“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 4th
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.
