THE PUMP ACT: BREASTFEEDING ACCOMMODATION OR BREAST MILK ACCOMMODATION?

“Words are the essential tools of the law.  In the study of law, language has great importance; cases turn on the meaning that judges ascribe to words, and lawyers must use the right words to effectuate the wishes of their clients.”—Professor Sheila Hyatt, University of Denver-Sturm College of Law

“But if thought corrupts language, language can also corrupt thought.”—George Orwell

Once again I see the word, breastfeeding, corrupted by the common belief that breast-milk feeding is equivalent to breastfeeding.  This time it is in a proposed law at the US House of Representatives (HR#3110) and the Senate (S#1658).  The proposed bill is called The Pump Act (described in the media) or The Pump for Nursing Mothers Act (described in the legislation).  This bill states, “An Act to amend the Fair Labor Standards Act of 1938 to expand access to breastfeeding accommodations in the workplace, and for other purposes.”

I decided to look for breastfeeding accommodations in this proposed legislation, and read nothing about “breastfeeding.”  The two main points of this proposed bill (the 3^rd amended text, October 22, 2021) are, “An employer shall provide—(1) a reasonable breaktime for an employee to express breast milk each time such employee has need to express breast milk for the 2-year period beginning on the date on which the circumstances related to such need arise, and (2) a place other than a bathroom, that is shielded from view and free from intrusion from co-workers and the public, which may be used by an employee to express breast milk.” This 3^rd version proposed from the House has changed from the 2^nd version. Instead of companies with less than 25 employees are exempted from the proposed law, it now states companies with less than 50 employees are exempted from the proposed bill.  It still states that mothers qualify for a 2-year period of breastfeeding. https://www.congress.gov/bill/117th-congress/house-bill/3110/text

The Senate’s version of this proposed legislation (#1658) varies from the House of Representatives 3^rd version in one major provision.  It states that mothers qualify for a 1-year period of breastfeeding not 2-years as proposed by the House bill.  The Senate’s version appears to be identical (in regard to these 2 issues) to the legislation in the Affordable Care Act of 2010.  https://www.congress.gov/bill/117th-congress/senate-bill/1658/text?r=77&s=1  

Will reconciliation of the proposed bills in the House and Senate, if passed, result in 1-year or 2-years?  I will be pleasantly surprised, if a 2-year period for pumping breast milk is accepted.  I was amazed that mothers donating breast milk was not listed specifically as a reason for pumping.  Employers might not like the idea of a mom taking time out from her job with them to make money (if donating to for-profit milk banks) from her breast milk.

This proposed law does not require that the employer pay the employee for breaks, unless the employee is required to also work during said breaks.  Federal law mandates that employers must pay for short, allowed, breaks of employees during the day; and lunch breaks must be paid, if employees are required to work thru their lunch.  Although, there is no Federal law that requires employers to provide lunch and rest breaks.  Federal laws take precedence over State laws.  But what about states, like the one I live in, Florida, in which employers don’t have to provide either rest or lunch breaks?  If the employee is not allowed any breaks, then I would assume this proposed law does not apply to them.  Currently there are only about 20 States that have break laws, and only 9 that mandate lunch and rest breaks.  https://quickbooks.intuit.com/time-tracking/flsa/labor-laws-breaks/

Is this proposed bill truly about breastfeeding accommodations?  This appears to me to only be about accommodations for breast-milk feeding.  Does pumping ultimately encourage breastfeeding?

According to a paper entitled, “Breastfeeding and the Affordable Care Act,” by Hawkins et al., statistically mothers who are employed fulltime have a shorter duration of breastfeeding than non-working mothers.  Mothers who have maternity leave of 12 weeks or less are less likely to even initiate breastfeeding.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4555840/

From my perspective wouldn’t paid maternity leave of at least 6 months encourage breastfeeding initiation and duration rates? Why is our society so hell-bent on separating mothers and babies?  This lack of recognition of the physical and emotional toll of separated moms and babies is an example of how women and children are treated in a capitalistic society.

This legislation supposedly about breastfeeding accommodations brings to my mind the following question. What about a mom who would like to breastfeed her baby during breaks?  Some employed moms have caregivers that are willing to bring the baby to the employed mom so that she could breastfeed.  If this became an acceptable practice, more women and their employers might consider it.  They might even consider having childcare facilities within their buildings, or close-by. This would in some cases alleviate the need for pumping so much.

I am curious about the role of breast pump companies in regard to “breastfeeding accommodation” legislation.  For instance back in 2017, Representative Carolyn Maloney, is pictured with breastfeeding advocates in support of a proposed bill,”Supporting Working Moms Act.” This appears to be similar to the Pump Act bill proposal of 2021.  I find it interesting that among the breastfeeding advocates pictured with Representative Maloney is a Medela representative and someone from a company (that sells/rents breast pumps) YummyMummy on the internet.  https://maloney.house.gov/media-center/press-releases/rep-maloney-joins-with-moms-and-advocates-to-support-mothers-rights-to

It is not surprising to me that a breast pump company and a company that sells a variety of breast pumps were supporters of the previous proposed bill.  After all,  business is a priority in our society.  Legislation certainly reflects that priority.    Words are important within the legal system.  Should we be surprised that our system of law-making considers breastfeeding and breast-milk feeding the same thing? 

There is nothing in the current proposed law which is truly making breastfeeding accommodations.  Should we believe that all or most of the moms pumping in the workplace are able to breastfeed at home.  How much time does a full-time working mom have at home to feed her family, pump her breasts, and breastfeed her infant?  And most working moms are still doing the majority of household chores, too.  Which obligation at home do mothers give up in order to make life less stressful? 

I found this interesting article in regard to Medela from Bloomberg Business Week entitled, “How Medela Lost Moms,” by Esme E. Deprez.  According to the author, Medela in US profited greatly for a couple of years because of the Affordable Care Act passage in 2010. After 2 years, many more pumps companies came into existence because the Affordable Care Act legislated that some pumps could be paid for by health insurance companies.  The following statement, “A new mother’s relationship with the brand often starts almost as soon as her baby is born, backed by the hospital’s seal of approval:  A nurse or lactation consultant parks a $2000 Medela breast pump by her bedside, places a silicone Medela protector over her inverted nipples, and provides relief from chafing with a packet of Medela lanolin.” https://www.bloomberg.com/news/features/2020-12-09/how-medela-known-for-its-breast-pumps-lost-its-monopoly-on-moms

Reading that very long sentence in the above article, I thought one could replace the words, Medela and breast pump, with the name of any infant formula company.  The infant formula industry often use these tactics of making moms believe that anything they see or get in the hospital is medically approved.  Hospital approved/doctor approved is a real old advertising tactic.  And sadly it works. 

The influence of companies in creating legislation, and their product placement influence in hospitals is great.  I remember a teen mom asking me some years ago, why would the nurses give her a case of formula, when she didn’t need it?  Why are nurses parking breast pumps in front of mothers who just gave birth?  Convenience? 

While I do not know, if pump companies influenced this current piece of proposed legislation; I think it an odd coincidence that breastfeeding accommodations are only about breast-milk feeding in the workplace.  This proposed bill does not help moms who work in jobs like restaurants where breaks only happen during slow times.  In breastfeeding and the Affordable Care Act, the authors’ state, “In fact, research demonstrates that the proportion of women protected by comprehensive breastfeeding policies in the workplace varied widely between states.”  I don’t see how the Pump Act resolves this very crucial issue of State variability of protection or how this bill creates breastfeeding accommodations in the workplace.

Copyright 2021 Valerie W. McClain

A RECENT TWEET ON HUMAN MILK

A recent Tweet by the US Breastfeeding Committee states that, "human milk is always clean, requires no fuel, water, or electricity."

 

Should we believe that the words human milk and breastfeeding are words that are interchangeable?  This tweet by the US Breastfeeding Committee is an example of how substituting the word, human milk, for breastfeeding makes the statement incredibly wrong.  As someone who has gone through multiple hurricanes over the years, I have a very different understanding about living in a disaster zone.

Human-milk-feeding requires access to electricity to store the mammary gland product.  Some breast pumps require electricity.  Guess what happens in a hurricane?  Power goes out, no electricity.  Those families that have a well for their water can no longer access their water supplies.  Why?  Wells require a pump that runs on electricity.  In tropical storms or hurricanes, city water supplies may also be shut down by flooding.  One cannot run backup generators, if the area is flooded.  If you have a generator, you need gasoline.  Guess what happens prior to an area in which the hurricane or storm is expected?  Gasoline becomes a scarce commodity.  Most gas stations are shut down prior to a storm because they have no gas. After the storm passes, there is still no gas because gas pumps run on electricity.

When Hurricane Charlie hit Volusia County some years ago, I was without power for 11 days.  I knew families who were without power for more than 11 days.  In order to bottle feed human milk to babies, one needs a way to clean bottles and nipples/teats. There is a need to refrigerate that milk.  In climates like Florida, high heat and humidity without access to refrigeration, spoils food within a short time.  While human milk, unlike infant formula, does not need to be refrigerated as quickly; it will eventually be questionable to use.  Freezers defrost quickly without electricity.  I had a deep chest freezer. It defrosted some 48 hours after the electricity went off.  Ice was difficult to obtain after Hurricane Charlie.  And the ice in picnic-style ice chests melted within 24 hours.

Does stored human milk have the same immunological properties as milk obtained through breastfeeding?  It is certainly a better food for babies than formula. What studies do we have that compares the health of babies fed bottled human milk versus babies that are breastfed?  Might there be differences?  We do know that nutritionally a food is best served fresh, then 2^nd best is a frozen food, and last is canned foods. 

I am surprised by how quickly the breastfeeding community has forgotten the fiasco of sending donor milk to a disaster, after the devastating earthquake in Haiti in 2010.  Breastfeeding mothers in the US were asked to donate their milk for the poor babies in Haiti.  What happened is that Haiti could not use that donated milk, because they didn’t have the infrastructure to store it. An article in Time called, “Breast-Milk from Haiti:  Why Donations Are Being Discouraged,” 1/29/2010

“That's why the World Health Organization, UNICEF and the United Nations World Food Programme issued a joint statement Jan. 21 that the necessary infrastructure isn't yet in place to utilize donated breast milk on the Haitian mainland.

Public-health officials maintain that breast is best in emergency situations, but only when Mom is right there to feed the baby — no need for temperature control or bottle parts to wash. Breast-feeding is self-contained, readily available and chock-full of antibodies that protect infants from infection and disease.”

http://content.time.com/time/specials/packages/article/0,28804,1953379_1953494_1957614,00.html

The belief that bottled human milk can be used in a disaster is predicated on unrealistic understanding of disasters.  Breastfeeding is the safety net in emergency situations. 

The belief that human milk and breastfeeding are one and the same words is prevalent in social media.  Why?  From my perspective the rise of this amnesia regarding the use of the word, breastfeeding, has happened at the same time as the rise of the human milk industry, and growth of human milk banking.  What makes money in our society?  No, not a mother breastfeeding her baby.  Nope. 

Copyright 2021 Valerie W. McClain

 

 

BREASTMILK OR BREASTFEEDING?

I ran across  the above meme on Facebook and it appears to be credited to a Lactation University.  The meme is an example of breastmilk advocacy not breastfeeding advocacy.  The use of a breast pump bottle is emblematic of the current direction of infant feeding.  

We are to believe that, "breastmilk has everything your baby needs." Everything?  I believe that breastfeeding has everything that your baby needs.  Something is seriously wrong with the thinking that a product is what babies need.  Babies need their mothers: their warmth, their touch, their smell,their voice.  It is mammalian survival of the next generation.  The primal need of the newborn is to seek the breast.  We have seen the videos of newly born babies crawling to the breast (based on Dr. Lennart Righard's research).  This biological drive is circumvented and suppressed in many medical facilities by separation of mothers and babies.

The baby bottle is a symbol of mother-baby separation.  Our society promotes this separation, and mothers buy into it even though they may feel torn apart mentally and physically.  It appears to me that we hold the bottle in more esteem than the breast.  If we want a accurate comparison of infant formula versus breastmilk, the container for breastmilk is the breast.

I am somewhat fascinated by the actual drawing of this meme.  The infant formula bottle appears to me to be larger than the breastmilk pump bottle.  The infant formula bottle is taller and wider than the breastmilk pump bottle. Our eyes are drawn to the infant formula bottle. The infant formula bottle does not show that formulas now include human milk components (usually genetically engineered) based on breastfeeding research:  DHA/ARA oils, various probiotic bacteria, human lactoferrin and Human Milk Oligosaccharides.  The water that is in breastmilk is produced through metabolism (glucose +oxygen).  Water is 87.5% of human milk volume (Breastfeeding and Human Lactation 2nd edition-Riordan and Auerbach, 1999. pg.134). This is very different from the water that is added to infant formula by the infant formula industry and/or parents.   In fact part of the concerns about infant formula is that many public water systems are contaminated with various toxic chemicals like PFAS chemicals.  Too much water from outside sources can cause water intoxication (which can be deadly) in babies.  Thus parents who use infant formula must use care in measuring ingredients if they are using powder or liquid concentrate.  The breastfeeding infant needs no extra water, not even in very hot climates. 

Are the ingredients in baby formulas equivalent to breastmilk?  Those ingredients must be able to have a shelf life of about 18 months.  Infant formula must be a sterile (without life) substance.**(please scroll down for a correction made 9/11/2021) Breastfeeding provides an infant with a live substance.  Breastmilk in many cases will be frozen and reheated by mothers or pasteurized at donor milk banks.  Or if breastmilk is given/sold to for-profit biotech companies, it becomes a substance more like infant formula than what is produced by the breast.  The for-profit company take breastmilk apart for its components, add or subtract the fats, defrost it, freeze it, defrost it again, freeze it again, add Martek oils (DHA/ARA oils which are genetically engineered) add other vitamins and minerals.

The promotion of breastmilk rather than breastfeeding benefits a number of companies.  It may have not been the intent of the designer of this meme, but the bottle is obviously a breastpump bottle. There is a belief system underlying this meme that bothers me.  It bothers me that other breastfeeding advocates seem enthusiastic about such memes.  I feel like we are going backwards.  Is the only way to get women interested in breastfeeding is to promote breastmilk and pumping?  Shouldn't we be promoting breastfeeding?  Which means we need to also promote legislative protections for moms to not be separated from their babies.  Family leave for moms should not be some farfetched dream.  Other countries pay moms to stay home, if they want.  Why can't we do this?  I have seen the health ramifications for moms going back to employment at 2 weeks postpartum.  Moms who had c-sections (major surgery plus caring for a newborn) who felt that they would lose their jobs, if they went back later than 2 weeks..  Instead they endure physical problems, and end up quitting breastfeeding because they are exhausted.  They don't complain, but there is the element of depression.  Somehow the joy of motherhood becomes a long to-do list that never ends.  

I think the above meme was an educational tool for future IBCLCs. But I see it as the direction of breastfeeding advocacy.  Like the infant formula industry, breastmilk advocacy seems to believe that women won't or can't breastfeed.  Won't or can't breastfeed, is a ramification of lack of real support.  Won't or can't breastfeed, is a society's lack of vision, driven by the ideology of products can replace relationships. 

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. CDC guidelines on preparing powdered infant formula.

 https://www.cdc.gov/cronobacter/infection-and-infants.html

 

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.