Monday, September 10, 2018

Infant feeding: Survival or Choice?



"If a multinational company developed a product that was a nutritionally balanced and delicious food, a wonder drug that both prevented and treated disease, cost almost nothing to produce and could be delivered in quantities controlled by consumers' needs, the announcement of this find would send its shares rocketing to the top of the stock market."  --Gabrielle Palmer, The Politics of Breastfeeding. (page1)

I read The Politics of Breastfeeding, when it was first published.  It seems like a life time ago.  I loved the book and shared it with a number of people I knew.  I never got it back but understood why someone would keep the book. So I bought another copy, a newer edition.  The above quote from Palmer's book was one of my favorites and of course she states after that sentence, "Women have been producing such a miraculous substance since the beginning of human existence."   

The statement is certainly a true statement. Yet the statement troubles me now.  The problem is that various multinational companies are mining human milk for the components that make it such a miraculous substance.  Through patenting, they can claim that genetic engineering duplicates the substance.  Of course anytime you mine a natural resource there will be costs passed onto the consumer.  So what was once a free resource has a price.  The infant formula industry is just part of many industries competing for patents on the components of human milk.  There is the vaccine, drug, food and supplement industries that somehow obtained that precious liquid, isolated its components, studied those components, and then proclaimed that they have found the magic bullet to create health.  

The good men and women of science believe in isolation, that separation from the whole can make powerful medicine.  Yet nature does not do isolation.  Isolation in nature is failure, life depends on multiple interconnections.  We see this when looking at the human body.  The organs and tissues of the body work in synchrony, disturb one organ or tissue and its impact is felt throughout the body.  Or consider how one simple act of spraying DDT to kill bugs, results in dead song birds.  Or dumping toxins in a river ends up with human clusters of cancer or birth defects.  The web of life is a complex system.  Disturb one small part of it and we often witness the ripple effect of the consequences of that disturbance. The sad thing about human disruption of nature is that often we do not see the consequences until it is too late. 

Life is complex and the wonder of it never ceases to entertain me.  The internet entertains me, for it too is a web, a web of ideas that ripple across the world.  The impact of those ideas can be beneficial or detrimental to our society.  We can easily get a distorted view of various subjects or we can see our politics more clearly.  I recently read a NY Times article, Breast-Feeding or Formula?  For Americans, It's Complicated by Christina Caron (July14, 2018)

 https://www.nytimes.com/2018/07/14/health/trump-breastfeeding-history-nyt.html

It was an attempt at being a balanced article on breastfeeding and infant formula.  Yet I immediately began to suspect that this article had an agenda.  The author gives us a little history,

"Wet nursing, which began as early as 2000 B.C., was once a widely accepted option for mothers who could not or did not want to breast-feed, but it faced criticism during the Middle Ages and the Renaissance. The profession eventually declined with the introduction of the infant feeding bottle in the 19th century."

Wet nursing was widely accepted because; if a mom refused to breastfeed her infant, the baby died.  If a mom died in childbirth, the need for someone to nurse the baby was imperative.  Who hired wet nurses?  Wealthy women.  I would not describe the history of infant feeding as one of options.  Rather I would describe it as survival.  In the text book, Breastfeeding and Human Lactation, 2nd edition (page 5)

"Wet-nursing may not have been the earliest alternative to maternal breastfeeding, but it ws the only one likely to enable the infant to survive."


Choice is the current ideology (promoted by the infant formula industry). Making it seem as, if women have always demanded options in infant feeding is not particularly accurate.  To ignore the connection between breastfeeding and infant survival, is to ignore a crucial fact regarding the history of infant feeding.  But choice as the bedrock of infant feeding,  does serve the purpose of this NY Times article.

The article goes on to telling an abbreviated history of infant feeding and the information seems geared towards sending a message that the US policy on breastfeeding is based on the need for choice and has always been that way.


"A couple of years later, in 1981, the W.H.O. voted 118 to 1 to adopt a nonbinding code restricting the promotion of infant-formula products. The United States, under President Ronald Reagan, was the lone dissenting vote.
The decision drew a chorus of critics, much like the Trump administration’s recent stance on the marketing of powdered formula to women in developing countries.
Elliott Abrams, then the assistant secretary of state for international organization affairs, said in 1981 that it was a free-speech issue."

But the article never mentions the Senate hearings lead by Ted Kennedy, a Democrat, in 1978 regarding the marketing of infant formula in developing nations which lead to talks which eventually resulted in the creation of the WHO Code. And yes I know a Republican administration (Reagan) refused to sign the WHO Code.

  

 Instead the impression left by this NY Times article is that politically the US has always been against the WHO Code.  The article leaves me with the belief that one side of the story is being told.  Might we believe that this is an issue of infant survival? The WHO Code was designed to save infants from illness and death.  Why do some Americans (and the industry) say this is a free speech issue? When a product sickens and kills some infants, how many infants should we accept as collateral damage?  (considering that 4-6 infants per year are damaged and/or die due to the intrinsic contamination by Cronobacter sakazakii in powdered infant formula, and many more from Salmonella)

The author briefly mentions the tragedy of the infant formula company, Syntex, that decided to delete salt from their formulas, Neo-Mull-Soy and CHO-free. It was believed that 22,000 US infants were affected by this change in formula.  Babies suffered serious health consequences due to the salt deletion.  Two mothers waged a campaign that eventually saw the creation of the Infant Formula Act of 1980.  Here is an article on the mothers who helped change US law regarding the regulation of infant formula.
 https://www.washingtonpost.com/archive/politics/1980/10/11/how-two-angry-mothers-beat-uncle-sam-at-his-own-game/e26a2490-72e6-4720-8d57-5c1b6887e536/?noredirect=on&utm_term=.c80256834a33

Fed Is Best movement emerges as the last topic of the author's history of infant feeding.  The author seems to believe that since the Infant Formula Act of 1980 that formula in the US is safe and bottles are safer because they are BPA-free.  Let's not bring up the fact that there are studies that the BPA-free plastics are not any safer than the BPA bottles.
https://www.scientificamerican.com/article/bpa-free-plastic-containers-may-be-just-as-hazardous/

The author mentions that Similac has organic formula.  Interesting that the author mentions a specific company.  I question this statement since I believe this "organic" product has the Martek oils made from algae and fungi.  These oils are genetically engineered, use hexane for extraction and are not considered organic by organic standards.
https://www.organicconsumers.org/news/brand-name-organic-infant-formula-ingredients-processed-toxic-chemical#close

The author states, 

"What is often missing from the debate over breast vs. bottle is the fact that so many women do both. Breast-feeding is still considered the gold standard, but formula supplementation is commonplace, especially as women return to work after maternity leave. For many mothers, this is the best of both worlds."

Mothers can have it all, the best of both worlds? Or does one negate the other?  Certainly, the infant formula industry can have it all.  The last statement the author makes in the article,

“Malnutrition and poverty are the precise settings where you absolutely do need to breast-feed,” Dr. Michele Barry, senior associate dean for global health and director of the Center for Innovation in Global Health at Stanford School of Medicine, told The New York Times. “Because that’s the setting where access to safe and clean water for reconstituting powdered formula is often impossible to find.”

Choice in infant feeding decisions is predicated on the belief that safe and clean water exists in every town in the US and other developed nations.  Yet tell that to the moms in Flint, Michigan where the levels of lead in their water require the use of expensive filters or buying bottled water.  Or tell that to the families that live down river of the teflon manufacturing plants.  Or tell that to people who read their water department statements.  Cryptosporidium is a parasite that infects water causing diarrhea and other ailments.  It is commonly found in lakes and streams contaminated by animal feces. In immune-compromised individuals it is so serious it may cause death.  It is suggested that severely immune-compromised individuals boil their water. Disinfection is difficult to do because the egg cell is immune to chlorination.  
http://www.health.state.mn.us/divs/eh/water/factsheet/com/cryptosporidium.html

Some babies born prematurely are considered immune-compromised.  Babies not breastfed may be considered immune compromised depending on your viewpoint.  The risk is the water and even if a formula fed infant is not considered immune-compromised, there is an obvious risk of diarrhea.  And diarrhea in an infant is a known-killer.  This article is from 1988.  Has water supplies in the US improved since 1988 or are we faced with another important element of our infrastructure that is broken? 
https://www.nytimes.com/1988/12/09/us/infant-diarrhea-kills-hundreds-yearly-in-us.html

The last quote from Michele Barry failed to mention that she is the director of the Yale/Stanford Johnson & Johnson Global Health Scholar Program.  One might presume that Johnson & Johnson funds this Scholar Program.  Johnson & Johnson sells pharmaceuticals and seems very involved in research regarding hiv/aids in Africa (they are working on a vaccine for hiv). Hm, now why would Michele Barry be interviewed for an article on infant feeding history that also involves the Fed Is Best organization?  

I still very much appreciate The Politics of Breastfeeding.  The last few sentences in the book state,

"A creature from another planet visiting the Earth might ask, "If women are the ones that keep the human race going, why do they get the rough deal?"

Why indeed?  Why is women's history so unknown?  Why does a NY Times reporter distort the history of infant feeding?  Perhaps she needs to read, The Politics of Breastfeeding?  Maybe we should develop a book campaign and send this book to Christina Caron as well as the founders of Fed Is Best?  I imagine they wouldn't read it--too political?  Telling half the history, leaving out the reality is another political choice.  Getting half the story does not illuminate the issue but mentioning all those wonderful products (Similac, bottles) we now have certainly tells us that consumerism is the prime directive.  Choice in products becomes the reality of our world.  
2018 Valerie W. McClain



Friday, August 31, 2018

Grassroots organizations or astroturf? How US Breastfeeding Policy Is Influenced.



"Journalism is printing what someone else does not want printed:  everything else is public relations."  --George Orwell

Suzanne Barston, CLC (Certified Lactation Consultant) is employed by AbbVie, a spinoff company from its parent company Abbott Labs.  And silence rains upon the land.  No one's talking, including breastfeeding advocacy organizations.  I did ask the certification organizations for the credential CLC, if they would care to comment.  Nope, nada and they can't even tell me whether Suzanne Barston is still certified or not.  Fascinating how blinded organizations are in regard to the infant formula industry and its influence.

Speaking of influence, exactly who influenced the US Health Department regarding the US position on breastfeeding at the World Health Assembly in May of this year?  Could it have been a task force meeting held in February by the US National Institute of Child Health and Development?  The Task Force was created regarding research on pregnant and lactating women (PRGLAC).

"The 21st Century Cures Act established PRGLAC to advise the Secretary of Health and Human Services (HHS) regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women.  PRGLAC is tasked with identifying these gaps and will report its findings back to the Secretary." https://www.nichd.nih.gov/About/Advisory/PRGLAC

**The US Secretary of Health and Human Services is Alex Azar, previously President and CEO of ELI Lilly and Company (US Division) and delegate in May of this year to the World Health Assembly's meeting on breastfeeding.  The US threatened various delegates about their support of breastfeeding.  And made various proposals to change the language of breastfeeding support.

The people who attended the February meeting held by the NICHD that reported to the Secretary of HHS, Alex Azar, included 3 members of the Fed Is Best Foundation-Beth del Castillo, Dr. Christie del Castillo-Hegyi, and Jody Segrave-Daly, RN, IBCLC. Representatives from various companies were there:  Novartis, Eli Lilly, and various government representatives of the CDC, FDA and NICHD.  Also various representatives from US hospitals, for example well-known in breastfeeding research, Diane Spatz.
https://www.nichd.nih.gov/sites/default/files/2018-03/PRGLAC_PostMeetingParticipants.pdf

Representatives from Lippe Taylor, a PR company also attended this meeting.  Their clients just happen to be, Nestle, Gerber, Pfizer, Reckitt Benkiser (Mead Johnson), P&G, Johnson & Johnson, Myriad, etc. Also the American Gastroenterological Association (AGA) which has an interest in the gut microbiome.
https://lippetaylor.com/

I have no idea how one gets an invitation to these meetings (not always the same people invited).  I am particularly curious how the FIB (Fed Is Best) Foundation was able to get seats at this particular meeting.  I certainly don't consider Jody Segave-Daly, RN, IBCLC to represent my views or those of IBCLCs I have known over the years.  And I most definitely feel that Dr. Christie del Castillo-Hegyi has little understanding of breastfeeding research.  Although she obviously is quite brilliant, having co-invented a patent with Edward A Berger, well known US government molecular biologist, using a genetically engineered monoclonal antibody against hiv.   

"A neutralizing monoclonal antibody (MAb) with potent and broadly cross-reactive activity would have great potential value in protocols aimed at preventing HIV infection before or immediately after exposure, for example in neonatal transmission, post-exposure prophylaxis, and as a topical inhibitor. Such a MAb may also be useful in treating chronic infection (D'Souza et al. J. Infect. Dis. 175:1056-1062, 1997). "  US Patent #8420099 owned by the United States of America as represented by the Secretary of the Department of Health and Human Services

MAb's can be created by using human milk fat globule and injecting into mice.  
https://www.researchgate.net/publication/20495176_Antibodies_to_Human_Milk_Fat_Globule_Molecules

Although this patent does not appear to use these older techniques to create MAb's.  But surprised that Dr. del Castillo-Hegyi can be an expert in molecular biology while also attending medical school.  Yet fail to understand breastfeeding research.

Some people may have first heard of the FIB Foundation, when Suzanne Barston introduced Dr. Del Castillo-Hegyi on her Fearless Formula Blog in 2015.
http://www.fearlessformulafeeder.com/2015/05/interview-with-dr-christie-del-castillo-hegyi/

I recently ran across an article by Dr. del Castillo-Hegyi and Jody Segrave-Daly, RN, IBCLC  on the World Health Assembly (WHA) breastfeeding decision.  I am amazed that they had so much information.  Information that I hadn't seen anywhere else regarding the suggestions by the US delegates in changing the language of breastfeeding support at the WHA.  They make the following statement,
"Two pediatricians, Dr. Alma Golden and Dr. Brett Giroir,  who were key members of the U.S. delegation attending the 71st World Health Assembly, wrote about the rationale for the U.S. opposition of the first draft"
https://fedisbest.org/2018/07/fed-best-foundation-response-u-s-delegation-actions-world-health-assembly/

Dr. Brett Giroir is Assistant US Secretary of the Department of Health and Human Services.  He is co-inventor to various patents owned by Baxter, Cytokine Pharma Science and Xoma Technologies.  Xoma technologies collaborates with many pharma companies including: Bristol Myers Squibb, Abbott, Elli Lilly and Company as well as the FDA.

Dr. Alma Golden works for USAID and is involved in faith-based organizations for family planning, HIV/AIDS in order to advance global health.

So I suppose I don't really wonder why the US delegates to the WHA seemed so breastfeeding unfriendly, lots of money riding on whether women breastfeed or not.  Read an article in Chicago Business from July 9, 2018.  It states,

"The Trump's Administration's moves to weaken a resolution promoting breastfeeding at an international forum had a potential local beneficiary, North Chicago-based Abbott Laboratories."
http://www.chicagobusiness.com/article/20180709/NEWS03/180709922/trump-s-moves-to-weaken-breast-feeding-standards-could-impact-abbott

I am left with a lot of questions about those who seem to influence US breastfeeding policy.  I understand industry's interest--its about the money.  But the FIB Foundation's interest in dismantling breastfeeding advocacy not just in the USA but world-wide is a curious thing.
Valerie W. McClain Copyright 2018



 


Sunday, August 19, 2018

Corporate Journalism and the Fearless Formula Feeder


"Authenticity.  Listening.  Finding unique angles.  Those are the keys for journalists seeking earned coverage via social media, according to Suzanne Barston, manager, corporate journalism, corporate communications at AbbVie.  As founding partner of AbbVie's StoryLab, Barton is responsible for creating stories around the company's therapeutic areas, pipeline and philanthropy."
--Jim Aikon, "How AbbVie Leverages Social for Earned Media."  8/7/18
http://www.prnewsonline.com/abbvie-social-earned-media-suzanne-barston 

Reading this article was an eye-opening experience, particularly since I have written in this blog about Suzanne Barston, otherwise known as The Fearless Formula Feeder.  She is the author of the book, Bottled Up:  How the Way We Feed Babies Has Come to Define Motherhood and Why It Shouldn't.   When her book came out;  she did the usual publicity tour of talk shows, book signing, etc.  I remember watching her on one talk show and thinking how does someone who is virtually unknown able to garner so many public and media appearances?  For that matter how did she get published?  I chalked it up to her being a writer and editor for health and parenting publications.  But of course now I wonder about her employment with Abbvie.  Was she employed by Abbott Labs or Abbvie during the time she blogged and wrote her book?  Or was this job the ultimate reward for attacking breastfeeding advocacy, by a company that is a spinoff of Abbott Labs, manufacturer of Similac?

 In 2011 Abbott Labs announced in the NY Times its intention to become 2 separate companies, a spinoff.  This became official in January of 2013.  Abbot Labs is considered the parent company.

 "A spinoff retains its assets, employees, and intellectual property from the parent company which gives it support in a number of ways, such as investing equity in the newly formed firm, and providing legal, technology, or financial services."
--definition of spinoff,  https://www.investopedia.com/terms/s/spinoff.asp

Corporate Journalist, Suzanne Barston, states in a session brief about her talk. Speak Softly and Carry a Big Narrative:  When Quiet Stories Speak the Loudest,  posted at epharma,

"Complicating things further, patients and external audiences are more media savvy than ever.  They can smell the complexity of marketing behind our best efforts;  taste the inauthenticity in our paid influencer communications."

and last sentence regarding her intended talk,

"In this session, we'll examine how unbranded, journalistic content boosted a company's reputation in a tangible way, despite less-than-perfect metrics, and show how in the end, authentic storytelling is worth more than SEO [Search Engine Optimization-common term used by social marketing sites]."
https://lifesciences.knect365.com/epharma/agenda/3#think-like-a-patient_speak-softly-and-carry-a-big-narrative-when-quiet-stories-speak-the-loudest

Reading that last sentence I wonder whether her "authentic storytelling" that boosted a company's reputation is about her blog-The Fearless Formula Feeder? As a corporate journalist, she is concerned that media savvy people may "taste the inauthenticity in our paid influencer communications."  Well, I am tasting it and I am a bit angry.  Our corporate journalist totally denied and dismissed the breastfeeding advocates who smelled something fishy about her blog.  I wrote about it back in 2014, 
http://vwmcclain.blogspot.com/2014/07/marketing-infant-formula-with-magic-of.html

The really sad thing about this is that her blog has been quite influential.  Her blog influenced quite a few breastfeeding advocates and some breastfeeding organizations to tone down their advocacy for fear of causing shame in formula feeding mothers.  But she also was politically influential.  In a position paper written by Jennifer Doverspike in 2013 to the The Federalist, a Republican conservative think tank organization, Doverspike writes in the second paragraph of her 6 page paper,

"Don't believe me?  Just ask Suzanne Barston, the founder of a website dedicated to freedom in infant feeding choices.  Her blog, Fearless Formula Feeder (Tag line: Standing up for formula feeders...without being a boob about it) is about the battle to destigmatize formula feeding.  When Mayor Bloomberg announced his Latch On NYC initiative in 2012, Barston went nuclear."
--Jennifer Doverspike, The Literal Nanny State--Breastfeeding and Public Health Officials, The Federalist  
http://thefederalist.com/2013/10/29/literal-nanny-state-breastfeeding-public-health-officials/

Doverspike continues on to discuss the WHO Code as restrictive to access of formula, formula advertising and samples given to mothers.  She states, "The WHO Code appears to be organized around a simple, if dubious, premise:  It's always the evil corporations' fault."  Then she writes about Iran taking control of the import and sale of infant formula (only available by prescription).  She considers this madness.  She considers it an encroachment on personal freedom.

No, Jennifer Doverspike, this is not about personal freedom, its about corporate freedom to influence generations of parents to use their products no matter what the risks.  Her introduction of don't believe me, read The Fearless Formula Feeder website seems rather ironic.  Maybe it would be more truthful if this paper had just given out the Abbot Labs or Abbvie websites rather than Suzanne Barston's website.  Has this paper influenced US politics?  I would say so after reading about the performance of the US delegation to WHA (World Health Assembly) regarding support of breastfeeding.  This Republican Administration appears to be under the sway of this particular paper.

Doverspike gives breastfeeding its token benefits but states they are exaggerated.  Her concerns are supposedly about the USA becoming a "Nanny State," where personal choice becomes limited.  Yet I have to wonder, if the real concern is about propping up a billion dollar industry, so that there is no governmental oversight, no regulations? 

She states that the benefits of breastfeeding are exaggerated.  She ought to read a few infant formula patents in which the infant formula company just has to use a synthetic/genetically engineered imitation of a human milk component to improve or make a safer product.  Interestingly I have read various breastfeeding advocates who state there are no benefits to breastfeeding.  Ignorance versus ignorance seems to be the way of our media-crazed social marketing internet.

Well, Fearless Formula Feeder, aka corporate journalist (although I fear I will never like the word-journalist-any more);  how do you sleep at night?  Any regrets?  It feels like a con, smells like a con, by god we have been conned.
Copyright 2018 Valerie W. McClain








Monday, August 6, 2018

Down the Rabbit-Hole-part 2: "Money is the mother's milk of politics."


                 
"But there is a 'creation myth' that is blind to both, nature’s creativity and biodiversity as well as to women’s creativity, intelligence and knowledge. According to this 'creation myth' of capitalist patriarchy, rich and powerful men are the 'creators'. They can own life through patents and intellectual property. They can tinker with nature’s complex evolution over millennia and claim their trivial yet destructive acts of gene manipulation as 'creating' life, food and nutrition."  --Vandana Shiva, "Tackling 'Monocultures of the Mind'"
https://www.commondreams.org/views/2013/04/24/tackling-monoculture-mind

Glued to my seat, I stare at the computer screen.  I learn that some Americans are deeply surprised that breastfeeding is political.  And some people are surprised and shocked that US delegates to the World Health Assembly in May had tried and partly succeeded in watering down (only minor changes they say) an international resolution supporting breastfeeding.  Why am I not surprised?  The only thing I am surprised about is that it took 2 months for this information to make it to the US new's cycle!

The Trump/Republican Administration has its priorities.  Chaos becomes a priority, a smokescreen that hides intention.  Changing stories, repetitive lying is designed to create a level of mental chaos on one's opponents and everyone is an opponent.  People have to make sense out of the decision-making of this Administration.   And the reality is that this Administration is not about sense.  It's about distraction and chaos.  Trying to make sense of it, is a fruitless task.

Having lived 60-some years on this earth, I have on occasion met people who are driven to create chaos in their lives as well as in everyone else's life.  I learned to not waste my time analyzing their behavior, trying to make sense out of senseless actions.  Instead, I realized that there is no appeasement with those who choose to rein chaos down on your life.  Walking away, keeping a distance has been a solution.  But what to do when those who are governing a people are intent upon reining havoc upon their nation as well as other nations?  

The Business of Patents

Over the years I have been told many things in regard to my "obsession," about human milk component patenting.  I have been told by some breastfeeding advocates that patents don't mean anything. so I suppose that comment means I am wasting my time by writing about it.  Yet corporations spend thousands upon thousands of dollars in fees to the US Patent Office and thousands of dollars in IPR (Intellectual Property Rights) lawyers, and court proceedings. An international patent is estimated to cost over $100,000.  A US patent can cost from $12,000 (less complex patent) to $20,000 (software patents) in filing costs alone.  Then there are attorney fees ranging from $5000-$15,000.  Large corporations have multiple patents and patent applications.  Court costs for patent infringement cases can cost a million or so dollars. So if money has any meaning, then patenting appears to me to be a huge investment by corporations.  So patents on human milk components have a economic and political impact.  And that impact can be and is already showing to be a negative impact on the promotion of breastfeeding.

I have to dismiss this attitude that patenting means nothing.  In an editorial in Intellectual Asset Management (july/August 2012) titled, "Key issues in building a strong life sciences patent portfolio," the article states,

"Patents are the engine that drives venture capital investment and initial public offer funding, as well as mergers and acquisitions in the life sciences industries.  Venture capitalists, Big Pharma and the stock market all need to be convinced that a start up has enough IP protection to gain an edge over its competitors."

In the Boston Business Journal, Joe Hadzima, Jr., Senior Lecturer at MIT Sloan School of Management states,

"Twenty years ago patents weren't very valuable in the sense that they were not upheld in court that often.  Today as a result of changes in the patent laws, inventors are more often prevailing in multi-million dollar lawsuits.  For example, the holder of a patent on the bar code process has reportedly received over $450 million in royalties and judgments."

While many people may think that patents are meaningless, it is quite apparent that in the business world they have monetary value.  Dismissing the thousands of patents based on human milk component research as meaningless seems rather peculiar.  Particularly when some of those patents are owned by the infant formula industry.  Protecting the enormous investment in patents would seem like a probable outcome, particularly when a world organization asks for support for and promotion of breastfeeding.  No corporation wants to throw money away on its investments by supporting the competition.  And breastfeeding is the competition
   
"Money is the mother's milk of politics" *

"Money is the mother's milk of politics."  This quote was used in an article that went on to discuss how 3 infant formula companies (Abbott, Nestle, and Mead Johnson which is now Reckitt Benckiser) spent $60.7 million on lobbying US lawmakers  during the last decade.
 https://maplight.org/story/infant-formula-makers-sweetened-mothers-milk-of-politics-with-60-million-in-lobbying-funds/ 

So not only does the infant formula industry use advertising to consumers to influence the buying habits of families but they also lobby the government in order to influence policy.  This influence peddling is not new but is an ongoing situation in which corporate interests influence health care policies.  Another form of influence is when heads of various governmental agencies have corporate backgrounds. For example the current head of the Department of Health and Human Resources, Secretary Alex Azar was President of Eli Lilly from 2012-2017 and also was on the Board of Directors of the organization BIO (Biotechnology Innovation Organization-trade association supporting biotechnology-genetic engineering-Monsanto). During his confirmation hearings for the job of Secretary for the Department of Health and Human Resources, he was questioned about his role in Eli Lilly's gaming of the patent  system by extending their erectile dysfunction drug-Cialis by testing it on pediatric patients who had a rare muscle-wasting disease.  
https://www.politico.com/story/2018/01/08/trump-azar-patent-drug-company-268942

As Secretary of the Department of Health and Human Resources, he is in charge of the reunification of immigrant families seeking asylum at the border.  He made statements about this reunification process that, "There is no reason why any parent would not know where their child is located."  And stated that the Department of HHS was acting out of "generosity for immigrant children."  All of these statements contradicted by the facts brought out by various news organizations and the ACLU.

Secretary Alex Azar was the head US delegate to the May meeting at the WHA (World Health Assembly) in which Ecuador was to introduce a supportive statement regarding breastfeeding. Most of us have heard the rest of the story.  Ecuador felt threatened and backed down and the Russian delegates made the introduction to support breastfeeding.  The US delegation says they did not threaten anyone.  But obviously something happened.

The US Deputy Secretary to Secretary Alex Azar is Eric D. Hargan who previously has been shareholder in a lobbying firm, Greenberg Traurig LLP.  Some of the lobbying firm's clients were Bayer (a pharmaceutical company that also manufactures infant formula), Albertson's Grocery, Samsung. etc.
https://www.opensecrets.org/revolving/rev_summary.php?id=71406

According to the Washington Examiner on the WHO meeting on sugar taxes,
"Eric Hargan, the U.S. deputy secretary for health and human services, reported that he was the commissioner who blocked advocacy for a levy on sugar on the said panel, arguing it was not clear that imposing taxes on sugary drinks like sodas and fruit juices would improve public health."
 https://www.washingtonexaminer.com/opinion/trump-administration-blocks-who-from-calling-for-sugar-taxes

Those who were appointed to the US Health and Human Services agency seem to side with business interests at the WHO.  One would suppose that this agency would be supportive of health promotion not business promotion.  But not to many people realize that the US Department of Health and Human Service owns patents.  They even own a patent on human lactoferrin (a component of human milk).

Patent #5948613, in which they state the following,

"Another embodiment of the present invention relates to a method of treating a condition in a patient characterized by a deficiency in lactoferrin by administering to the patient an amount of human lactoferrin according to the present invention in sufficient quantities to eliminate the deficiency. The conditions include neutropenia, AIDS, skin infection, gastrointestinal bacterial overgrowth syndrome, vaginal infection and septic shock."




The patent was filed in 1996, so it is a dead patent.  A patent is valid for 20 years from date of filing, although extensions are possible.  Fascinating that the US Department of Health owned a patent that stated that human lactoferrin, a component of human milk, could eliminate a variety of health issues including AIDs.  Yet, they are not supportive of breastfeeding by women who test positive for hiv.  Maybe they forgot to read their own patent? Or maybe it is that money is the mother's milk of politics?
Copyright  2018 Valerie W. McClain

* "Money is the mother's milk of politics," is attributed to statements made in 1960's by California Democrat, Jesse Unruh, who died in the 1980's.






        












 












  





 

Thursday, July 12, 2018

"Down the Rabbit-Hole" The USA and its fickle breastfeeding policy


                                            "CURIOUSER AND CURIOUSER"
                                         Alice in Wonderland by Lewis Carroll


We are down the rabbit-hole, living in Trumplandia, where what was up is now down and down is up.  We are Alice in Wonderland.  Our Heartless King rampages through an early morning; spreading his Story for the Day, only to retract the Story the next day, and then to retract the retraction.  Around and around we go, a merry-go-round that never stops.  The Queen in Silence does not care.  The Chessboard beckons the world of players.  The King, his Bishops, and Knights capture the Pawns.  Black against white, republican against democrat, and one nation against the world;  the strategy of never-ending chaos of words and wars.  And now the Jabberwocky King bestows his wisdom onto the world. America the Great "strongly supports breastfeeding" but (always a but with the word breastfeeding) "we don't believe women should be denied access to formula."  And in his wisedom adds,  "Many women need this option because of malnutrition and poverty."  Yes up is down and down is up.  The Jabberwocky King's wisedom in one twitterly-tweet. 

Does the Heartless King really care about women or children?  Or is it business as usual?  Patents and Trademarks hurrah-hurrah?  Capture the Pawns, silence them quick.  Cage them, deport them, and shut them up quick.  Up is down and down is up.

The Delegation parades onto the Chess Board, capturing the Castles. Baiting and bullying those who do not understand the game.  The Delegation has property to defend.  Companies must be fed.  Royalties must be paid.  

"One pill makes you larger
And one pill makes you small
And the ones that mother gives you
Don't do anything at all
Go ask Alice
When she's ten feet tall."
--White Rabbit by Jefferson Airplane

*******************PATENTS********************

"Consumption of human milk is one of the most cost-effective strategies known to medicine for protecting infants against morbidity and mortality due to infectious disease. Human milk may be considered a natural and efficacious "nutriceutical," i.e., a model food that conveys immunologic benefits. Protection against infectious diseases occurs through a variety of complementary mechanisms found in human milk, including oligosaccharides and their related glycoconjugates. Significantly enhanced immunologic protection by breastfeeding has been demonstrated for diarrheal diseases, respiratory tract illnesses, bacteremia, meningitis, and necrotizing enterocolitis. Protection by breastfeeding is especially efficacious against diarrheal disease." 
--Patent #7893041 entitled, "Oligosaccharide compositions and use thereof in the treatment of infection," filed in 2004, owned by Children's Hospital Medical Center (Cincinnati,Ohio), Instituto Nacional De Ciencias Medicas Y Nutricion (Mexico, Mx), and University of Massachusetts (Boston, Ma) 

"During postnatal development, a newborn's intestine experiences a process of maturation that ends with the production of gastrointestinal epithelium that functions as a selective barrier (i.e., gut barrier). The gastrointestinal epithelium permits the absorption of nutrients, electrolytes and water, while preventing exposure to dietary and microbial antigens, including food allergens. Specifically, this barrier limits the passage of antigens to the systemic circulation, thereby preventing infection, inflammatory reactions, and other gastrointestinal diseases and disorders that may occur during infancy and later in life. For very young infants, and particularly, preterm infants, who have an immature immune system and intestinal tract, development of suboptimal intestinal flora may result in infection, diarrhea, allergies, and food intolerance.

Barrier formation and maintenance has been found to be affected by the diet. 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 systems." 

Patent #9539269, entitled, "Methods for decreasing the incidence of necrotizing enterocolitis in infants, toddlers, or children using human milk oligosaccharides."  filed in 2011 owned by Abbott Laboratories

"The present invention pertains to a composition for inducing a pattern of gut barrier maturation similar to that observed with breast feeding and able to improve gut barrier maturation, e.g. during neonatal stress. In particular, the present invention relates to an infant formula containing a combination of specific ingredients designed to provide a synergistic effect all along gastrointestinal tract and barrier function.

During the postnatal development, the newborn intestine experiences a process of maturation that ends by the establishment of a functional barrier to macromolecules and pathogenic bacteria. This phenomenon is called gut closure and appears to be affected by the diet. Hence, different studies with infants (JPGN, 1995, 21: 383-6) and animal models (Pediatr Res, 1990, 28: 31-7) show that the maturation of the barrier is faster in breast-fed than in formula-fed newborns. This could explain the higher prevalence of allergy and infection in infants fed formula than in those fed with mother milk."

Patent # 8394370, entitled, "Nutritional formula for optimal gut barrier function," filed in 2004, owned by Nestec [Nestle]

Copyright 2018 Valerie W. McClain



Tuesday, December 12, 2017

Mastering the Art and Science of Human Milk Oligosacharide: The Joy of Genetically Engineering HMOs Cookbook


"Glycom has confirmed...that the 2'-FL manufactured by Glycom is chemically and structurally fully identical to the 2'-FL that is present in human breast milk.  Glycom's 2'-FL is therefore referred to as a human identical milk oligosaccharide (HMO)." US FDA Generally Recognized As Safe (GRAS) Notice 650  https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm513832.pdf

THE 2'-FL HUMAN MILK OLIGOSACCHARIDE  RECIPE

*One host organism, your choice:
E. coli K12 DH1 or Helicobacter pylori

*Genetically modify using knockout genes and inserting a promoter gene.

*Use a plasmid vector from donor strains, Klebsiella pneumonia and Salmonella Typhimurium. Make sure the undesirable genes that are pathogenic or toxigenic are taken out.  The ampicillin and tetracycline resistance genes should not be expressed during fermentation.

*With fermentation the E. coli or H. pylori will express the Human Milk Oligosaccharide, 2'-FL. Use various solvents to extract the pure 2'-FL Human Milk Oligosaccharide such as pyridine, or benzoyl chloride, or DCM, or Methanol. While some of these solvents are highly toxic-unfit for consumption, various processes will be used to make sure none of these solvents remain in the Human Milk Oligosaccharide product.

 *This recipe makes a crystallized powder identical to the Human Milk Oligosaccharide made in the human mammary gland. 

This recipe is my interpretation of the information given in Glycom's GRAS notice 650 to the FDA regarding their 2'-FL Human Milk Oligosaccharide.  My attempt at humor.  Biotech industries use microbes genetically engineered and the process of fermentation to create food products.  Perhaps a cookbook would be somewhat informative for those of us who want to know what is in our food.  

It must be a joke that the FDA has no questions regarding the manufacturing of 2'-FL Human Milk Oligosaccharides.  How could anyone believe that this product is identical to what women produce in their breasts? Glycom "convened" (another word for hired?) an expert panel to critically evaluate their HMO product.  The 4 experts were Dr. Joseph F Borzelleca of the Virginia Commonwealth University School of Medicine, Dr. Ronald Kleinman  of Massachusetts General Hospital for Children, Dr. Robert J Nicolosi of the University of Massachusetts Lowell, and Dr. John A. Thomas of Indiana University School of Medicine.

In 2012 Dr. Joseph F. Borzelleca received a Lifetime Service Award by the International Association of Color Manufacturers. He was responsible for the standards developed in the 70's and 80's for food color safety.
https://www.iacmcolor.org/wordpress/wp-content/uploads/2012/06/IACMBorzellecaReleaseFinal092412.pdf
The importance of white color to infant formula is not often recognized. Even though babies do not notice the color of their infant formula, parents notice the color.  I blogged about the use of lutein in baby formulas. http://vwmcclain.blogspot.com/2011/04/lutein-dye-supplement.html

When industry thanks researchers, I get a little uneasy.  Of course this is not about food coloring but whether a genetically engineered food product is safe for babies.

Dr. Ronald E Kleinman of Massachusetts General Hospital is notable.  He is one of the authors of a study that questioned the safety of Baby Friendly Hospitals/exclusive breastfeeding. https://jamanetwork.com/journals/jamapediatrics/article-abstract/2546142?redirect=true 

Interestingly, Massachusetts General Hospital (also known as The General Hospital Corporation) is a co-patent owner to a number of Human Milk Oligosaccharide patents (inventors being David S Newburg, Ardythe Morrow and Gillermo Ruiz-Palacios)

Dr. Ronald E Kleinman has in the past been funded by Mead Johnson and Nestle. He did a study on the optimal duration of breastfeeding which was funded by Gerber.  He also was a paid expert witness for Gerber in a court case.  https://ethicalnag.org/2011/01/27/integrity-in-science-report/

Dr. Robert J Nicolosi is also the Chief Science Officer for a Nanotech company.  Nanotechnology is being used in manufacturing infant formula but not being used as far as I know in the manufacturing of HMO's.

John A. Thomas PhD is or was employed in the Department of Pharmacology and Toxicology as well as a member of the Society of Toxicology since 1971.

Whether the experts convened by Glycom have a lot of expertise in the safety of genetic engineering is unknown.  Perhaps Dr. Robert J Nicolosi with his financial involvement in nanotechnology (not genetic engineering but a newer technology) has a high level of expertise in genetic engineering.  I question whether the other experts have a background in genetic engineering. 

Glycom is a Danish biotechnology company that manufactures HMOs.  Nestle has a strategic stake in Glycom (at least half the BOD are from Nestle).  So I suppose one might just consider Glycom a Nestle company or at least a company with a lot of Nestle influence.
https://www.glycom.com/about/history/

The safety of Glycom's 2'-FL Human Milk Oligosaccharide is based on a clinical trial that was funded by Abbott.  One of the authors of that clinical trial is Rachel Buck who is a listed inventor to many of Abbott's patents on HMO's for use in infant formula.  
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4645963/

The Abbott clinical trial was registered NCT01808105.  The trials were conducted in the USA in various locations and Puerto Rico.
 https://clinicaltrials.gov/ct2/show/NCT01808105

One clinical trial by a company with a vested patented interest in using HMOs seems rather strange to me.  And to declare this HMO identical to the real HMO made by the mammary gland of women seems even stranger.  Yet this is where we are at nowadays.  Deluded, delusional...and these people and institutions determine safety and what products parents believe are being regulated by governmental agencies.  When the formula company advertises their new formula with HMO's identical to human breast milk,  should we laugh or cry?*  
Copyright 2017 Valerie W. McClain

*The label on Abbott's infant formula with HMOs states in small print, "Not from human milk."  Glycom's GRAS statement to the FDA on this particular HMO states that their manufactured HMOs are the same structurally and chemically as real human milk oligosaccharides.  









Wednesday, November 8, 2017

Time Magazine article on motherhood: "The Goddess Myth"


"Propaganda is amazing.  People can be led to believe anything."--Alice Walker

Guilt and shame and more guilt and shame, brought to you by Time Magazine or should we say brought to you by the Genetic Literacy Project.  I found the article, "The Goddess Myth:  Why Many New Mothers Feel Guilt and Shame," (10-19-17) to be a great social marketing piece.  We might all want to send our letter of thanks to Alice Park and Alexandra Sifferlin, who were listed at the end of this article. Both Park and Sifferlin contributed to this article and their names are listed in the author section of the Genetic Literacy Project website

In bold letters prior to the article, it says, "Motherhood Is Hard to Get Wrong, So Why Do So Many Moms Feel So Bad About Themselves?"
I am already feeling the guilt.  I always questioned my mothering ability, there must be something wrong with me to believe that motherhood is not easy.  There were days when I felt like a good mother and there were days when I think I failed motherhood 101.  I thought that was normal.  I am a grandma now. While I like to see the little fairies under the toadstool with my grandchildren; I do not believe that motherhood was an easy trip, and hard to get wrong.  Nor do I believe that birth and breastfeeding is about being a goddess, like the earth goddess Gaia.  Yet I had my babies at home and I breastfed them. 

I had a homebirth because I didn't have health insurance--lost it because my husband's new job had a insurance company that considered my pregnancy a pre-existing condition. We had to pay out of pocket anyways and at that time homebirth with midwives was far less expensive than a hospital birth. And the reason I wanted to exclusively breastfeed my baby was another economic decision-infant formula was costly--and I planned on being a stay-at-home mom for the first 3 years.  I did those things out of practicality.  And the crazy thing is the practicality became a love, an attachment to the value of homebirth with midwives and to the value of breastfeeding, with La Leche League as my support system.

I am not sure where the author and her reporters got their data regarding home births (1.5% of all US births) being almost as many as "elective" c-sections.  Or that c-sections are down to 26% of "low risk first births."  Sounds good but no references to where this data comes from.  No discussion regarding the rising morbidity and mortality rate of mothers giving birth in the USA.  Nor discussion of the high morbidity and mortality rate of African-American mothers and babies.  The critique is centered around women who choose to have a more natural birth or want to exclusively breastfeed.  If you want a more natural birth or want to exclusively breastfeed, it would seem that you suffer from a goddess complex.  

The article states, "it [breastfeeding] may help reduce gastrointestinal infections, middle-ear infections, some immune-based diseases like allergies and asthma."  May help?  I think the author and her trusty reporters need to read some infant formula patents regarding the use of human milk components to treat all the illnesses they mention. The article states that 80% of American women "try" breastfeeding.  Try is an interesting and very tentative word.  When I worked as a lactation consultant some moms told me that they were going to "try" and breastfeed.  It reminded me of someone saying that they are going to try and exercise tomorrow. Maybe they will exercise, maybe not.  Of course sometimes we are only mimicking what we heard someone else say or repeating phrases from something we read.

The thrust of the article seems to be a criticism of the Baby-Friendly Hospital Initiative.  In horror they write that, "You won't see any formula, bottles or pacifiers on display.  They are forbidden..."  Yes but mothers can bring those items from home.  The hospital can't display them or give them to mothers-- remember nothing is free in hospitals.  So if they are giving you something for free, then one might suspect that there is a marketing deal in which a company is benefiting.  

The article discusses a paper published in 2016 JAMA Pediatrics authored by several doctors regarding rooming-in and their concerns that this will lead to "hazardous practices" and "counterproductive outcomes."  Their concerns are about babies being smothered and a rare fatal respiratory failure.  Interestingly, one of the authors, Dr. Ronald Kleinman, has been funded in past research by Nestle, Mead Johnson and Coca-cola.  Hospital nurseries in years past were often designed and funded by the infant formula industry.  Separation of mothers and babies may work wonderfully for babies who are formula-fed;  especially since most nurses love feeding babies.  But separations don't work well for getting breastfeeding off to a good start.

Fed Is Best is discussed towards the end of the article.  And the word starvation and exclusive breastfeeding is tied together.  How to make mothers fearful of exclusive breastfeeding. They quote Dr. Del Castillo-Hegyi, "If you have leaders telling you this is what's best [exclusive breastfeeding], it becomes ideology, policy, identity." Back at ya, Dr. Del Castillo-Hegyi.  One could easily say that the Fed Is Best organization is about ideology, policy, identity.

This whole article reminds me of the Similac Ad called the Mother-Hood regarding the mommy wars.  Heaven forbid anyone make any judgments or really read the last 50 years of medical literature regarding the value of breastfeeding.  And heaven forbid we ask why the Genetic Literacy Project appears to be so involved in trying to subvert the Baby-Friendly Hospital Initiative and exclusive breastfeeding.  Here is an interesting article on how the Genetic Literacy Project has behaved regarding its use of writers to spread a positive spin on GMOs. 
http://progressive.org/magazine/how-the-biotech-industry-cultivates-positive-media/

As author, Alice Walker, said:  "Propaganda is amazing.  People can be led to believe anything."  Time for people to use their critical thinking skills when reading this article. 

Copyright 2017 Valerie W. McClain