Thursday, January 30, 2014

Brewing microorganisms to create an amino acid used in baby formulas

                    "The Canadian Study leaves no doubt that ingredients that 
                     contain process free glutamic acid (MSG) and free aspartic-
                     acid--known neurotoxins--are used in baby formula."

Over a decade old, the Canadian Study analysed 5 formulas purchased in Canada.  The study noticed that the hypoallergenic formulas contained much more glutamic and aspartic acids than the non-hypoallergenic formulas.  According to the truthinlabeling website, the FDA sponsored a study in 1992 regarding the, "Safety of Amino Acids Used in Dietary Supplements."  They quote in part from that 1992 study, " is prudent to avoid the use of dietary supplements of L-glutamic acid by pregnant women, infants, and children..."

Dr. Gregory J. Georgiou, PhD, a clinical nutritionist, states in his article, "The Toxicity/Safety of Processed Free Glutamic Acid (MSG),"Today scientists know that MSG kills brain cells and causes neuroendocrine disorders in laboratory animals..."  He describes the many adverse reactions and states, "Obesity, reproductive disorders, and learning impairment, that sometimes become obvious only after puberty, may have their origins in neuroendocrine dysfunction caused by exposure of infants and small children to MSG.  He describes the hidden sources of MSG for those who read the ingredient list on their processed foods like infant formula.  These ingredients always contain MSG:  Glutamate, Glutamic acid, Gelatin, Monsodium glutamate, Calcium caseinate, Textureized protein, Monopotassium glutamate, Sodium Caseinate, Yeast nutrient, Yeast extract, Yeast food, Autolyzed yeast Hydrolyzed protein.  Then he lists those ingredients that often contain MSG or create MSG during processing:  Carageenan, Maltodextrin, Malt extract...Soy protein isolate....Whey protein concentrate....(see his article for a full listing) 

Dr. Georgiou also states that MSG is sprayed on crops as they grow (growth enhancers, fertilizers, fungicides).  And that MSG is used in waxes applied to raw fruits and vegetables.   Originally, seaweed was used to extract glutamic acid.   My understanding is that there is a couple of ways to manufacture this amino acid.  Fermentation is one process in which bacteria is used.  The bacteria is used because it has the ability to excrete glutamic acid.  The amino acid is separated from the liquid by filtration and various manufacturing processes are applied to creat the product.

Ajinomoto Company, Inc. is one company that manufactures this particular amino acid that is used by the infant formula industry.  They have several US patents and a European patent, too.  The first patent I read about was the US patent # 6331419 entitled, "L-glutamic acid-producing bacterium and method for producing L-glutamic acid," filed in 1998.  In this patent L-glutamic acid,"is produced by culturing in a liquid culture medium a microorganism belonging to the genus Enterobacter or Serratia.  The microorganism is "transformed with a vector containing a nucleic acid encoding at least one enzyme..." (enzymes may be citrate synthase, phosphoenolpyruvate carboxylase, or glutamate dehydrogenase).  I conclude that the use of a vector and transformation means that this product is produced by genetic engineering.  Part of the claim specifically mentions the use of Enterobacter agglomerans or Serratia liquefacience.  In 1982, Enterobacter agglomerans was considered a new cause of primary pneumonia (Thorax 1982;37:865-866).  It is a known plant pathogen that causes human disease. Enterobacter agglomerans has been renamed and now called Pantoea agglomerans.

Ajinomoto has a European patent entitled, "L-glutamic acid producing bacterium and process for producing l-glutamic acid,"  EP 0999282 A2.   The abstract states, "L-glutamic acid is produced by culturing in a medium a microorganism belonging to enterobacteria and having L-glutamic acid productivity, into which a citrate synthase gene derived from a coryneform bacterium is introduced to produce and accumulate L-glutamic acid..."  According to this claim the mircroorganism belongs to Enterobacter agglomerans or Klebsiella planticola.  This patent was filed in 1999.  And it is obvious to me that this is a process in which fermentation and genetic engineering techniques are used.

Ajinomota has another US patent entitled, "L-glutamic acid producing bacterium and process for producing L-glutamic acid, " filed in 1999 but published in 2007.  One of their claims is that the isolated microorganism "belonging to enterobacteria selected from the group consisting of the genus Enterobacter, Pantoea, Klebsiella, Erwinia and Serattia and having L-glutamic acid productvity with is transformed by a polynucleotide sequence encoding a citrate synthase obtained from Cornebacterium glutamicum or Brevibacterium lactofermentum..."

Rather fascinating that we use these pathogens to produce an amino acid for use in foods (it is also used in intravenous solutions, various medical products  and prescription drugs).  I am rather astounded that we use it in baby formula (and as you can see by Dr. Georgiou's listing of ingredients, this amino acid is in quite a few of the listed ingredients of baby formula besides being an added amino acid used in specific formulas).  This is a fermented brew of bacterium genetically engineered to produce greater amounts amino acid.  I just start wondering about what research was done that proved this was a risk-free ingredient for infants?
Copyright 2014 Valerie W. McClain 

Saturday, January 25, 2014

Human milk: The Mother of Inventions

                       "Oh lord won't you buy me a Mercedes Benz.
                        My friends all drive Porsches, I must make amends.
                        Worked hard all my lifetime, no help from my friends.
                        So oh lord won't you buy me a Mercedes Benz."
                              -written by:  Janis Joplin, Michael McClure,& Bob Neuwirth

How could I forget those times?  Janis Joplin wailing over the radio and riding around in borrowed cars in heavy traffic.  It was the summer before I headed off to college.  Working in a motorcycle parts warehouse was really boring but it had its moments of fun.  We all had our dreams and time to dream them.  Making money and spending it.  Dreaming about the car I would buy.  I wanted a Karmann-Ghia, preferably a convertible.  Pricy for me, couldn't afford it.  I laugh now; it was about $3000.  It was way beyond my meager income.  And then I went away to college.  I sort of forgot about the car dreams and found myself in a very different world.  It was a world of thought, textbooks, a dash of beer and a chaser of wild turkey.  And it was about late night discussions about world politics, Vietnam, protest, and a world gone mad.  It was life-changing in many ways.  But in many ways it was as isolating as my dreams of owning a purple Karmann-Ghia.  Are we directing our dreams?  Or do our dreams create us?  How much of consumerism is embedded in our youthful dreams?  How much rationality and understanding do we have as teenagers?  Why do we want what we want?  How much of our wants are being directed by market forces or advertising?  Are our minds free to think or are we drowning in the cacophony of the social media likes and dislikes?  How much is too much?  And what price are we paying for our concrete, digitized world of sound bytes and twitter feeds?

Well, I must admit to myself, that the world is getting more than freaky.  Its like entering a science fiction novel and finding out that its not fiction--its science!!!
Its consumerism gone mad.  Its the mad-hatter of maddness.  Loney-tune city and daffy duck rolled into one comedy-hour.  And everyone walking and talking like life is normal.  Seriously and sincerely, we will be making diapers based on human milk oligosaccharides.  Proctor & Gamble has a patent application entitled, "Substrate Comprising One or More Human Milk Oligosaccharides and Disposable Absorbent Article Comprising the Substrate," #20130281948. It is also a European Patent Application EP12165272.0.     The application states, "It is generally known that skin covered by disposable absorbent articles tend to be more susceptible to skin disorders, including diaper rash, erythema (i.e., reddness), heat rash, abrasion, pressure marks and loss of skin barrier function."  So the answer is, "One or more human milk oligosaccharides may act either by attachment to the receptors of harmful pathogenic microorganisms and render these microorganisms harmless."  The example they use of a pathogenic microorganism is Candida albicans.  Ta-da!!!Presto-chang-o, with the magical application of human milk oligosaccharides we will create a better, safer product.  Sound familiar?  This patent application is also directed at making disposable tampons, sanitary napkins and adult diapers.  

Human milk, the mother of, sell, trade.  No wonder the NJ legislature wants to control milk banking, its an investment that keeps on giving.  Oh yeah, the diaper invention,  probably a gmo product, can't imagine there is enough real human milk oligosaccharides at your local milk bank. Although maybe someday in the future?  I can just see the advertisement for diapers with Human Milk Oligosaccharides.  Because women can't or won't breastfeed, we are creating this product to protect your baby's butt from harmful pathogens.  It's organic, it's natural!!!!! Mother Nature's protective shield...  What a sad indictment of our society that women will reject this substance while the corporate world enshrines and markets it!!
Copyright 2014 Valerie W. McClain


Friday, January 17, 2014

Paradigm Shift

                     "Make it possible for me, in imitation of you, O Lady of
                      La Leche, to nurse my child to perfect health."
                                      -excerpt from prayer 
                                      -La Leche League Shrine, first shrine to be
                                      dedicated to the Blessed Virgin Mary in USA,

The La Leche League Shrine resides in St Augustine, Florida.  One of the oldest cities in the US.  I have visited there many times, and find the grounds of the shrine to be so very peaceful.  I look at some of the graves dated from those early times and think how difficult life must have been for the women and men.  Life and death, whole families wiped out from epidemics.  Walking around the grounds of the shrine in the summer, one feels the heat and wonders how these settlers coped without air conditioning or medical facilities or pharmaceuticals.  No wonder this shrine was built and dedicated to Mary.  Survival must have seemed so tenuous, and the only hope, prayer.

So unlike today in the US.  We presume that there will always be air conditioning, medical facilities, clean water to drink, food to eat, and drugs to make us better.  Until some disaster hits, like a hurricane, a flood,a tsunami, or a nuclear tragedy.  Then we realize what a fine thread exists between our "modern" society and living without our amazing conveniences.  We believe what is, will always be in our lifetimes.  Never factoring in that other civilizations thought the same thing.  And now their civilizations are the dust we pave over and the lives we have forgotten.  Survival of infants in the 17th century in the frontiers of the sub-tropics/tropics depended upon breastfeeding.  We no longer believe in the imperative of breastfeeding for infant survival.  Instead, we believe that an industry will keep our infants safe.

At this moment in time we are caught up in a paradigm created by an industry in which we believe that artificial feeding can be made safe for all infants.  That belief is centered on the safety of our water supplies, the close proximity of medical facilities and access to the finest doctors and nurses, and that the government regulates the industry.  Artificial feeding creates the need for a clean source of water.  Of late, one may doubt that everyone in the US has access to clean water.  Recently, West Virginia experienced a chemical spill that effected hundreds of thousands.  Supposedly, 7500 gallons of 4-methylcyclohexane methanol was accidently spilled into the Elk River  effecting the water supplies of many citizens in the area.  Those people effected had to find another source of water (provided by the government).  How many people drank the water or bathed (caused rashes and burns) in it before realizing that there was a problem?  How many formula-fed infants ingested this toxic water?   

One could argue that the poor of this country do not have ready access to health care in the US.  And one could argue that the baby food industry is not highly regulated by government agencies.  Yet, the paradigm our nation envisions is one of wishful thinking.  If we live in middle-class suburbia, we think everyone else lives like we do.  We avoid the "bad" sections of town and have no comprehension how the people of the "projects" [ghetto] live. We see what we want to see.  Some of our politicians (many who are lawyers) view single mothers living in poverty as worthless.  Human value has become dependent upon wealth, maleness, and and an ivy-league education.  If you aren't running in those circles, your value to society does not exist.  Their projection of value because of the power they hold has become our whole society's projection of value.  Value is billion dollar industries.  Thus, we have created a whole ideology about regulating an industry that feeds babies.  Our society believes only those members of society that are employed are valuable.  Women despite gains in the workplace are still under-valued and underpaid.  And the basic need of babies to be near their mothers is never factored into our society.

But even more strange about our current paradigm of infant feeding is the seemingly lack of knowledge/concern over some of the devastating effects of infant formula.  Most recent is the evidence about a pathogen whose name was Enterbacter sakazakii (now called Cronobacter) in powdered infant formula.  Powdered infant formula is not a sterile product.  It can be contaminated at the factory with various organisms (salmonella, botulism, etc).  Enterobacter sakazakii is considered to have a 40-80% infant mortality rate.  Survival often means that the infant is brain damaged.  In 2011, in the USA there was 12 cases of this contamination in infants.  There was a recent lawsuit.  Mead Johnson was sued in October of 2012 by parents of one infant that died, and two other parents whose infants were made sick.  According to the Associated Press, "The lawsuit alleges that a Mead Johnson executive warned health care workers but not consumers that powdered infant formulas should 'not be used in neonates or immunocompromised patients in hospital settings.

Abbott was sued in March of 2011 by a family who believes that their infant daughter contracted neonatal Enterobacter Sakzakii meningitis from Abbott's formula.  The daughter survived but suffered permanent brain damage. Their court battle continues and mentioned in this newspaper dated Jan. 5, 2014.

When a product causes death and damage to infants and the industry cannot resolve the problem, is it not time for a paradigm shift?  In a recent patent application filed in April of 2013 by Mead Johnson entitled, "Adherence Inhibition of Pathogens by Prebiotic Oligosaccharides,"  application #20130287895; the patent states, "It [Enterobacter sakazakii] is an opportunistic pathogen that has been implicated in severe forms of meningitis, necrotizing enterocolitis, and sepsis in neonates."
And this patent application states that powdered infant formula has been implicated in "several outbreaks as well as other sporadic cases."  Then they state, "Human milk oligosaccharides are believed to elicit an increase in the number of Bifidobacteria in the colonic microflora, along with a reduction in the number of potentially pathogenic bacteria."  Thus, this particular infant formula patent application will create, "compositions comprising  a prebiotic component for inhibiting adherence of pathogens in the gastrointestingal tract..."

The industry sees the problem and chooses to imitate human milk components because human milk inactivates pathogens.  Will this create a safe product, this new concoction of various novel ingredients?  Maybe  and maybe not.  But what will it take to get a society to see that the paradigm of choice in infant feeding comes with a high cost not only emotionally but financially to parents, to the community, and to our society.  We are investing in a product that promises safety, nutrition, and female liberation from the demands of female biology.  What we are getting is a billion dollar industry that is constantly changing its products to imitate human milk because the old formula was unsafe.  Will the new formula be safer?  Why are we allowing this kind of risk without demanding more regulations in how this product is marketed?  Don't you think its time to envision a new paradigm regarding infant feeding?
Copyright 2014 Valerie W. McClain

Thursday, January 16, 2014

Pandora's Box--part 4-

                               "Every year 10 million children under five, most in poor
                       countries, die from infections of the chest and gut.  Babies
                       under six months who are not breastfed are five times              
                       more likely to die from pneumonia and seven times more
                       from diarrhoea.  In Brazil, artificially fed babies were 17 times
                       more likely to need hospital admission for pneumonia than
                       breastfed babies.  There is a dose related effect."
                                           --Gabrielle Palmer, "The Politics of Breastfeeding"

Why is it that policy-makers, in the US, feel that somehow our infants are immune from these statistics?  They believe that poverty only exists in developing countries. They believe that infant mortality and morbidity has nothing to do with the way in which babies are fed.  They believe that only vaccination can build immunity, that our food choices for babies has no impact on health and well-being of our infants.  

There are many reasons why policy-makers in the US are so blind to the risks of infant formula.  One big reason is that corporate advertising works on the minds and hearts of all of us.  Through advertising we see a world, a world invented by an industry (actually industries--the dairy, packaging, vitamin, oil companies--base of plastics for bottles and nipples).  Our society believes in "choice" when it comes to feeding babies.  Is that belief of "choice" based in reality or the advertising campaigns used by the infant formula industry?  How much of what we believe is based in reality and how much of it is based on the use of advertising.  Most people would deny the impact of advertising on their perceptions of reality. Yet consider the symbol of babyhood to most Americans, the bottle.  Play the word association game, baby??? Most people would respond with bottle not breast.  Have you ever gone to a baby shower and not seen one bottle?  It's on the gift-wrap or cards we give to the mother-to-be.  Does that influence us?

Is "choice" about female liberation?  Or is "choice" really a denial of female biology?  Men seem particularly enamored with giving women "choice."  Yet I suspect that men would not appreciate women telling men that they have a "choice" about the functions of their biology.   When the "choice" doctrine enriches an industry, at what point will we realize that "choice" is the underpinnings of an advertising campaign and not about women's liberation?

I am fascinated with a more recent theme on the internet of formula feeding mothers being offended by almost anything stated by breastfeeding advocates.  And even more interesting is the response of some breastfeeding advocates.  The response is to implore others to not upset formula feeders.  Meaning what?  Let's not talk about the risks of infant formula, instead lets make everyone feel good.  It's almost as if no one understands the advertising or should I say the social marketing budget of the infant formula industry.  (to be clear I do not believe in attacking others for their choices, formula feeding or breastfeeding)  But I do not believe that silence is the answer to misinformation.  Would you keep silent, if a mom said it was okay for a child to put a fork in an electrical socket?  Gee, I don't want her to feel bad?  

How much of what we believe in our world is influenced by the advertising we have seen throughout our lives?  Funny how people remember all the advertising jingles.  I still remember the TV Marlboro ads and guess what cigarettes I smoked?  Yet I am sure, when I was smoking cigarettes that I would have denied being influenced by advertising.  I also remember the Virginia Slims advertising.  Yes, I smoked that brand,too.  I would swear on a bible that ads don't effect me.  Yet to my chagrin, advertising has effected my buying habits.  

When infants die or get sick from a product, why is it so hard to envision some kind of advertising regulation on that product?  It's not like asking a company to shut down and no longer exist.  These companies in their patents admit to adverse effects of their product.  They state the need to recreate a formula more like breastmilk because infant formula creates greater health problems.  So why is our nation, which sells these products to poorer countries, willing to turn a blind-eye to the damaging nature of artificial feeding?

Patent application #20120172319
Title:  "Method for decreasing the incidence of necrotizing enterocolitis in infants, toddlers, or children using human milk oligosaccharides."
Assignee:  Abbott

"Breast milk contains components that not only act as pathogen receptor analogues, but also activate immune factors by infant intestinal epithelial cells and/or associated immune cell populations to enhance development and maturation of the infant's gastrointestinal and immune system."

This patent application believes that "suboptimal intestinal flora may result in infection, diarrhea, allergies and food intolerance."  I believe suboptimal intestinal flora is the result of infant formula feeding (reading between the lines).  So Abbott will create a new formula based on human milk's ability to optimize the gut flora using human milk oligosaccharides (real or genetically engineered?).  

So there is acceptance that a product may create infections, allergies, etc.  And there is acceptance of "choice" without knowledge of the potential for infections, allergies, and even death are part of this product.  Regulation of advertising?  No.  Product mentions adverse effects?  No.  Rather odd that consumers are so willing to accept the consequences of such a product.
Copyright 2014 Valerie W. McClain


Friday, January 3, 2014

Pandora's Box-part 3-

                          "Breastfeeding promises significant cost savings
                            compared to formula feeding:  according to the
                            US Department of Agriculture, the USA would
                            save a minimum of $3.6 billion per year in health
                            care and indirect costs if at least 75% of mothers
                            initiated breastfeeding and 50% breastfed until
                            the infant is at least 6 months old."
                            "Marketing Breastfeeding--Reversing Corporate Influence
                              on Infant Feeding Practices," by DL Kaplan & KM Graff
                              published in 2008

According to the CDC Breastfeeding Report Card of 2013, nationally we have reached or almost reached those goals.  Although nationally, exclusive breastfeeding is only 16.4%.  Individual states in the US have varied statistics.  In Florida, we have 71.8% "ever breastfed," 40.9% breastfeeding at 6 months and only 10.6% exclusively breastfeeding at 6 months.  This data is taken from national immunizations survey and I believe there may be some inaccuracies. 
When I worked in the WIC Program, the "ever breastfed" statistic was based on a mother's recall of "ever" making an attempt to breastfeed.  That could mean that a mother made one attempt and then quit breastfeeding but would be included in the ever breastfed category.  The most important figures in terms of cost savings and health is the duration of breastfeeding and how many mothers are exclusively breastfeeding (which creates the most cost savings and health benefits).  We can deduce from this data that most women in the USA are doing both breast and infant formula feeding--exclusivity being a rare practice.  Anyway saving $3.6 billion is quite a savings in health care and indirect costs. 
The savings would probably be a lot more, if exclusive breastfeeding was practiced. 

What is the problem with mothers doing both breastfeeding and infant formula feeding?  What we do know is that the introduction of infant formula usally means less time at the breast, lowered milk production, triggering the use of more infant formula.  It becomes a spiraling circle and before too long the mother is no longer breastfeeding or barely breastfeeding.  The statistics show this quite plainly--very few mothers exclusively breastfed.  So the question has to be why?  What is happening that is creating this situation?  There are many reasons--employment is one, short maternity leaves, misinformation, etc.  But high on my least is the marketing of infant formula.  The targeting of the new breastfeeding mothers with information and free samples of infant formula that makes it seem like you can do both and there are no consequences to doing both.  Weaning from the breast is a direct consequence of the introduction of infant formula.  Most mothers do not understand the impact of infant formula on breastfeeding.  Nor do they understand how infant formula changes the gut flora of the infant which in turn impacts the infants immune system.  Thus the hospital gift bags of free infant formula to breastfeeding mothers is a trojan horse, the pandora's box.  It is marketing that works well as we can see by the CDC statistics.

To understand the marketing influence of an industry on medical institutions and physicians, one might take a journey back in time and see how physicians were used to market cigarettes. [corrected by author, VWM] A 1930 ad for Lucky Strike's (a cigarette brand) states, "20,679 Physicians say "LUCKIES are less irritating." Another brand, Philip Morris, declared in their ads in the 30's, "Men and women with irritation of the nose and throat due to smoking were instructed to change to Philip Morris Cigarettes."

The title of the article regarding marketing of cigarettes is aptly called, '"The Doctors' Choice Is America's Choice"  The physician in US Cigarette Advertisments, 1930-1953,' by Gardner and Brandt.  They say, "For the tobacco companies physicians' approval of their product could prove to be essential..."  and, "Physicians became, through this process, an increasingly important conduit in the marketing process."  Maybe marketing of infant formula is not this bad (dependent upon your point of view), it still has undertones that imply approval by pediatricians and hospitals with free gift bags only part of the marketing endeavor.

In 1999 in the USA Mead Johnson sued Abbott in the US Distric Court of Indiana.  Why?  Because Abbott advertised Similac under the banner, "First Choice of Doctors."  Mead Johnson believed that claim as false and misleading and violated the Lanham Act.  They sought an injunction to stop Abbott from advertising, "1st Choice of Doctors" claim.  Not sure how this all turned out.  I think Mead Johnson won this court battle and got an injunction against Abbott.  Because Abbott no longer makes that claim.  Their claim now is "#1 Brand Fed in Hospitals."  And Mead Johnson's claim is, "#1 Pediatrician Recommended Brand."  Rather funny,  since Mead Johnson in the court case in 1999, used the argument that "most doctors do not have a preference between the two leading brands and there is no evidence that one product is medically superior to the other."  

So I think we can understand that marketing through physicians and through medical institutions is important to industry, and in this case to the infant formula industry.  It gives a product a validity, a respectability, and a belief in the scientific basis for a product.  But like cigarettes, the science is bought by the industry.  It took a long time for people to recognize that cigarettes were hazardous to health.  Partly because of the merging of mutual interests between industry and medical institutions/health care providers.  Advertising works or industry would not use it.  Advertising in which consumers believe that hospitals or doctors recommend a product, works even better.  There is enormous faith placed on health care professionals and their institutions. 

In an article by the George Washington law review dated in 2010 on, "Medical Marketing in the United States:  A Prescription for Reform," the author, Joshua Weiss states, "On average, the drug and medical device industries spend over $20,000 per doctor each year on marketing efforts that include gifts, meals, travel, consultancy fees and continuing medical education programs.  The reach of medical marketing has grown so broad that one recent survey reported that ninety-four per cent of physicians have received some form of benefit or payment from the drug and device industries."  [Many of the infant formula companies are part of the pharmaceutical industry]. 

We know that breastfeeding saves billions of dollars in health care costs.  We have stopped the Tobacco Industry from marketing directly to consumers and no doctor or health care facility would promote smoking now.  So why are we reluctant to regulate the marketing of infant formula to the public?  Particularly when these companies are making claims that they are supported by the health care institutions and profession.  Why?  What do we believe? 
Copyright 2013 Valerie W. McClain

for further information:  Mead Johnson & co. v. Abbott Laboratories 1999