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


Saturday, February 7, 2015

Infant Formula Advertising in the USA, the WHO Code, and a profession

"Is breastfeeding 'worth the bother'?  The epidemiologic evidence is strongly affirmative.  Important protection against gastrointestinal infections in every setting has been confirmed and reconfirmed;  most clinicians now accept such observations.  Many clinicians, however, are surprised to learn that breast-feeding is associated with significant reductions in nongastrointestinal infections, including pneumonia, bacteremia, and meningitis, and with a reduced frequency of certain chronic diseases later in life.  Much of the important data concerning the health benefits of breastfeeding appeared in the last decade and are not widely known..."
--Breastfeeding and Health in the 1980's:  A Global Epidemiological Review, by Allan S. Cunningham, Derrick B. Jelliffe, E.F. Patrice Jelliffe
Journal of Pediatrics 118: 659-666 

I would venture to say that the epidemiological evidence regarding the value of breastfeeding to the health and well-being of babies and mothers are still relatively unknown.  The infant formula industry says, "Breastfeeding is Best." But ask a parent or even some health professionals why breastfeeding is best and listen to the response.  The answers are usually generalities nothing specific and never about the risks of infant formula.  There is a presumption that in developed countries like the US, that infants do not die from the way in which they are fed.  The belief is that infant formula is only a risk in developing countries, like countries in Africa.

Yet according to US infant mortality data, babies in the US die from pneumonia, gastrointestinal infections. bacteremia, meningitis and SIDs.  Would breastfeeding have prevented or reduced some of these deaths?  What do we really know about infant mortality statistics in the US and the relationship to how an infant is fed?  It would be easy to find out, if we required each infant death certificate to state how the infant was fed in the last 24 hours (or last 48 hours or last week) before death. 

I read "Breastfeeding and Health:  A Global Epidemiological Review," over a decade ago.  And the evidence from research done in the 80's is still relatively unknown to the general US population.  But now that evidence is being used to create novel and "improved" infant formulas, create patents, and monopolize those "inventions."  We see the advertisements that the new formula is closer to breast milk.  Are these formulas closer to breast milk because the industry has claimed the DNA (cDNA) of various breast milk components?   In US patents and patent applications, infant formula companies are creating novel ingredients through genetically engineering.  How much of those novel, genetically engineered ingredients are actually placed in infant formula is unknown.  The US infant formula industry does not have to label gmo ingredients because the FDA considers gmo and natural ingredients equivalent.

How much of our society's ignorance of what is in the can of infant formula and ignorance of risks regarding infant formula is orchestrated by industry?  How much of it is caused by an unwillingness to openly discuss risks of infant formula.  It seems that breastfeeding advocacy can only discuss the risks of not breastfeeding.  The risks of not breastfeeding is not the same statement as risks of infant formula.  The risks of not breastfeeding presumes that there are also risks in breastfeeding.  Is that true?  Risks of not breastfeeding is in reality an avoidance of discussing the risks of infant formula.  Its a word game to avoid offending infant formula feeding mothers but also results in letting an industry "off the hook."  

The consequences of letting an industry off the hook is that advertising/marketing gets more and more outrageous.  The recent Similac Ad, which some parents refuse to understand is an advertisement, is a prime example of how the internet not only impacts one country but the global community. With the rise of the internet and the multitude of devices that now connect to the internet, the infant formula industry has a global reach in advertising.  The wealth and power of an industry's marketing department has the ability to influence the hearts and minds of many, many people.  We have marketing that is so sophisticated that the audience does not even understand that what they are watching is an advertisement.  

Our society believes in choice, when it comes to infant feeding.  Yet making a choice presumes that that the person is making an "informed" choice.  Does direct advertising of infant formula to the public give parents an "informed" understanding of the benefit/risk ratios involved in their decision-making?  The infant formula industry has millions in which to advertise their products.  How much money does breastfeeding advocacy organizations have in their budgets to promote breastfeeding?  Not much in comparison.  Are parents around the world getting a balanced view in making their "choice" to breastfeed or not?  

Advertising directly to the public, gives the infant formula industry an unfair advantage.  When choices are made because of advertising, is it really choice?  We have had regulation of advertising in regard to the Tobacco Industry because of their unfair influence over young people to smoke.  Once a person starts to smoke it is very difficult to quit.  Likewise once a mother starts using infant formula, it becomes very difficult to reverse that decision.  Regulations on Tobacco advertising have not ended the industry, people are still smoking despite the known risks.  The curtailing of tobacco advertising and the use of extra sales tax on cigarettes to use in anti-smoking advertising campaigns has balanced public information.  Likewise we need balanced information regarding the choice of infant feeding.

So what is stopping us from using the WHO Code to balance the public information on infant feeding?  There are many reasons.  One reason I suppose is that in the US there is a belief in "free markets" and the rights of corporations (corporations are legally considered persons).  What this means politically is that any regulation of corporations is often dismissed by various political groups.  Although amazingly enough, our country started regulating the advertising of tobacco because more and more people understood the health risks of tobacco.  If more and more people understood the health risks of infant formula, I believe advertising of infant formula would be curtailed in the US.  We would then be abiding by at least one of the provisions of the WHO Code.
One of the provisions of the WHO Code is "No advertising of breastmilk substitutes."

Another thought I have is that IBCLCs request that the IBLCE re-institute the principle of ethical practice in which, "IBCLCs must adhere to those provisions of the International Cod of Marketing Breast-Milk Substitutes and subsequent resolutions which pertain to health workers." (#24)

In 2011, the IBLCE (the certifying organization for IBCLCs) eliminated the Code of Ethics for IBCLCs and renamed it the Code of Professional Conduct for IBCLCs.  There is no principle regarding the need for IBCLCs to adhere to the WHO Code.  Although interestingly enough they did keep the principle of respecting intellectual property rights (which includes patents).  The WHO Code does appear briefly on the Code of Professional Conduct for IBCLCs prior to the Preamble but it is no longer a principle.

I realize that people think that because the WHO Code is mentioned prior to the listing of principles that this is just as good as having it as a principle.  But I think that by removing this as a principle seems to imply that the WHO Code is really not an important principle.  And in the FAQ regarding the Code of Professional Conduct for IBCLCs, I find the statement regarding the question of whether it is unethical for an IBCLC to work for an infant formula company to be most illuminating.  "However, from a legal perspective IBLCE cannot prohibit, or pursue ethical sanctions against a certificant who chooses to work for an infant formula company."

I have been rather astounded by this perspective by the IBLCE.  It's one of the reasons I let my IBCLC credential lapse.  I think if one believes as I do that breastfeeding is a health care decision not a personal lifestyle choice, then one of the principles of a profession that serves mothers and babies has to be the WHO Code.   

I think if we understand the history of the last 50 years regarding the epidemiology of breastfeeding, we would regard the WHO Code as vitally important.  If we continue to avoid the need for the Code, then we will continue to see more of the kind of advertising like the Similac Ad.  Scapegoating breastfeeding advocates will silence the willingness of parents to listen to breastfeeding advocates.  And it will also create advocates who are even less likely to discuss the risks of infant formula.
Copyright 2015 Valerie W. McClain