REFLECTIONS ON OUR WORLD-WIDE PANDEMIC

“It is through body contact with the mother that the child makes its first contact with the world, through which he is enfolded in a new dimension of experience, the experience of the world of the other.  It is this bodily contact with the other that provides the essential source of comfort, security, warmth, and increasing aptitude for new experiences, the fountain of which begins with breastfeeding.."
Touching:  The Human Significance of the Skin by Ashley Montagu

I must have been in 5^th or 6^th grade, when the principal of our elementary school walked into our room.  He was very tall, a lanky elderly-looking man.  My child-mind thought he was ancient.  Now that I am older than he was back then, I must say he wasn’t ancient!  How our perspective changes, as we get older.   

This ancient man in his 3-piece suit scared me.  I believed that he could only be here, if our class or someone in our class was in trouble.  But for the life of me I couldn’t figure out what we had done wrong.  Instead of getting yelled at or threatened by this adult in charge of our elementary school.  He said he was going to recite one of his favorite poems from his childhood.  This man had been a child?  That boggled my child-mind.  But fear of this adult dissipated and all 40+ classmates of mine seemed to let go of our fear of this strange adult.

The ancient one leaned against the window sill near my seat and he began to recite a poem.  His voice was strong and the poem was long.  Even as a child, I was impressed by his ability to recite from memory a poem from his childhood.  I have always remembered the first 2 lines of the poem and mostly forgotten the rest of the poem. 

“If you can keep your head when all about you are losing theirs…” (If by Rudyard Kipling)  As a lactation consultant, I have done home visits where parents (and sometimes the grandparents) have been panicking about their newborn’s health and/or a mother’s ability to adequately breastfeed their little one.  Their panic has washed over me and I have had to force my mind to stay calm. Part of my job was to calm everyone down, so that everyone can figure out the best way to solve the situation.  In rare cases their panic was justified. But panic is never a useful reaction to real or imagined fears.  From another century Kipling’s poem speaks to our 21^st century humanity.  We must take a breathe, be that calm in the center of the storm.

I thought of this poem when I was in the grocery store the other day.  It was 7am and people over 65 were given the opportunity to shop before the store actually opened. There was a crowded line outside the store, which was packed with some very sullen senior citizens.  I thought I was early because I got there at 7:02am.  Most seniors don’t get up at the crack of dawn and this was a mob scene.  Some seniors had obviously gotten to the store, hours before it was to open because they were now exiting the store with their prizes:  toilet paper and paper towels.  The look of triumph on their faces as they walked by those of us waiting in line was curious.  One might believe that grocery shopping had become part of a Senior Food Shopping Olympic Games—winner takes all-- the toilet paper and paper towels.  One senior winner said that he had got his necessities.  I am not sure that toilet paper and paper towels qualify as necessities.  How many trees do we cut down in order that people can wipe their butts or wipe spills off the floor?

There were long lines in the grocery store to pay for our prizes.  Some seniors didn’t understand that the lines snaked around the store and they cut ahead of others assuming the line could not possibly meander around the store.  At one point I thought there was going to be a fist-fight near me over cutting in line.  Memories or should I say nightmares of lining up in school flashed in my mind.  I remember asking my parents why the school made us line up in alphabetical order during nuclear bomb drills.   We went to the basement of that old school building to save us from a nuclear bomb.  Would that save us?  Was it so God would know who we were because we were in alphabetical order when we died from a nuclear holocaust?

Back to present day reality, tempers were definitely rising in the grocery store.  I could see the headlines, “Senior Citizens Riot in Grocery Store.”  The me-first generation believes that toilet paper and paper towels are worth fighting over. Isn’t the me- first generation bumper sticker, “He who dies with the most toys wins.”  Only the toys are toilet paper and paper towels!

There was some friendly faces in that senior crowd but not many.  To my surprise there were no actual brawls or fist-fights.  But I decided I am not going to any more Senior Food Shopping Olympics.  They are certainly not following the recommendation of social distancing.  And standing in lines for long periods of time surrounded by unhappy, possibly sick, and disgruntled people only accelerates my stress.

I was glad to go home wash my hands and practice some social isolation.  And maybe that isolation will give me the mental energy to do some research and writing.  I have been staying away from Facebook and away from writing in my blog.  My computer’s hard drive died and for 2 months I had limited access to a computer.  I realized how much I enjoyed the time away from the internet.  I felt peaceful and found myself writing with pen and paper.  I felt like I was doing something primitive in this day and age of computer technology.  Its simplicity was soothing to my brain.  I realized though that I depended on the computer for many things and after a few months decided I “needed” a computer.  I missed writing on my blog.  So I am back looking at patents.

But I was not looking at patents on human milk components.   I found myself doing a patent search on the corona virus.  I wanted to know a number of things, like what is the corona virus?  I found that some researchers suspect that some corona viruses are responsible for colds.  What about the “novel” COVID-19 corona virus?  Microbiologists define novel as that which is genetically engineered.  I found a youtube video dated 3/9/2020 of a Fox News interview of Alex Azar, Secretary of the US Department of Health and Human Services, in which he states that SARS, MERS, and COVID-19 are genetically modified and different from the common cold.  Alex Azar was the President of Eli Lilly & Company (USA) from 2012-2017.  One would suppose that a President of a pharmaceutical company would know a lot about drugs and genetic engineering (since a lot of our drugs and vaccines are genetically engineered). 

Meanwhile many US news outlets state that COVID-19 is not a man-made virus, not genetically engineered.  Who is telling the truth?  I believe that COVID-19 is genetically modified.  I don’t normally watch Fox News but this statement by Alex Azar is eye-opening.  
Azar's statement starts at 6:32 of the FOX News video

https://www.youtube.com/watch?v=aSBWlKC7reM

“If you can meet with Triumph and Disaster and treat those two imposters just the same” IF by Rudyard Kipling

The history of the corona virus as seen through US patents is interesting.  In a patent owned by the US Department of Health and Human Services and the CDC filed in 2004 and entitled, “Coronavirus isolated from humans,” they state,

“Coronavirus have not previously been known to cause severe disease in humans, but have been identified as a major cause of upper respiratory tract illness, including the common cold. Repeat infections in humans are common within and across serotype, suggesting that immune response to coronavirus infection in humans is either incomplete or short lived. Coronavirus infection in animals can cause severe enteric or respiratory disease. Vaccination has been used successfully to prevent and control some coronavirus infections in animals. The ability of animal-specific coronaviruses to cause severe disease raises the possibility that coronavirus could also cause more severe disease in humans (Fields et al. eds. Fields Virology, 3rd edition, Raven Press, Philadelphia, 1323 1341, 1996; Mahey and Collier eds. Microbiology and Microbial Infections, Volume 1 Virology, 9.sup.th edition, Oxford University Press, 463 479, 1998).

In late 2002, cases of life-threatening respiratory disease with no identifiable etiology were reported from Guangdong Province, China, followed by reports from Vietnam, Canada, and Hong Kong of severe febrile respiratory illness that spread to household members and health care workers. The syndrome was designated "severe acute respiratory syndrome" (SARS) in February 2003 by the Centers for Disease Control and Prevention (MMWR, 52:241 48, 2003).”

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=7220852.PN.&OS=PN/7220852&RS=PN/7220852

In another patent owned by the US Department of Health and Human Services and Versitech Limited of Hong Kong, filed in 2014, entitled “Human monoclonal antibodies against the middle east respiratory syndrome coronavirus (MERS-CoV) and engineered bispecific fusions with inhibitory peptides,” they state,

“Emerging viruses present a serious threat to human health and safety. In the past few decades, many infectious diseases, such as those caused by the human immunodeficiency virus (HIV), Ebola virus (EBOV), Nipah (NiV), and Hendra (HeV) viruses, have effectively made the jump from animal to human hosts and devastated entire populations and economies.

In 2012, a novel human coronavirus, the Middle East Respiratory Syndrome Coronavirus (MERS-CoV), was isolated from a Saudi Arabian patient suffering from severe pneumonia who later died of respiratory and renal failure (see Zaki et al., N Engl. J. Med., 367: 1814-1820 (2012)).”

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=10421802.PN.&OS=PN/10421802&RS=PN/10421802

It appears that some researchers knew that there was a novel corona virus that caused severe respiratory infections that morphed into pneumonia with high mortality.  It surfaced in the Middle East as well as China, Vietnam, Canada, and Hong Kong.  The patents suggest to me that some scientists, medical people, and researchers were aware of this as far back as 2002. And now we have another novel corona virus that seems to be far worse than these older, novel corona viruses. Or should we say genetically modified corona viruses?  What is known and what is being hidden from the public? 

What about the 4 US Senators who profited in the stock market from knowledge they were privy to in the Senate.  Insider trading?  This became news worthy headlines, only to be buried in an avalanche of novel COVID-19 statistics of those who tested positive and those who died. Are we witnessing a dysfunctional government or a emergency situation too difficult for any government to handle?  Should the US Government Health Department own patents?  Has the US Department of Health and Human Services become just a business entity with no outside oversight?  While the US government patents are not on the novel COVID-19 virus (newly named), they certainly show that somehow the corona virus of years ago had transformed into virulent forms.  

Genetic engineering?  Alex Azar called it genetic modification.  When genetic engineering is discussed in the media, the industry waxes poetic about the wonders of the science.  We are told that man-made splicing and dicing of genes is safe.  It’s in human food, infant formula, baby food, pet and livestock foods, supplements, drugs, and vaccines. Risks of genetic engineering:        https://www.sites.ext.vt.edu/newsletter-archive/cses/2000-02/risks.html

The other day I received a post card in the mail entitled, “President Trump’s Coronavirus Guidelines for America.” On the card it states that for further information visit the White House and the CDC website.   One might get the impression that the CDC, Donald Trump, and the White House wrote the Guidelines. Elections will be in November.  Who paid for the postage of all these postcards?  The CDC?  Was the CDC aware that President Trump would be using the corona virus guidelines postcard as a political advertisement?            

“If you can bear to hear the truth you’ve spoken twisted by knaves to make a trap for fools.” IF—by Rudyard Kipling

I recognize that my thoughts put down on this particular blog post are scattered.  There is a wind storm stirring up random thoughts that to me seem connected.  It appears that this world- wide emergency situation will not disappear as quickly as the news cycles in our media.  We are all in for some very difficult times.  My heart goes out to everyone who is struggling.  We are all struggling with our fears of the future.  Fear can tear us apart. It can paralyze us. We no longer know what is the Truth and what are lies.  Truth has become a thread of gossamer shimmering in the air, tossed by the winds of Greed and Avarice. 

Copyright 2020 Valerie W. McClain

THE COST OF LIFE--PART 2

“Corporations are like protean bacteria; you hit them with accountability and they mutate and change their names.”  --Doug Anderson

Years ago I was employed by a plastic manufacturing company. Every time I punched my time card at the time clock, I would read the banner above the time clock, “Plastic is the solution to pollution.”  I was amused yet annoyed by the irony of such a motto.  It was obvious to me that plastic polluted.  I saw the pollution created by the manufacturing process.  I witnessed some of the workers leave the building covered in a white chemical dust.  They were the employees who worked directly with the chemicals in the compound room that created the company’s plastic. None wore any kind of protective clothing.  The plastic that was being manufactured was called polyvinyl chloride (PVC) and it was implicated in a specific rare liver cancer (angiosarcoma).  It is now believed to have a 20-year latency period from time of exposure to cancer diagnosis. PVC is now considered a risk factor for a long list of cancers. Workers who handled the PVC were at the highest risk of a liver cancer called angiosarcoma (45 times more likely than other people to get this kind of cancer).  Inhaling PVC particles, skin contact, and ingesting it (for example, drinking water contaminated with PVC) are health risks for all people, not just for workers in the plastic industry.

Every day of the 6 months I worked at that company, I parked my car and walked across a little bridge to the company’s massive brick building.  It was winter in New York State and the creek that ran under the bridge was frozen.  Giant pipes ran next to the creek and rainbow-colored ice spilled from these pipes into the creek.   I figured out much later that the rainbow-colored ice must have been the chemicals used to create the plastics we molded.  That creek flowed into the Mohawk River which flowed into the Hudson River.  I can hear Pete Seeger singing, “sailing down my dirty stream, still I love it and I’ll keep the dream, that some day though, maybe not this year, My Hudson river, will once again run clear.”

It was the winter of 1973 and I was hired by this company to work on their Ford Torino assembly line.  They were hiring women for that particular assembly line.   I believe I was paid $2.10 per hour (minimum wage was $1.85/hour) for standing 8-10 hours per day assembling plastic strips to be pressed together, heated, and cooled.  I stood in one spot on a cement floor that had a large clock above me.  Time stood still as I watched the minute hand inch its way around the clock face.  Watching the clock made for long days.  I hated that clock and the job.  I convinced myself that the job was great, since good-paying jobs for women with little work experience had been hard to find.  But the work was repetitive, dangerous at times, and the treatment of women workers was childish.  If a woman had to go to the bathroom, she would have to raise her hand for permission.  I don’t remember any males having to raise their hands to go to the bathroom.

I got to know some of my co-workers at our two 10-minute breaks during the day and at our 30-minute lunches.  I learned rather quickly that the assembly line runs to the sweep of the company minute hand.   Most of the other women were older than me, married, and in their 30’s and 40’s.  What struck me about these women was their attitude towards life. They had a mental and physical strength that deserved respect.  Many spoke of their children and their desire for their children to have a better life than working in some factory job.  Some women were setting aside most of the money they earned for their children to go to college.  Would their children understand the sacrifices of these women?  Does a society respect the sacrifices women make to give their children a better life?

It was over 40 years ago that I worked for the “plastic is the solution to pollution” company.  I was there for a half a year but it felt like lifetime.  I promised myself that I would never work another assembly line.  And I never did work for another assembly line.  I have had other bad jobs, but never as bad as that job.  After working that very short time, I have an aversion to the smell of plastic. 

Writing about my long ago job experience triggered an interest in seeing, if the company still existed.   I found an abstract, “Health-hazard evaluation determination report No. 73-123-298, Campbell Plastics, Inc., Schenectady, New York.”   https://www.cdc.gov/niosh/nioshtic-2/00074986.html

The evaluation was done by the National Institute for Occupational Safety and Health (NIOSH) which was part of the CDC and the US Department of Health.  The investigation occurred on 4 dates; and 2 of those dates were, when I was employed by the company.  “The survey regarded exposure by inhalation of smoke, fumes, and vapor from work with polyvinyl chloride, toluene, and methyl ketone, and also skin contact with the same agents.”  According to the report 40% of the workers had “minor eye and respiratory irritation.”   I knew nothing about this investigation.  So this paper is a surprise to me.  It makes me glad I only worked there for 6 months.

Interestingly, I found another website that stated that the manufacturing plant I once worked for was the site of an EPA Superfund Site.  Superfund sites are areas that have been contaminated with hazardous waste that has not been managed properly. 

https://www.homefacts.com/environmentalhazards/New-York/Schenectady-County/Rotterdam/Superfund-Campbell-Plastics-Nyd096925524.html

So the “plastic is the solution to pollution” company left a polluted toxic mess that the US Government had to clean up. And we, the people, pay the government through our taxes so that the mess gets cleaned up.  Did the company pay anything to clean up their mess?  I don’t know.  The arrogance of a company that dumped chemicals (known to be toxic and carcinogenic) into waterways and lands in the area, while espousing that plastics was the solution to pollution is beyond belief. The lack of regard for workers is a sad reminder that a company that does not care about the environment probably does not care about the health and well-being of its workers.

Tell a big lie, repeat it often enough and people will believe it.  Corporations often tell big and little lies through their company mottos, slogans, and advertisements.  Do we question those mottos, slogans or advertisements?  Or accept it because we have heard it so many times?  Unthinkingly, we may accept what corporations tell us about their products, even when we suspect that it is just propaganda.  We want to believe what we are told because it is so much easier to go along with corporate fantasy. When the fantasy we are told to believe in collides with reality, we may reject the reality rather than face the discordant nature of our world. 

How many companies or corporations use false or distorted statements to sell their products?  The doublespeak or cognitive dissonance created by a plastic company to sell its products and its philanthropy is not uncommon.  Companies in the human milk business such as Prolacta, Evolve, Medela, etc use similar tactics.

Are their slogans, mottos, or advertisements supportive of breastfeeding?  Or does their financial interest in human milk take precedence over breastfeeding support.  Why does Medela consider itself “a long-time champion of breastfeeding?”—stated on their website.  Is that a true statement?  I consider La Leche League a long-time champion of breastfeeding.  Why does Medela use the same sales tactic as the infant formula industry?  They say on their website, “Medela’s breast pumps are the number one choice of healthcare professionals and healthcare facilities worldwide, including 80% of US hospitals.”  The infant formula industry sells its products based on being the number one choice of pediatricians and hospitals.  Who do we believe—the infant formula industry? Medela?

Medela says their products are based on research by world leading lactation experts.  Those world leading lactation experts appear to me to be funded by Medela (some are listed inventors to Medela patents) or the Family Larsson-Rosenquist Foundation (a corporate foundation that owns the Larsson Family’s companies, including Medela)

Meanwhile Prolacta Bioscience states that they are a for-profit milk bank.  Yet the FDA classifies their products as exempt infant formula—human milk-based infant formula.  Do you believe that this company is a milk bank or are they actually a human milk-based infant formula company?  Are we feeling some cognitive dissonance?

Evolve, a company that is selling its bifidobacterium to breastfeeding mothers, based on research on human milk states that they are “Pediatrician Recommended,” and “Clinically Proven.”  Clinically proven means through the company’s funded research.  While selling their product to breastfeeding mothers, they have partnered with RB (Reckitt Benckiser who bought out Mead Johnson) to sell the bacteria to the infant formula industry.

http://www.rb.com/us/media/news/2019/december/rb-and-evolve-biosystems-team-up-to-advance-infant-gut-health/

This world of ours is influenced by corporate propaganda.  The company paints a picture through words, music and art that often conflicts with what we know of as reality.  We read it, hear it and see it so much that we start to believe what the corporation wants us to believe.  Sometimes the message is so subtle that we believe what is against our best interests. 

Years ago I saw a colorful rainbow of ice sculpted into a frozen creek.  I didn’t see the toxins pouring into the earth and the water.  I was so entranced by the man-made spectacle of rainbow ice that I never dreamed that I was standing on a toxic time bomb.  Despite the company’s slogan, plastic is not the solution to pollution.  We now know that plastic is pollution. 

Copyright 2020 Valerie W. McClain

THE COST OF LIFE

“I think the American people should see that the corporations abandoned them long ago.  That people will have to build their own economies and rebuild democracy as a living democracy. The corporations belong to no land, no country, no people.  They have no loyalty to anything apart from the base-line—their profits.  And the profits today are on unimaginable scale, it has become illegitimate, criminal profit—profits extracted at the cost of life.” Vandana Shiva

I heard the screech of the red-shouldered hawk.  Searching, searching for food in the barren wasteland we, humans call home.  Mother Earth:  poisoned, plundered, robbed; a land that has been bulldozed and beaten into submission.  “What to eat?”screeches the hawk. This is the man-made landscape of suffering in a world of avarice and greed.  The hawk surveys the land from her metal antennae perch. No trees in sight to sit upon.  A barren land, no food in sight; the hawk moves on, crying out her anger and frustration.

In every direction, land developers are laying claim to wetlands, beaches, and pine forests.  They say they will replace the land they destroyed with a natural landscape but all that we see are lawns, and the humming of water sprinklers to keep the lawns alive.  This is Florida, a subtropical paradise. We will be a land of velvet green useless lawns, high priced homes, big box stores, and toll roads that take you to nowhere.  A Disney World where few bugs exist because pesticides have eradicated most of them.  The promise of pest-free living creates a world of magical thinking.  Yet, people wonder where have the honey bees gone?  Where are the fireflies?  Where are the butterflies?

There is a saying, “Water, water everywhere but not a drop to drink.”  Green lawns need water, lots of water.  And the cattle ranches residing on those ancient wetlands will need lots of water.  Our hamburger addiction means that the cattle industry has priority.  The destructive nature of cattle-raising is a result of a cattle industry utilizing large amounts of land, water, and grain crops.  Grain crops could feed more people.  Instead the grain goes to cattle.

A once free natural resource, water, has become a commodity.  This commodity bottled in plastic has created a huge environmental problem.  The disposal in landfills of all these plastic bottles is part of the problem.  Plastic bottles take some 400 years to disintegrate.  Meanwhile landfills are overflowing and needing to find more land.  In Florida we have our Mt. Trash-mores, our modern day middens of unwanted objects, aka garbage.  Treasures once worshipped on the altar of capitalism.

In my hometown land developers are building hundreds and hundreds of homes on wetlands and pine forests.  I am curious about the thousands of people who are supposedly moving into our small city.  Where are they coming from?  How do we know that all these people will be buying homes and moving into an area that has few job opportunities.   Maybe they are wealthy retired folks?  Where will the poorer folks go to live since housing will be so expensive?  Will they be living in tents on the street like in Los Angeles? Not in my backyard, say the wealthy homeowners.

Is this all purely land speculation by land developers?  Across Florida it appears that a lot of land will be bulldozed, thousands of wildlife (animals and vegetation) killed in order to make room for a massive human population boom.  One of several reasons why people move to Florida is because of the natural environment.  Will people want to move here, as the environment becomes more and more degraded, filled with dead and dying wildlife,  blue-green algae (cyanobacteria)covering our rivers and canals?

Meanwhile, men and women of lactology (scientists who study human milk feeding) are disemboweling human milk to make a more perfect substance for babies and children.  Because they believe that nature cannot be trusted and its presence means that it is free to exploit.  Do they consider the ramification of such exploitation?  Not only are they exploiting a substance, but they are exploiting women and babies while pretending to support breastfeeding.  They will create a huge network of milk banks.  They just know that human milk in a bottle is equivalent to breastfeeding.  Of course one must pasteurize the substance and since it has to be cleaned up one has to add back the substances that were destroyed by pasteurization.  Those additives will be almost like the real substances in human milk because now modern science has genetic engineering.

Like water, human milk has become a commodity.  The corporation buys up the water for a token price or sometimes gets it for free.  The human milk industry does the same thing.  This commodification requires plastic packaging-bottles-and therefore creates an environmental problem.  Plastic, endocrine disruptors, leach various chemicals into the contents of the bottles. Consequently these products also create health issues depending on the kind of plastics used and the environmental conditions in which they are stored.

Water in bottles is promoted as better for your health than the soda pops or energy drinks and it is a better choice.  Human milk in a bottle is considered better than infant formula and it also is a better choice.  What once was a free substance has now become something that must be purchased.  Now the ownership and control of water and human milk resides with the corporations.  Economic independence and even survival, itself, becomes very difficult; when what nature provides is no longer free.

After 70 years of creating supposedly better and better infant formulas, scientists still recognize that infant formula cannot duplicate breastfeeding.  Tragically, many infants die because the general public has no real understanding of the protective nature of breastfeeding for both babies and mothers.  Just as the corporate world of greed clear-cuts Amazon forests in “ignorance” to the health of the planet; the human milk industry strips human milk into various components looking for a magic bullet to sell to consumers.

Is the corporate world ignorant of the ramifications?  The reality is that the corporate world is not so ignorant.  Rather they have made a choice, to present their bought and paid-for science as scientific truths.  The corporate ideology is profits before people.  Destroy a pine forest in speculation and watch the vultures feast upon the lifeless victims of forest life.  Destroy breastfeeding and replace it with a plastic bottle of denatured human milk and additives.  Watch the vultures circling overhead as women and children suffer the consequences of breastfeeding destroyed.  Can one ever replace what has been destroyed?

Copyright 2020 Valerie W. McClain  

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?

https://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices

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.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5450358

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 used.  Shouldn'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.

 https://patents.google.com/patent/WO2016065324A1

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

 https://www.360dx.com/point-care-testing/evolve-bioscience-developing-baby-gut-microbiome-test-guide-probiotic

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

https://www.evolvebiosystems.com/news/2017/10/30/evivo-gains-health-canada-approval-providing-first-international-expansion-opportunity

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 

 

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