Breastfeeding Medicine

Physicians blogging about breastfeeding

Reclaiming “Breastfeeding” from “Human Milk:” Politics, Public Health, and the Power of Money

with 4 comments

If there is one thing that formula makers and breastfeeding advocates agree on, it’s that mother’s milk is amazing stuff. Researchers have identified countless compounds in human milk such as lactoferrin, erythropoietin, docosahexaenoic acid (DHA), immunoglobulins, and human milk oligosaccharides, or HMOs. There are at least one hundred different HMOs in human milk and the infant doesn’t digest any of them—rather they seem to exist to feed the bacteria in the infant’s gut, its “microbiome,” and have some other properties, too.  Each mother secretes unique sets of HMOs for her infant. Often researchers discuss adding HMOs to formula in hopes of transforming the microbiome of a formula fed infant into one that more resembles that of a breastfed infant, as the microbiome of a breastfed infant is thought to better protect against disease.

Research into human milk composition has been exploding, funded by the federal government, private foundations, but especially by the $70 billion infant formula industry and other industries looking for commercial applications for the components of human milk. The motives for research might vary: to help understand why breastfeeding is truly superior; to help use components of human milk to fight diseases in infants, children and adults; or to synthesize components of human milk in order to add them to infant formula. The US government’s interest in human milk composition revolves around ensuring that infant formulas meet minimal nutritional requirements.

At the heart of the study of milk composition is the distinction between “human milk” and “breastfeeding.” The term “human milk” disembodies the substance from the precious act of nurturing, bonding, and intimacy between a mother and child. Language around “human milk,” as opposed to “breastfeeding,” is often used by entities concerned with breast pumps and infant formula, as well as for the necessary provision of milk for infants too tiny to suckle at the breast.

For breastfeeding advocates, the dark side of research on human milk composition is its application to the formula industry. The biggest recent application has been the synthesis of HMOs, which have been patented and added to formula, now for sale on supermarket shelves where they cost at least 30% morethan formulas without HMOs. It is unclear if these products are actually better for babies, even though they might technically resemble human milk slightly more than formula without HMOs. But given that genuine mother’s milk has unique HMOs for a unique infant, it’s unclear which HMOs a manufacturer should even be adding to a formula. So, is this product actually better, or is this just a marketing ploy and an excuse to mark up the price?

Even if it’s possible that HMOs and other additives do improve the quality of infant formula, this formula will never match mother’s own milk. No company can provide a mother’s own living cells, her unique antibodies, and the change between the watery foremilk and creamy hindmilk during the course of a feed. And nothing on a shelf can substitute for the act of breastfeeding itself. No improvements in infant formula are likely to approach the differences in childhood health outcomes seen with breastfeeding. Finally, even if it were possible to create the perfect infant formula that mimicked mother’s milk, that would still have no impact on the maternal health impact of breastfeeding, in terms of lowering the risk of maternal diabetes, cardiovascular disease, breast and ovarian cancer. And nothing on a shelf would substitute the experience of breastfeeding for mother and child.

From a public health perspective, the goal of creating an improved infant formula will have far fewer public health benefits than getting more people to breastfeed. This is partly because improvements to formula are likely to be modest at best when compared to breastfeeding, and partly because the maternal health impact of breastfeeding on public health is actually greater than the pediatric impact, in terms of both lives saved and health care dollars. In addition, so much research would need to go into determining which of the 100+ HMOs should go into formula and in which combinations, that it would be more cost effective to just research getting more people to breastfeed.

The misplaced emphasis on human milk and its components turns out to have profound political ramifications. The US is in the process of adding nutritional recommendations for children ages birth to 24 months to its Dietary Guidelines for Americans. These recommendations, slated to be published in 2020, have been in the works since at least 2014, when the first Work Group Planning “B-24” document was published.

Given that breastfeeding is the normal way infants are fed at least the first 0-12 months of life, (see position statements from the American Academy of Pediatrics or the World Health Organization), what might the strategic priorities be for the US for nutrition in this age group, at least for the infants? I would want to think about how to increase breastfeeding, consider paid maternity leave so as to increase breastfeeding, how to help parents of preemies to support giving mothers’ own milk, investigate availability and efficacy of banked donor milk. I would want to prioritize why breastfeeding rates were so low in certain populations of the country, and why so few people breastfeed in light of the different health outcomes for infants and mothers, and how improving maternity care practices could change this landscape. These issues and others, were addressed in the 2011 Surgeon General’s Call to Action to Support Breastfeeding, and priorities named in the Call the Actionshould be integrated into the B-24 planning document. In addition, we should investigate whether prices of infant formula are fair or if there is price gouging which are paying too much (a subject that has been investigated by the Government Accountability Office in the past), and if WIC is effective enough in meeting clients’ needs, as WIC now serves about half of all US children. I would want to know about new research in differences in health outcomes between breastfeeding and formula feeding, and how these differences affect health costs and the US economy. I’d want to know if “toddler formulas” serve any nutritional purpose, if they put children at risk for obesity, and if families are misusing them to give to babies.

Instead, there was almost nothing in the 2014 B-24 Planning Document about promoting breastfeeding. In fact, the document questioned whether current breastfeeding recommendations should be lowered, despite universal agreement on current recommendation from all major medical organizations in the US and the Europe. It focused on whether health outcomes for breastfed infants were indeed superior to formula fed infants or were confounded by socioeconomic status, an issue that many experts have long considered settled, as the 2007 government-commissioned seminal metanalysis extensively examined this issue. There was not a word about eliminating racial and geographic disparities in public health. Most of the focus of the infant section of this document was on “human milk” and its components, and whether individual components of milk might affect particular health outcomes and the pediatric microbiome.  The document reads as if the panel is trying to figure out a way to ignore breastfeeding altogether, while making it look like it’s carrying out its mandate to do something for infant nutrition. Virtually noneof the pressing questions asked above were in addressed as part of the nation’s nutritional priorities for our youngest citizens.

How this could happen is revealed when one looks at the surprising list of people working on the B-24 project. The Work Group Planning Chair was Dr. Ronald Kleinman, a powerful voice in pediatric nutrition from Harvard, who was responsible for choosing B-24’s leading personnel, according to the document. Kleinman had numerous conflicts of interests, having worked with  formula companies (Mead Johnson Nutrition, and Nestlé) and having served as a consultant for Burger King, the Sugar Association, and Coca Cola, among others. At the time the initial B-24 work was going on (2012-2014), Kleinman was also serving as chair of Mead Johnson Nutrition’s Iron Expert Panel (meeting in 2014 but presumably organized prior). Several authors from Kleinman’s iron panel also served on this B-24 group. In addition to formula, Mead Johnson makes an iron supplement largely intended for breastfed infants, a product whose market would be significantly diminished if delayed clamping of the umbilical cord were routinely practiced, but this was hardly mentioned in the iron panel’s recommendations. Many of the names on the B-24 group were researchers in human milk composition and zinc metabolism, many received formula industry funding; several were known mostly for their roles in a Nestlé nutrition study of infants and toddlers (the FITS), many others had published almost nothing relevant to infant and early childhood nutrition. Of the 0 to 6 month working group, only one of six people was a breastfeeding expert (yet it did include an expert in leucine supplementation to neonatal pigs).  What was most notable about the list of B-24 participants was who was NOT on it. Of 31 participants, all of whose scientific publications I reviewed in PubMed, almost none were leading breastfeedingpolicy experts. Then in 2016, Kleinman announced that his pediatrics department will receive funds from Mead Johnson to collaborate on research on the pediatric microbiome. In sum, the B-24 process shows how industry conflicts of interest can use a shift in focus to human milk composition, instead of breastfeeding, to advance the interests of industry at the expense of public health.

When researchers and policy-makers talk about how components of human milk may affect particular health outcomes, as we saw in the B-24, that information can eventually be used to add those components to formula. Regardless of whether the resultant product is actually better for babies, its cost would certainly be higher, and formula companies would be able advertise a seemingly “better product.” When the federal government funds research in human milk composition, ultimately the fruits of that research are often likely to end up enriching the formula industry, the biotech industry, and the researchers who hold their patents. Most importantly, federal research money spent on human milk composition may mean the government has less to spend on research issues that will help increase breastfeeding rates and improve population health.

Human milk composition is a fascinating topic, but it is not a public health priority for infants at this time. The best way to achieve a healthy infant microbiome in the population is through promoting breastfeeding, not through addition of human milk components to formula. Perhaps one day, we can we use compounds found in human milk to fight disease in older people, in part by manipulating their microbiomes. But that is a far different research priority from studying human milk composition for the sake of infant health. We must be cautious when we talk about “human milk” instead of “breastfeeding” and be aware that excessive focus on human milk composition instead of on breastfeeding is already coming at a significant cost to public health.

Disclosure: I co-authored a letter complaining about Dr. Kleinman’s conflicts of interest to JAMAPediatrics regarding a 2016 publicationin that journal. In rejecting our letter, JAMAPediatrics sent a response from the authors in which Kleinman defended his breastfeeding bona fides by citing his activities from 1989 (!) published in the Chicago Tribune. A partial disclosure of Kleinman’s conflicts of interest was published 2017. I also filed a complaint about Kleinman’s conflicts of interest to the Harvard Medical School Office of Academic and Research Integrity in December 2017, which was never addressed. I receive research funding from the WK Kellogg Foundation for research in breastfeeding and economics.

Melissa Bartick, MD, MSc is an internist at Cambridge Health Alliance and Assistant Professor at Harvard Medical School. 

Posts on this blog reflect the opinions of individual ABM members, not the organization as a whole.

 

Written by Melissa Bartick, MD, MSc, FABM

November 4, 2018 at 10:45 am

4 Responses

Subscribe to comments with RSS.

  1. Another dimension to bear in mind when we talk about breastmilk is that some transgender parents prefer to talk about chestfeeding and human milk. https://www.lllc.ca/joint-statement-use-term-chestfeeding

    Hilary Lynn Johnston

    November 4, 2018 at 2:54 pm

  2. Eye opening. I am aware of all kinds of conflicts of interest but I wasn’t aware of the B-24 work. If the government tool all the money being spent to help the formula companies, including the exorbitant price of formula WIC supplies, they could afford for maternal and parental leave in order to fully establish breastfeeding.

    JennP

    November 4, 2018 at 6:32 pm

  3. I was pleased to read Melissa Bartick’s recent post regarding, “Reclaiming Breastfeeding.” It is an issue near and dear to my heart. I have been writing about patenting of human milk components for 18 years. I feel I need to add some further information to her excellent post. Human Milk Oligosaccharides (HMOs) are already in 2 of Abbott’s formulas that are sold in the USA. (Similac Pro Advanced and Similac Pro Sensitive). Abbott has added a HMO named 2′-FL. This particular HMO was given FDA GRAS status in September 2015 (GRAS Notice #546), when Glycom A/S of Denmark declared that this component was FDA GRAS and the FDA had no questions. If one reads the FDA GRAS letter written by Glycom to the FDA regarding their request for premarket exemption approval, one of the Safety Experts used by Glycom was Dr. Ronald Kleinman. Glycom is owned by its founders, Nestle, and other entities not named on their website. The premise of safety of the HMO, 2′-FL, manufactured by Glycom is stated in their letter to the FDA,

    “As mentioned Glycom’s 2′-FL is chemically and structurally identical to the 2′-FL present in human breast milk, and therefore, the safety of Glycom’s 2’FL for all intended uses and population groups was found to be supported by the known consumption of 2′-FL from human breast milk in infants.” (page 17 of letter from Glycom to FDA)

    There are various methods to manufacture HMOs. The most common method I have seen in recent patents of various companies (Glycom-Denmark, Jennwein-Germany, and Glycosyn-USA) manufacturing HMOs is to genetically engineer the component using the bacteria, e.coli. Glycom has a number of patents on its methods to create the HMO, 2′-FL. Its more recent patent on 2′-FL filed in 2014 is patent #9902984 called “Fermentative production of oligosaccharides,” filed in 2014 in which it uses a genetically engineered e.coli. Using the safety of human milk as a reason to accept these chemically and/or genetically engineered ingredients in baby formulas is scientifically questionable.

    Valerie W. McClain

    November 7, 2018 at 6:37 am

  4. Dear Melissa,

    Thank you for another excellent post.

    You ask as do countless others why so few people breastfeed in light of the different outcomes for infants and mothers and how improving maternity care practices could change the landscape.

    Perhaps our collective focus on the benefits of breastfeeding is perhaps concealing a better argument which is that formula is so detrimental to both mother and child. Breastfeeding has evolved over hundreds of millions of years and it is no surprise that it provides so many evolutionary advantages. What is difficult to fathom is why so many are unaware of the detrimental effect associated with even minor use of formula.

    Breastfeeding is the standard by which others should be judged. Formula falls well short and causes great harm to both mother and child. When smoking was identified as a health risk, governments did not legislate in favour of clean air, they rather focused on the cause of the harm which was cigarettes. Likewise, we should focus less on the benefits of breastfeeding (clean air) and focus our attention on highlighting the disadvantages of formula (cigarettes).

    George Anthony Mobbs

    November 11, 2018 at 5:29 am


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: