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!” 



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.

Photo by Ermias Tarekegn

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.

Photo by Polina Tankilevitch

“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.

Photo by Ekaterina Bolovtsova

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.

Photo by Parinda Shaan

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:

  1. A private system does not get around addressing causation difficulties.
  2. 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

Constitutional challenge to lactation consultant license moves forward

The team at Reaching Our Sisters Everywhere (ROSE) exemplifies resilience through tumultuous times. A bright spot shone through tragic recent events when the Georgia Supreme Court unanimously ruled in May 2020 that ROSE’s constitutional challenge to the state’s 2016 Georgia Lactation Consultant Practice Act will go forward.

Source: United States Breastfeeding Committee.

Our Milky Way spoke with ROSE Chief Empowerment (CEO) and Change Leader Kimarie Bugg, DNP/FNP-BC/MPH/IBCLC/CLC, Vice President Mary Nicholson Jackson, CLC and Program Director Andrea Serano, CLC, IBCLC who provided an update and commentary on the case. 

The team says that the recent reversal feels like a victory because it means that the 2016 law is still not enforceable and lactation care providers (LCPs) with any credential can continue their work. 

“The problem is that it’s still being misinterpreted in some places,” Jackson explains. “Sometimes trying to figure out what’s going on is the real concern.”

The Georgia Lactation Consultant Practice Act calls to prohibit provision of lactation care and services for compensation without obtaining IBCLC licensure. But in June 2018, the court put a freeze on the implementation of the law after Jackson, in partnership with the Institute for Justice (IJ) and ROSE, filed a lawsuit to preserve the right to earn an honest living.

The recent reversal affects close to 1,000 Certified Lactation Counselors (CLCs) among other breastfeeding helpers practicing in Georgia, all of whom would have not been lawfully permitted to continue their work under the law after July 2018. 

The ROSE team explains that while LCPs continue to legally offer services and support, there’s still some confusion within the community. Individuals lobbying for the Lactation Consultant Practice Act have offered up erroneous guidance at places of employment for example.

Especially in the current context of Covid-19, the team expresses relief that they and other lactation supporters are still able to provide support to families. Many long-standing and already-dire situations have been illuminated and compounded during the pandemic, like labor and birth support. 

In Georgia, only one support person is allowed to accompany a laboring person in certain maternity care facilities, and that support person is not allowed to leave and return to the hospital.  In many cases, this restriction is not sustainable for families who have other children or employment obligations.  

“We know that if [the law] would have been in effect, [birthing people] could not fall back on the resources that they know of and are familiar with after already being traumatized after labor and birth,” Bugg explains.  

Source: United States Breastfeeding Committee.

Racial inequities and structural racism have been brought to the forefront of our national conversation especially in light of Covid-19, and the issues at hand are no different in the world of lactation.

Not surprisingly, some have suggested that the entire premise of the Lactation Consultant Practice Act is fraught with racism. 

The case is not only about economic freedom, but equally important, access to lactation care especially in marginalized communities. 

Jackson’s petition points out that “the Act defeats its own purpose of promoting public health because it will, overnight, put hundreds of highly qualified lactation consultants… out of business. This will dramatically reduce breastfeeding support statewide, particularly in the minority and rural communities where CLCs are most active.” 

Pages 19 to 25 of the petition detail ways in which the Act causes harm to LCPs including those who work as milk lab technicians, Baby Café support people, military families, and the list goes on. 

In Why is That IBCLC Licensure Lawsuit in Georgia Such a Big Deal? author Liz Brooks, JD, IBCLC, FILCA details how lactation professionals of color are disproportionately impacted by the 2016 Act citing one example in particular where an African American RD IBCLC practitioner of many years had her application halted.

Brooks writes, “The systemic racism is made obvious because an IBCLC of color now has to take the time, and money, and lawyer up, and dig through paper work from 29 years ago, and file an appeal, and show people that she is an excellent, honest, forthright person who just wants to **continue** working to help families breastfeed/access human milk, which is what she was showing them when she filed her license application in the first place.” 

IJ explains that the “drive toward licensure is not motivated by health or safety concerns, but rather by IBCLCs’ interest in billing health insurance companies for their services.”

“In 2010, the Affordable Care Act mandated that insurance companies provide coverage for lactation services. Since then, insurance companies have used licensure as a means of limiting the expense of that coverage. To ensure they could bill insurance companies, the IBCLCs’ lobbyists have begun pushing state-mandated licenses across the country to artificially differentiate IBCLCs from CLCs,” the IJ statement continues. 

Source: United States Breastfeeding Committee.

SELCA released a response in regard to the Georgia Lactation Consultant Practice Act claiming that the law’s passing “has already improved access to clinical lactation care” citing new jobs, a community college program, and the promise of in-network lactation consultants for mothers using Medicaid. 

The ROSE team reports that this large scale change has not transpired. 

“That panacea that they thought was going to happen has not happened,” Bugg says.  

Again in Why is That IBCLC Licensure Lawsuit in Georgia Such a Big Deal? Brooks makes note:

“Who in the heck thinks any license, waived high over their head by an IBCLC, will now instantly generate credibility, job offers, insurance company cooperation, money in the bank? Anything having to do with payment for/coverage of health care services in the USA in 2018 is a humongous pain-in-the-neck. Ask any hospital, doctor, nurse, midwife, speech therapist, dentist, etc etc etc just how easy-peasy it is to see patients, spend quality time with them, have all services fairly and easily covered, and so on. Yeah. Not so much.

I’ve said it countless times: The issue should be about HOW to pay [for lactation care, from counseling on up through skilled clinical care], not WHO to pay [which is what flawed and even better-than-most licensing bills necessarily must focus on].” 

While ROSE moves forward, Serano urges maternal child health advocates to keep the issue of licensure on the radar on a state-by-state basis. When legislation is presented, look at it through an equitable lens, she suggests. Educate local and federal legislators. 

On this note, starting at the state level is an effective way to vindicate rights for others, as pointed out in IJ’s video Can the Government Throw You Out of Work? (Not in Some States!). An IJ attorney explains that the U.S. has a long history of looking at what state high courts have done, and that it’s a traditional method for achieving constitutional change. 

It’s important to make clear that it is not solely the fault of one or a handful of organizations or individuals for carrying out a racist agenda. We are all called to this work, striving for an antiracist society. 

You can stay up to date and support this ongoing case here.