Saturday, May 25, 2019

BIFIDOBACTERIA






"You cannot insert a gene you took from a bacteria into a seed and call it LIFE.  You have not created life, instead you have only polluted it."--Vandana Shiva

BIFIDOBACTERIA

Likewise I would add to Dr. Vandana Shiva's statement that scientists cannot rearrange genes within a bacteria and call it a probiotic.  Probiotics are live microorganisms that are suppose to create health benefits by improving the gut flora of an individual.  There is a history of safe use of Bifidobacteria in the food industry.  But historically the safe use was based on a natural microorganism not on a genetically engineered microorganism.  For instance Nestle has had concerns about Bifidobacteria used in creating probiotics.  In patent #8071353 entitled, "Genetic Remodeling in Bifidobacteria," filed in 2007.

"Use of any bacterium that possesses 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. Examples of such a bacterium can be found among the Bifidobacterium spp., for example, Bifidobacterium animalis such as Bifidobacterium animalis subsp. lactis (also referred to as Bifidobacterium animalis subsp. lactis subsp. nov., previously regarded as Bifidobacterium lactis and sometimes referred to herein as such). One such strain, B. animalis subsp. lactis strain NCC 2818, CNCM I-3446, is commercially available, has been used for over 20 years as an additive to food products and is generally regarded as safeIt has recently been discovered that this bacterium, in common with certain other gram(-) and gram(+) bacteria of human and animal origin has a tetracycline-resistance gene, tetW, present. Although tetracycline resistance transference is theoretically possible, it has so far not been possible to demonstrate this even under laboratory conditions. It is, however, known from cloning experiments that tetW from this strain is active in gram(+) bacteria although not in gram(-) bacteria."

According to the patent the use of genetic engineering techniques will disrupt or delete the tetracycline-resistance gene.  The patent also states the following:

"The above-described method may also be practiced on Bifidobacterium cells of the species B. longum."

and

"Thus, in a preferred embodiment, the Bifidobacterium cell according to this aspect of the invention is substantially lacking the nucleic sequence for the tetW gene. In one embodiment the coding sequence is at least substantially deleted. Alternatively, one or more noncoding sequences related to the predetermined functional gene may also be deleted."

Sometimes they cannot totally eliminate or disrupt the tetW gene, nor can they always substantially eliminate or disrupt the gene.  And it appears that some supposedly noncoding sequences are sometimes deleted.  Hm, reading this should give people pause to wonder about the accuracy of genetic engineering.  And should a genetically engineered microorganism be treated the same as microorganisms that have not been genetically engineered?  We know that antibiotic-resistance is creating a health crisis.  Is this the only antibiotic resistant gene in bacteria that is harvested for the probiotic industry?  

In 2014 a preterm infant died in a US hospital NICU from a fungal infection of the gastrointestinal tract.  The infant was given a probiotic supplement that was marketed for infants and children.  Are probiotics safe for preterm infants, full term infants, children?  
https://www.forbes.com/sites/davidkroll/2014/12/17/infant-death-triggers-fda-health-provider-warning-on-probiotic-risks/#2e1c88041835

Which leads me to questions about a probiotic being marketed internationally at breastfeeding mothers.  The probiotic is Bifidobacteria longum, subsp. infantis and sold by a company called Evolve Biosystems and their probiotic product is called Evivo.

The company was founded in 2011 in California, USA.  The founders are David Mills, Bruce German, Samara Freeman, Carlito Lebrilla, Daniella Barile.  All 5 founders are co-inventors to various Evolve US patent applications and/or patents.  They are also co-inventors to patents and patent applications owned by the Regents of the University of California.
https://www.evolvebiosystems.com/founders

Bruce German was employed by Nestle and has been funded by other infant formula industries.  He has also collaborated with Prolacta Biosciences (the for-profit milk bank that makes human milk-based infant formula for NICUs).

The company's chief scientifc officer and executive chairman of the board of directors for the company is David Kyle.  David Kyle was one of the founders of Martek Bioscience, manufacturer of DHA/ARA from algae and fungi (gmo ingredients) used in infant formula and supplements.  Martek Bioscience was sold to DSM of the Netherlands.  David Kyle is a listed co-inventor to many Evolve patent applications (also co-inventor to some Martek patents).  Timothy B. Brown is the CEO.  He was previously employed in executive positions with Mead Johnson and Proctor & Gamble.  (Proctor & Gamble co-owns with an Irish company US patent #10,233,433 on Bifidobacteria longum, subsp. infantis.

Some issues that are of concern regarding the company Evolve Biosystems
1.  The company states that they have FDA GRAS.  Yet the FDA GRAS inventory list of ingredients appears to have nothing listed for the company, Evolve Biosystems.  There are 4 Bifidobacteria ingredients listed in this 17-page inventory list.  One is from Nestle and the FDA had no questions, FDA GRAS #49. One is from Morinaga Milk Industry Co., Japan, FDA GRAS 268. Another one was from a Canadian company, Lallemand Health Solutions-FDA GRAS #758-one of 3 bacterial species to be used together.  And the Korean company Bifico Co. #813 FDA GRAS which is still pending. Perhaps the FDA has not published the Evolve's FDA GRAS request?

2.  At this point in time the clinical trial that proves its safety was funded by the company.  And at least 2 of the authors of the paper on that clinical trial have been funded by Evolve.  The lead author, Jennifer T. Smilowitz is a private consultant for Evolve.  Mark Underwood, another author, has received funding from Evolve.

3.  Evolve's World Patent Application states the following, 
"The composition of any one of claims 1-15, wherein the Bifidobacterium is B. longum, B. breve, B. bifidum or B. pseudocaternulatum."   
Are all these Bifidobacteria species equivalent and are safety studies done on each possible bacteria?  Consumers may presume that the one specific bacteria is being usedShouldn't people who buy this product have accurate information?

4.  Evolve's World Patent Application states the use of oligosaccharides (some are gmo) with Bifidobacterium longum.
"0004] The instant invention provides compositions comprising isolated complex oligosaccharide fractions from mammalian milk sources, optionally supplemented with purified fucosylated/sialylated oligosaccharides. The mammalian milk may be from human or bovine sources, and including but not limited to, the bovine source is from bovine colostrum. The fucosylated oligosaccharide(s) may comprise synthetically produced and purified 2'- fucosyllactose, 3-fucosyllactose, difucosyllactose, or lacto-N-fucosylpentose." 

5. Evolve's World Patent Application states the use of flow agents,
"[0039] Any of the compositions described herein can further comprise a secondary metabolite. The secondary metabolite can be a short chain fatty acid, such as acetate, lactate, or combinations thereof. The compositions described herein can further comprise a stabilizer, such as a flow agent. Flow agents may include starch, silicon dioxide, tricalcium phosphate, powdered cellulose, magnesium stearate, sodium bicarbonate, sodium ferrocyanide, potassium ferrocyanide, calcium ferrocyanide, bone phosphate, sodium silicate, calcium silicate, magnesium trisilicate, talcum powder, sodium aluminosilicate, potassium aluminum silicate, calcium aluminosilicate, bentonite, aluminum silicate, stearic acid, and polydimethylsiloxane. The stabilizer can be a milk protein or another suitable pharmaceutical grade or infant formula grade diluent (e.g., lactose). The milk protein can comprise a protein fraction of non-fat dry milk."

6.  Evolve's World Patent Application seems to imply genetic modification,
"[0031] In various embodiments, the bifidobacteria encodes gene clusters containing ATP-binding cassette (ABC) transporters and glycosyl hydrolases involved in HMO utilization, typically including one or more genes coding for a fucosidase. In some embodiments, the bifidobacteria contains a gene coding for a complex oligosaccharide transporter. In some embodiments, the bifidobacteria contains a gene coding for a fucose transporter. In some embodiments, the bifidobacteria contains a gene coding for a fucose or sialic acid transporter. In many embodiments, the genes encoding these components are upregulated or expressed. The genes may be constitutively upregulated or induced."

7.  Recent patents on Bifidobacterium longum, subsp. infantis use genetic engineering to create an improved product (Nestle and Proctor & Gamble US patents).  Evolve has stated in their US patent application that their source for the bacteria is either the International Milk Bank or from the ATCC (American Type Culture Collection).

8.  Evolve has many patent applications around the world.  They have a World Patent WO/2016/065324 entitled "Activated Bifidobacteria and Methods of Use Thereof."  This same patent application is also filed in Mexico, USA, China, Singapore, Australia, Brazil, and the European Union.

9.  Since 2014 Evolve has received some $70 million in funding, $20 million was from the Bill Gates Foundation/Li Ka Shing Foundation

10.  Evolve has stated that it has received Health Canada approval for its product, Evivo.

CONCLUSION
It seems to me that safety questions need to be asked regarding the use of probiotics for infants (especially preterm and newborn) and children.  Especially when there is limited independent research and so much investment in IPR's (Intellectual Property Rights).  Does probiotics impact exclusive breastfeeding?  The infant's gut will change by a company's design, by their understanding or misunderstanding of breastfeeding.  Should infant's be guinea pigs to a new growth industry without independent evidence?  What do we really know about the use of genetic engineering of probiotics for infants and children?  Will exclusive breastfeeding survive?  Are we jeopardizing the next generation by manipulating gut bacteria?  
Copyright 2019 Valerie W. McClain 
 


Tuesday, May 7, 2019

WORDS: HUMAN MILK or BREASTFEEDING?


"The source of patriarchal power over women and nature lies in separation and fragmentation." --Vandana Shiva, "Biopiracy:  The Plunder of Nature and Knowledge."

Much of the current memes circulating on social media platforms extols the wonders of human milk or breast milk.  We read, "The Impressive Power of Breast Milk" in Discover Magazine.  Or we go online at a Medela website and read, "The Healing Power of Human Milk."  Or an article that circulated last year on Facebook, "The Healing Power of Breast Milk Will Amaze You."  That article included pictures of pumped milk in Lansinoh bags, one bag of white milk and one bag of orange-tinted milk containing high levels of carotene that supposedly combated a baby's illness.  (High levels of carotene are present in colostrum causing the milk to look very orange)  If a woman doesn't pump her milk, she may never know the color.  We do know that human milk can be of various hues from greenish, gray, blue to orange.  Women question their own milk, if the color does not fit the image of the cow's milk they bought at the store.

One of the more recent meme's circulating on Facebook was a picture of Tormund from Game of Thrones with a white milk mustache that had the words, "The Awesome Power of Your Milk."  The mischievous Tormund displayed a rather humorous tale of why people called him Giantsbane. Tormund says that he got so strong because at the age of 10 he suckled for 3 months at the breast of a giant.  The giant woman thought he was a baby.  

The meme struck me as just another meme extolling the virtues of human milk.  Another headline where breastfeeding has disappeared from the text replaced by the words human milk or breast milk.   Yet was this tale really about this giant of a man, at the tender age of 10 ingesting human milk?  The word Tormund used was suckle and so the tale he told was not just about ingesting human milk. He was a 10 year old boy breastfeeding.  The sexual innuendo in that scene between Tormund, Brienne of Tarth, and Jaime seemed so Hollywood.  There have been many cultures in our human past where children of 10 or older still breastfed, mostly for comfort.  Yet current Americanized culture confuses breasts/breastfeeding with sexuality.  The scene in Game of Thrones seems mostly influenced by our current culture that pairs breasts/breastfeeding with sexuality.  

But whoever created the meme seemed unaware of the implications but rather saw this as an opportunity to promote human milk.  Maybe I am wrong thinking the author didn't understand the intent of Game of Thrones.  Maybe that is why the choice to use human milk in the text of the meme rather than breastfeeding.  Who knows?  The internet reality seems to be one of proclaiming the greatness of "the milk" and avoiding the words breastfeeding.  

When we think that human milk is the equivalent terminology to breastfeeding, then we have created a cognitive dissonance.  They are not equivalent actions.  Human milk is about separation, separating the milk from the mother.  Human milk comes into sight because of products like pumps and bottles.  Human milk is pumped because mother and baby are separated.  Breastfeeding is the scary unknown.  We cannot easily measure it, see the amount of it or even the color of it.  It is a natural mystery that science believes it must uncover.  But in uncovering its mystery by stripping it into many of its components, are we encouraging breastfeeding?   Or are we making the simplicity of the natural function of the breast into a fragmented, unintelligible science used to benefit the infant formula and human milk industries?

Noam Chomsky wrote, "Science is a bit like the joke about the drunk who is looking, under a lampost for a key that he lost on the other side of the street, because that's where the light is.  It has no other choice."

How blinded is our science when driven by the infant formula and human milk industries?  What do we, the common people, believe to be true when the driving force of our science is beholden to pump companies and to building a human milk industry?  Is breastfeeding a priority?  A hospital in Philadelphia advertises its NICU with an article entitled, "The Power of Pumping."  I'd rather see the power of breastfeeding as an article.  But, of course, how many babies are allowed to breastfeed in NICUs?  

How blinded is our science, when a human milk researcher states that the purpose of research is to create a company or a product? (stated to me on Facebook) What are we advertising when human milk is considered the same thing as breastfeeding?  How many women are breastfeeding and how many are human milk feeding?  If our science views breastfeeding and human milk feeding as equivalent actions, then is our vision clear or cloudy regarding our science.  Will we ever consider that breast pumps might be creating breastfeeding failure?  Or will our corporate science refuse to consider that possibility?  When breastfeeding and human milk feeding are lumped into one category in research, how accurate will that science be?

In the following patent owned by Medela (US Patent #9517294), the inventors mention breast-pump dependent mothers of premature babies because they state that premature infants are not capable of feeding at the breast.  While I recognize that some premature babies are too unstable to breastfeed, I wonder about the research regarding premature infants inability to breastfeed.  Is this belief based on evidence?  And is science blinded by corporate desire to sell pumps? Note the abstract only mentions newborns.

"When a baby is born premature, the baby is often in the Neonatal Intensive Care Unit (NICU) and may not be able to breastfeed. Thus, the mother is solely breast-pump dependent. Breast-pump dependent mothers do not experience this unique sucking pattern from their premature infants who are not capable of feeding directly from the breast. Because this unique sucking pattern appears to be a critical "first step" in establishing an adequate milk volume, breast pump-dependent mothers with premature infants may miss this critical stimulation, negatively affecting their ability to produce a sufficient amount of milk. " 


Our belief about what is possible and what is not possible is based on evidence or the need to sell products.  While this patent mentions premature infants, the abstract states newborns.  Thus a pump supposedly intended for mothers whose babies cannot breastfeed because of their prematurity, is also created for a market that will include newborns.  How many newborns cannot breastfeed or cannot because of medical interference in the birthing process?  Innate inability of premature or newborn babies, or some other unexplored reason? 

Is human milk powerful or is it breastfeeding that is powerful?  Why do you believe what you believe?  When pumps become the standard equipment promoted for breastfeeding mothers, are we supporting breastfeeding? or human milk?
Copyright 2019 Valerie W. McClain








Wednesday, April 17, 2019

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





 











 









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
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





Tuesday, February 12, 2019

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

Monday, February 11, 2019

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 [,,,,].
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/





















Sunday, December 16, 2018

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