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 

 

Glints of hope and control in a burning world

As I gathered my thoughts for an Earth Month and infant feeding installment, I got an email notification that Valerie McClain had published something new on her Substack. Of course I hurried over, because her pieces are always illuminating. She writes in Standing on the Precipice:  “We are self-destructing on our Mother Earth, and she may be the last woman standing amidst the rubble and miles of corpses.”

Photo by Tatiana Syrikova: https://www.pexels.com/photo/anonymous-little-kid-touching-tree-with-hand-3932861/

In all of the pieces and years past that we have covered the connections between infant feeding and planetary health, it never actually occurred to me that there might be a scenario where Mother Earth outlives us. This will surely strike some of you as naive, absurd, delusional, or something else considering what has happened and continues to happen on our planet. Even so, I envisioned humans dying alongside our planet, our self-destruction agonizing and inevitable, as we claw, infect, and deplete Mother Earth with our beastly antics, taking down the innocent in our path to complete decimation. 

On a recent trip to The Museum of Modern Art, I was shaken out of this sense of Doom and flurry of eco-emotions. Victor Grippo’s lead containers with beans first spoke to me, metaphors “for the force and persistence of life”. This display coupled with Niki de Saint Phalle’s phrase “What is now known was once only imagined” infused me with a little glint of hope that I’ve been craving. 

Then on a Throughline episode about consumer protections and trust in and accountability from companies and elected leaders, I heard the voice of Ralph Nader. He offered: Cynicism is “a cop-out. That’s an indulgence. That’s an indulgence of quitters that makes them feel good. Because when you’re cynical, you’re obviously smart, aren’t you? You think you’re smart. No, you’re not smart. You’re playing into the hands of the corporate supremacists. You’re playing into the hands of the few who want to control the many who could easily outvote the few and make the corporations our servants, not our masters.” This offered me a shift in perspective too.

Source: https://www.gifa.org/en/international-2/green-feeding/

Among the hopeful is coverage of the Green Feeding Tool by Kristi Eaton. Eaton quotes Julie Smith, co-creator of the tool: “…with the Green Feeding Tool—designed to provide policymakers, climate scientists, advocates and others with clear data about how increasing support for breastfeeding can help save the planet—we have the evidence to support action.”

Now, consider this headline: Breast milk can expose babies to toxic ‘forever chemicals’

“For decades, physicians and scientists have touted breast milk as liquid gold for its immunological benefits.

But nursing parents with considerable exposure to cancer-linked ‘forever chemicals,’ or PFAS, may unwittingly be exposing their babies to these compounds as well…” the author begins. 

The article acknowledges contaminated water could be a potential source of PFAS which infant formula is often mixed with. The author also includes that “the benefits of nursing likely outweigh the potential risk of PFAS exposure through breast milk.” [Note the language used here. There are generally no benefits to breastfeeding. Instead, there are risks associated with not breastfeeding.] 

Nikki Lee asks some important questions: “Why doesn’t formula get tested for these chemicals?  Do folks believe that somehow cows are protected against pollution?”

As with anything, there will be risks associated with any variation of infant feeding. 

Healthy Children Project’s Karin Cadwell points out that if toxins are being detected in human milk, it means we need to reconsider the products being used in industry.

Photo by willsantt: https://www.pexels.com/photo/woman-breastfeeding-her-toddler-under-the-tree-2714618/

The author of Study Finds High Levels of Toxic Chemicals in Mothers’ Breast Milk quotes Erika Schreder, science director at Toxic-Free Future who shares a similar sentiment: “’If we want to make pregnancy and breastfeeding safe and free from PFAS, we really need to eliminate the use of these chemicals and products, so that we can have clean food, clean air, and clean water… We really don’t believe that responsibility should be placed on individuals when we need regulations to end the use of these chemicals.’”

In the predicament(s) we find ourselves in, I’d like to leave you with a few more of McClain’s words: “A mother cannot control events such as: wars, sieges, shortages of infant formula and pitocin, fires, floods, hurricanes, tornadoes; but she has a semblance of control in her and her baby’s world through breastfeeding. Dependency on always having access to infant formula, health care, freedom from human or environmental violence, should be tempered with the reality that there may be times, when all the civility of life vanishes.” 

More for Earth Month 

Industry lies and the Code

Infant feeding and planetary health go hand in hand 

Breastfeeding is eco-friendly 

Goats and Soda’s How do you keep calm and carry on in a world full of crises?



Opportunity to join research project documenting Code violations

Surveying the Landscape of Breastmilk Substitute (BMS) Marketing Practices in Four Countries is well underway!

Launched this summer, the purpose of the research project is to document violations of the World Health Organization’s International Code on Marketing of Breast-milk Substitutes and subsequent WHA resolutions (the Code) in the U.S., Canada, the UK and Australia. 

On behalf of those conducting the study, Ellie Mulpeter, MPH, CLC Director, Academy of Lactation Policy and Practice (ALPP) says that they are excited about the level of engagement.

“It seems that participants are seeing and monitoring code violations across all four countries, perhaps even more than they expected!” she exclaims. “This is such a fun and engaging project – both active and practical – and is telling us so much already about what is happening throughout these four countries.” 

So far, the most prevalent violations have been reported on online social media platforms, influencers and online advertising and sales platforms. Read Scope and impact of digital marketing strategies for promoting breastmilk substitutes to understand why this finding is unsurprising. 

Mulpeter says of the research that “raising awareness is the first goal, particularly in countries that do not currently monitor or enforce the Code.” 

According to this 2022 WHO status report, “as of March 2022, a total of 144 (74%) of the 194 WHO Members States (countries) have adopted legal measures to implement at least some of the provisions in the Code. Of these, 32 countries have measures in place that are substantially aligned with the Code. This is seven more countries than reported in the 2020 report.” The U.S. and Canada have no legal measures. 

Mulpeter comments, “Policy makers in the U.S. are behind the ball when it comes to protecting breastfeeding individuals and their babies. That is nothing new. For many, I believe that seeing the sheer number of violations that the average individual can identify when walking along the aisles of their grocery store(s) will be eye-opening. Additionally, it’s great to have a study where those who care about maternal and child health can get out there and help with this project. If we are fortunate to find one or more advocates in the legislature that are passionate about this legislation, I think we can find a way to bring the U.S., Australia, the UK and Canada up to speed with other countries that effectively monitor and enforce The Code and its subsequent WHA resolutions.” 

Examples of countries with legal measures include Brazil, India and Bangladesh though compliance and enforcement is not always substantial. 

“It is inspiring to see the successes that other countries have had in protecting breastfeeding parents and their babies from the harmful practices of the infant formula and other breastmilk substitute industry,” Mulpeter continues. 

In the U.S., the Federal Trade Commission (FTC) provides an avenue to monitor false advertising and hold companies accountable for making claims that are not evidence-based. Mulpeter reports that INFACT USA has submitted several different reports of false advertising on infant formula cans and other commercial milk formulas in the U.S.

“Unfortunately, the FTC does not actively investigate those submissions, but does keep a database of those submitted,” she explains. “After submitting those cases, a message is relayed to the submitter notifying them that they will not receive a response from the FTC, but that the report will be logged in their database.” 

Though the U.S. has not adopted the Code, this research may eventually feed into the NetCode Protocol which supports the development of a monitoring framework, protocols and training materials for monitoring of the International Code and relevant WHA resolutions, and the formulation, monitoring and enforcement of national Code legislation. 

The study will be capped at 1,000 participants. Once enrollment closes, new submissions of violations will be accepted for approximately six months. You can join here

Further exploration on the topic

First ever Global Congress on Implementation of the International Code of Marketing of Breast-milk Substitutes spurs multi-national project

Earlier this summer, the World Health Organization (WHO) hosted its first ever Global Congress on Implementation of the International Code of Marketing of Breast-milk Substitutes.

INFACT USA’s Cadwell and Mulpeter ready for the Congress

INFACT USA Convener Karin Cadwell PhD, RN, FAAN and INFACT USA Program Coordinator Ellie Mulpeter, MPH, CLC were of the roughly 400 Congress participants.

The conference aimed to to increase knowledge and skills of national actors on strategies to end the unethical marketing of breast-milk substitutes, bottles, and teats, develop national roadmaps/work plans to strengthen legislation, monitoring and enforcement of the International Code of Marketing of Breast-milk Substitutes, and build regional networks to share information and support of national action on the Code.

Mulpeter says the overall energy was upbeat and eager.

“It was inspiring to see so many people from around the globe all dedicated to the same mission, and all passionate about implementation and enforcement of the Code to protect families across the world,” she reports.

Congress participants proudly pose

The Congress was intended to be as interactive as possible with breakout sessions organized by region. The U.S., Canada and the Caribbean were grouped together.

“The work being done in all of the Caribbean Islands is very impressive,” Mulpeter explains.  “They are all unique islands with their own unique policies and legislative processes, so it was fascinating to hear their representatives brainstorm together and discuss ways to work regionally in the future.”

Congress conveners created an industry influence grassroots monitoring simulation where participants had the opportunity to spot and record Code violations using the KoboToolbox platform.

Congress leaders also shared the the International Special Dietary Foods Industries (ISDI) statement released in response to being excluded from the Congress.

“It really drove home the point about how integrated the industry is when it comes to Code monitoring and enforcement,” Mulpeter comments.  “It’s a wild marketing tactic to blatantly lie about their dedication to breastfeeding families.”

As laid out by INFACT USA: “Here in the United States, there is an incredible amount of work to be done to advance the Code and its subsequent resolutions. To date, the U.S. is one of three countries in the world that did not sign onto the Code back in 1981. While that step may never come for the U.S., there are other options and avenues to implement protections against predatory marketing practices of these commercial baby-food product companies.”

Mulpeter points out that the Federal Trade Commission (FTC) already has an avenue to monitor false advertising and hold companies accountable for making claims that are not evidence-based.

“Additionally, the fact that the US is hyper-focused on data sharing and digital privacy at the moment may allow an opportunity to explore how targeted advertisements of formula companies are directed towards pregnant individuals and new parents,” she goes on.

Participants engaging at the Congress

What’s more, last week INFACT USA started the recruitment phase for a multi-national research project on the Code. The U.S., Canada, the UK and Australia are all participating in a Code monitoring project that will collect real-world violations from the general public.

Research participants are asked to download the Goose Chase Adventures application on their mobile device and participate in the missions outlined within the app. Submissions will help monitor Code adherence in several countries.

Individuals interested in learning more about this research study can visit: https://surveyswesternsydney.au1.qualtrics.com/jfe/form/SV_cN14ryUEZriqHL8

Should you have any questions about the project prior to or after signing up to participate, please contact Ellie Mulpeter at: info@infactusa.org or Jeni Stevens at: Jeni.Stevens@westernsydney.edu.au

Mulpeter explains: “We hope that the results from this study will not only allow us to assess what types of violations are happening most frequently in these four countries, but also to assess the frequency with which people see and recognize them as problematic at all. Pending the outcomes of the study, we hope that INFACT USA will be able to use the evidence gathered in this project to persuade legislators in the U.S. to implement stricter monitoring of predatory marketing practices of infant and young child feeding products. Ideally, Australia, Canada and the UK can use the results from this study to enforce stricter implementation and monitoring of the Code in their respective countries.”

Mulpeter and Cadwell applaud the efforts of the hosts of the first Global Code Congress: “It was a huge success!”

Efforts to curtail dubious marketing practices of commercial milk formula industry

The commercial milk formula (CMF) industry uses marketing tactics similar to those of the tobacco, alcohol, and ultra-processed food industries.

Photo Credit: Boston Public Library
Date: ca. 1870–1900 https://ark.digitalcommonwealth.org/ark:/50959/3b591d51p Please visit Digital Commonwealth to view more images: https://www.digitalcommonwealth.org.

Earlier this winter, the Lancet published a three-paper series outlining the multifaceted and highly effective strategies used by commercial formula manufacturers to target parents, health-care professionals, and policy-makers.

“The industry’s dubious marketing practices—in breach of the breastfeeding Code—are compounded by lobbying of governments, often covertly via trade associations and front groups, against strengthening breastfeeding protection laws and challenging food standard regulations,” the Lancet summarizes.

Two new publications corroborate WHO findings on the digital marketing of commercial milk formulas in Mexico:

In another recent publication, Pediatricians’ Reports of Interaction with Infant Formula Companies, the authors found that: “Of 200 participants, the majority reported a formula company representative visit to their clinic (85.5%) and receiving free formula samples (90%). Representatives were more likely to visit areas with higher-income patients (median = $100K versus $60K, p < 0.001). They tended to visit and sponsor meals for pediatricians at private practices and in suburban areas. Most of the reported conferences attended (64%) were formula company-sponsored.”

The authors write that “Seventy percent of countries follow the World Health Organization International Code of Marketing Breast Milk Substitutes that prohibits infant formula companies (IFC) from providing free products to health care facilities, providing gifts to health care staff, or sponsoring meetings. The United States rejects this code, which may impact breastfeeding rates in certain areas.”

The Lancet series authors provide recommendations to restrict the marketing of CMF to protect the health and wellness of mothers and babies, and ultimately society and the planet.

  • Curtail the power and political activities of the CMF industry
  • End state practices that do not uphold, or that violate, the rights of women and children
  • Recognise, resource, and redistribute women’s care work burdens in support of breastfeeding
  •  Address structural deficiencies and commercial conflicts of interest in health systems
  •  Increase public finance and correct the misalignment between private and public interests
  • Mobilise and resource advocacy coalitions to generate political commitment for breastfeeding

In Mexico, UNICEF and Instituto Nacional de Salud Pública have designed infographics for policymakers as well as parents and caregivers to educate on the impact of digital marketing.

The partners are also working on proposed modifications to current Mexican regulations that involve commercial formula milk and ultra processed food marketing to infants and young children. Further, development is underway for a mobile app tool for monitoring the Code in Mexico.

Legislation in El Salvador was recently passed–“Love Converted into Food Law, for the Promotion, Protection, and Support of Breastfeeding.”

PAHO is monitoring the implementation of the Baby-friendly Hospital Initiative in the Americas BFHI requires full compliance with the Code and subsequent WHA resolutions.

In other efforts to protect parents and babies, Breastfeeding Advocacy Australia released a video on how the organization monitors predatory marketing. Find it here. You can find their Facebook group here.

Also read:

Follow IBFAN’s coverage of the 43rd Codex Nutrition Session of the Committee on Nutrition and Foods for Special Dietary Uses here.