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 

 

Where are they now? Lessons from ruins with Carin Richter RN, MSN, APN-BC, IBCLC, CCBE

Photo by Aykut Eke on Unsplash

The peafowl is a bird known for attracting attention. Whether flaunting their colorful, unfurled plumage or delivering a resounding cry, peafowl are undoubtedly expressive, insistent creatures.

Occasionally, when Healthy Children Project’s Carin Richter, RN, MSN, APN-BC, IBCLC, CCBE hosts Lactation Counselor Training Course (LCTC) competencies from her Florida home, a curious peacock will poke its head into the frame of the video call demanding attention from her and the participants. 

“The big inquisitive bird insists on being part of the session on breastfeeding!” Richter exclaims.  

Since we featured her last, Richter has fully retired from her responsibilities at St. Anthony’s Medical Center in Rockford, Ill. and now helps facilitate the online LCTC once a week.

Our Milky Way caught up with Richter this winter as part of our Where are they now? series. 

Now 70 years old, Richter shares with a stirring of anger, worry and dismay in her tone: “Women’s health… We are in crisis mode. I’m personally struggling with any kind of optimism.”

She cites a few culprits: a political climate that tolerates division and disrespect, the marginalization of maternal child health issues, and the stripping of rights as marked by the reversal of Roe v. Wade. 

From these ruins, Richter has constructed several lessons. For one, she implores us to become politically involved. 

“Keep women’s issues right smack dab in the conversation,” she advises. “Look around. Search out areas where you can sit at that decision making table.” 

Political involvement, Richter suggests, can come in the form of participating on a shared governance board, community advisory boards, church councils, and rotary clubs. Engagement doesn’t need to look like shaking hands with the mayor. 

She continues, “My friends always say, ‘Oh Carin, you never have one conversation without the word breast coming through.’ We need to live that! Because if we don’t we’re going to lose what we have.”

Photo by Nicole Arango Lang on Unsplash

In other words, be a peafowl. Demand attention. 

Richter lays out what happens when we don’t. 

During her nursing career, Richter and her colleagues’ involvement with the Baby-Friendly Hospital Initiative (BFHI) eventually gave rise to seven hospitals in her area being designated by 2013. As of 2022, only one of those hospitals had retained their designation. 

“Because there was no one sitting at the decision making table speaking for the initiative,  administration lost sight of it and breastfeeding took a back seat or perhaps didn’t have a seat at all,” Richter reflects. “No one spoke of keeping breastfeeding issues in the forefront. It’s an experience that brings me to tears.”

Another insight she’s gained is the difficulty in beginning and sustaining a community-based lactation business. She watched friends with solid business plans, well-researched proposals, and passionate ambitions to help dyads get crushed by lack of insurance reimbursement, lack of mentorship and lack of collaboration.

“We need a lot of work on that front,” Richter comments. 

She suggests a reimagination of the way lactation services are viewed where insurances and companies recognize the importance of breastfeeding and elevate lactation support to a professional state. 

For instance, while working at the hospital, Richter brainstormed ways to give value to and justify the services of in-house lactation care providers. She found that postpartum breastfeeding support offered in-hospital  resulted in a marked increase in patient satisfaction scores. A creative solution suggested that  initial lactation and breast care be embedded in the room rate available for all patients, not billed as a separate line item, allowing for a higher reimbursement rate, Richter explains.  

Photo by Hannah Barata: https://www.pexels.com/photo/woman-having-skin-to-skin-contact-with-her-newborn-baby-19782322/

After retirement from the clinical setting, Richter cared for her aging parents. She says she felt the pinch many women of today experience as they juggle personal, familial and work responsibilities.

As she lived the struggle to find workable solutions for the care of her elder parents, she says she was surprised to find that barriers were similar to those she encountered while working for change in the community surrounding breastfeeding. For both, breastfeeding and elder care, resources are often limited, frequently expensive, and often inaccessible or unavailable.

Her focus now has broadened from maternal child health advocacy to the broader realm of family care issues. She finds herself
advocating for maternal child health and family care issues like pay equity and affordable child care.

“The struggle continues across the continuum, in arenas frequently dominated by women who bear the majority of responsibility,” Richter reflects. 

Despite a sometimes discouraging climate, Richter says she sees “little bright spots” here and there. 

“Not a week goes by that I don’t have a [medical professional] seeking lactation credentialing… I am thrilled with this,” she begins.  The practitioners seeking lactation credentials are not only specializing in women’s health; instead they’re an interdisciplinary group of folks, a sign that breastfeeding and lactation care is breaking free from siloed confines.  

“This is what keeps me excited,” Richter says. “More knowledgeable, eager voices speaking for mothers and babies.” 

Looking back, Richter remembers when it caused a fight to require lactation credentialing for OB nurses. 

“We got so much backlash not only from administration but from OB nurses themselves,”  Richter recounts. “Some OB nurses took no ownership of lactation. ‘That’s the lactation counselors’ job,’ they would claim.”

In this culture, Richter pointed out that trauma nurses are required to be trauma certified, oncology nurses  are required to be oncology certified; why were OB nurses not required to be certified in lactation when it’s such a large portion of their work?

“It was a bit of an eye opener,” Richter says. 

Retrieved from ALPP. Used with permission.

Now almost all hospital OB nurses need to be certified within the first one to two years of hire, and Richter says she’s encouraged by the ever-increasing number of OB nurses she speaks with weekly who are seeking breastfeeding certification and are supported by their department managers.

As for physicians certified in lactation, an already developed template existed. The state of Illinois had issued a Perinatal state wide initiative to mandate that all anesthesiologists caring  for pregnant patients were to be certified in Neonatal Resuscitation Program (NRP). All obstetricians soon followed. Richter says her wish would be that the template could extend to mandating lactation credentials to all professionals caring for pregnant and breastfeeding families.

Another bright spot Richter’s noticed are the larger, private sector industry and private employers in the Midwest offering adequate workplace lactation accommodations and services  that go beyond what is mandated by law. 

Moreover, Richter continues to be  impressed by the work that the United States Breastfeeding Committee (USBC) is doing, namely increasing momentum for workplace protections across the nation.

Though she adds, “The spirit is really strong, but the body is really weak. Getting the body to make the decisions and the policies is difficult.” 

Retrieved from ALPP. Used with permission.

Yet another area of encouragement is the inroad made into the recognition of perinatal mood disorders (PMD). Acknowledging that there is always room for improvement, Richter extols the improvements in detection, treatment and the lightened stigma around PMDs.  

Richter shares on a final note that while maternal child health issues have been largely well promoted and mostly supported in the last decade, she hopes to see more emphasis and energy put into the protection leg of the triad. That will require involvement in the work of policy change at the institution, community, state and national level. Policy development and change is the first stepping stone, she advises. 

“Do not be afraid of policies, because policies have power,” Richter states.  “Get involved and find your place at the decision making table.That’s your homework assignment for the year!” 



Balancing family health and economic well-being in Kenya

Josephine (Josie) W. Munene is the Director of Community Engagement at Maziwa Breastfeeding, an organization that helps mothers balance their babies’ health and their families’ economic well-being in Kenya. Munene leads the lactation education training programs and the Community Breastfeeding Ambassador peer support initiatives.

Munene completed her graduate work in the UK with a focus on international development, and while she imagined she would spend her life working globally, and after spending some time working in the corporate world, she determined a need for helping moms in her home country. 

After her first son (now 14 years old) was born, she struggled to find breastfeeding support. Munene noticed that many of the resources and programs were established in the Global North and lacking for women in her community. So Munene switched gears and launched a business that sold breastfeeding supplies like breast pumps and nursing bras and nursing pads different from the “lumps” handed out by the hospital. She was looking to infuse dignity in the experience, she explains.  But Munene quickly realized that it wasn’t enough to sell products to women, so she pursued the Infant and Young Child Feeding Counselor Training in order to meld her lived experience with technical knowledge and offer evidence-based care to breastfeeding dyads.   

Kenya ranks quite well in the World Breastfeeding Trends Initiative (WBTi) coming in at number 10 worldwide. Still, Munene shares that in Kenya, lactation professionals are not widely accepted as competent nor essential care providers. Instead, they are often considered “quacks” or the profession is regarded as a “hobby”. Munene has therefore made it a priority to engage in policy change with a goal to establish a national accreditation curriculum in her country that will recognize lactation care as an essential part of the continuum of care. Munene sees engagement of social enterprises in public private partnerships as an important piece to this work; reliance on governments alone or donor partners alone has proven to be ineffective, she comments. Further, Munene emphasizes the importance of engaging the people who the policies are intended to benefit. 

She sees an opportunity to adapt well-established accreditation programs in the Global North to Sub-Saharan countries’ needs. Growing the membership of the Kenya Association of Breastfeeding would signal to the Kenyan government the need for a local accreditation, she proposes. 

Recently, Munene and her colleagues helped facilitate a  Kenya Association for Breastfeeding workshop during the Amref International University (AMIU) Public Health Care Congress. A range of participants including gynecologists, pediatricians, students were invited to learn about the fundamental principles of lactation and breastfeeding. They then participated in reflecting on case studies using Healthy Children Project’s (HCP) 8-Level Problem Solving Process by Karin Cadwell and Cindy Turner-Maffei as a framework. 

Munune reports that the most interesting finding from the interactions was the participants’ identification of the need for breastfeeding support early on to alleviate or to eliminate challenges. 

Another takeaway illuminated  the specialized care that breastfeeding can require. Munene explains that in Kenya, breastfeeding generally falls under the nutrition category which overgeneralizes the “benefits” of breastfeeding and ignores the need for practical support that is tailored and effective. 

Munene mentions that Kenya employs Community Health Promoters which are important players in preventive health care, but the program does not address the need for more targeted support for breastfeeding dyads. 

Overall, Munene sees a need for a more comprehensive approach to lactation and breastfeeding care in her country. She calls for policies that go beyond “paperwork and guidelines”. 

For instance, Kenya has established lactation laws for working mothers, but she finds implementation and enforcement is lacking. [Check out this qualitative study for interesting  perspectives from women, families and employers in Kenya.] 

In Breastfeeding challenges for working mothers and their families in different workplace settings, around 18 minutes into the webinar, Munene presents on maintaining exclusive breastfeeding for working mothers.

Munene also reflects on maternity cash benefits for those working in the informal sector. These interventions can only be effective if they come with proper education, she reports. Cash benefits have the potential to influence personal nutritional wellness, and if individuals use the money to purchase indigenous foods from their neighbors, they have the added potential to boost income for the community as a whole. 

You can learn more about these endeavors and connect with Munune here

You might also be interested in learning about The Cost of Not Breastfeeding in Kenya. Check it out here.

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

Opportunity to submit comments on the most recent World Breastfeeding Trends Initiative’s (WBTi) report for the United States and territories

The amount of work that needs to be done to improve families’ lives can sometimes feel paralyzing. Over the next few weeks though, individuals and organizations will have the opportunity to engage with an important endeavor: submitting comments on the most recent World Breastfeeding Trends Initiative’s (WBTi) report for the United States and territories.

The WBTi report assesses the status of benchmarks on the progress of implementation of the Global Strategy for Infant and Young Child Feeding.

The first national assessment in the U.S. was completed in 2016 with an update made in the spring of 2019.

The U.S. as a nation scores consistently low in most indicators.

In 2017, Healthy Children Project also released a national report based on the WBTi criteria that monitors the progress of infant and young child feeding (IYCF) in each of the 50 U.S. states plus six  territories.

This year, the subject matter expert panel is calling on any individual with an interest in maternal child health to submit their comments on the next update by June 30. In order to include any initiative on the report, the information must be documented on a publicly available source.

Healthy Children Project presented the preliminary reports at the United States Breastfeeding Committee’s National Conference and Convening June 8- 10 to gain feedback from state coalitions.

What we measure as a nation is what we value, thus the report helps guide lactation policy by gauging the success of current practices and determining where improvement is needed.

On a state, organizational or individual level, the reports can help channel opportunities to engage in areas where states are lacking.

Find the preliminary reports and submit comments here: www.wbtiusa.org

You will need to enter your email address to receive a password, which will allow you to suggest changes and additions.

The Details

WHO: Individuals vested in maternal child health in the U.S. and territories

WHAT: 2023 World Breastfeeding Trends Initiative’s (WBTi) report for the United States and territories

WHEN: Now until June 30

HOW: www.wbtiusa.org

WHY: To help guide and improve maternal child health policy