Conflicts of interest everywhere one turns

The authors of Call to end sponsorship from commercial milk formula companies published in The Lancet last month urge all health-care professional associations (HCPAs) to commit to ending sponsorships from companies that market commercial milk formulas (CMFs) by the end of 2024.

Greed depicted in an image that is part of a series of prints of the Seven Deadly Sins, engraved by Pieter van der Heyden after drawings by Pieter Bruegel the Elder. More at https://www.metmuseum.org/art/collection/search/338698

The CMF industry targets healthcare providers, because they understand providers’ influence on parents’ decisions.

The group of leading HCPAs  is working to compile case studies, references, guidance on how to manage without sponsorship, and more to help any associations in ending such relationships. 

The effort is not a restriction on parental choice, and the authors recognize that all healthcare professionals (HCPs) must support parents on a case-by-case basis. 

Instead, this work focuses on combating the inappropriate marketing of CMFs which interferes with parents getting accurate information to make decisions. The 2023 Lancet Series offers much more information on the industry’s tactics. Find it here.

The CMF industry has its tentacles tangled in affairs beyond the health care provider-patient relationship, raising concerns about conflicts of interest everywhere one turns. 

Healthy Children Project’s Karin Cadwell, PhD, RN, FAAN, ANLC, CLC, IBCLC points out that other fields have separated themselves from industry.  For instance, the Accreditation Council for Continuing Medical Education (ACCME) will not accredit an organization that it defines as a commercial interest. The American Medical Student Association (AMSA) adopted policies opposing gifts to physicians and medical students from the pharmaceutical industry in the early 2000s. This piece describes some of the more recent policies governing physician interactions with industry. 

Yet, formula companies and breast pump companies are right in the middle of the baby feeding arena at conferences, like at  WIC (Women, Infants, and Children) and the American Academy of Pediatrics (AAP). 

Industry at conferences 

Rob Revelette MD, PhD FAAP questions the AAP’s relationship with formula companies in this essay where he notes that the AAP, both at the national and state level, accepts money from formula companies for advertising and sponsorship of meetings.https://www.metmuseum.org/art/collection/search/335169

Greed Breaks the Bag (“La codicia rompe el saco”)
Leonardo Alenza y Nieto Spanish
1807–45
https://www.metmuseum.org/art/collection/search/335169

Saroj Jayasinghe offers in Pharmaceutical industry sponsorship of academic conferences: ethics of conflict of interest, “The most definite way to prevent COI is to completely avoid industry funding of conferences…” 

Because this isn’t always feasible, Jayasinghe writes, it is crucial to establish these proposed guidelines:  “(1) avoid the sponsors having any influence on the decision-making of conference; (2) avoid promotion of specific products; (3) transparency of sponsorship; (4) develop guidelines for future interactions; (5) consider contextual factors such as the trust in the profession and social roles of physicians; (6) ensure that the long-term objective of the organisations is independent of influences of the industry.” 

Dr. Revelette points out that The Royal College of Pediatrics and Child Health and the British Journal of Pediatrics have both cut ties with formula companies. He writes that “The time for the American Academy of Pediatrics to do the same and comply with the Code is long overdue.” 

CMF companies in science 

CMF marketing commonly and effectively uses science to build brand credibility and influence the scientific community as Rollins, et al detail in Marketing of commercial milk formula: a system to capture parents, communities, science, and policy.

‘Landscapes and seaports’ (Paysages et ports de mer, dans des ronds)
Stefano della Bella Italian
1639
https://www.metmuseum.org/art/collection/search/412519

The authors detail how they misrepresent research and their sponsorship of journals and conclude “the capture of science as a strategic objective of CMF marketing fundamentally shapes medical practice in addition to boosting CMF sales. Science is used in a pincer movement: parents looking to resolve problems accentuated by marketing, with health professionals offering marketing-constructed solutions.” 

One government employee, a practicing physician, who asked to remain anonymous suggests that “most academicians can’t survive (as academicians) without getting sponsor grants for research”. That’s because public funding has decreased in the last couple of decades.  

Patricia Baird notes in Getting it right: industry sponsorship and medical research “…the pharmaceutical industry has become the single largest direct funder of medical research in Canada, the United Kingdom and the United States.”

The anonymous physician says that the number and type of potential competing interests do not tend to concern him especially when there is supplementary data available for review. 

He shares that “Most multi-center studies are done by funding from sponsors since no one Institution has deep enough pockets to do these critically important studies.  I get red flags going off and my ‘BS detector’ starts sounding when I see a small, short author list with a single sponsor funding the study that lacks supplementary data and is making extraordinary claims.” 

One of the touted benefits of working with industry in research is the development of new therapies for patients, as Baird writes and is also noted in ‘Deal with the Devil’: Harvard Medical School Faculty Grapple with Increased Industry Research Funding

However, Baird shares: “…a lack of balance in research activities, with a focus mainly on potential medications, is likely to divert talented researchers from the pursuit of profound scientific questions, or divert them from the pursuit of questions without market relevance but with an aspect of public good. A company has little incentive to support trials evaluating whether inexpensive, off-patent drugs, or whether nonpharmaceutical interventions, could replace their profitable patented drug.”

Because profits are foremost for industry, Baird continues that “it is unrealistic to expect drug companies to stop making drugs to treat diseases that result from [unhealthy behavior].”

This reality, Baird goes on, “highlights the need for funding of research into new and effective ways to get people to change behaviour, and of research into policies that provide incentives and support for healthier behaviours at a population level.” 

*Ahem… Family-friendly policies that support breastfeeding and adoption and adherence of the Code!*  One has to wonder, would maternal infant health look differently if we put as much effort into breastfeeding and supportive policies as we did responding to the formula crisis

One group, the Access to Nutrition Initiative (ATNI) conducts the BMS and CF Marketing indexes which assess the marketing policies of the 20 largest baby food companies globally. This spring, the organization released the Breast Milk Substitutes and Complementary Foods Marketing in the United States: Launch of the 2024 Country Report as a complement to the indexes. The recording of this event can be accessed here

ATNI has created a model policy for companies’ full compliance with the Code. 

Interestingly, ATNI itself has been criticized for its interactions with CMF companies. 

During the release event, ATNI presenters addressed their involvement with CMF companies. It was reported that ATNI consults independent expert groups and releases their methodology on their website. It was also stated that ATNI engages companies at certain points in their process, but that companies cannot decide whether or not they will be evaluated and do not have influence over the research results.

CMF business affairs within nations 

The United States has an enmeshed relationship with formula companies.

L’Avarice (Greed), from “Les Péchées Capitaux” (The Deadly Sins)
Jacques Callot French
ca. 1620
https://www.metmuseum.org/art/collection/search/417673

For instance, in Scorched Earth Legal Tactics author Valerie McClain illuminates that “Both the CDC and the FDA have foundations that partner with corporations that donate to their organizations. While these US governmental bodies are not allowed to take money directly from corporations, their foundations through partnerships donate for programs run by the CDC or FDA. The CDC Foundation has a long list of partners who donate various amounts.” 

McClain goes on: “From a political science perspective, corporations entangled with governmental agencies is part of the definition of fascism-a merger of state and corporate power. Every US governmental agency that I have seen has a foundation. So one gets the impression that is one way to pretend that corporations have no influence on governmental policy.” 

She details some of these relationships with specific dollar amounts in the remainder of her piece. 

In another revealing article– The U.S. Government Defended the Overseas Business Interests of Baby Formula Makers. Kids Paid the Price.— author Heather Vogell demonstrates how “the U.S. government repeatedly used its muscle to advance the interests of large baby formula companies while thwarting the efforts of Thailand and other developing countries to safeguard children’s health.” 

And there was the disgraceful act when the U.S. opposed a WHA resolution in 2018 and “blackmailed” Ecuador. 

An administrator from Breastfeeding Advocacy Australia (BAA) explains their country’s involvement with industry: “…Our Government gave the Formula Industry co-operative body, the Infant Nutrition Council (INC) a government grant to expand their international markets. This government one was for India, a country working hard to improve breastfeeding. Last government gave a grant for expansion in Cambodia, a country with historically high breastfeeding now rapidly plummeting. It is immoral and unjust. We must fight for women and babies. It gets worse here in Australia as a developed nation who is enabling this industry. One of our main research organisations SAHMRI has joint trials with Nestle and validates their participation. Unsurprisingly, the result of one trial we’ve seen requires the administration of a Nestle product as an outcome. Then our Doctor group the RACGP, the doctors that virtually all Mums and Bubs see, has their annual conference sponsored by Nestle and that’s just what we’ve seen publicly stated. There is probably much more. We have much work to do.” 

Until our governments do a better job of protecting health over profits and untangle their industry ties, how can we, as maternal child health advocates,  turn down the commercial noise when its notes seem to play everywhere? 

Steven R. Brown’s, MD, FAAFP American Family Physician editorial Physicians Should Refuse Pharmaceutical Industry Gifts offers guidance that is easily adopted for those working as lactation professionals. 

Certified Lactation Counselors should remember the specific line in the Academy of Lactation Policy and Practice (ALPP) Code of Ethics for Certified Lactation Counselors (CLC) which reads that we must “Abide by the International Code of Marketing of Breast-Milk Substitutes and subsequent resolutions which pertain to health workers.”  

The aforementioned Call to end sponsorship from commercial milk formula companies is a promising launching pad in the dismantling of inappropriate care provider- industry relationships. It signifies progress and as BAA offered, we have so much more work to do.  

 

Further reading/ related resources 

 

‘Full pandemic mama’ becomes full spectrum doula

Allysa Singer was, as she describes, a “full pandemic mama.” Singer became pregnant with her first child in the winter of 2019. As she became aware of the threats and the consequences of COVID-19, she started researching her options and her rights in the delivery room she’d find herself in August 2020.

What started as personal preparation– How many support people would she be allowed? Would she be allowed a support person at all? What restrictions would she encounter? How could she advocate for herself? What were her options?–  propelled her into a world of birth support and autonomy advocacy.

“I was just dumbfounded by the disparities that exist in maternal health,” Singer begins.

In 2020, Alabama, where Singer and her family live, had the third-highest Maternal Mortality Rate in the nation, at 36.4 per 100,000 live births.

BIPOC families suffer from massive disparities in maternal and infant deaths. In a recent piece, Childbirth Is Deadlier for Black Families Even When They’re Rich, Expansive Study Finds, Tiffany L. Green, an economist focused on public health and obstetrics at the University of Wisconsin-Madison is quoted: “It’s not race, it’s racism…The data are quite clear that this isn’t about biology. This is about the environments where we live, where we work, where we play, where we sleep.”

Still, unlike so many of her peers, Singer reports having had an amazing birth experience.

Inundated by birth horror stories, she decided to change care at 27 weeks in hopes that she would be better supported in her choices at a different institution.

Here, she was allowed a doula and support person to accompany her during her birth.

“Not a lot of women had that luxury,” Singer comments.

Knowing well that birth support is a right and not a luxury, she started her own doula practice in December 2021. 

Singer shares that she experienced severe postpartum depression, but she was able to divert and ultimately reshape this energy into her doula work.

“My doula training was the lifeboat that saved me from drowning in my PPD,” she says.

And now her practice, Faith to Fruition, has become the lifeboat for many of the birthing people Singer supports.

She shares: “I don’t believe that a birther’s desire to have more children should be dictated by their birthing experience. I have heard so many stories from people who had one kid but say, ‘I would never do this again because my experience was so traumatic.’ One of my biggest missions and goals is to support birthers to feel empowered in their process; not as bystanders of their process.”

Singer also holds a full time position as an industrial psychologist where she channels her advocacy work, pushing for organizational change and understanding of proper maternal support.

In fact, as part of a public speaking course for a training curriculum, Singer presented on why it’s important to support breastfeeding. She reports that her audience of roughly 25 was engaged, especially as she pointed out the absurdities of infant feeding culture in our country: How would you feel if I asked you to eat your meal in the bathroom? How would you like to eat with a blanket tossed over your head? for instance.

Singer also points out the “insanely amazing public health outcomes” breastfeeding affords.

If 90 percent of U.S. babies were exclusively breastfed for six months, the United States would save $13 billion per year and prevent an excess 911 deaths, nearly all of which would be in infants ($10.5 billion and 741 deaths at 80% compliance). [Bartick, Reinhold, 2010]

“Not only is there a personal investment, there is a public investment and value to understanding the larger implications,” Singer comments. “As a taxpayer, [breastfeeding] impacts you; as someone who utilizes our healthcare system, [breastfeeding] impacts you.”

With the recent passing of the PUMP Act and the Pregnant Workers Fairness Act coming soon, Singer says “We still have a long way to go.”

Organizational policy doesn’t support motherhood; instead it fuels detached parenting which goes against nature, Singer goes on.

“Mothers feel the brunt of that more than ever,” she says.  “[We aren’t] supported to be able to care for our children the way that we want to.”

Singer says she sees it as her mission as an organizational psychologist to encourage change that supports parenthood, so that women don’t feel threatened to care for their children the way that they want to. This means ensuring that women are provided with ample space to pump their milk while away from their babies and empowering them to approach HR when there aren’t appropriate accommodations.

“Outside forces shouldn’t be able to dictate how you care for and feed your child. The end of one’s breastfeeding journey should be a personal decision.”

She continues, “It’s amazing that legislation is catching up. The thing that I fear with any law, there are still people behind those laws that have to enforce them and carry them out. Education and garnishing an understanding of what this looks like is a key component to implementation. The people behind those policies have to make them successful, but this is  moving things into a very good direction, and I hope that more changes to legislation follow suit, especially with paid parental leave. It’s a catalyst for change; I am hopeful but cautiously optimistic.”

Singer says she owes her personal success continuing to breastfeed her two-and-a-half year old to Chocolate Milk Mommies, where she now serves as a board member.

Through Chocolate Milk Mommies, Singer started a subcommittee to focus on education for individuals within the breastfeeder’s support system.

“The people in the village need to be supportive. When you don’t know better, you can’t do better,” she explains.

Singer recently completed the Lactation Counselor Training Course (LCTC) as part of Chocolate Milk Mommies’ mission to best support their constituents and as a way to benefit her doula clients with more well-rounded support.

“I really loved the training because I already thought that our bodies are amazing, but learning more science was great. I would text my friends the ‘Boobie Fact of the Day’,” Singer shares. “[The science] allows me to really appreciate my journey that much more and how impactful I’m being with my daughter.”

You can follow Singer’s work here and here.

Breastfeeding is an opportunity to learn.

–This post is part of our 10-year anniversary series “Breastfeeding is…”

Breastfeeding is an opportunity to learn. Although breastfeeding is an ancient practice, there is still so much to learn about the lactating breast, breast function and the process of breastfeeding, especially as our modern lives continue to change.

Many current textbook depictions of the anatomy of the lactating breast are largely based on research conducted over 150 years ago, Donna T. Geddess points out in The anatomy of the lactating breast: Latest research and clinical implications.

“…Few studies have actively investigated the anatomy of the lactating breast despite the obvious importance a clear understanding of the lactating mammary gland has to both mother and infant,” Geddess writes. “Perhaps this lack of information is a part of the greater reason why many women continue to experience breastfeeding problems.”

Katherine Lee writes in Katie Hinde Championing the Fun Side of Science Through Virtual Animal Games, Thunderdome Style about Hinde’s hope to change the perception about breastmilk and quotes her saying “‘Still to this day, there is no integration between breastfeeding and milk composition and volume,’ noted Hinde. ‘In Pubmed, there are more articles about tomatoes than human breast milk.’ When they listed the human microbiome project, they didn’t include breastmilk…”

This week we present several  recent (in the last 5 years) publications that are helping to shape our understanding of infant feeding. We have also included studies that relate specifically to pregnancy as pregnancy, birth and breastfeeding are all part of a continuum.

It is important to note that research published in medical journals is not the only way to capture and develop an understanding of infant feeding experiences. For instance, Camie Jae Goldhammer,  MSW, LICSW, IBCLC, (Sisseton-Wahpeton), founder of  Hummingbird Indigenous Doula Services says that their program is proudly not rooted in “evidence”; instead, it’s a community designed program. Anecdotal evidence and indigenous knowledge and wisdom should be honored. Moreover, as with any research, we must always consider how the research is funded, who is or is not being represented, and how the research is presented. For more on equity in science, check out Increasing equity in data science and the work being done at the Urban Indian Health Institute.

 

Lactation duration and stroke risk 

In February 2022, Ziyang Ren, MD, et al released Lactation Duration and the Risk of Subtypes of Stroke Among Parous Postmenopausal Women From the China Kadoorie Biobank.

Stroke is a growing global health problem. It is the third leading cause of disability adjusted–life years (DALYs) worldwide and the first leading cause of DALYs in China, Ren, et al point out. Stroke  imposes a financial burden on patients, families, and society. The cohort study found that lactation duration significantly lowers the risk of stroke.

Up until now, most research has focused on the association between lactation and cardiovascular diseases (CVDs), but this piece lays out the association between lactation and stroke subtypes.

Specifically, the study found that parous postmenopausal women with lifetime lactation duration of at least 7 months had lower risks of ischemic stroke and intracerebral hemorrhage (ICH) compared with women who never lactated. For subarachnoid hemorrhage (SAH) though, such associations were found only in participants with lifetime lactation duration of longer than 24 months. In addition, the authors found that those with an average lactation duration per child or lactation duration for the first child of at least 7 months were less likely to develop stroke and its subtypes.

 

Marijuana exposure in utero 

Birth Outcomes of Neonates Exposed to Marijuana in Utero: A Systematic Review and Meta-analysis by Greg Marchand, et al, the largest meta-analyses on prenatal cannabis use to date, the authors  found significant increases in seven adverse neonatal outcomes among women who were exposed to marijuana during pregnancy versus those who were not exposed during pregnancy.

Photo by Solen Feyissa on Unsplash

The systematic review and meta-analysis demonstrated higher rates of low birth weight (<2500 g) and small for gestational age (<fifth percentile), lower mean birth weight, preterm delivery (<37 weeks’ gestation), higher rate of admission to the neonatal intensive care unit, poorer Apgar scores at 1 minute, and smaller head circumference in those exposed to marijuana.

The prevalence of marijuana use during pregnancy is significant, and many people cite the belief that marijuana use is relatively safe during

pregnancy. This work may help to raise awareness and be used to educate patients about adverse outcomes with the hope of improving neonatal health.

With increased marijuana legalization in mind, Kara R. Skelton, PhD and  Sara E. Benjamin-Neelon, PhD, JD, MPH in Reexamining Risks of Prenatal Cannabis Use—Mounting Evidence and a Call to Action urge states that have legalized and commercialized cannabis to retroactively prioritize protection of neonatal health.

More on cannabis during the perinatal period here.

 

Childhood obesity 

The authors of Childhood Obesity and Breastfeeding Rates in Pennsylvania Counties-Spatial Analysis of the Lactation Support Landscape examined the relationship between childhood obesity and breastfeeding rates in Pennsylvania (PA) counties, the relationship between geographic access to professional lactation support providers  (LSPs) in PA counties and breastfeeding rates, and  the relationship between geographic access to professional LSPs and childhood obesity in PA counties. They found a significant, inverse relationship between breastfeeding rates and childhood obesity prevalence at the county level and a significant, inverse relationship between the number of CLCs and the number of all professional LSPs and childhood obesity rates at the county level. Thus,  the authors conclude, the availability of breastfeeding support is significantly related to breastfeeding rates and inversely related to childhood obesity rates across Pennsylvania.

 

Measuring optimal skin-to-skin practice 

The authors of Mapping, Measuring, and Analyzing the Process of Skin-to-Skin Contact and Early Breastfeeding in the First Hour After Birth show how process mapping of optimal skin-to-skin practice in the first hour after birth using the algorithm, HCP-S2S-IA, produced an accurate and useful measurement, illuminating how work is conducted and providing patterns for analysis and opportunities for improvement with targeted interventions.

More specifically, the algorithm provides a tool to help reduce delays or decrease interruptions during skin-to-skin contact (SSC). The authors note, “Not suckling in the first hour after birth places newborns at higher risk for neonatal morbidities and mortality. Examining patterns and developing strategies for change optimizes patient outcomes.”

 

Acknowledging the social determinants of health

Pregnancy and the origins of illness (2022) by Anne Drapkin Lyerly begins by acknowledging that the COVID-19 pandemic has induced a collective trauma that is expected to be felt for generations after the virus is contained. The study of epigenetics has shown that children gestated or born during times of great tragedy, carry a genetically coded and inherited imprint of their mother’s experience with lifelong consequences to their health.

Recognizing the “maternal-fetal interface” as the “nexus of inter-generational trauma” raises the question of how we should think about this implication of maternal bodies, especially in light of the current pandemic.

The author explores the growing field of developmental origins of health and disease (DOHaD) and its use of epigenetics. Thinking about the tools of history, philosophy, and gender studies of science, the author advises we proceed with caution as we consider maternal effect science which raises several concerns that can impact practice and the well-being of mothers and consequently their children.

Namely,  there may be a tendency to ascribe blame on pregnant people for the health outcomes of their offspring that are well beyond their control. This approach doesn’t adequately weigh the effects of paternal, postanal, and other social and environmental factors that also influence the long-term health of children.

Analyzing epigenetics can eventually contribute to the erasure of the mother as a person, and further, characterizing the maternal body as an environment may excuse women from being appropriately considered in public health policies, clinical care and health research.

The author considers DOHaD research a corrective approach to near-sighted fetal origins science and urges that we expand our understanding of the gestational environment from not simply the womb, but to the broader environment in which a person gestates, marking the importance of acknowledging the social determinants of health. To best direct our efforts during the current pandemic, the author suggests shifting the focus off of maternal behavior and choices and instead focus on limiting the harm of climate change, racism, and other structural inequities.

 

Can’t get enough? 

Check out the Breastfeeding Medicine Podcat’s episode Review of a Potpourri of Research Topics with co Hosts Anne Eglash MD, IBCLC and Karen Bodnar MD, IBCLC. You can find a full list of their podcast episodes here.

Subscribe to SPLASH! Milk Science Update

Check out The International Society for Research in Human Milk and Lactation

 

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As part of our celebration, we are giving away an online learning module with contact hours each week. Here’s how to enter into the drawings:

Email info@ourmilkyway.org with your name and “OMW is 10” in the subject line.

This week, in the body of the email, tell us: What fascinates you about breastfeeding and/or what do you wonder about breastfeeding?

Subsequent weeks will have a different prompt in the blog post.

We will conduct a new drawing each week over the 10-week period.  Please email separately each week to be entered in the drawing. You may only win once. If your name is drawn, we will email a link with access to the learning module. The winner of the final week will score a grand finale swag bag.