QUESTIONABLE RESEARCH PAPERS-PART 2

    "Young mother breastfeeding her son" by French artist Jules Breton

Living in a small town in Northern New York, near the Canadian border, there was not much to do on a Saturday afternoon.  My girlfriend told me that there was going to be a party in a house outside of town. It was a small party with young men drinking beer, and watching football on TV.  It was not the kind of party one would remember, just the usual small town party of men glued to the TV set, and women in the kitchen fixing food and talking.  The party became memorable, when the hostess of the party asked those of us in the kitchen, if we wanted to watch her nurse her baby.  We followed her into her bedroom.  She closed the door for privacy, sat down on the bed, and opened her shirt to nurse her baby.  It was a magical moment.  Sunlight slowly danced across the shadows of the room, creating a vision of a baby and mother that seemed like a painting from 150 years ago.  I had never seen a baby breastfeed.  I had seen plenty of babies being bottle-fed.  Bottle-feeding a baby seemed pretty boring compared to watching this baby breastfeed.  After all, it was the 1970’s, breast and breastfeeding were not words often used in public.  I remember feeling this sense of awe watching our hostess nurse her baby.  I decided that if I ever had a baby, I would breastfeed. 

Many years later, when I had my own babies, I realized I owed this mom and baby a debt of gratitude.  I have never forgotten that first experience of watching a mother and her baby breastfeeding.  Now I have many memories of breastfeeding my own children and watching my grandchildren nurse. As a retired La Leche League leader and IBCLC, I have seen a lot of breastfeeding moms and babies. Yet, I still believe that breastfeeding is magical, a dance between a mother and her baby.  It can also be a tug of war between a mother and her baby.  A battle between the strong will of the mother and the strong will of her baby. It can also be a mundane moment of duty in the ho-hum of life. It also has its comedic moments. But I will always believe that there are those magical moments that are never, ever forgotten.

Recently I read an article in the News Medical Life Sciences reviewed by Emily Henderson entitled, “PFAS Exposure Associated with Decreasing Nutritional Value of Breast Milk.”  One of the authors of that particular study was Tuulia Hyotylainen, Professor of Chemistry at Orebro University, Sweden  who stated in the article, “Breast milk is becoming less nutritious because chemical exposure causes changes in lipid composition—the fat in breast milk.”  She goes on to state, “Of course mothers should continue breastfeeding their babies if they are able to.”  If PFAS chemicals are ubiquitous in the environment, I suppose not too many women will be “able” to breastfeed.  Is it possible that the research scientists do not understand the science of breastfeeding?  I realized that I now had to read the research paper that Hyotylainen co-authored this year, “Exposure to per-and polyfluoroalkyl substances associates with an altered lipid composition of breast milk.”  https://www.sciencedirect.com/science/article/pii/S0160412021004803?via%3Dihub

In 2018 Hyotylainen co-authored a research paper published in Pediatric Research entitled, “Serum, plasma and erythrocyte membrane lipodomes in infants fed formula supplements with bovine milk fat globule membranes.”  Two of her co-authors (Ollie Hernell, and Bo Lonnerdal) to this study were funded by Hero Group, Switzerland (infant formula manufacturer) and Semper AB, Sweden (infant formula and gluten-free baby food manufacturer.   The conclusion of this research paper is that bovine milk fat globule membranes used in infant formula has beneficial benefits of positive cognitive and immunological properties to infants. “The study was funded by grants from Sweden Innovation Agency (Vinova), Semper/Hero [2 formula companies] and Vasterbotten County Council.” https://www.nature.com/articles/s41390-018-0130-9

Wondering about bovine milk fat globule membranes I found another research paper entitled, “Clinical Benefits of Milk Fat Globule Membranes for Infants and Children,” states, “The benefits of breastfeeding are greater for preterm than term infants…”  I find that an odd statement to make.  Somehow breastfeeding loses its benefits in term infants?  Of course it makes sense, when a person reads the section on funding.  All 4 authors (Ollie Hernell, Niklas Timby, Magnus Donnelly, Bo Lonnerdal) have been funded by various infant formula companies.  Milk fat globule membranes added to infant formula will supposedly be beneficial to preterm infants. https://www.jpeds.com/article/S0022-3476(16)00300-0/fulltext#relatedArticles

Let’s go back to the research paper, “Exposure to per- and polyfluoroalkyl substances associated with an altered lipid composition of breast milk.”  We find out as we read this paper that this paper is listed under clinicaltrial.com NCT01735123.  https://clinicaltrials.gov/ct2/show/results/NCT01735123

The clinical trial of NCT01735123 results were published in 2021 by Journal of Pediatrics and entitled, “Effect of early feeding on intestinal permeability and inflammation markers in infants with genetic susceptibility to type 1 diabetes:  a randomized clinical trial.” The clinical trial recruited Finnish mothers during their pregnancy. According to the Finnish Diabetic Association, “Finland has a population of 5.5 million.  There are about 50,000 people with type 1 diabetes and about 400,000 people with type 2 diabetes in Finland.  About 4,000 children under the age of 15 have diabetes.” DOI: 10.1016/j.jpeds.2021.07.042

https://www.diabetes.fi/en/finnish_diabetes_association/diabetes_in_finland

Both  papers (“Exposure to per-and polyfluoroalkyl substances associated with an altered lipid composition of breast milk” and “Effect of early feeding on intestinal permeability and inflammation markers in infants with genetic susceptibility to type 1 diabetes:  a randomized clinical trial”) are tied together.  In order to understand and get some of the background information on the study on altered lipid composition (I will call it the Lipid Study) of breast milk associated with PFAS chemicals one must also read the research paper on early feeding effect on type 1 diabetes (I will call it the Diabetes Study). 

The Diabetes Study states, “Randomization for the study formula was performed during the 35^th gestational week and families received their first batch of the study formula before the delivery.” The Diabetes Study also states, “breastfeeding was encouraged,” while they randomly handed out the experimental extensively hydrolyzed formula (Mead Johnson) or the control cow’s milk formula (Mead Johnson).  Mead Johnson guarded the randomization codes. Seventy-three infants were in the experimental goup and forty infants were in the control group.

Thus the Lipid Study is examining a majority of mothers who are doing both breastfeeding and formula feeding.  According to the Diabetes Study there were 7 mothers in the study who exclusively breastfed (no definition of exclusive breastfeeding disclosed) to 9 months. They obtained cord blood at 2-4 days and serum from moms at 3 months, 6 months, and 9 months. They also obtained stool samples of all the babies to determine intestinal permeability and inflammation.

The Lipid Study was on a subgroup of mothers from the Diabetes Study, 44 mothers.  I assume all of the mothers in the Lipid Study must have been breastfeeding; since they obtained breast milk samples at 2-4 days postpartum and at 3 months postpartum.  It is questionable how many of the babies were exclusively breastfed because all the moms received infant formula in their 3^rd trimester of pregnancy.  The Lipid Study had serum samples from the 3^rd month postpartum but I found no statements made about serum samples at 2-4 days postpartum.  The Diabetes Study got cord blood for HLA genotyping in the 2-4 day postpartum.  But the Lipid Study states under “Results”, “Maternal PFAS levels were measured in serum samples collected 3 months after the delivery.”  But I could not find any discussion about collected serum samples on days 2-4 postpartum. 

The Lipid Study states the following, “As another limitation of the study, the data on the daily volume of BM [Breast Milk] were not available, which restricted us to study infant growth only in relation to lipid composition of BM.  Nonwithstanding this, maternal diet is a major factor that influences the breast milk volume.  (Samuel et al., 2020)” Bold is my emphasis because this reference is to the Samuel et al. research paper that I discussed in Questionable Research Papers-PART 1 of my blog. Maternal Diet is not a major factor that influences breast milk volume.  If you haven’t read PART 1,   https://vwmcclain.blogspot.com/2021/11/questionable-research-papers-part-1.html

I have a real problem with the ethics of infant feeding studies in which infant formula is given out to all pregnant moms.  Exclusive breastfeeding is important to the health and well-being of the mother and baby. It appears to me to be a breach of ethics to give out formula to pregnant moms.  Some moms may believe that they have to use the infant formula, because medical professionals are giving it to them.  Just stating that recruited moms were encouraged to breastfeed (which they state), while handing out infant formula undermines breastfeeding.  What about the WHO Code?  No free samples?  No promotion of products in health care facilities?  Do research scientists in infant feeding feel they are exempt from the WHO Code?  I guess so.

How can a researcher determine a cause for a health issue, when there are more than one variable?  If breastfeeding infants are getting breast milk plus infant formula, is the health issue the breast milk, infant formula, or both? What about other foods and drinks in the first year of life?   How can research state categorically that breast milk is the problem, when mothers are also formula feeding? 

The fat of breast milk is the most variable component.  It changes from moment to moment, from day to night, day to day, month to month.  Thus, depending on when a researcher gets a breast milk sample, it may vary in fat content.  It seems to me that at least 2 or 3 samples of breast milk at varied times are necessary to get an average of the fat content.  Concerns were expressed in the Lipid Study about the milk fat globules being too large.  Yet human milk fat “globules vary from 1 to 10mm in diameter, with 1 mm- globules predominating.” (Lawrence et al. Ninth Edition Breastfeeding: A guide for the Medical Profession, 2020, pg. 105) The Lawrence text book references that to a paper published in 1992. The Lipid Study did not measure the globules, and a number of presumptions are made regarding the supposedly large size as being an indicator of PFAS chemical contamination.

One of the funders for the Lipid Study was the Novo Nordisk Foundation (Novo Nordisk sells insulin). Novo Nordisk Foundation also owns the company Novo Holding which has invested in the company, BIOMILQ (US $21 million).  BIOMILQ will be the first company to manufacture novel infant feeding from human mammary cell culture.  https://www.prnewswire.com/news-releases/novo-holdings-leads-us21m-series-a-financing-in-biomilq-301404490.html

The Diabetes Study received funding from Mead Johnson and other US government health institutions.

What is most curious and sad is that there is research that shows that introduction of cow’s milk or cow’s milk-based infant formula in diabetes susceptible infants increases their risk of diabetes.  Here is sample of the research from 1988, and recently 2021.

“Genetically susceptible children weaned  too early onto cow’s milk-based formula had a risk of Type 1 diabetes that was 13.1 times greater than children who did not have these genes and who were breast-fed for at least three months (thus minimizing their exposure to cow’s milk).”  1996 research paper in the Journal of Molecular Medicine by Perez-Bravo et al.  From The China Study by T. Colin Campbell, PhD and Thomas M. Campbell II, 

“Formula feeding accounts for 2-26% of insulin dependent diabetes mellitus in children.”  1988 research paper in Diabetes by EJ Mayer et al. From International Lactation Consultant Association (ILCA), Summary of the Hazards of Infant Formula. 1992, compiled by Marsha Walker, RN, IBCLC

“In conclusion, this study supports that infant and childhood diet may influence the risk of T1D [Type 1 Diabetes].  The most convincing evidence was seen for beneficial effects of breastfeeding, later introduction to gluten, cow’s milk, and fruit, and lower consumption of cow’s milk during childhood.” 2021, research paper in EBioMedicine by Ana-Maria Lampousi et al.

The introduction of cow’s milk-based formula in infants who are considered genetically susceptible to type 1 diabetes seems almost insane to me.  I wonder about the world we live in, when researchers turn a blind eye to the risks created to Finnish mothers and babies involved in this kind of research. I read a recent document in which they stated that in Finland exclusive breastfeeding was 66% at birth in the hospital and only 9% at 6 months.  The article was lamenting about the low rates of breastfeeding.  Certainly these kind of clinical studies only add to the abysmal rates of breastfeeding in Finland.

Copyright 2021 Valerie W. McClain

 

 

QUESTIONABLE RESEARCH PAPERS--PART 1

Dexin infant formula manufactured by Burroughs Wellcome & Company, screenshot from Etsy website

“… but if your lives were embittered as mine is by seeing day after day this massacre of the innocents by unsuitable feeding, then I believe you would feel as I do that misguided propaganda on infant feeding should be punished as the most criminal form of sedition, and that these deaths should be regarded as murder.”  ---Dr. Cicely Williams, was speaking at the Rotary Club in Singapore in 1939 in front of the local president of Nestle. https://everything.explained.today/Cicely_Williams/

Many books on breastfeeding have the Cicely Williams’ quote from her 1939 speech at the Rotary Club in Singapore, yet all her papers now reside in the UK Wellcome Collection archive.   Dr. Cicely Williams is an example of speaking truth to power.  She was born in Jamaica, and lived from 1893-1992.  During WWII she was held in a Singapore Japanese internment camp along with a number of mothers and babies.  Through her influence all the babies at that camp were breastfed, and survived despite the starvation conditions the mothers and Dr. Williams faced in the camp.  Dr. Williams was also tortured, and nearly died from the malnutrition she experienced. After her death her family gave the Wellcome Collection 56 boxes of her papers as well as 2 outsized folders of documents.   The Wellcome Collection is an archive of documents derived from Burroughs Wellcome & Company and the Wellcome Trust. https://wellcomecollection.org/works/fy2n52en

Burroughs Wellcome & Company manufactured an infant formula called Dexin from 1932-1992. How ironic that a company that manufactured infant formula during Cicely Williams’ lifetime has ownership of all her papers. https://wellcomecollection.org/works/ndxuvvxy

It appears to me that while membership is free to the Wellcome Collection, access to documents in the collection would be difficult for those who live outside of the UK. The Wellcome Collection states the following, “Our collections were first assembled in the early 20^th century, following a racist, sexist, ableist system of cultural hierarchies. We have begun to change the ways we manage and use our collections.”

Besides her stance on infant formula, Dr. Cicely Williams named and described a severe form of malnutrition that young children suffered in what is now called Ghana.  The young children had sufficient calories but not enough protein. She named the protein deficiency of young children, Kwashiorkor. Among the people who lived in Ghana it was described as the “disease of the deposed child.”  A new baby is breastfed, while the weaned, older child may suffer from not having enough protein foods because of famine conditions within a society.  https://hekint.org/2017/01/28/cicely-williams-and-kwashiorkor/

The understanding of breastfeeding and its importance to babies and young children’s health and survival is still so little understood.  Corporations continue to globally influence infant feeding decisions that ultimately influence morbidity and mortality of babies and children. Advertising is one of the ways in which parents are influenced.  With the internet, advertising has become world-wide. 

New research on human milk appears to be overturning long held evidence in the science of breastfeeding.  A lot of the new research is funded by the infant formula industry and the breast pump company, Medela.  New knowledge or evidence that overturns old knowledge or evidence may very well be correct.  But corporate funding of the new knowledge calls into question whether the new knowledge on breastfeeding/human milk is slanted towards making profits from products rather than increased understanding of breastfeeding.

For example, it seems little understood by environmental researchers on toxic chemicals in human milk that US infants not only breastfeed and/or receive human milk in a bottle; but are often given infant formula, water, other drinks, and even solids before 6 months. According to the US CDC National Immunization Survey for the year 2018, 46.3% of US moms were exclusively breastfeeding at 3 months postpartum; and at 6 months postpartum only 25.8% were exclusively breastfeeding.  Exclusively breastfeeding was defined as “only breast milk—no solids, water or other liquids.” Breastfeeding mothers who supplemented with infant formula (with or without other supplemental liquids or solids) before 3 months were 31.3% and before 6 months were 35.8%. Breastfeeding at birth was 83.9%.  Thus according to these statistics some 31%-36% of breastfed infants are also getting infant formula. So why are there so few studies on PFAS chemicals in baby formula?  https://www.cdc.gov/breastfeeding/data/nis_data/results.html

Just measuring toxic chemicals in human milk tells us very little about the health risks of these chemicals to infants. Why? Because most infants under 1 year get a variety of drinks (infant formula, water, juice, soda) and foods besides human milk. Revelations in the media regarding toxic chemicals in breastmilk cause parental fear of breastfeeding and human milk, based on research that is a partial understanding of the risks.

I am not sure how accurate the CDC statistics are because a mom’s recall of information regarding infant feeding is often inaccurate.  In my IBCLC practice I had moms who told me they were exclusively breastfeeding their babies.  But when I did a home visit, they had infant formula on the counter.  Some moms say what they think you, the interviewer, want to hear.  I did a home visit with a mom whose husband was a doctor, and he wanted her to breastfeed.  She didn’t want to, and they compromised with her pumping and bottlefeeding her milk.  Bottlefeeding human milk exposes babies to ingestion and inhalation of various plastic chemicals. On the other hand in comparison to plastic bottles and nipples, the breast is an eco-friendly container!  Researchers doing environmental studies on human milk need to consider the variety of ways mothers feed their babies.  Human milk is only part of the picture of infant feeding exposure to toxic chemicals.  

A Questionable Research Paper

Let’s look at a recent (2020) paper that is used as a reference to a research paper on a infant’s exposure to PFAS chemicals in breast milk.    The paper’s title is “Nutritional and Non-nutritional Composition of Human Milk Is Modulated by Maternal, Infant, and Methodological Factors.” There are six authors.  Four of the authors are or were employed by Nestle Nutrition. One author, Valerie Verhasselt received funding from Nestle Nutrition, but also is the 1^st Chair in human lactology in biochemistry at the University of Western Australia through an endowment of AUD 8.6 million from the Family Larsson-Rosencrist Foundation.  Two of the authors received speaking fees from Medela.  Funding for the research was provided by the Nestle Foundation. https://www.frontiersin.org/articles/10.3389/fnut.2020.576133/full#T3

The authors of this paper did a literature review of maternal, infant, and methodological factors that varies human milk composition and volume.  They state, “Maternal diet is an important factor that influences the volume and composition in human milk.” The statement has no footnote and I assume this is the authors’ conclusion.  Another research paper entitled "Exposure to per- and polyfluroalkyl substances associated with an altered lipid composition of breast milk" uses their paper as evidence that maternal diet in a breastfeeding mother is influential to milk production and composition. While I would not dispute that a mother’s diet somewhat impacts the composition of human milk (DHA/ARA fatty acids, some vitamins), I would say that there is evidence that the volume of milk is only impacted by maternal malnutrition/starvation.  There is plenty of evidence that mothers in concentration camps during WWII who were able to have babies despite the starvation conditions in those camps; were able to breastfeed and keep their babies alive.

Dr. Ruth Lawrence in the “9^th Edition Breastfeeding:  A Guide for the Medical Profession” (2020) discusses the factors that influence the volume of milk.  She states, “Any factor that influences the frequency, intensity, or duration of suckling by an infant influences the volume.”(pg.248)  In the Darling Study by KG Dewey et al in 1991, It states, “The results suggest that infant demand is the main determinant of lactation performance in populations such as this.”

Why is this a important issue?  If diet is an important factor on the volume and composition of human milk, then maternal diet becomes the focus of fixing the problem of PFAS chemicals.  We know from past history of breastfeeding promotion that some mothers who believe that they have to be on special diets to breastfeed do not breastfeed.  I think we need to be very sure of the evidence that it is maternal diet that impacts PFAS chemicals in human milk. 

The infant formula industry is also involved in the manufacture and sale of supplements for infants and breastfeeding mothers.  Research that shows that maternal diet is deficient or influences the amount of PFAS chemicals in breast milk is financially lucrative to the supplement industry, and ultimately to the sale of infant formula.  The following infant formula companies also own vitamin/supplement companies:  Abbott, Bayer, Nestle Health Sciences (had the most vitamin/supplement companies), Reckitt Benckiser (Mead Johnson).  https://drnealsmoller.com/rant/the-14-mega-corporations-that-own-your-supplement-brand/

This study on maternal diet’s influence on milk volume and compositions was a literature review.  There are 274 references/footnotes.  Yet the paper left out the following references in their literature review or having read the research decided not to use the following information. 

 The fat content of human milk is the most variable component, “varying in concentration over a feeding, from breast to breast, over a day’s time, over time itself, and among individuals.”  (Lawrence, Ninth Edition Breastfeeding:  A Guide for the Medical Profession, 2020, page105)

According to the 1997 Breastfeeding Answer Book edition, “Research from developing countries and other parts of the world indicates that even mothers who are mildly malnourished produce plenty of good quality milk for their babies and that only under famine or near famine condition will a mother’s nutrition affect her milk supply or the composition of her milk. (Perez-Escamilla 1995; Prentice 1994)” pg.372

Breastfeeding and Human Lactation, 2^nd edition by Riordan & Auerbach (1999) states, “Worldwide studies, considered together, support the idea that maternal nutrition has only a modest effect on milk production and milk composition.” pg. 515

Ninth Edition Breastfeeding:  A Guide for the Medical Profession (2020) states, “The quantity of breast milk produced can be affected by maternal dehydration (when severe, >10% weight loss) or severe maternal malnutrition, but the quality of breast milk as adequate nutrition for the infant is maintained.” Pg.247

Should we accept that the newer research is the more accurate research?  How influential are these two corporations, Nestle and Medela, in this research paper?  The paper never mentioned an infant’s suck as critical to milk volume and composition.  Either they dismissed the past research as irrelevant, or they never looked at this particular research.  If the infant is the driver of volume and composition, then we cannot always believe that mothers are responsible for a low milk supply.  Rather health care providers must take into account the health of the infant, an infant’s suck, and the frequency and length of feeds.  Who makes money when mothers’ believe that their diet is one of the most important aspects of breastfeeding success?  Who makes money when the focus of a low milk supply is to change the mother’s diet and purchase a pump; rather than evaluating the health of the infant, and encouraging the mom to increase the frequency and length of breastfeeding?

Copyright 2021 Valerie W. McClain