Thursday, February 14, 2019

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 

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.

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

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

Tuesday, February 12, 2019

Part 2 continued-What's in a Name?

" 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."

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

Monday, February 11, 2019


"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"

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.

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)

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." 

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 [,,,,].
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."