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

Saturday, January 31, 2015

The Similac Ad and the Tobacco Industry: Similar Marketing Strategies

"We think we should start not by raising barriers, but by lowering our voices.  We think smokers and non-smokers can work out their differences together in a spirit of tolerance and fairness and respect for each other's rights and feelings."
--RJ Reynolds 1986 from Strategies of the Tobacco Industry by Larry Breed


"I was interested to read the descriptive names and phrases used to describe those involved in the anti-tobacco movement.  They are 'zealots,' 'anti-smoking agitators,' 'health campaigners,' 'tobacco prohibitionists,' 'overzealous do-gooders' and 'busybodies.'"  Strategies of the Tobacco Industry

"Tobacco's message is free choice."  Strategies of the Tobacco Industry

If the Similac Ad was instead an ad for a specific brand of cigarettes, what would we see and hear?  What music would be in the background?  I envision that it would be Michael Jackson's Billie Jean. My feet start tapping to the beat and the words drift through my mind..."Billie Jean is not my careful of who you love  and be careful of what you do cause the lie becomes the truth."

 I see the playground and the players:  the smokers, and then we see the zealots. The do-gooders pushing through the swings.  "Look,the Tobacco police are here!"  If only smokers and non-smokers would get along because after all this is about civil liberties and free choice.  It's not about health.  It's about choice.  There is no proof that cigarette smoke cause human disease.

All the smokers and non-smokers in my imagined ad start a verbal "rumble." Who's right and who's wrong?  Just as this verbal war reaches a crescendo to the tune of Billie Jean, a smoker accidently drops her lit cigarette into an overflowing trash can.  The trash can ignites and suddenly everyone races to the trash can and together they put the fire out.  See, simple if we would all get along, our problems would be solved!!  

Then across the screen our new mantra is unveiled and the soft soothing background music--the music we hear at the grocery store to keep us soothed and buying-buying.  "No matter what our beliefs, We are people first."   Yep...I believe I believe...we are people!!  

In stark black and white we see the "Brand," the cigarette product doctor's and hospital's recommend.  And then under the "Brand" is #Peoplehood Unite.  

Should we honestly believe that the infant formula industry has no strategy? They are playing the Tobacco Industry playbook.  The playbook that reinforces the self-esteem of the people who are using their product while scapegoating advocates who consider their product a health risk.  This particular ad establishes the credibility of the company as fair players.  Its a playbook we need to understand.  And it's why we absolutely need the WHO Code to regulate the marketing of infant formula.
Copyright 2015 Valerie W. McClain


Monday, January 26, 2015

Escaping MotherHood and joining the SisterHood

PATENT #8802650 "Methods of using human milk oligosaccharides for improving airway respiratory health."  filed in December 2011 owned by Abbott Laboratories. The patent states:

"The HMO [Human Milk Oligosaccharide] or HMOs may be isolated or enriched from milk(s) secreted by mammals including but not limited to human, bovine, ovine, porcine, or caprine species."  [also may be manufactured by microbial fermentation and/or chemical processes]

"Furthermore, the use of HMOs in nutritional compositions can reduce the growth of respiratory viruses (e.g. RSV, human parainfluenza virus type 2, and influenza A virus), and thus, reduce viral-induced upper respiratory infections.   As such, by utilizing HMOs, alone or in combination with other immune enhancing factors, in a nutritional product, such as an infant formula, it is now possible to provide infants with an alternative, or supplement, to breast milk that closely mimics the benefits thereof."  

Hm...should we ask Abbott Laboratories (manufacturer of Similac) how it is that Human Milk Oligosaccharides can be found in the milks of cows, chickens[correction sheep-ovine is sheep--sorry], pigs or monkeys?  Yes human milk oligosaccharides are found in human milk but how is human milk oligosaccharides produced by other mammals?  Genetic engineering?

This patent is almost as strange as the "Similac" Ad that some people are writing about and watching on you tube.  The ad is Abbott's promotion campaign called, "sisterhood of motherhood."  This is a you tube video to end the "Mommy Wars."  Ironic, if you believe as I do, that the Mommy Wars was a public relation campaign brought to you by Similac. 

As we watch the video, we find ourselves in the Hood, the realm of "mommies" and stay-at-home daddies.  The scene takes place at a playground.  We see mommies everywhere:  sitting on benches with their babies strapped to their bosoms, striding through the park pushing strollers like their are weapons of war, mothers bottlefeeding, mothers breastfeeding in their hooter hiders, lesbian mothers, working mothers, and stay-at-home fathers cooking hot dogs while taking care of their babies.  

We are in the Hood.  The music brings us back to the place we want to escape from--the Hood or is it MotherHood?  Like so many people stuck in the ghetto of lost desires, we subliminally accept this message.  We are at war with each other and ourselves.  Mothering has become a battleground in which we all struggle to escape. The battle fronts are clearly seen as mothers march through the park.  The first words spoken in this music video are from the formula feeding mothers, "Oh look the Breast Police have arrived."  We see the breastfeeding mothers pushing through the empty swings.  One breastfeeding mother angrily shakes her breast towards the formula feeding mothers.  One breastfeeding mom states that those who don't breastfeed are, "too lazy to breastfeed."  Who do we sympathize with in this video?  It appears to me that the breastfeeding moms are the bullies of this Hood.  Most women would hate to be perceived as bullies and most women are brought up to not be aggressive on our playground called life.  Will the audience sympathize with these breastfeeding moms?

The video ends with the name Similac against a black background and the slogan, "Sisterhood Unite."  Similac is a brand of formula, the company that manufactures this particular brand is Abbott Laboratories.  I have read comments by various moms who mix this up, believing that there is a Similac company who sells Similac formula.  After watching the video I understand why Abbott is doing this.  Using the brand name of the formula rather than the company name means that more product is sold.  The company name is not as important as the name of the product they are selling. Abbott Labs is a huge well-known pharmaceutical company with no need to keep their name in your brain. 

At the end of the video, the music becomes softer as everyone chases the baby in the runaway stroller.  They all save the baby, and they all start hugging each other.  What a creative and easy solution to the "supposed" mommy wars.  Life just isn't that simple.  Solutions to problems in real life take longer than a few minutes of running downhill.  The video ends with the mantra, "No matter what our beliefs, We are parents first."  What does this really mean?  I know a lot of religious parents who would say that their faith comes first, before their parenting.  Usually we start out with a set of beliefs about parenting prior to our first child and that is often refined and even changed once we actually parent.  The mantra Similac uses is really devoid of understanding of the complexity of human conflict.  Does parenting unite us?  Or, is it just as likely to divide us?

 I have begun to imagine a Father Similac, the parent figure to us all. He comes to our rescue, quoting scripture from the book of corporate values.  The price of going along with corporate values is to ignore some uncomfortable truths, to stay silent in order to keep the peace.  Peace at any price...where have I heard that before? 
Copyright 2015 Valerie W. McClain

Wednesday, January 7, 2015

Commercialization of Human Milk--Part 2

"Indigenous  peoples worldwide are now at the forefront of a new wave of scientific investigation:  the quest for monopoly control of genetic resources that will be useful in new pharmaceuticals, nutriceuticals and other bio-engineered products."  by Debra Harry, Executive Director of the Indigenous People's Council on Biocolonialism, in 2001.


In 1990 Dr. Ivan Casas (who would later become Research Director of BioGaia of Sweden/USA- a company that markets and sells probiotics) went looking for a strain of Lactobacillus reuteri (L. reuteri) that could be commercialized.  It is quite probable that the interest in L. reuteri derived from the observation that this bacterium produced a substance called reuterin,a broad-spectrum antibiotic. With increasing antibiotic resistance, a natural occurring antibiotic, would be a great discovery, as well as of great financial interest.  In Peru he found the strain he was looking for in the breastmilk of Indians from villages high in the Andes.  He had examined breast milk from mothers in the USA as well as South American mothers in Lima Peru and had not found this particular strain.  Whether these Indian mothers from the Andes were direct descendents of the Inca or Arawak, I do not know.  But who would have believed that the milk that these women donated would contain a bacteria that would become very popular as a supplement for infants and children, as well as adults.  It would also become known as Lactobacillus reuteri Protectis, and BioGaia in 2012 would sell the rights of its patent for use in infant formula to Nestle.  "BioGaia received EUR 40 million up-front and a commitment to a further EUR 10.8 million during the period 2014 to 2017 upon achievement of certain milestones."

Initially this strain of bacteria from human milk was deposited at the American Type Culture Collection (ATCC) as Lactobacillus reuteri SD 2112 but later given the number ATCC 55730In 2007 it was replaced and became Lactobacillus reuteri DSM 17938.  According to Biogaia literature, the strains ATCC 55730 and DSM 17938 are "considered comparable in all aspects of probiotic function."  The only difference is that DSM 17938 no longer carries the two plasmids that carried resistance to tetracycline and lincomycin.  The original ATTC 55730 had these plasmids that carried antibiotic resistance.

According to the ATCC the Lactobacillus reuteri that was isolated from human milk is connected to patent #7344867,  This patent is entitled, "Selection and use of lactic acid bacteria for reducing inflammation in mammals." filed in 2005, invented by Eamonn Connolly who was the Senior VP for Research at BioGaia, and patent inventor to quite a few other patents owned by BioGaia.  Eamonn Connolly is now Head of Research and Development at Infant Bacterial Therapeutics AB of Sweden, a subsidiary of BioGaia.  He also is one of the authors of a recent paper published in The American Journal of Tropical Medicine and Hygiene entitled, "A Phase One Safety Study of Lactobaciluus reuteri Conducted in the Peruvian Amazon:  Observations from the Field,"  published 2/10/2014.  The was a phase one trial under the FDA Investigative New Drug program.  Forty-five healthy adults received either L.reuteri DSM 17938 or a placebo.

Thus the bacterium from the breastmilk of Peruvian Indian mothers of the Andes lives on and on.   And breastfeeding mothers and infant formula feeding mothers around the world will use and benefit from the donated milk/bacterium of Peruvian Indian mothers.  And a few companies will financially benefit from "their invention."  And people will continue to believe that the commericalization of human milk has not happened yet.  I find it fascinating that one of those industries that benefits from this kind of invention is the infant formula industry and particularly that it is Nestle.  If moms make the choice to not breastfeed, then industry will make sure moms get the human milk component equivalent to the real thing.   Don't ask questions about these kind of inventions.  Don't ask about ethics regarding donating human milk (breastmilk is often called white blood-the collection of white or red blood is often about collecting DNA) for research. But the next time you dose your infant or child with this particular probiotic or give the infant formula with Lactobacillus reuteri Protectis, say a little prayer of thanks to the Indian women of the Andes!
Copyright 2015 Valerie W. McClain

Tuesday, December 30, 2014

The Commercialization of Human Milk

"Human milk is not a uniform body fluid, instead, it is a secretion from the mammary gland of constant changing composition.  In nature, the composition of human milk changes not only from day to day, but also throughout the course of a single day.  While the reasons and outcome of these changes are not fully understood, it is intuitive to believe that these changes benefit the species and that substantial advantages may be gained for the infant who is provided an opportunity to reap the benefits of a modified formulation of 100% human milk."--PATENT #7914822 "Method of producing nutritional products from human milk tissue and compositions thereof," invented by Elena Medo, owned by Prolacta Bioscience

Prolacta Bioscience was founded in 1999 by Elena Medo, an inventor, and entrepreneur.  Over the past decade she has raised $33 million for 3 start-up companies:  Prolacta Bioscience (manufacturer of standardized human milk products), Neolac (dba Medolac Labs--a milk bank owned and controlled by qualified milk donors, Mother's Milk Cooperative, which has created a human milk product that is in a 4oz foil pouch with a shelf life of 3 years and can be stored at room temperature), and North American Instruments which has developed the Calais Human Milk Analyzer which uses infrared spectroscopy to analyse human milk

Elena Medo is a listed inventor to at least 9 US patents (two are patents on a breast pumps-and she is the only listed inventor/owner).  The other 7 US patents are owned by Prolacta Bioscience and about methods of testing human milk, compositions of human milk and/or compositions of human lipids.  She also is a listed inventor to 6 US patent applications (not yet patented) on human milk compositions and/or testing of human milk owned by Prolacta Bioscience.  She started two more companies in 2009:  Neolac, Inc. (DBA-Doing Business As-Medolac) and North American Instruments.  She also is the only listed inventor to a WIPO (World Intellectual Property Organization) patent application entitled, "Human Milk Preparation" filed in 2011 and owned by her company, Neolac, Inc.  

The name Neolac has generated a lot of confusion because it is also the name of a brand of infant formula made by a company, Neolac Nutrition B.V. of the Netherlands, part of the Ausnutria Hyproca Dairy Group.  There is also a Neolac Nutrition in Shanghi China, which sells Neolac infant formula.  Medolac/Neolac of the USA in their website states that they are, "in no way affiliated with the Neolac infant formula company in the Netherlands."  Although there is another unusal similarity between Medolac and the Dutch infant formula company.  The history of the Netherland's infant formula company includes a co-operative (a group of farmers in 1910 created a co-operative and owned the company for some years).  Medolac is supported by its Mother's Milk Cooperative.

 Of interest to some readers is that the name Neolac, as a trademark has been disputed in the past.  In 1988 in the Philippines. Nestle filed a notice of opposition to the trademark, NEOLAC, filed by a company called Nutritional Dietetic Corporation for their infant formula named, NEOLAC.  Nestle believed it was "confusingly similar to their trademarked product, NESLAC."  

All rather confusing but obvious that the dairy/infant formula/human milk industries like the name, Neolac.  And so when it comes to selling products of similar names, it can become a legal nightmare for companies, if someone disputes the ownership of a trademark.  Neolac is a trademark owned by Ausnutria Hyproca B.V. of the Netherlands (2009-Word, 2012-Figurative).  There is no US trademark for Neolac.  Medolac is a US trademark, filed in 2013, and owned by Neolac, Inc. USA.

In the patent owned by Prolacta Bioscience and invented by Elena Medo, she describes that human milk is not a uniform body fluid (quote from the patent quoted above, #7914822).  She believes that these changes are not understood but benefit the species.  Yet her patent also states, "Accordingly it would be desirable to provide a standardized source of human milk that can be modified to reflect the various stages of lactation and various immune responses."  


"It is at the core of the present invention to utilize such human milk constituents, in their processed form, in such a sequential fashion as to provoke the same type of chain reaction in the body.  With this concept the pairing of the processed milk tissue with the sequential and differentiated delivery methods, patients may enjoy a new type of preventative and therapeutic medicine."

This patent states that the human milk constituents will be in a processed form.  What research do we have that shows that there is an equivalency between unprocessed and processed human milk consitutents?  We know that processing of human milk changes some of the components of human milk.  Dr. Ruth Lawrence states in a paper published by Acta POdiatr in 1999, entitled, "Storage of human milk and the influence of procedures on immunological components of human milk," She states,

"The potential for alteration of the constituents begins with the mode of collection and the nature of the collecting and storage vessel.  The temperature for storage, i.e. room temperature, refrigeration or freezing, and pasteurization or sterilization have an impact."

and she also states

"The nutrient value of human milk is essentially unchanged, but the immunological properties are reduced by various storage techniques."

Medela, well-known breast pump manufacturer, in their literature for a product called, Calesca ( a waterless, warming device for human mik, designed for NICUs) states:

"...the handling of human milk may compromise its bioactivity and practices must therefore be carefully optimised.  Various human milk components show very different sensitivity.  Proteins and vitamins are among the most sensitive consituents, whereas carbohydrates and most fats are much more stable."

The pasteurization of milk does destroy pathogens in the milk but it is also destructive of vitamins, beneficial bacteria (probiotics), and enzymes.  Pasteurization does increase the shelf-life of milk, making it easier to mass-market a product.

In some of the Prolacta patents the processing of human milk is described for various standardized formulations of human milk.  In general and from my understanding, donor milk is pooled, screened for viruses, filtered, ultrafiltered--water is filtered out of the milk, called permeate, then the watery milk called permeate is added back in, cream from another batch of milk may be added, then the composition can be frozen and thawed out later for futher processing, minerals are added (and/or vitamins), then pasteurized at 63 degrees C. for minimum of 30 minutes, cooled to 2-8 degrees C., samples taken for nutritional and bioburden analysis, and finally product packaged and shipped.

It appears to me to be a lot of processing, which creates in my mind the question of how equivalent are these standardized human milk formulations to the milk that a baby receives from breastfeeding?  How equivalent to the donor milk provided by the non-profit milk banks, which is pasteurized without additives?  Where are the scientific studies to show that the methods used by Prolacta (and Medolac with its 3 year shelf-life product) to create a standardized human milk product are based on clear facts?  We seem to be investing in products rather than breastfeeding.  What is our knowledge base regarding preterm infants ability to breastfeed?  Are preterm infants given the earliest possible opportunity to breastfeed?  Or will we presume because we have these human milk products that breastfeeding is not a necessity?  And will we continue to presume like the mantra brought to you by the infant formula industry that some women don't want to or can't breastfeed?  Is that a truth or a self-forfilling prophecy?  Will these products that are only created for preterm babies eventually be marketed to mothers whose babies are full term?  How else can profits be made unless one expands the market?  

The commercialization of infant formula happened in the late 19th century and expanded in the 20th century.  Commercialization took place because of a number of inventions.  Milking machines became more and more efficient.  Although some physicians in the 19th century were alarmed by the abandonment of milking by hand.

"L.B. Arnold, secretary of the American Dairyman's Association wrote about the great value of hand milking in the development of the bovine udder and warned against resorting to machine milking."

Likewise in the 21st century, some lactation professionals, remind us of the great value of hand expression over breast pumps.  Yet it seems the widespread use of breast pumps by breastfeeding mothers, has devalued and limited the use of hand expression.  Is the growing use of breast pumps rather than breastfeeding in the USA facilitating the growth of a human milk industry? 

Aren't the standardized human milk products and its rationales, similar to the history of the infant formula industry?  Author Rima D Apple in her book, "Mothers and Medicine:  A Social History of Infant feeding 1890-1950," writes,  

"Once their research had disclosed the variable nature of breast milk, some physicians promoted artificial feeding with a food compounded of known ingredients in preference to the uncertainty of maternal nursing."

Despite our greater scientific understanding of human milk, we like our forebears of the 19th century are deeply uncertain about breastfeeding.  The medical and scientific communities are still leery of breastfeeding, particularly for the preterm infant.  Anything that cannot be quantified, standardized is pure mystery and somewhat dangerous. Perhaps it is the ideology that women cannot be trusted to provide for their infants and that only industry should be trusted.
Rima D. Apple writes in her book, "Mothers and Medicine,
"Believing that breast milk was the best food, but that in actuality 'the ideal breast milk is rare,'"

"As infant feeding became the keystone of the emerging specialty of pediatrics in the twentieth century, the manufacture of infant food became a lucrative industry.  More and more mothers reported difficulty in nursing their babies."

Deja vu?   The 21st century seems stuck by the same infant feeding ideology as the 19th century. What is possible?  Breastfeeding?  Should we let women control how their infants are fed?  Or should we let the scientific/medical community lead by industry, control the feeding of infants?  Is controlling and patenting a natural resource, like human milk, about wisdom or scientific truths?  Or is it about finding gold in them there hills?

Copyright 2014 Valerie W. McClain

Saturday, December 6, 2014

Probiotics: manufacturing health and holism or manufactured claims?

"Despite conflicting clinical trials, highly variable products, and lack of FDA approval, probiotic supplements containing Lactobacillus and/or Bifidobacterium species have been increasingly used in neonatal intensive care units to prevent death due to necrotizing enterocolitis (NEC), a disease of premature infants where the intestinal wall becomes inflamed and bacteria invade the bowel wall."
--Forbes, "Children's Probiotic Supplement Contaminated with Disease-Causing Fungus," by David Kroll, 11/18/2014

A very premature infant died from gastrointestinal mucormycosis.  The cause of this infection was determined to be from a fungus called Rhizopus oryzae, which had contaminated a product called ABC Dophilus Powder, distributed by Solgar Inc. of Leonia, New Jersey.  Three lots of this product were believed to be contaminated with the fungus.  The product is distributed in 29 states in the USA, as well as Puerto Rico.  Internationally, it is sold in the UK and Israel.  It is a product that has been available through the internet.

Probiotics have in recent years been promoted for use in the prevention of NEC (necrotizing enterocolitis), in preterm infants.  What is the medical evidence for use of probiotics in the preterm infant?  A recent Cochrane Summary of the evidence states, "There is insufficient data with regard to the benefits and potential adverse effects in the most at risk infants weighing less than 1000 grams at birth."

Probiotics seem to have side effects that often are not discussed widely.  Side effects noted in adults as well as children.  Some studies have shown an increased sensitivity to allergies, in the Dutch Pancreatitis Study Group the death rates of those treated with probiotics increased, and it has been known to cause lactobacillus septicaemia in immune-compromised patients.

What interests me is that my research on patents and human milk components,  found a number of patents and patent applications that used various human milk components (human lactoferrin, Human Milk Oligosaccharides for example) to prevent and treat NEC in preterm infants.  A Cochrane Summary on studies of the use of formula milk versus donor breast milk states, "This review of nine randomized controlled trials suggests that feeding formula increases short-term growth rates, but is associated with a higher risk of developing the severe gut disorder called 'necrotizing enterocolitis.'"

The American Academy of Pediatrics states in their policy statements in the document "Breastfeeding and the Use of Human Milk" dated 2012, "Meta-analysis of 4 randomized clinical trials performed over the period 1983 to 2005 support the conclusion that feeding infants human milk is associated with a significant reduction (58%) in the incidence of necrotizing enterocolitis (NEC).  A more recent study of preterm infants fed an exclusive human milk diet compared with those fed human milk supplemented with cow-milk-based infant formula products noted a 77% reduction in NEC." 

It appears that we have medical evidence that human milk/breastfeeding protects against NEC, particularly exclusive human milk feeding/breastfeeding.  What is the basis for using probiotics in preterm infants?  We have insufficient data.  So why are NICUs (Neonatal Intensive Care Units) using probiotics?  And how many NICUs are encouraging exclusive human milk feeding/breastfeeding in their NICUs?  

One of the fascinating facts I recently learned about probiotics is that of a scientist named Henry Tissier of the Pasteur Institute in France in the 1900's.  He isolated a microorganism from the intestinal flora of breastfed infants, called Bifidobacterium.  Throughout his life he promoted the therapeutic use of this bacterium to prevent diarrhea.  (breastfed infants are protected against diarrhea).  Thus it is rather ironic in my opinion to give a breastfed infant a product off the shelf that has Bifidobacterium because breastfeeding provides this protective bacterium.  We now consider Bifidobacterium a probiotic ("for life") and it is being added to all kinds of products:  infant formula, yogurts, cereal, sports drinks, cereal, nutritional bars, etc.  Some how consumers now believe that adding probiotics to their foods somehow makes it healthier.  Yet consumers and medical professionals have very different feelings about human milk and its components.  The medical evidence for these probiotic products are not confirmed by studies.  We have a confusion regarding what probiotic bacterial strain is really in these products.  How do these substances survive packaging?  And some experts are concerned that some bacterial strains are toxic to humans.  In the USA we have no governmental regulation regarding labeling of those probiotics that are genetically engineered.  

Frightening is the fact that the Rhizopus oryaze is used by food manufacturers to create lactic acid (which is used to create probiotics).  And this fungus can be genetically engineered.  A patent  (# 6849444) filed in 2002 and owned by Archer Daniels Midland Company (a well-known food company) entitled, "Strains of Rhizopus oryzae and uses thereof," states the following:

"The strains of the invention are temperature-resistant and convert a carbon source to lactic acid at high temperatures."  and, "If desired, a Rhizopus strain of the invention can be transformed with a genetically engineered vector to express a coding sequence."

So I wonder about the contamination of a product with Rhizopus oryaze.  Is this a simple case of contamination of probiotic product? Or a result of the use of this fungus in the genetic engineering of lactic acid cultures?  What do we really know, as consumers, about the products we buy that are considered foods or supplements?  And why are hospitals using these products without clear medical evidence?  Particularly when it appears to me that we have clear evidence that exclusive human milk feeding or breastfeeding, is protective against NEC.  Human milk/breastfeeding contain what we now call probiotics.  This has been known since the early 1900s.  The food and supplement industries are basing their probiotic products on the studies of human milk bacterium.  These industries are creating these products through the use of synthetic materials and/or gene technology.  Consumers have become part of a experiment that enriches industry without being fully informed of the risks. 
Copyright 2014 Valerie W. McClain