research Archives - Our Milky Way

July 23, 2023July 22, 2023

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.

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.

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!”

June 25, 2023June 21, 2023

Monumental ‘Skin-to-skin contact after birth: Developing a research and practice guideline’ calls for immediate, continuous, uninterrupted skin-to-skin contact for all mothers and all babies from 1000 grams, after all modes of birth

In Western culture, we tend to trust the process of pregnancy and the capability of a human body to grow and nourish a fetus, but there’s a moment between then and the approaching birth of the baby and beyond when that confidence is lost. Among other reasons, loss of trust in the female body forces mostly unnecessary and often harmful interventions on the process of labor and birth. Thereafter, though the safest place for most newborns immediately after birth is skin-to-skin with their birthing parent, common maternity practices often strip the dyad of this sacred, critical transition diminishing the capability of the mother and the infant.

Skin to skin in the NICU Forældre og Fødsel

Source: United States Breastfeeding Committee (USBC)

As the authors of The nine stages of skin‐to‐skin: practical guidelines and insights from four countries put it, alarmingly, “despite the research and compelling directives from world authorities, the implementation of immediate, continuous and uninterrupted SSC for all healthy mothers and newborns, regardless of feeding choice, has not become standard practice.”

Last month, Kajsa Brimdyr, et al published the monumental Skin-to-skin contact after birth: Developing a research and practice guideline.

Authors not in order of appearance: Kajsa Brimdyr, Jeni Stevens, Kristin Svensson, Anna Blair, Cindy Turner-Maffei, Julie Grady, Louise Bastarache, Abla al Alfy, Jeannette T. Crenshaw, Elsa Regina Justo Giugliani, Uwe Ewald, Rukhsana Haider, Wibke Jonas, Mike Kagawa, Siri Lilliesköld, Ragnhild Maastrup, Ravae Sinclair, Emma Swift, Yuki Takahashi, Karin Cadwell

It’s an “excellent overview of the huge quantity of evidence supporting skin-to-skin contact after birth and give evidence-based guidelines, endorsing the recommendations of the World Health Organisation, that ‘immediate, continuous, uninterrupted skin-to-skin contact should be the standard of care for all mothers and all babies (from 1000 grams with experienced staff if assistance is needed), after all modes of birth,’” Andrew Whitelaw writes in this editorial.

In the review, the expert panel– representing all continents but Antarctica– sifted through roughly 8,000 articles and ultimately pared down to only include those with a clear definition of immediate, continuous, uninterrupted skin-to-skin contact.

The panel concluded that “delaying non-essential routine care in favour of uninterrupted skin-to-skin contact after birth has been shown to be safe and allows for the progression of newborns through their instinctive behaviours.”

The guideline includes the Pragmatic Implementation Guide for Skin-to-Skin Contact after Birth which serves as a how-to for staff, preparing them to facilitate skin-to-skin contact before and during the birth. The document is downloadable here: Appendix S1.

Brimdyr points out that none of the information presented is new; instead it’s consolidated in a way that hasn’t been done before.

“It takes the expertise of so many people and puts it in one place,” she explains.

Brimdyr says she believes it will give practitioners the confidence to make this practice work for moms and their infants.

“All of these babies, all of our mothers really deserve this opportunity,” Brimdyr advocates. “They deserve to have the best start. This research is so well established… the fact that we’re not doing it everywhere is absolutely upsetting.”

Also last month, Brimdyr released a new film, The 9 Stages of Premature Infants, which documents the nine stages as demonstrated by premature infants. The film brings to life the implementation of facilitating skin-to-skin for this population of infants and their parents.

“There is something absolutely magical seeing how capable babies are that really transforms any words on a page into reality,” Brimdyr says. “The research has been there to say premature babies can do this, but it’s so much more powerful to see premature infants do this.”

You can find a collection of skin-to-skin research here.

June 18, 2023June 9, 2023

Centers for Disease Control and Prevention (CDC) changes their breastfeeding policy for HIV-infected mothers

Without major announcement, in February 2023, the Centers for Disease Control and Prevention (CDC) changed their breastfeeding policy for HIV-infected mothers and no longer recommend advising against breastfeeding.

The new recommendation gets closer to the updated 2010 World Health Organization (WHO) guideline on HIV and infant feeding. Before 2010, “WHO guidance on HIV and infant feeding (UNICEF et al., 2003; WHO et al., 2006) recommended an individualized approach in which women living with HIV would be counselled on feeding options according to their household circumstances.”

The new CDC guideline acknowledges that, “For mothers on antiretroviral therapy (ART) with a sustained undetectable HIV viral load during pregnancy, the risk of transmission through breastfeeding is less than 1%, but not zero,” as determined in the PROMISE Study.

The guideline goes on to recommend “patient-centered, evidence-based counseling on infant feeding options, allowing for shared decision-making.” Read the full document here.

Organizations like the National Institute of Health Office of AIDS Research, the Infectious Disease Society of America and National Association of County and City Health Officials announced the new guidance, but it has gone largely unacknowledged in the field of lactation.

“This change in HIV policy serves as a reminder to always check sources. New research findings and policy reconsiderations make it imperative that the most up-to-date information is available to the families we serve,” Healthy Children Project’s Karin Cadwell PhD, RN, FAAN, IBCLC, ANLC comments.

In the U.S., HIV diagnoses among women have declined in recent years; still, nearly 7,000 women received an HIV diagnosis in 2019. (The CDC has commented on the effect of the COVID-19 pandemic: “Data for 2020 should be interpreted with caution due to the impact of the COVID-19 pandemic on access to HIV testing, care-related services, and case surveillance activities in state and local jurisdictions. While 2020 data on HIV diagnoses and prevention and care outcomes are available, we are not updating this web content with data from these reports.”)

How does the U.S. compare in their recommendations to other high-income countries?

The British HIV Assocation’s 2018 guidelines for the management of HIV in pregnancy and postpartum states that “Women who are virologically suppressed on cART with good adherence and who choose to breastfeed should be supported to do so, but should be informed about the low risk of transmission of HIV through breastfeeding in this situation and the requirement for extra maternal and infant clinical monitoring” among other recommendations for helping manage lactation in HIV-positive mothers.

A National Health Service (NHS) Greater Glasgow and Clyde document Management of infants born to HIV positive mothers reads: “There is now evidence from developing countries that breast feeding while mum’s viral load is fully suppressed is safe, and BHIVA/CHIVA no longer regard a decision to breast feed as grounds for referral to child protection services. For HIV positive women who choose to breast feed, maternal HAART should be carefully monitored and continued until one week after all breastfeeding has ceased. The mother’s viral load should be tested monthly to ensure that HIV virus remains undetectable; this testing will be undertaken by the obstetric/ID team. It is recommended that breastfeeding be exclusive, and completed by the end of 6 months.”

You can learn more about Canada’s approach here and Switzerland’s here.

For more, check out Lacted’s Clinical Question and the CDC’s Preventing Perinatal HIV Transmission.

April 30, 2023

Laughing matters

“… A proper ringing toast soothes the savage beast,” Karen Krizanovich writes. “Taste has a sound and it’s the thing with the ding that is the ding an sich of the memorable toast.” We teach our little ones civility and celebration and merriment at a young age; the clunk of a sippy cup meets a mug of coffee, toasting the adventures of a toddler. One mother shares that her 15 month old decided to start “cheers-ing” her breasts together before she nurses.

Closing out National Humor Month, this endearing anecdote is the inspiration for this week’s post.

Parenting is serious business, and those who support parents through their responsibilities undertake weighty duties too, but amidst the seriousness, there is hilarity and light.

In 2019, we published Cheap medicine: laughter, where you’ll find research on laughter as it relates to infants, development, breastfeeding, and prosocial behavior.

This week, we’ve compiled a collection of breastfeeding-related material to make you laugh. Interestingly, in our search for funnies, we found that many of these pieces are reactions to the absurdity of infant feeding culture in the U.S. For instance, there is a comic depicting a breastfeeding dyad in front of an ad of a buxom woman. Two men approach, shaming the dyad, “Nursing?! This is a shopping mall! We can’t allow women to brazenly display their breasts!” It makes you chuckle, but of course the undertone is depressing. Nikki Lee wrote commentary on the real-life manifestation of this absurdity. Find it here.

In another case, humor is used as a coping and healing mechanism as well as commentary on the Pinkwashing of the breast cancer epidemic. Poet and performer Christine Rathbun Ernst’s delivery will make you laugh and ask you to consider some really raw, hard topics. Find her work here.

And, without further ado…

Hungry Toddler Tries To Feed On Bras

Sibling love

Todd Wolynn’s engaging presentation about human milk

The nursing cover

Breast Side Stories: 100 unusual breastfeeding stories

Could you not do that?

Lactation consult on livestock

The breast crawl

Put some breast milk on it

Necklines

The Milk of Hathor

Seven alternatives to evidence based medicine

We’d love to hear your funny stories, as a professional or parent. You can email us at info@ourmilkyway.org, or share your story in the comments below.

April 23, 2023April 18, 2023

Pregnant and breastfeeding individuals’ involvement in clinical trials

During her second pregnancy, a mother tested positive for cytomegalovirus (CMV). The CMV virus can cross through the placenta and infect a developing fetus, potentially causing birth defects or other long-term health problems. This mother was contacted and presented with the opportunity to participate in a clinical trial where she would be infused with a drug that would potentially mitigate the risks of her child developing congenital CMV.

The mother reports that because her child was already at risk, she saw participating in the trial as something she could do to avoid the risk of potential health problems.

The process of participating was relatively simple considering her work-from-home arrangement and having reliable child care for her older child.

At last, her daughter was born healthy and continues to thrive.

This mother reports that, until recently, she hadn’t considered what she would have done if something had gone wrong as a consequence of participating in the trial. She said that she’s unsure what kind of compensation might make up for a hypothetical injury to her child who was unable to consent to the trial. She emphasized that parents dedicate themselves to making the right decisions for their children, so the stress of raising a child with special needs coupled with the guilt of having made the “wrong” decision, could be shattering.

The inclusion of pregnant and lactating people in clinical trials is part of an evolving national and international conversation.

Earlier this spring, the Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons held a workshop to discuss how institutions make risk-benefit decisions regarding the inclusion and exclusion of pregnant and lactating persons in clinical research, and the role of liability, risk management, and trial insurance in those decisions as well as reviewed existing compensation schemes for research-related injuries and potential to scale these models to serve the needs of research participants.

Historically, pregnant and breastfeeding women have been excluded from clinical trials, due to concerns about the real or perceived potential risks to the fetus or child. [FDA Voices, 2021] Namely, the thalidomide crisis in the 1950s largely shaped the culture around risk aversion and clinical testing on the pregnant population.

“A 2011 study on all medications approved by the FDA from 1980 to 2010 found that 91 percent of the medications approved for use by adults did not have sufficient data on safety, efficacy and fetal risk of medication taken during pregnancy,” the authors of Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach write. “At the same time, the number of pregnant women who take medications, as well as the number of medications that these pregnant women take, has increased.”

Today, health advocates are pushing for the inclusion of this population in clinical research on the basis that patients should have solid evidence in order to make informed decisions about their health.

“Not having this evidence can result in unfairness in the distribution of benefits and burdens (injustice) and can curtail the autonomy in making informed choice,” Catriona Waitt writes in Clinical trials and pregnancy. “This may make it impossible to provide the best treatment, undermining the principle of beneficence, and risking increasing harm.”

Speakers at the workshop cited several roadblocks to the inclusion of pregnant and lactating people in clinical research.

Institutional Review Boards (IRBs) are charged with keeping patients safe, so they often take a very conservative approach. [White, 2021] Elisa A. Hurley, PhD, executive director of Public Responsibility in Medicine and Research (PRIM&R) explained that the current framework does not encourage or assess the risk of not doing research on this population, and that the culture needs to shift from exclusion to inclusion as the default. Dr. Hurley cited the University of Washington where there’s been a shift to require justification to exclude pregnant and lactating populations.

Lorien Urban, Ph.D., Senior Medical Director Clinical Development at Ferring Pharmaceuticals pointed out that IRBs tend not to acknowledge a distinction between pregnancy and lactation when reviewing trials. In fact, while the placental barrier can be sensitive, there are very few drugs that pass through to mothers’ milk. [InfantRisk Center]

Photo credit: United States Breastfeeding Committee

Metin Gülmezoğlu, M.D., Executive Director at the Concept Foundation argued that pregnant and lactating women should demand to be included in research, and that governments should react accordingly, assuming responsibility and taking action.

Gülmezoğlu’s project AIM responds to the created culture of risk aversion in the field. Gülmezoğlu said that risk aversion doesn’t get rid of risk; instead it shifts risk to another person: either the care provider or the pregnant person themself.

Risk is of primary concern for companies and organizations conducting research in these populations.

Sara E. Dyson, M.P.H., C.P.C.U.,Vice President of Underwriting Operations & Risk Management at Medmarc laid out the ways in which institutions can make their trials less risky and more attractive to underwriters:

demonstrate for the potential risk,
conduct significant bench testing,
conduct informed consent on video,
ensure compensation is reasonable and cannot be construed as coercion
consult with reputable IRB (multiple IRBs in some cases),
select a trial site (for instance an institution with specialty in high risk pregnancy)

Niranjan Bhat, M.D., M.H.S., Senior Medical Officer at PATH, shared that PATH’s global umbrella policy which covers any adverse event during participation of the study is a key research enabler.

Michelle Mello, J.D., Ph.D., Professor of Law and Health Policy at Stanford University and Renée J. Gentry, Esq., one of the leading experts on vaccine injury litigation in the National Vaccine Injury Compensation Program (NVICP), laid out the ways in which tort versus private compensation programs can be successful or unsuccessful in compensating injured clinical trial participants. In either case, proving causation tends to be the primary difficulty on the battleground for product liability.

The tort system is capacious enough to handle injury claims, Dr. Bello began. However, using Winston Churchill’s metaphor for democracy– “Democracy is the worst form of government – except for all the others that have been tried.”– it tends to favor the wealthy, is laborious in terms of time, and presents high volatility in terms of settled amounts.

Perhaps not a solid alternative, a system like NVICP, is at a “breaking point”, according to Gentry. The program started with eight special masters when it began in the 1980s; today this number remains. Set up to cover six vaccines, the program now covers 16 vaccines; as such the number of complaints have quadrupled in the past decade. People are waiting two to three years to have their trials scheduled. In fact, some seniors have died waiting for their trials.

Gentry advises that when considering the creation of a compensation system, there should be flexibility built in to include the modification of staffing levels and scheme.

In a private system, like the UW-Washington Human Subjects Compensation Program, this flexibility is a positive attribute; however, speakers pointed out that private systems do not address two major points:

A private system does not get around addressing causation difficulties.
A private system does not necessarily address equity and has the potential to lead to a patchwork of compensation of different solutions at different levels of generosity.

As health professionals, consumers and other individuals and organizations work to shape the legal, ethical and policy frameworks that affect research on the pregnant and lactating population, you might consider consulting the following readings and resources.

Further reading

Clinical trials and pregnancy

A Comparison of FDA and EMA Pregnancy and Lactation Labeling

FDA’s Pregnancy and Lactation Labeling (Drugs) Final Rule (2014)

FDA Updates: Pregnant Women Subjects and Medical Device Investigations (2018)

Current resources for pregnant and lactating individuals and care providers

The Trash the Pump and Dump (TPD) app encompasses medical conditions, medications and substances of concern during lactation.

Drugs and Lactation Database (LactMed®)

FDA Pregnancy Categories

E-lactancia: comprehensive medication and herbal medicine database in Spain, available in English and Spanish

Organization of Teratology Information Specialists

Brigham and Women’s Hospital Drugs, Herbs, and Supplements during lactation