Thursday, February 19, 2015

A 1950's infant formula patent: reflections and questions

"Following the termination of breastfeeding, there is evidence of ongoing protection against illness due to protective influences on the immune system mediated via human milk.  Industry continues to attempt to improve infant formula with the addition of compounds such as fatty acids, oligosaccharides, nucleotides and lactoferrin.  However, human milk has such far-reaching effects on the infant's immune response that optimal development depends heavily on its provision."  The Impact of Breastmilk on Infant and Child Health by Wendy H. Oddy BAppSc MPH PhD (Breastfeeding Review 2002; 10(3): 5-18)

Deja vu?  Remember the movie, Groundhog's Day, with actor Bill Murray?  I feel like I am living that movie and its rather hilarious and sad at the same time.  Frustrating, you bet it is frustrating.  What we know about breastmilk and infant formula is still well hidden in our society.  So reading papers from a decade ago, like Ms. Oddy's paper in Breastfeeding Review is...well its a Groundhog's Day moment.   I read the epidemiological evidence in the early 1990's and presumed or assumed that this evidence would take hold in our society.  Instead it seems we have had a media campaign for the past 3 years to convince people that infant formula is just as good as breastfeeding.  Ms. Oddy states boldly in the abstract of her paper, "Infant-formula-feeding is inferior to breastfeeding because human milk provides specific and non-specific factors that have long-term consequences for early metabolism and the devlopment of disease."

As I reread Ms. Oddy's paper, I found myself reflecting on why our society is so resistant to the information that infant formula has health risks.  Why is this information consistently buried in our society?  I remember as a La Leche League leader in the 80's and early 90's that the emphasis was on promoting breastfeeding, discussing the benefits.  Not much was said about the risks of infant formula.  It seemed to be an unspoken rule.  I remember reading, Breastfeeding Matters by Maureen Minchin in 1990 and being blown away by the information.  Then reading in the Journal of Human Lactation an article by Marsha Walker, IBCLC in 1993 entitled, "A Fresh Look at the Risks of Artificial Infant Feeding," JHL 9(2): 97-107 in which she states, "Declining breastfeeding rates and the aggressive marketing of breast milk substitutes has blurred the distinction between breast milk and formula."   Around the same time, I read, "The Politics of Breastfeeding," by Gabrielle Palmer.  These 3 publications influenced me enormously.  At the time I remember thinking that parents should know this information and they should know this information before their babies are born.  In fact all of society needs to know the risks of infant formula to better understand why infant formula advertising needs to be curtailed.  The reason for the establishment of the WHO Code in the 80's was the recognition that aggressive infant formula marketing was causing a decline in breastfeeding.  Now in recent years, we have seen the rise of breastfeeding initiation rates but continuation rates are poor.  Mixed feeding (breast and bottle feeding) is the predominant mode of feeding in the USA.  Infant formula advertising has changed to meet the challenge of increased breastfeeding initiation rates.  Current themes in advertising seem to be geared towards scapegoating breastfeeding advocates, trying to make advocacy appear to be aggressive and mean-spirited.  Yet there is still the repetitive advertising theme from the 1990s in which breastfeeding and infant formula feeding is promoted as a choice, a personal lifestyle choice.  The risks of infant formula do not exist while breastfeeding is put on a pedestal.  The pedestal in which most women, mere mortals, will admire but never truly obtain.  Countering such advertising is difficult.  It is not impossible, if the WHO Code was utilized to balance public information on infant feeding.

The other day I ran across an infant formula patent filed in 1952 and owned by American Home Products (which became Wyeth in 2002, which became Pfizer in 2009, which Pfizer sold to Nestle in 2012 for $11.85 billion--yes billion) invented by RM Tomarelli et al and entitled, "Infant feeding compositions."

This patent from the 1950s is about supporting the growth of Lactobacillus bifidus in baby formula.  The inventors found that a growth promoting factor that supports the growth of Lactobacillus bifidus in the infant intestinal tract in hog gastric mucin.  I had never heard of hog gastric mucin. While researching this I found an article entitled, "Pig stomach mucins are effective as anti-viral agents for consumer products," dated April 25, 2012.  One product that this current research suggested was to use pig stomach mucin in infant formula.

American Home Products (Wyeth) knew about hog gastric mucin (aka pig stomach mucin) in the 1950s.  Although they weren't trying to find an anti-viral component for infant formula but rather trying to promote the Lactobacillus bifidus (L. bifidus) factor for their infant formulas.  Their reasons for trying to promote L. bifidus were,

"Medical authorities are now in general agreement that many of the advantages which a breast-fed infant seems to have, in so far as its nutrition and resistance to certain diseases are concerned, are attributable, at least in part, to the predominance of L. bifidus in his intestinal tract."


"In any event, where the gram-positive bacillus L.bifidus is present in large numbers in the infant intestine, which is now found only when the infant is breast-fed, there is considerable less growth of other microorganisms, particularly of the gram-negative B. coli, the Clostridia, and of certain air born microorganisms such as the Sarcinae bacteria."


"The fact that a stable L. bifiaus [misspelled? I believe they mean bifidus] flora is characteristic only of the intestinal tract of breast-fed infants is now fully understood and appreciated by pediatricians and other specialists in the medical, biological and nutritional sciences....the original observations of Tissier concerning the predominance of L. bifidus in nurslings stool have been amply confirmed is pointed out in the more recent publication of Norris, Flanders, Tomarelli and Gyorgy..."

Interesting to find this patent written so many years ago and find that the infant formula industry was trying to imitate human milk using hog gastric mucin.  And 60 years later, they are once again interested in hog gastric mucin (pig stomach mucins).  But more curious is that they knew that L. bifidus (what we now call a probiotic) created positive health effects in the breastfed baby.  They knew that there was a difference between the breastfed and the formula fed baby.

How far have we really come in our understanding?  We seem to be spinning our wheels, playing Groundhog's Day with information on the health effects of breastfeeding and not breastfeeding.  How far has the infant formula industry come in improving infant formula?  In the 1950's they would use hog gastric mucin and in 2012 they are back to thinking about using this component.  I imagine it will be genetically engineered because that is the current fad in our biotech world.  Have we gone forward in making a safer infant formula?  Or perhaps are we just spinning our wheels, in a circle of belief that somehow men and women of science have the god-like understanding of human milk and making a safer infant formula.
Copyright 2015  Valerie W. McClain


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