LAWSUITS: NEC IN THE NICU

“One has to understand that to be born is to enter the world of microbes.”

and,

“If the newborn baby has only consumed colostrum, the dominant microbes belong to the bifidobacterium family and are accompanied by some coliform bacteria to which the baby is already adapted, since they come from the mother.  The newborn needs to be contaminated as early as possible by the domestic microbes that are satellites of its mother, and in this way be as well protected as possible in the event of an attack by more dangerous microbes.”  Michel Odent, “The Nature of Birth and Breastfeeding,” 1992 pg.72

 

NEC IN THE NICU (Neonatal Intensive Care Unit) LAWSUITS

“Similac and Enfamil products contain cow’s milk that has been hydrolyzed, or broken down, to remove certain proteins known to cause allergic reactions.  However, when given to premature or low birth weight babies, Similac and Enfamil may cause NEC [Necrotizing Enterocolitis] at much greater rates than is associated with babies fed breast milk, donor milk, or breast milk-based formula.” Saianitz & Kirk law firm  https://www.youhavealawyer.com/baby-formula-nec-lawsuit/

Recently, there has been a number of law firms on the internet who state that there are pursuing lawsuits against the manufacturers of Similac (Abbott Labs) and Enfamil (Mead Johnson).  They are looking for parents of premature infants who were fed these formulas in US hospitals and suffered health issues and/or death from NEC.  Currently, there is at least one case going through the courts and one settled court case from some years ago that I found on the internet.  There may be more cases, since a number of law firms around the country are advertising for parents whose premature babies were diagnosed with NEC to contact their lawyers.

WHAT IS NECROTIZING ENTEROCOLITIS (NEC)?   

“NEC is a condition characterized by variable injury or damage to the intestinal tract, causing death of intestinal tissue.  The condition most often occurs in premature newborns, but it may also occur in term or near-term babies.”  https://rarediseases.info.nih.gov/diseases/9767/necrotizing-enterocolitis

Ruth Lawrence, MD in her text book, “Breastfeeding:  A Guide for the Medical Profession 4^th edition  1994 (pg. 423) states,

“NEC is a major cause of morbidity and mortality in preterm and other high risk infants.”

And,

“In a large prospective multicentered study of 926 infants, 51 (5.5%) infants developed NEC.  Mortality was 26%.  In exclusively formula-fed infants, the incidence was 6 to 10 times more common than in those who received human milk exclusively.  In those who received human milk and formula, it was 3 times more common than in the exclusively breastfed group.”

I imagine that some people may be surprised to learn that the use of infant formula in preterm infants as well as some full-term infants is a risk for NEC.  Who would believe that infant formula is a risky product?  Some human milk researchers and patent holders have known the relationship between NEC and infant formula for years.  The infant formula industry has known of the problem for years, and some companies think the answer is adding genetically engineered human milk components.

The dissemination of this important information to the public has not been done.  Or at least I have not seen this information other than within breastfeeding advocacy organizations, human milk banks, medical professionals working in NICUs, and Prolacta Bioscience-a corporation that sells human milk-based infant formula to NICU’s.

A few months ago a friend of mine sent me a text about a law firm’s website on NEC lawsuits. The words, human milk-based infant formula had her questioning whether there was such a thing as human milk-based infant formula.  I replied yes, there is such a thing.  A company, Prolacta Bioscience manufactures a human milk-based infant formula for use in hospitals for premature babies.  They use donor milk from moms and those moms are compensated for their donation. Prolacta also sells a human milk fortifier called Humavant. They have a financial investment in promoting human milk/breast milk.  http://prolacta.asia/products/human-milk-fortifier

Prolacta Bioscience devotes a page on their website to the issue of NEC.  Is human milk-based infant formula equivalent to breast milk or breastfeeding?  According to their patents, it is manufactured by taking some human milk components apart (the fat is skimmed off), the donor milk is frozen and refrozen a number of times, human milk oligosaccharides are harvested from the milk, and then rearranged to form various formulas of different fat levels.  Then various vitamins and minerals are added as well as DHA/ARA (genetically engineered oils) added.  This makes the substance very different from donor milk (which in US is pasteurized).  No way does it compare to breastfeeding. http://prolacta.asia/parent/about-necrotizing-enterocolitis

 

I find it interesting that legal firms use these words on their website: breast milk, donor milk, or breast milk-based formula.  Nowhere is the word, breastfeeding.  The presumption seems to be that premature babies are not breastfed or at least not breastfed in hospitals.  Surprisingly or maybe not so surprisingly, the lawsuits are only about premature infants, despite the fact that full term infants are also at risk for NEC.

Breastfeeding is becoming not only a lost art but a word that seems to be disappearing from the medical and legal lexicon.  Instead, medical and legal institutions seem to only be aware of a substance, a product that needs legal protection. In a capitalistic society the needs of an industry outweigh the needs of the individual.  There is a power struggle between the financial and legal needs of the human milk industry versus the infant formula industry.  Breastfeeding, as usual, gets a backseat to the needs of these industries.  This society has lost the understanding that it is breastfeeding that needs the most medical and legal protection.

Premature babies can experience very painful touch by medical staff.  There are studies that it is now believed that pain in babies is far more stressful than for adults. The importance of human contact in which touch is gentle, and lovingly given should not be underestimated. Skin-to skin contact, breastfeeding de-stresses babies.  How many medically stable babies in US NICUs are given the opportunity to breastfeed?   All babies, not just premature babies benefit from skin-to-skin contact.  The skin-to-skin contact facilitates breastfeeding.  Separation of babies from their mothers increases stress in both the mothers and the babies. See, “Should Babies Sleep Alone?” https://www.biologicalpsychiatryjournal.com/article/S0006-3223(11)00639-1/fulltext

Are we being conditioned to believe that just giving a human milk product will decrease NEC in babies?  It seems we are already conditioned to easily accept  the separation of moms and babies as normal.  

A 1987 PATENT RELEVANT TO UNDERSTANDING NEC

Before I discuss the patents to treat or prevent NEC, I want to discuss a US patent filed in 1987 by Baylor College of Medicine.  It was entitled, “Lactoferrin as a dietary ingredient promoting the growth of the gastrointestinal tract.” (patent # 4977137) https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=4977137.PN.&OS=PN/4977137&RS=PN/4977137  

The patent states:

“A substantial growth of the intestines of newborn animals takes place in the first one to three days after birth.  For example in newborn pigs who are nursed by the mother, there is a substantial growth, approximately eight to ten inches of the intestines of the infant within the first few days after birth.  In a large number of human newborns who are not nursed by the mother but are placed on an infant’s formula, the growth of the gastrointestinal tract during the first few days may not occur, and, as a result, the infant is predisposed to chronic intractable diarrhea which must be managed for a period of three or more months at considerable expense and discomfort to the infant.”

The patent supposes that adding one human milk component, lactoferrin, will rectify the problem of a lack of growth of the gastrointestinal tract for babies that are not nursed.  The patent proposes to use either human or bovine lactoferrin as an additive to infant formula, treatment for short gut syndrome and diarrhea in infants.

If the research behind this patent is correct, then infant health and survival is dependent upon breastfeeding.  The belief by these researchers and many other researchers involved in infant nutrition is that many women will not or cannot breastfeed.  Thus, to safeguard infants from damaged guts created by the use of infant formula, science will add one human milk component in hopes that this component will solve the problem.  In this patent the inventors do admit that the lactoferrin used “should not be processed, such as pasteurization, which destroys the effectiveness.”  The problem with this statement is that infant formula must be made shelf stable for at least 18 months, which would require pasteurization.  Live substances like human milk components or probiotics that are pasteurized are not as effective.

Buford Nichols, patent co-inventor to the above patent, co-edited a book for Bristol-Myers Squibb/Mead Johnson Nutrition Symposia entitled, “Malnutrition in Chronic Diet-Associated infantile Diarrhea:  Diagnosis and Management,” in 1990.  https://www.findbookprices.com/author/Buford_L_Nichols

There is a long history of some researchers from Baylor College of Medicine being funded by Mead Johnson, now known as Reckitt. In 2021 Baylor thanks Mead Johnson/Reckitt on the website of Pediatric Academic Societies.                              https://www.pas-meeting.org/grant-supporters/

In 2019 a paper was published in Human Cell  by Ninkina et al. entitled, “Stem cells in human breast milk.” This paper states,”… exosomes purified from breast milk are able to promote intestinal epithelial cell growth in infants.” Exosomes are small particles that transfer DNA, RNA, and proteins to other cells.  This appears to confirm patent inventors (Nichols & McKee) observations from 1987 regarding the growth of the intestines in breastfed newborns.  Stem cells are important to medical researchers because they naturally generate new cells. This could be used in therapies for various cancers or other diseases. It also can be used in medical labs in the generation of cell lines. No infant formula delivers live cells that can generate stem cells. Infant formula is a sterilized product**(please read important correction) that is designed to have a shelf life of 18 months. The product is life-less because it is sterile.  Breastfeeding produces a substance that is full of life, and full of regenerative cells.  I have heard some mothers say that there is no difference between infant formula and breast milk.  Research by the infant formula industry in which they are trying to imitate breast milk components is indicative of a basic understanding that there is a huge difference between infant formula and breast milk.  https://link.springer.com/article/10.1007%2Fs13577-019-00251-7

PATENTS OWNED BY THE INFANT FORMULA INDUSTRY TO PREVENT NEC

This is a sample of some of the US patents that seek to address the problem of NEC in babies.

In 1997, Abbott Labs filed for a US patent (#6080787) called, “Methods for reducing the incidence of necrotizing enterocolitis.”  They determined that adding omega 6 and omega 3 oils plus egg yolk lipids would prevent NEC.  The patent states, “NEC is rare among infants fed only breastmilk.”  Susan E Carlson et al were co-inventors to this patent.  At this time there was much interest in adding DHA and ARA (omega 3 & 6) to infant formulas.  Martek Bioscience scientists were publishing many papers in various journals. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6080787.PN.&OS=PN/6080787&RS=PN/6080787

In 2011 Abbott Labs filed for a US patent (#8877812) entitled, “Methods for decreasing the incidence of necrotizing entercolitis, colic, and short bowel syndrome in an infant, toddler, or child.” Abbott Labs plans to use predigested fats which may include monoglycerides and/or fatty acid components as a preventative against NEC. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8877812.PN.&OS=PN/8877812&RS=PN/8877812

In 2012 Mead Johnson filed for a US patent (#8968722) called, “Milk-based nutritional compositions containing lactoferrin and uses thereof.”  The patent will add a prebiotic plus lactoferrin to prevent NEC. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8968722.PN.&OS=PN/8968722&RS=PN/8968722

 

In 2014 Nestec S.A. (Nestle) filed for a US patent (#10940158) called, “Compositions for use in the prevention or treatment of necrotizing enterocolitis in infants or young children born by C-section.”  The patent states, “It should be noted that, in the healthy vaginally-delivered breast-fed infant, Bifidobacteria form the basis of the microbiota for 60-90% of total bacteria in the infant gut.  Breast feeding also promotes intestinal barrier development which together with bifidobacteria domination leads to enhanced absorption and therefore utilization of ingested nutrition.” Nestle will use a mixture of Human Milk Oligosaccharides to prevent NEC. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10940158.PN.&OS=PN/10940158&RS=PN/10940158

In 2015 Mead Johnson filed for a US patent (#9730969) entitled, “Nutritional compositions for promoting gut barrier function and ameliorating visceral pain.”  The patent would use a probiotic, Lactobacillus rhamnosus GG (LGG) in their formulas to prevent NEC and other intestinal issues. Remember that human milk researchers consider human milk to be a probiotic. (Researchers in Spain published a paper in the British Journal of Nutrition on probiotic bacteria derived from human milk specifically mentions the clinical trials of LGG used in infant formula that decreased the incidence of rotavirus and the duration of diarrhea). The patent describes the research of visceral pain in which they used Sprague-Dawley rats, and separated some mother rats from their babies in comparison to mother rats not separated from their babies.  The patent states, “Early life stress induced by maternal separation lowered threshold of pain perception in rats…”  Should we be surprised by this? We stress mother and infant mammals (including human) by separating them, but our society seems to ignore this reality.  https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9730969.PN.&OS=PN/9730969&RS=PN/9730969

In 2017 Abbott Labs filed for a US patent (#10471081) called, “Methods for decreasing the incidence of necrotizing enterocolitis in infants, toddlers, or children using human milk oligosaccharides.”  The patent makes several statements of importance, “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.”  And

“Not all infants, however, are in a position to receive human breast milk.”   https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10471081.PN.&OS=PN/10471081&RS=PN/10471081

 

CONCLUSION

The infant formula industry has known for many years that NEC is a problem.  Over the years, the industry has patented various, genetically engineered human milk components to be added to their infant formula to prevent or treat NEC.  With increasing number of babies getting NEC, one has to question whether the industry can solve this serious health problem caused by their products. 

As for the lawsuits against two infant formula companies, I find it interesting that the word, breastfeeding, is missing.  Instead the focus is on breast milk, donor milk, and human milk-based infant formula as the answer to NEC.  Is human milk-based infant formula equivalent to donor milk?   The research on these very expensive human milk-based products is funded by Prolacta Bioscience.  Should we accept that research?  Are we creating a medical environment in which our priority has become a product rather than the action of breastfeeding? 

Copyright 2021 Valerie W. McClain

** This is an important correction.  While infant formula must be made sterile, manufacturers of infant formula cannot make powdered infant formula sterile.  Due to cases of Cronobacter and Salmonella in young infants causing hospitalizations and deaths, the recommendation from the WHO and the US CDC is that parents need to sterilize all feeding equipment and that water used to reconstitute the powdered formula should be at least 158F/70C degrees to inactivate pathogens. These infections can cause NEC.

 

PFAS, "FOREVER CHEMICALS," & BREASTFEEDING- PART 2

“Broad conclusions about potential contamination of breastmilk are hard to make. Not only does each case involve a wide array of factors from the diet of the mother to the air she breathes, many of the suspected toxins are new enough to preclude any long-term studies.  Claims of contamination must be looked at in light of their source:  environmentalists often exaggerate the degree of contamination to boost their case for greater safe-guards, and formula companies freely spread fears of toxins in the hopes that mothers will choose formula as a way of erring on the side of safety.  On the other hand, some breastfeeding promoters would have you believe that breastmilk is impervious to contamination.”—Naomi Baumslag, MD, MPH & Dia Michels in the book, “Milk, Money, and Madness:  The Culture and Politics of Breastfeeding” 1995.  p96.

After rereading the above paragraph; I am bemused, frustrated, and angry.  I read the book some 26 years ago and the only thing about that paragraph that has changed is that we are living with   more toxic chemicals.  Environmentalists still use breastmilk contamination as a means to galvanize the public to create a better environment.  Parents read the media reports, become frightened, and believe that infant formula is the answer to contamination in our environment.

MEDIA RESPONSE  

This year the media (The Guardian and recently The Seattle Times) have focused on the research paper from   Environmental Science & Technology called, “Per-and Polyfluoroalkyl Substances (PFAS) in Breast Milk:  Concerning Trends for Current-Use PFAS,” by Guomao Zheng et al.  The Seattle Times article was a more informative exposé on the research paper than The Guardian.  While The Seattle Times article was informative, it was uncritical of the research paper itself.  The article also featured one of mothers, who donated her milk for the research.  While personalizing this issue may sway people to support the need to restrict PFAS chemicals in our environment, the uncritical stance of the research paper presumes the accuracy of the research.

https://www.seattletimes.com/seattle-news/environment/seattle-study-of-breast-milk-from-50-women-finds-chemical-used-in-food-wrappers-firefighting-foam/#comments

The Guardian article that was published a few months ago was inaccurate and alarmist.  One of the Guardian’s partners is the Joseph Rowntree Foundation as well as the Bill & Melinda Gates Foundation.  Interestingly, the Joseph Rowntree company (maker of the Kit Kat candy bar, Smarties) was bought out by Nestlé in 1988 for $4.5 billion.  Nestlé appears to partner (the Living Wage Project in UK) with The Joseph Rowntree Foundation. Nestlé responded to recent queries regarding the history of the Rowntree company and its relationship to the slave trade. When a newspaper partners with foundations that are allied with corporations that have an economic agenda, one might consider that articles in that newspaper might be slanted or biased.

https://uknewstoday.co.uk/2021/05/15/british-chocolate-maker-rowntree-apologises-for-shameful-role-in-slave-trade/

https://www.nestle.co.uk/en-gb/media/pressreleases/nestl%C3%A9-becomes-living-wage-principal-partner

https://www.theguardian.com/environment/2021/may/13/pfas-forever-chemicals-breast-milk-us-study

https://www.theguardian.com/info/2018/oct/02/philanthropic-partnerships-at-the-guardian

 

“Per- and Polyfluoroalkyl Substances (PFAS) in Breast Milk: Concerning Trends for Current-Use PFAS” by Guomao Zheng et al.

https://pubs.acs.org/doi/10.1021/acs.est.0c06978

After reading and rereading this paper which was the basis for US media headlines this year,  I find myself questioning the accuracy of their measurements of PFAS concentrations in breast milk.  As a lactation consultant for many years, and having read many research papers over the years; I am somewhat taken aback that research is still being done on breast milk in which a paper does not define feeding methods.  Were these mothers breastfeeding exclusively, and how was it defined?  Were they partially breastfeeding and using other milks, water, and/or food?  Were they pumping their milk exclusively or occasionally or not at all?  One might wonder why this would matter, since they are only looking at PFAS chemicals in breast milk.  A mother who is exclusively pumping her milk and bottlefeeding the milk or a mom who is partially breastfeeding (using animal or plant milks, water, or foods) would  potentially expose her infant thru water, packaging of food products, and plastic bottles to more PFAS chemicals than a exclusively breastfeeding mom (no water, infant formula, or other food and drinks).

One of the facts of breast milk is that it is a substance in which its many components change from hour to hour, day to day, month by month with the fat content being the most variable component.  Taking one sample at one moment in time will not give us a full picture of the toxins in breast milk. A woman that is partially breastfeeding or in the process of weaning (protein and sodium increased with a decrease in lactose) will have milk in which the components are more or less concentrated than a woman who is exclusively breastfeeding.  This would mean that at different times in the day the woman donating her breast milk may have more toxins in her milk than at other times.   Taking human milk samples over a day or over weeks, would give a more accurate view of toxins in a milk sample.

Focusing on PFAS chemicals in breast milk, obscures the reality that babies under a year in the US are not solely being fed at the breast.  Most breastfeeding moms by 3 months postpartum are no longer exclusively breastfeeding.  Breastfed babies under 6 months may be receiving lots of formula feeds as well as bottles of water.  Thus avoiding the issue of other foods and water being ingested by infants is a very narrowed approach to the problem of infant exposure to PFAS chemicals.

It is particularly a problem, when one reads various research papers in which dairy products (some studies includes infant formula), and water are considered high risk foods and drinks for PFAS chemical contamination.  Infant formula is often reconstituted with water from municipal water systems.

“Recent studies in the Journal of Dairy Science and Food Science, have examined the bioaccumulation and transfer of PFAS from contaminated feed and drinking water to cow’s milk and results suggest that certain PFAS compounds have a relatively high potential to transfer to milk and beef from the diet of dairy cows.” https://www.bbjgroup.com/blog/crying-over-spilled-milk-the-latest-victims-of-pfas-contamination-in-new-mexico

.“…the number of Americans exposed to PFAS from contaminated tap water has been dramatically underestimated by previous studies…” https://www.bbjgroup.com/blog/crying-over-spilled-milk-the-latest-victims-of-pfas-contamination-in-new-mexico

In a research paper called, “Infant Dietary Exposures to Environmental Chemicals and Infant/Child Health,” published in September of 2018 in Environmental Health Perspective, compared the number of research papers on toxins in breast milk versus toxins in infant formula.  They found plenty of studies on breast milk but very few on infant formula.  The authors did a literature search using PubMed and the Web of Science (WoS) on human milk and infant formula.  They initially found 1,151 studies and 259 citations on human milk, and 139 studies and 644 citations on infant formula.  They narrowed down these numbers in both categories according to specific criteria (PECO-Population, Exposure, Comparison, Outcome).  None of the infant formula studies passed the PECO criteria and only 74 studies and 11 citations of human milk passed their criteria.  I highly recommend this particular study for an understanding of the importance of having data on prenatal exposures of infants, the need for a comparison group-such as infant formula, and documentation of health outcomes of infants.

“A critical gap is a lack of research on environmental chemicals in formula and infant/child health outcomes.”

https://ehp.niehs.nih.gov/doi/10.1289/EHP1954

When we examine the research paper cited by The Guardian and The Seattle Times, there is no comparison of infants being breastfeed versus infant formula fed. Nor do we have any prenatal blood data; even more telling this paper has no data on the mothers’ blood levels of PFAS chemicals.  Without paired blood samples from the mothers, they instead used the CDC’s breast milk and serum data published in 2015-2016 of the NHANES (National Health & Nutrition Examination Survey) to calculate the lactational transfer efficiencies.  I consider this to be very problematic, a fatal flaw. They also used the US EPA average age-based daily breast milk consumption rates.  The US EPA defines exclusive breastfeeding as the “sole source of milk from human milk with no other milk substitutes.”  This definition would mean that a mother who gave water and/or food would be considered to be exclusively breastfeeding.  Yet we know that water consumption can be a high risk for PFAS chemical exposure.

There are other issues regarding this research.  Sixty-eight percent of the mothers were over 33 years old and having their first baby.  Older moms would potentially be exposed to more PFAS chemicals than younger mothers. It is believed that first time mothers deliver more toxins to their first born than to their subsequent children.  Fifty-two percent of the babies were over 6 months of age.  This means that the milk collected for these older babies would be very different from babies under 6 months. I would have liked to have seen samples of milk from mothers with newborns, and at 3 months postpartum.  Again, one sample of donated milk does not tell us enough about a breastfed baby’s exposure to toxins.  And no comparison made with mothers who do not breastfeed and use infant formula, means our understanding is limited.

The mothers who participated in this research were mostly Caucasian.  Sixty-two percent of the mothers had advanced degrees with 46 percent having middle incomes ($70,000-100,000).  It would seem that these women would probably have far less exposure to PFAS chemicals than women of lower income.  While all populations are important to study PFAS chemicals exposure, I would like to see more studies done on women/babies from riskier environments (those living in more industrial areas where these chemicals are manufactured) in order to get a total picture of the reality of this problem.

One of the more interesting issues brought up in a research paper I ran across states, “Levels of PFASs in breast milk have been reported to be lower than PFAS levels in maternal plasma and serum in matched samples collected from the same donors (Hinderliter et al. 2005; Karrman et al. 2007; Liu et al. 2010).” “Per- and Polyfluoroalkyl substances in human breast milk and current analytical methods,” Macheka-Tendenguwo et al.  Environmental Science and Pollution Research, 2018.

This has also been documented in rats.  Are breastfed infants being protected from toxins in their mother’s milk? This needs to be more fully explored.  This means that studies need to have not just donor milk samples, but also paired blood samples from the mothers in the study.

https://link.springer.com/article/10.1007%2Fs11356-018-3483-z

CONCLUSION

We do have to clean up the environment for the safety of people on earth now and into the future; that is if we want a future.  The risk of chemical toxins to infants should be based on  accurate statistics of what babies are being fed in their first year of life, babies’ exposure levels prenatally, defining feeding methods as well as including infant formula feeding, the need for multiple milk samples paired to mother’s blood samples, and long term studies on how chemical toxins impact the short and long term health of babies.  Focusing only on the chemical toxins in human milk, does a grave disservice to our society, and its ability to safeguard the next generation. 

 

 

 

 

 

PFAS, "FOREVER CHEMICALS," & BREASTFEEDING PART 1

“I would like you to show me, if you can, where the line can be drawn between an organism and its environment.  The environment is in you.  It’s passing through you. You’re breathing it in and out.” –Wendell Berry, author, poet, environmental activist

INTRODUCTION

We cannot separate ourselves from our environment.  From the first breath as a newborn, to our last breath on this earth; we are one with our environment.  We breathe in gasoline fumes at our local gas station or the fresh paint fumes of a newly painted room; and our lungs, blood, and cells must process those chemical toxins.  Breakfast, lunch, and dinner reflect the environment of where our foods are grown, processed, and packaged.  With the global food economy, it is very likely that what we eat reflects the global rather than local environment.  Our skin protects our internal organs from the environment but it also absorbs and transfers chemicals in our environment into our blood stream. As Wendell Berry so eloquently says, “The environment is in you.  It’s passing through you.”

The burden of chemical toxins in our environment is also passed onto the next generation.  The fetus lives for months inside the mother’s womb.  The womb does not provide a barrier against many chemical toxins but rather transfers them to the fetus.  If the mother in her pregnancy is in contact with toxins in her environment; she transmits those toxins to her fetus.  Scientists believe that exposure prenatally and during infancy can be more harmful than later in life. It is also believed that the first born baby receives substantially more toxins in utero than subsequent siblings.  Mother’s milk reflects the mother’s environment; passing on the chemicals the mother encounters to her offspring.   While mother’s milk reflects the mother’s environment it also is the mechanism in which newborn’s are protected from pathogens (bacteria, viruses, fungi, and parasites) in the mother’s environment.  The mammary gland creates antibodies to the pathogens in the mother’s environment. Some toxic chemicals (PFAS, forever chemicals for example) attack the human immune system, suppressing the antibody response.  

US newborns/babies are fed a variety of ways and exposed to a variety of food and environmental products.  Studies that actually define breastfeeding categorize breastfeeding into 2 groups:  exclusive breastfeeding and partial breastfeeding/mixed feeding. Exclusive breastfeeding is usually defined as babies given no foods/solids, water, or liquids, only breastmilk.  Partial breastfeeding/mixed feeding is often defined as babies given infant formula, as well as solids/foods, water, or other drinks. These definitions do not categorize babies that are fed human milk in a bottle either exclusively or partly.   In the US about 20-30% of infants are never breastfed.  Of those babies, some are exclusively formula fed, and some also receive food/solids and drinks besides their formula.  While some 70-80% of mothers exclusively breastfeed in the early weeks postpartum, only 30% are exclusively breastfeeding at 3 months postpartum.  US infants are exposed to a variety of foods, baby formulas, and drinks in their first year of life.  How researchers define the way babies are fed is critically important to our understanding of which babies are more at risk to exposure of toxic chemicals.  Yet environmental studies usually do not define breastfeeding or breastmilk feeding. Studies on infant feeding that totally focus on environmental toxins in breast milk without defining breastfeeding or also measuring toxins in infant formula, do not give a clear or actual picture of the risks of toxic chemicals to infants.  And when these studies are broadcast in the media, are they helpful to parents?  Or do these media reports create more harm than good?  Why are researchers focused on human milk and its contamination; rather than looking at the broad spectrum of feeding methods and products given to US newborns and babies? US media headline’s scream toxic, contaminated breast milk, but have no apparent interest in why most scientists aren’t researching toxins in baby formula. [US CDC data on exclusive breastfeeding] https://www.cdc.gov/breastfeeding/data/nis_data/results.html

FOREVER CHEMICALS, PFAS IN HUMAN MILK

There are some 5000 PFAS chemicals; these forever chemicals are described in the recent US media articles.  For example The Guardian published the article, “Study finds alarming levels of ‘forever chemicals’ in US mothers’ milk,” written by Tom Perkins in May of this year.  The author states breast milk levels of PFAS in a new study are “at levels nearly 2,000 times higher than public health advocates advise is safe for drinking water.”  https://www.theguardian.com/environment/2021/may/13/pfas-forever-chemicals-breast-milk-us-study

The article does state that no standards exist for PFAS in breast milk.  But does not mention that water standards vary from state to state and the 1 parts per trillion (ppt) recommended by the Environmental Working Group is not the same recommendation made by the EPA (Environmental Protection Agency-US Governmental agency).  The EPA recommends 70 ppt. There appears to be no consistent water standard for PFAS chemicals in the USA.   The study that Perkins is revealing states that the levels of PFAS in this new study ranged from 50ppt (lower than the EPA water standard) to more than 1850ppt.  Yet at the Toxic-Free-Future-Action-Center, in which many of the researchers in this particular study were a part of, they state, “…the study finds that 50 out of 50 women tested positive for PFAS, with levels ranging from 52 parts per trillion (ppt) to more than 500ppt.”  There is a huge difference between “more than 500ppt” to “more than 1850ppt.”  One would suppose that the article from Toxic Free Future would be correct.   https://toxicfreefuture.org/research/breast-milk-study/

The research paper states that the PFAS concentrations in breast milk were the sum of 16 different PFAS chemicals with the predominant PFAS being PFOS and PFOA.  Those 2 PFAS showed a decline from breast milk samples taken in US in 2004.  Both these chemicals are no longer manufactured in the US and have been around since the 1940s.  Yet the Guardian article did not mention this decline, but focused on the “alarming levels of PFAS chemicals.” 

BACKGROUND INFORMATION

There are some 5000 or more PFAS chemicals, “forever chemicals,” being manufactured around the world. Two of the most commonly detected PFAS chemicals in the US are PFOA and PFOS.  These two chemicals are no longer manufactured in the USA but are still manufactured in other countries.  PFOA was used to produce Teflon products and PFOS was used to produce ScotchGard-a water/stain resistant product used in fabrics. PFAS chemicals are suspected to increase the risk of various cancers:  kidney, thyroid, prostate, bladder, ovarian, liver, testicle, breast, and pancreas. Other suspected health risks are increased cholesterol levels, increased risk of high blood pressure or pre-eclampsia in pregnancy, small decreases of infant birth weights, decreased vaccine response in children, changes in liver enzymes.  Lab animals have shown damage to their livers and immune systems, birth defects, and newborn deaths.  PFAS chemicals do not concentrate in the fat/lipids of the body.  They bind to serum proteins (albumin, globulin).  The human body stores PFAS chemicals in the liver, blood, kidney, and muscle.  The chemicals are slowly excreted in the urine and feces.  Humans are exposed to PFAS chemicals primarily through ingestion of food or drink.  But also exposed to these chemicals through inhalation, and skin contact.

PRODUCTS THAT CONTAIN PFAS CHEMICALS  

Fire fighting foam-contamination of wells near airports and military base  

     Flame retardants in clothing-found in 80% of baby and children’s clothing

     Most US infant car seats- flame retardant/stain and water resistant fabric

Water resistant fabrics-found in upholstery and upholstery in cars

Teflon used in cooking pots/pans;  The chemical contamination of the Ohio River in West Virginia and Ohio by Dupont now Chemours (a spin-off company of DuPont)  in the production of Teflon products has resulted in a US lawsuit. https://pfasproject.com/2018/02/12/ohio-attorney-general-sues-dupont-chemours-over-c8-contamination/ Lawsuits in North Carolina https://www.ncdoj.gov/attorney-general-josh-stein-takes-legal-action-against-dupont-over-pfas-pollution/  Interestingly, Dupont’s Nutritional unit manufactures Human Milk Oligosaccharides (HMOs) for use in baby formulas.  Dupont applied for FDA GRAS for their manufactured HMOs derived form Escherichia coli K12 strain.  FDA had no questions. GRAS notice #897  https://www.fda.gov/media/136755/download 

Pesticides mosquito spray, migration of PFAS from storage container such as High Density Polyethylene (HDPE)

Carpeting

Microwave popcorn bags

      Food packaging-for example pizza boxes 

     Cosmetics

Hand Sanitizers

Dental floss

Plastic food storage containers

Drinking water in many US muncipalities and water bottles

Laptops and smart phones 

*Lab equipment-for example: reagents, glassware, tubing, vial caps, aluminum foil, filters

*This poses problems for researchers of PFAS chemicals, requiring that lab equipment must be checked for PFAS chemical contamination before its use.

THE MEDIA PORTRAYAL OF PFAS CHEMICALS IN HUMAN MILK

There is very little objectivity in articles published in the US media.  Most articles in this past decade appear to be biased in favor of corporate interest; which is about increasing profits.  Reality is far more nuanced than the media portrays.  Scientific studies are not necessarily a true description of the natural world and how it works.  Nor is one study necessarily a definitive understanding of what is being researched.  The reality is that isolating one component from other components may give us some understanding of that one component but that one component does not work in isolation. Isolated cells only exist in science labs and only with the aid of various chemicals and human manipulation.  

Copyright 2021 Valerie W. McClain