Saturday, May 25, 2019


"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


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."


"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?

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.

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.

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


"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