Part 2-The Battle for Control of "Donor Human Milk"

"The ultimate goal is to understand the role of human milk oligosaccharides for infant physiology and to provide human milk oligosaccharides to those infants that cannot be breast-fed and need to receive formula instead."--Lars Bode
http://biomedsci.ucsd.edu/faculty/faculty_descrip.aspx?id=297 

When one considers the essence of the infant feeding dilemma, it appears to me to be what human milk researcher, Lars Bode, stated in the above quote.  The improvement of infant formula is based on the need to to make it closer to human milk.  And the reason stated is because there will always be infants that cannot be breast-fed.  Human milk is the gold standard.  It is the reason why the infant formula industry funds human milk research.  

Should we question this endeavor?  I think so.  There are some assumptions that need to be addressed.  Is it really possible to imitate nature?  Human milk has thousands of components that work intricately and synergistically together.  How does one imitate the component or should we say components?  Bruce German et al's research abstract from Nestle's Nutrition Workshop estimates that there are 200 unique oligosaccharides in human milk (abstract entitled:  "Human Milk Oligosaccharides and bioselectivity as substrates for intestinal bacteria").  How do we manufacture this component?  Chemical synthesis?  Genetic Engineering?  How do we know it's safe?  What is the track record of use for such components on infants, our most vulnerable population?  How does reductionism (reducing human milk to its components) explain health effects?  Is there one magical bullet?  Is there a synergy between various components in human milk that account for health effects?

What about the belief that infant formula is a necessity because there will always be women who can't or don't want to breastfeed?  How many women can't breastfeed?  Do we know the actual numbers?  How many women don't want to breastfeed?  And how many of these women who can't or won't breastfeed do we need to sustain the infant formula industry?  And doesn't society by its lack of support for breastfeeding create the increasing numbers of those women who can't or won't breastfeed?  What about donor milk and our newly formed human milk industry?  Do we really need formulas based on other animal or plant proteins? 

Surprisingly this relates to the current battle on access to human milk between the human milk industry (called for-profit milk banks) and HMBANA (not-for-profit milk banks).  How so?  HMBANA milk banks feel that the for-profit milk banks are limiting their access to donor milk.  The complaint appears to be that it is the fault of for-profits that they have a shortage of donor milk.  

Yet, part of the mission of HMBANA milk banks is to "encourage research into the unique properties of human milk and its uses."  The Mother's Milk Bank of San Jose provided 31 batches of donor milk to Lars Bode and fellow researchers for a paper that was published in the JHL (Journal of Human Lactation) 2014 Feb;30(1):54-61.  [The Mother's Milk Bank of San Jose is one of the listed supporters of the proposed legislation that limits for-profit milk banks access to human milk.]
http://jhl.sagepub.com/content/30/1/54.abstract 

The paper is entitled, "Human milk oligosaccharide composition differs between donor milk and mother's own milk in the NICU and the paper was published in Feb of 2014.  Lars Bode is the one and only inventor to a patent application #20130315990 filed in Feb of 2012.  The patent application is entitled, "Disialyllacto-N-Tetraose (DSLNT) or varients, isomers, analogs and derivatives therefore to prevent or inhibit bowel disease."  And it states, "We discovered that certain Human Milk Oligosaccharides protect the breast-fed infant from NEC."  One of the claims is that the invention may be added to infant formula, breast milk or baby food.  The application is owned by the Regents of the University of California.  Since they don't manufacture infant formula, I imagine this invention will be licensed out.

If there is a shortage of donor milk, why is the Mother's Milk Bank of San Jose giving or selling (?) their donor milk to researchers.  Do mothers who donate to HMBANA milk banks understand that their donated milk may not go to NICU babies but may go to researchers?  Some of those researchers will patent based on that donor milk and some of those researchers have associations with the infant formula industry.  For instance Lars Bode is co-inventor to a patent owned by Nutricia (an infant formula company), entitled, "Gangliosides with a modified acyl function."  (patent #7851450)  The patent states, "The biological functions of gangliosides extensively described in literature are mainly associated with the composition of the oligosaccharide chain." 

Is there a real shortage of donor milk?  I find myself upset that a donor human milk bank declares that there is a critical shortage of donor milk.  But then is able to give or sell their donor milk to researchers.  Researchers who are funded by the infant formula industry.  Are potential donors to HMBANA fully informed that their donated milk may be used for research purposes?  For many years HMBANA has had researchers who have known associations with the infant formula industry on their Board of Directors.

This legislative battle is a lose-lose situation. Both sides are not really interested in the protection of breastfeeding.  Instead the focus is on human milk feeding which we now call breastfeeding.  There is no right side to this issue.  I am not for or against either side.  I think its a mess of vested interests and the grand loser is breastfeeding mothers.
Copyright 2016 Valerie W. McClain

The Battle for Control of "Donor" Human Milk

"Due to the plasticity of the pluripotent stem cells, these isolated cells can be utilised for a multitude of different applications.  For example these cells can be;  used to create tissues for the benefit of the mother and infant (and potentially other individuals), including gene therapy treatments, intrauterine foetal treatments, and the generation of cells, tissue, glands, or organs for the treatment of disease.  This includes their use in scientific research, clinical, diagnostic or commercial applications."  Patent #7776586, "Method for isolating cells from mammary secretion," owned by Carag AG, inventors: Mark Cregan and Peter Hartmann

CALIFORNIA SENATE BILL 1316
And the legal battle begins over control of human milk.  It appears to be a legal battle between for-profit milk banks (for example companies like Prolacta) and the non-profit milk banks (Human Milk Banking Association of North American-HMBANA). This California Bill was introduced by Lois Wolk, a Democrat from Davis (a center of human milk research) as a bill to "protect low-income, nursing mothers and their infants."  It will supposedly introduce, "thoughtful, ethical standards for emerging human milk industries."  
http://sd03.senate.ca.gov/news/2016-02-23-bill-introduced-protect-low-income-nursing-mothers-and-their-infants

But will it really introduce more thoughtful, ethical standards?  Or is this just part of a battle in which legislation is used to control a natural resource, human milk? Is it a fair bill?  Will it really protect low-income nursing mothers?  Who benefits from this bill?  And it appears that the bill is only beneficial to non-profit milk banks (HMBANA).
 http://www.leginfo.ca.gov/pub/15-16/bill/sen/sb_1301-1350/sb_1316_bill_20160219_introduced.html

This new bill revises an existing California law that requires the licensing (issued and renewed by the Department of Public Health)of every tissue bank (which included human milk).  The revision of the bill changes the definition of "tissue bank."  The existing law defines "tissue bank as a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings."

The proposed law defines "'Human milk tissue bank' as a tissue bank that provides a participating mother with financial compensation for procuring human milk for the purpose of human consumption."  Financial compensation being the defining factor in the definition.  This proposed law defines "participating mother as a woman who provides her human milk to a human milk tissue bank in exchange for financial compensation." 
Which suggests to me  that HMBANA milk banks in California will not be required to have a license, since mothers are not financially compensated. There are a number of exemptions to tissue banks being licensed.  So is the change of language actually a request for HMBANA to be exempt from licensing? This language has been questioned in committee whether it means that for-profits will have to have 2 licenses: a tissue license plus a human milk tissue bank license.  The legislators presume that non-profits will still require licensing.  Its worded badly and may be changed because obviously there is a number of interpretations.

The proposed law requires that "human milk tissue banks comply with HMBANA guidelines for safety in working with human milk until the DPH (Department of Public Health) adopts rules and regulations, work with local, community-based or hospital-based lactation support groups to provide ongoing breastfeeding education to ensure that nursing children are adequately nourished, and disclose to a prospective participating mother the purpose for which the procured milk is used."

I believe that Prolacta and even Medolac (not based in California but mentioned in legislative documents) supposedly have guidelines for safety regarding their use of human milk.  Are their standards better or worse than HMBANA guidelines.  Of course, there is the possibility that more for-profit milk banks will be established as time goes on and there would need to be some safety guidelines for the protection of consumers.  I am not sure how one can require a for-profit business to work with local community based or hospital based breastfeeding support groups?  What would the legal liability be for the business regarding that association?  How do consumers trust a supposedly "independent" breastfeeding support group that has associated itself with a business that buys and sell human milk?   With this proposed law HMBANA milk banks will not be required by law to disclose how they use their donor milk.  HMBANA milk banks (as I have discussed before in the blog) give or perhaps sell their donor milk to human milk researchers who have patented on that donated milk.  And some of those researchers are funded by the infant formula industry.  In fact HMBANA milk banks lack of transparency regarding this issue is something I have written about numerous times.  

This proposed law "prohibits a human milk tissue bank from procuring human milk from a mother within her first 180 days postpartum (6 months).  Yet we know from this legislation proposal that in the US only 19% of infants are exclusively breastfed by six months  and that rates are significantly lower for African-American infants.  So basically for profit milk banks will be limited in obtaining human milk since fewer women are breastfeeding at 6 months postpartum.  But HMBANA milk banks will not be restricted from obtaining human milk in that 6 month postpartum period.  This proposed law will prohibit "the term 'donor' to describe a participating mother and the term 'community benefit' to describe itself or its activities."

I find it interesting that the discussion paper on this proposed legislation discusses how concerned donor milk banks and health care providers are about compensating lactating women.  Prolacta charges about $180 an ounce and participating mothers get $1 an ounce or the mothers can donate their money to a charity of her choice.  The cost of Prolacta's human milk-based products are paid by hospitals, or insurers not parents.  Prolacta does not directly sell to consumers.  So will this proposed bill protect low income breastfeeding mothers?  I don't see how this bill does that because low income mothers have the lowest breastfeeding statistics.  If they do breastfeed, it is often for a short-time.  If they want to make some extra money through participating in for-profit milk bank programs, they won't be able to until 6 months postpartum.  They will only be able to gift their milk to HMBANA milk banks prior to six months postpartum.  Is this bill really about helping low income mothers or limiting their ability to make some extra money?  Is their fear that low income mothers would deprive their own babies of milk in order to sell it?  Is the premise that low income mothers are less attached to their babies?   The legislation discussion paper states, "Non-profit human milk banks fear that paying women for donating breast milk can lead to women selling their breast milk while relying on formula to feed their babies." Since the California WIC Association (which is a non-profit organization of WIC directors that supports the WIC Program and can accept industry funding-not to be confused with the government WIC Program) supports this bill, and they recognize that this would be a financial burden to the WIC Program. Since a majority of breastfeeding women are doing both breastfeeding and formula feeding, I really don't understand the opposition.  Oh wait, is it possible that this about the RISKS of INFANT FORMULA (god I said it and didn't get struck by lightening-not yet at least).  Actually I don't know what to think.  When I was employed by WIC and doing some public speaking regarding supporting breastfeeding, I was cornered by a well-dressed, highly educated woman.  She liked my speech because she thought WIC mothers should be "made" to breastfeed.  She spoke about WIC moms with such contempt that I found myself repulsed by her attitude.  This contempt permeates the area in which I live--Florida.  Poverty seems to be considered a crime.  Mothers with babies who have no or limited resources considered the lowest of the low.  Is it hatred of women particularly single women with babies and particularly if the mother's skin color is not white?  I wonder about the ideology behind pushing donating milk but opposition to paying women for that milk.  Particularly when it is now known that human milk contains stem cells, cells that are worth considerable money to the pharmaceutical and medical industries.  So women are to freely give away what is so valuable to various industries?   

The list of supporters to this bill is very illuminating.  The American Academy of Pediatrics (AAP) supports this bill.  Really?  Then they must be thumbing their noses at Prolacta.  Prolacta donated to the Friends of Children Fund (a foundation that funds some of the AAP endeavors) somewhere between $10,000-$24,999.  Maybe they should have donated like Nestle or Pfizer--$50,000 or more. 
 https://www.aap.org/en-us/about-the-aap/corporate-relationships/Pages/Friends-of-Children-Fund-President's-Circle.aspx
 Another supporter is the California Breastfeeding Coalition, who is fiscally sponsored by the California WIC Association.  And the California WIC Association is another supporter of this bill.  The California Center for Public Health Advocacy, which is a lobbying firm, the California Conference of Local Health Department Nutritionists, March of Dimes, Monterey County Nutrition Programs, NEC Society, and no surprise-Mother's Milk Bank of San Jose (a HMBANA milk bank) are listed supporters.  UC Davis Foods for Health Institute was also a listed supporter which surprised me because their industry sponsors are Prolacta, Nestle, Abbott and others. Opposed to this bill was the National Coaliton for Infant Health which has some kind of association with Prolacta (video of Prolacta interviewing two directors and 4 individuals not named (also 4 individuals not named who support the bill).
http://www.legtrack.com/bill.html?bill=201520160SB1316   (click on Senate Health and the document opens in Word)

This proposed legislation is tailored to promote non-profit milk banks at the expense of the for-profit milk banks.  In fact this bill seems all about HMBANA and what it needs.  It is in my estimation an unbalanced, poorly thought out bill.  Are the for-profit milk banks really milk banks?  Prolacta is considered by the FDA as a provider of Exempt infant formula.  
 http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm106456.htm
Both Prolacta and Medolac (and Medolac is not in California so I am not sure why they are discussed) are not really milk banks.  They are part of a human milk industry.  Breastfeeding advocates continue to call them milk banks.  But theses companies are really a human dairy industry.  And yes they need regulation but not as milk banks but as infant formula companies- as human milk-based infant formula companies.

The language of the proposed bill "appears" to exempt non-profit milk banks from having to have a current and valid tissue license.  Is this what they meant to do and if so, why should they be exempt from licensing?  Or is this just poor legislative language?  If transparency is the issue then I believe that both non-profit and for-profit milk banks should be transparent about their use of human milk.  I find it odd that this bill was created by what appears to be a coalition of non-profit organizations.  Should non-profit organizations be involved in creating legislation that benefits themselves?  And most importantly in my mind is that Prolacta and Medolac are not milk banks.  They are part of a human milk-based infant formula industry.

Coopyright 2016 Valerie W. McClain