to their children, social marketing is telling us to embrace the idea that anyone can be a mother.  Is this really what feminism is all about?  Isn't this rejection of the female and a furthering of human survival based on corporate science?  Standardize how humans are fed, instead of embracing the diversity of the gift of breastfeeding by a mother to her child serves what purpose?  The purpose appears to be so that people have to buy more products.   Will buying more products satisfy people emotionally and spiritually?  Or is this just another form of enslavement to a corporate world that uses science to hold on to their power?

*Dolly, the sheep, was cloned  using electrical pulses fusing a mammary gland cell and an unfertilized egg cell.  She was born in 1996. The mammary cell's ability to act like male sperm in fertilizing the egg is rather astounding.  
 https://www.britannica.com/topic/Dolly-cloned-sheep
Although we shouldn't be surprised by how mammary tissue (breastfeeding) is amazingly unique and life-promoting.  We now know that human mammary cells have stem cells that have great potential to treat disease.

Copyright 2018  Valerie W. McClain