Infant formula: Debt and dependency on the tradewinds of an industry

Is it cultural belief or our social media experts that have us believing that women can't or won't breastfeed?  Since some women can't or won't breastfeed, then our community, our nations, must invest in the creation of a "convenience food" that imitates human milk.  Certainly, there are women who can't or won't breastfeed.  But how much of this is a reflection of a society that has invested in industries over humanity?  How much of this is about creating a populace dependent upon a food industry? Like indentured servants, most of the people are in debt from school loans to car loans to home loans.  Independence is an illusion brought to you by the careful scripting of advertisements from industries that want you to buy their products.  The car you drive becomes the statement of who you are and your power in the economic caste system.  Your house, your clothes, and all those little trinkets become the illusion of who you are and your status in a society gone mad for things.

Infant formula is marketed by an industry that in all probability spends as much on its marketing budget as in the raw material it buys to create its products.  The industry sells us the images of the liberated woman who can have it all.  We trust the images of beautiful fat rolly-polly babies with a cool, collected, and very sane mothers who can do it all.  We trust in its safety and in its convenience to mothers.  We have this huge infant formula industry because mothers  cannot be trusted to create it safely. [infant formula is always a risk, even when created by an industry] Only industry has the smarts and research to create a substitute for human milk.  When babies don't gain fast enough or gain too much, the default option to breastfeeding has always been infant formula.  Our government and the medical community has mostly supported this kind of thinking because they, too, believe industry marketing.  We are a society that believes its illusions never realizing that the illusions are a product of industries seeking bigger markets.

This dependency of ours on industry and its illusions means that we are at the mercy of economic conditions at a time when the world is facing economic uncertain times.  It means that a product may not always be available depending upon where you live.  This can happen during times of emergencies like hurricanes, earthquakes, tsunamis, wars, and nuclear accidents.  Mothers become dependent upon a product being available.  With global warming making weather situations unusual and in some instances catastrophic for farming, we are facing difficult times for people who have become overly dependent upon the convenience food industry.

Yet onward our societies go building more and more dependency of its citizens to the winds of economic game-playing.  The industry continues to sell its illusions to the public.  Dependency and debt become the driving force that makes us continue to believe in the illusion.

"A new study has reveled that InFat--a vegetable-based fat for infant formula with a similar sturcture to breast milk--provides beneficial effects for the health and well-being of formula-fed infants."
                                     "Speciality fat for infant formula boosts gut health,"
                                       by Gary Scattergood 2/12/13
                                       http://www.foodmanufacture.co.uk/Ingredients/Speciality-fat-for-infant-formula-boosts-gut-health

A joint venture of AAK, a Swedish company, and Enzymotec, a biotech company based in Israel (Advanced Lipids) have created a fat that imitates human milk's high beta-palmitate content using a patented enzymatic process.  According to a pdf file from Advanced Lipids, "InFat ensures better uptake of energy and calcium." and "Infants fed InFat also benefit from signifciantly higher whole body bone mass, compared to infants fed standard vegetable oil based formula."  The title of this pdf file is, "InFat--Closer to mother's milk."  This is not the first time I find myself questioning the standard belief that human milk does not provide enough calcium for preterm infants.  If infant formula sponsored studies show the need to imitate human milk in order to get better calcium absorption than where does this belief that preterm infants need supplemental infant formula to get their calcium needs met?

This fat/oil for use in infant formula was declared GRAS by Enzymotec and the FDA has no questions regarding that declaration.  The GRAS notice is No. GRN 000192 and the agency response can be read at the FDA website.  The letter from the FDA to Enzymotec is interesting in that it discusses the two-step process of manufacturing this oil.  The second step of the process is what interests me.  The letter from the FDA states:

"Enzymotec states that this process uses a safe and suitable immobilized GRAS lipase enzyme preparation from Asperigillus oryzae carrying a gene encoding a lipase from Thermomyces laguninosus (the subject of GRN 000043)." and

"Enzymotec states that potential residues from the manufacturing process include protein, sorbitan oleate, methanol*, and epichlorhydrin**, but that all residues were below the limits of detection." [if detected they would be removed]  Seems like a contradictory statement to me.  

 *methanol is poisonous to the central nervous system, may cause blindness
**epichlorhydrin according to the EPA is moderatedly toxic, an irritant to the stomach as well as being carcinogenic

Enzymotec has a number of US patent applications and a patent.  Two applications seem to pertain to use in infant formula entitled, "Human Breast Milk Lipid Mimetic As Dietary Supplement (application # 20070218169)  and EDIBLE FAT COMPOSITION FOR ENHANCING BONE STRENGTH (application # 20110244071)  Clinical trials for their infant formula with InFat have been completed although one is still ongoing but not recruiting volunteers (although infants don't volunteer, their parents volunteer them)  The one that is ongoing is called,
"Effect of InFat Product on Stool Biochemistry and Stool Characteristics in Formula-fed Infants in China."  The sponsor is Enzymotec and the collaborator is Biostime, Inc (Guangzhou).  Two completed clinical trials on InFat on Bone strength and "intestinal parameters," were done in Israel. 

The clinical trial in China is interesting and if anyone wants to watch a video on the product and how it mimics human milk in Chinese, its on youtube, type in InFat. There is copyright on it.

The questions I have on the use of genetically engineered enzymes are many.  Enzymes are not considered foods and there is a belief that the enzymes used whether gmo or natural are only used as catalysts and are taken out of the product--the basis for so little regulation on them.  But I wonder about that belief and whether it is just wishful thinking that we believe that it doesn't matter where enzymes come from because residues are not left in the foods we eat.  I guess I leave it to others to question and try to make sense of the situation.

Breastfeeding represents to me self-sufficiency, autonomy from an industry that is creating new/novel products that make us more indebted and dependent on the whims and winds of industry.  Media marketing creates a dependency and indebtness to these industries.  Breastfeeding has always meant survival and health to our young.  And it does this without placing families into more debt.  Troubling that our society does so little to help families stay independent and solvent.  But I suppose the real concern is about investments, patents, and profits.  We are like the serfs in the Middle Ages tied to a system that benefits a few and harms so many.
Copyright 2013 Valerie W. McClain   
   

The Daffodil Study, infant formula research

I am not particularly fond of daffodils.  And I don't really know why.  They don't grow well in Florida.  In fact, I have never seen them growing in the ground in Florida, but I have seen them in pots in the grocery store around Easter.  When I think of daffodils, I think of Easter and its symbolism.  Rebirth comes to mind, spring, rising again;  religious symbolism that are embedded in my psyche.  I think of the color, yellow;  when I think of daffodils.  Then my mind trips over to patents and inventions.  Yes, I never stop thinking about inventions or patents, particularly when it involves infant feeding.  Remember Golden Rice and how biotech would save the world from vitamin A deficiency 
by creating a rice with lots of vitamin A.  Do you know how they created Golden Rice?  The rice carries the gene from a daffodil;  a gene that expresses phytoene which is a key to the synthesis of beta-carotene.  The petal of the daffodil or the petal of the marigold holds the key to producing carotenoids.   Vitamins for you and me and baby makes three.  

So what has this got to do with the Daffodil Study in Indonesia, a study that has been receiving a lot of criticism from breastfeeding advocates in Indonesia as well as around the world?  I don't know, if there is a connection between the symbol, the Daffodil and the study?  It seems to be just a curiosity in my head.  Does the daffodil symbolize a specific brand of infant formula?  Or the Indonesian University?  Or the Indonesian Pediatric Society?   I really don't know.  What infant formula are they testing on infants that are younger than 4 months old?  What baby formula company is involved with this study?  Is it just the Indonesian University and its Department of Pediatrics that is funding this study?  The study is called, "Effect in Using Formula Composed with Cow's Milk Fat, Enriched with Mixed Fats and Added Fosfolipid [Phospholipids] on Duration and Infection in Babies' Digestive and Respiratory System."  How does informed consent work in regard to research on babies using infant formula, particularly in countries that have high levels of poverty and high infant mortality rates?  

The BBC News Asia-Pacific (dated November 2010) reported, "In Indonesia a new law has been passed that stipulates all babies should be exclusively breastfed for the first six months of life.  From early next year [2011], anyone who stands in the way of this will be fined up to 100m rupiah (7000 pounds, $11,000) and sentenced up to a year in prison."  Researchers are under some serious obligations to see that exclusive breastfeeding is not disrupted by such studies.  Since there is a petition up on change.org to stop this research, I wonder whether the law was revoked or been unenforceable?  For those interested in signing the petition to stop this research, this is the website:
https://www.change.org/en-GB/petitions/daffodil-study-research-team-stop-the-daffodil-study#  

At the NIH clinical trials website there is 132 infant formula studies going on world-wide, most funded by various infant formula companies in various stages.  Some studies are completed, some terminated, some no longer recruiting and some actively recruiting babies.  Studies in countries such as China, Mexico, Vietnam, Indonesia (2 stated but neither is the Daffodil Study-Danone and Fonterra funded), and the USA.  Within the last decade the infant formula industry is introducing new/novel ingredients.  Most of those novel ingredients have never before been eaten by human beings.  And yes its about genetic engineering those ingredients, using genes from one species in combination with genes from other species.   A recent patent application from an employee of dupont de Nemours is called, "Carotenoid production in a recombinant oleaginous yeast."  They mention the use of genes from the petals of daffodils or marigolds to add to a recombinant host.  This is to produce/engineer not only carotenoids but also omega3/omega6 polyunsaturated fatty acids.   And yes this patent application is about using this in foods and infant formula.   So we are recombining genes and creating substances that have never been eaten before by the human species.  Should infants be a part of this experiment?  And no I don't know if the Daffodil Study has anything to do with using novel ingredients.  And I really don't know what these 132 infant formula clinical trials are testing.  Are we testing for safety?  Are parents being given informed consent about all the possiblities in these clinical trials?  And really, really should infants even be in clinical trials involving novel foods??  How do researchers protect exclusive breastfeeding doing this kind of research?  What populations are enrolled in this study?  Is this research done in poorer districts, those marginalized by society?  In the US, is this research directed at the poorer communities and/or the African American communities?  Who does the recruiting of mothers and how is it done?  

So what is the daffodil to me?  Symbolic of the ease in which genetic engineering has become part of our food industry which not only impacts adults but our most vulnerable population, infants.  The Daffodil Study may have nothing to do with the genetic engineering of ingredients of infant formula.  But it should raise questions for many around the world who are concerned about research and the problems of ethical research when it involves infants.
Copyright 2013 Valerie W. McClain 

 

THE TIME ARTICLE

What Time article you ask?  It's not the one with the cover of the 3-year old breastfeeding his mother standing up.  It's this one, "Is the Medical Community Failing Breastfeeding Moms?"  Anyone in breastfeeding advocacy could answer that question.  I call it a rhetorical question.  The Medical Community has been failing breastfeeding mothers for years and will probably do so into the future.  Hey, come on, is breastfeeding a medical condition?  Is childbirth a medical condition?  If ya believe that childbirth is a medical condition in need of fixing then of course breastfeeding is a medical condition in need of fixing.  Funny how when the medical community bullied their way into dictating childbirth, the c-section rate went through the roof.  So I find it eye-opening that docs who have the required human lactation training (note we aren't talking about breastfeeding training; words are important in reading the media), are stating that "as many as five percent of all women have medical conditions that prevent or seriously hinder lactation."  I guess this article banks on some people having significant memory loss.  Back 30 years ago, when I was a breastfeeding mother that percentage was 2%.  So like childbirth that has been medicalized and suddenly women can't give birth anymore, medicalization of breastfeeding has changed so that women can't breastfeed anymore.

Let's look at some of the statements made by the author, Lisa Selin Davis.  She is an excellent writer, by the way, having written articles and won awards for writing about real estate and various issues like parenting.  I love the statement, "well-meaning lactation consultants urge them to try harder..."  Yeah, if I was still a lactation consultant I wouldn't be so pleased about this comment.  That sentence goes on to say,"...while doctors might advise them simply give up and go the bottle-and-formula route."  Hm, let's grade this clinical trial, docs 10, ibclcs 1.   

"...but the truth is that breast-feeding is very difficult for many women."  Yes I do believe that psychologically we have just been given the stab in the back.  Is breastfeeding the difficulty or is it a society that creates those difficulties?  Is breastfeeding a totally physical function or is there enormous social and psychological issues in our culture (along with the ever-present infant formula marketing) that predispose breastfeeding "failure."  Oh wait, lets get the terms correct, lactation failure.

Last quote that makes my day, "Perhaps most importantly, we need to stop demonizing mothers who can't breastfeed, guilting them into starving their kids with insufficient milk supplies rather than supplementing with formula."

Yes, you-you, IBCLCS are creating guilt in mothers.  I never heard of an IBCLC doing that except in PR articles and blogs that I suspect were paid for by the infant formula industry.  So we are going to perpetuate the myth that it is IBCLCs who are browbeating mothers?  Let me see but the Doc who is an IBCLC doesn't do this because they will prescribe infant formula for insufficient milk supplies?

Hm...you know I think that IBCLCs instead of applauding this article might consider asking who paid for this article?  Or who wanted this PR, because this is absolutely what this article is...public relations.  Let's get more docs to be IBCLCs because according to this article they will take the time to visually inspect breasts (yes you can produce, no you can't-you are the 5% oh wait next year it will be the 10% who can't breastfeed).  Oh wait, I think all the IBCLCs I know actually do look at breasts and do medical histories.  But you wouldn't know this by this article.  
  
I understand why I am no longer an IBCLC.  Reading the comments by other IBCLCs who think this article is so-so wonderful, is totally baffling. The medicalization of breastfeeding will most certainly screw breastfeeding, just like the medicalization of childbirth has created our soaring c-section rates.  This article is PR, big time.  There are wonderful doctors who support and help breastfeeding mothers. But if the theme from the medical community becomes that breastfeeding is very difficult, then that is what we will build a nation full of women having a difficult time breastfeeding.  The percentage of women unable to breastfeed will increase because breastfeeding is a confidence game.  Breastfeeding is more than a product decision, human milk vs. infant formula, its about how society cares for mothers and babies.  And our society doesn't much care for women or babies and certainly not together.  Insufficent milk syndrome is the infant formula calling card.  It is played and a replayed theme in the media and in this particular article.  Where are we going?
Copyright 2013 Valerie W. McClain