Maternal vaccines: Safe for mom and baby

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

In the last few weeks, I’ve noticed an old friend from high school, a mother of an infant, consistently posting anti-vaccine content to her social media. Her posts, which were initially mere reflections, have transformed into full-on conspiracy theories about the safety of the COVID-19 vaccines and cast doubts about to the speed of their approval.

At first, I bypassed these posts, not wanting to create tension with an old friend. However, as they became more inflammatory, I realized that she was essentially spreading falsehoods about vaccines. As a public health advocate, I decided to reach out and offer my perspective. I assured my friend that vaccines have gone through rigorous testing and approval by multiple regulatory bodies in order to be deemed safe for widespread use.

She argued that she went through her entire pregnancy without being vaccinated and that she felt mask-wearing and proper hygiene would offer sufficient protection, ending her thoughts with, “maybe I’m crazy, because I think with this big push, that maybe there’s something else in it that the public doesn’t know about.” While my friend may need more and better information to convince her of the benefits of getting vaccinated, it’s important to know what the science says about vaccine safety for expectant or new mothers.

Per the  *Centers for Disease Control and Prevention (CDC) guidance, vaccines are an extremely safe and effective method of avoiding communicable diseases. Certain *vaccines for pregnant people not only help the mother stay healthy, but the antibodies developed in response to the vaccine penetrate the placenta and offer protection to the unborn child as well. If you are pregnant or planning on becoming pregnant, the specific vaccines you should receive depend on your age, lifestyle, medical conditions, and other factors. You should consult your doctor for the most up to date information.

The *CDC recommends that pregnant women receive two vaccines during the gestational period, the inactivated flu (injection) vaccine, and the tetanus, diphtheria, and pertussis or Tdap vaccine. Vaccines that are not recommended during pregnancy include the nasal influenza vaccine, the human papillomavirus (HPV), measles, mumps, and rubella (MMR), and Varicella (chickenpox) vaccines. Some travel vaccines, such as yellow fever, typhoid fever, and Japanese encephalitis are not recommended during pregnancy, but can be administered based on a health provider’s advice.

Vaccines also offer immense protections via lactation. With exception to live virus vaccines like smallpox and yellow fever, most vaccines provide safety to new moms and babies during pregnancy and postpartum via lactation. There is also evidence that breastfed babies respond better to routine pediatric immunizations than those on formula. The CDC has provided a chart of vaccines that are safe for use in lactation.

An even more convincing case for maternal vaccines are the protections offered against COVID-19.  Data  shows that pregnant people are more vulnerable to severe illness with COVID-19. *COVID-19 complications during pregnancy include hospitalization, intensive care, or the use of a ventilator or special equipment to breathe, or illness that results in death. Additionally, pregnant people with COVID-19 are at increased risk of adverse pregnancy outcomes, such as preterm birth.

The CDC has found the *COVID-19 vaccine to be safe for pregnant and lactating people. The CDC and Food and Drug Administration (FDA) have safety monitoring systems in place to gather data regarding adverse reactions to vaccines. Currently, neither the mRNA (Pfizer and Moderna) nor the viral vector (Johnson & Johnson) COVID-19 vaccines have demonstrated adverse outcomes and have been deemed safe for use in pregnant populations. While more data are needed to assess potential adverse reactions in pregnant individuals before or early in pregnancy, the agencies have vowed to closely monitor that information.

Expectant and new mothers are often faced with a host of difficult decisions about their own health and the health of their babies. Adding to the uncertainty brought on by COVID-19, it’s understandable that people are apprehensive. Through compassionate and non-judgmental conversations, we can help encourage vaccine confidence. Even though my friend seems adamant in her stance, I still see an opportunity to turn the tide. There are so many great resources to help address these concerns, like these ones by the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians. It’s up to everyday immunization advocates like you and me to quell concerns related to vaccine safety to ensure our friends and loved ones are safe.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

AAPI Heritage Month: The ‘Model Minority Myth’ and its negative impact on health disparities

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

The month of May marks Asian American Pacific Islander (AAPI) Heritage Month, a time where we celebrate, honor, and reflect upon the vast contributions members of the AAPI community have made to our collective society. The AAPI community comprises more than 23 million individuals with origins from 20+ countries, who speak more than 200 languages or dialects, and it is the fastest growing subset of the population.

The AAPI community is one that harbors complex cultural and historical narratives, and varied generational traumas, such as colonialism, war, and the trials of immigration. The AAPI community’s resilience against these factors, while commendable, has contributed to the myth of the “Model Minority,” and has led to a host of social and health inequities. The model minority myth is one rooted in “positive” stereotypes. It is the assumption that deems AAPI individuals as docile, over-achieving, high-earning, and well-educated—denoting AAPI individuals as exemplars to other communities of color. While at face value these qualities are considered desirable, they tend to relegate an astoundingly diverse community to a monolith, resulting in a detrimental impact on their overall wellbeing.

Due to these unrealistic cultural standards, AAPI consumers face a host of internal and external barriers when interacting with the healthcare system, and are often deterred from seeking necessary care. According to a 2019 Substance Abuse and Mental Health Services Administration (SAMHSA) study, AAPIs have the lowest help-seeking rate for mental health services than any racial or ethnic group. Cultural identity, faith, stigma, and fear contribute to lower utilization of mental health services. Other systemic barriers such as disparities in access to culturally competent care also influence underutilization.

AAPIs are also the only racial or ethnic group for whom cancer is the leading cause of death. Despite facing a confluence of cancer risks, due to unique exposures and environmental factors, AAPIs are screened significantly less for cancers compared to other Americans. Because the model minority myth implies that AAPIs are “better off,” screening, public health, and cultural needs are often masked.

This is best demonstrated by the case of Susan Shinagawa, a leading Asian American breast cancer activist and cancer survivor, whose multiple attempts to obtain screening for a suspected lump in her breast was denied, due to the belief that “Asian women don’t get breast cancer.”

The pandemic has illuminated disparities experienced by AAPIs, such as being overrepresented among frontline healthcare workers, increasing risk of exposure to COVID-19. As a result, case fatality among AAPI healthcare workers is three times greater than their white counterparts. AAPIs also tend to live in multigenerational households, more than other minorities, where 29 percent of AAPI households consist of two or more generational families, further increasing risk of household transmission. Approximately 30 percent of AAPIs have limited English proficiency, augmenting overall barriers to care and government relief resources. This disparity has been especially cumbersome for AAPI consumers seeking telehealth, an integral part of our lives throughout the pandemic, where 50 percent of AAPIs with limited English proficiency were less likely to utilize telehealth than individuals with English proficiency.

One way to dispel the model minority myth and encourage greater health equity for AAPI consumers, is to disaggregate racial and ethnicity data in research studies. Disaggregation of data simply means breaking data into smaller, more precise segments. For example, recent United States census data reveal that AAPIs were less likely overall to live in poverty. However, when that data is disaggregated, it shows that Hmong, Bhutanese, and Burmese Americans experience higher incidence of poverty, in contrast to the greater AAPI community. Disaggregating data not only paints a more accurate picture regarding the different social and demographic characteristics that impact varied health statuses within the community, it influences proper allocation of community resources.

Disaggregation of data can only also happen when there is a prioritization of AAPI participants in research. The most illuminating example of this is highlighted by a 2019 study, which revealed that in the past 26 years, only 0.17 percent of the National Institute of Health’s (NIH) budget was allocated to research focused on the AAPI community. These gaps in funding have led to a paucity in data necessary for public health officials and policy makers to meaningfully address AAPI-specific health disparities. A lack of representation in research impacts how AAPI consumers seek, access, and utilize healthcare. It also impacts the greater community public health goals, impacting health equity for everyone.

Greater investments in culturally competent care, AAPI-focused research, and preventive services, such as screening and early intervention, can help improve overall health outcomes for AAPI consumers. The National Consumers League commends the Biden-Harris Administration’s efforts, such as the COVID-19 Hate Crimes Act and the establishment of a *subcommittee on Structural Drivers of Health Inequity and Xenophobia, which aim to ensure the federal government’s response to COVID-19 mitigates anti-Asian xenophobia and bias. These measures are critical in addressing structural inequities experienced by the AAPI community, enhancing community health outcomes as a whole.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

Jeanette Contreras portrait

Como detectar el COVID-19 en casa

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By NCL Director of Health Policy Jeanette Contreras

Tras la efectiva campaña de vacunación, las pruebas de detección serán claves para seguir evitando contagios del coronavirus y resumir a la normalidad. Reconociendo que estamos en buen camino para controlar la pandemia del coronavirus, los estados están eliminando las restricciones de la cuarentena. Pero el 11 de mayo, el director de la Organización Mundial de la Salud (WHO, por sus siglas en inglés) nos alerta que seguimos en una situación peligrosa porque los estudios de la variante que se ha propagado en la India indican que esta se transmite más fácilmente y provoca una enfermedad más grave.

Expertos de salud siguen cuantificando y analizando los casos positivos para vigilar las variantes. Una recomendación importante es seguir administrando las pruebas de detección de COVID-19 aunque las personas sean asintomáticas. En abril, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) autorizó varias pruebas de uso personal que detectan el COVID-19 y que se pueden comprar en las tiendas y farmacias como CVS, Walgreens y Walmart sin receta médica .

Para los fines de mayo esperamos ver estas pruebas caseras disponibles en todo el país. Los Centros para el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés) *ofrecen consejos sobre cómo usar un kit de recolección y realizarse la prueba en casa. Todas funcionan igual: toma el espécimen de tu nariz o de saliva, envíala al laboratorio por correo, y recibirás los resultados por el internet en un par de días.

Como todavía falta vacunar a los niños menores de 12 años, a las personas que por su religión no han sido vacunados, y personas con enfermedades graves que no se les permite vacunarse, los expertos de salud pública temen no poder eliminar el coronavirus por completo. Una de cada tres personas en el EE. UU. no confía en la vacuna. Y si la mayoría de la población no se vacuna, el COVID-19 será endémica en nuestro país. Solo el país de Israel ha logrado llegar a la inmunidad de grupo- incluso jóvenes de 16 años de edad se han vacunado.

Con acceso a estas pruebas personales, organizaciones y empleadores pueden comprar cantidades de kits de recolección para uso en sus comunidades. Las *escuelas y lugares de trabajo ya están estableciendo programas de pruebas para detectar el COVID-19 rápidamente. Para proteger los más vulnerables en nuestras comunidades, todos los casos positivos se deben reportar al departamento de salud del condado en donde vives y al estado para iniciar un rastreo de contactos. Es importante saber dónde se inició el contagiado y con quien ha tenido contacto cercano las personas infectadas.

Aunque el CDC afirma que *las personas con la vacuna completa que no presentan síntomas del COVID-19 no necesitan hacerse la prueba de detección después de haber estado expuestas a una persona contagiada con el COVID-19, es muy posible que personas que quieran viajar tengan que mostrar una prueba de detección negativa para entrar a otro estado o país. Mientras que no haya un pasaporte de vacunas, muchos países requirieran que los visitantes demuestren una prueba de COVID-19 negativa para ingresar a su territorio. El CDC tiene un *planificador de viajes que las personas pueden utilizar para buscar información sobre el COVID-19 en las comunidades estatales, locales, territoriales y tribales que atraviesen en ruta a sus destinos.

La facilidad de obtener pruebas caseras nos ayudar a detener la propagación del COVID-19 e identificar los orígenes de contagio. Poder hacer un seguimiento de contactos en las comunidades afectadas no solo puede prevenir enfermedad, pero también controlar la evolución de nuevas variantes del COVID-19. La conveniencia de poder hacerse la prueba del coronavirus desde la comodidad de la casa y sin receta de un doctor significa tener un mejor control del bienestar de cada persona en nuestras comunidades.

*Links are no longer active as the original sources have removed the content, sometimes due to federal website changes or restructurings

The decline in COVID-19 testing nationwide could derail pandemic response wins

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

COVID-19 testing has been a critical component of the nation’s pandemic response, as health officials monitored the virus’s progression and set policies that supported back-to-school and return-to-work initiatives. Increased testing capacity has enabled our most essential industry sectors to resume activities that continue to carry us through the pandemic. However, as vaccines become more accessible and we surpass initial goals for population-wide immunizations, testing has declined by 35 percent daily since mid-January.

Testing provides a reliable snapshot into the virus’s trajectory that allows for proper allocation of vital resources (e.g., supplies, personal protective equipment (PPE), and medical equipment) and essential personnel. Data from testing rates are also critical for vaccine manufacturers, as they evaluate how the virus is mutating and further efficacy of the vaccine. The uptick in vaccinations, while incredibly promising, may have induced an inflated sense of security and diminished caution towards the virus. However, in the midst of rising variants, the decline in testing may very well be the Trojan horse that derails national efforts to combat the virus.

Testing has also declined in part due to a shift in focus to getting vaccinated. While vaccines are equally important, we need adequate COVID-19 testing for public health surveillance purposes. There needs to be sufficient capacity and public health messaging in place to encourage individuals who have potentially been exposed to SARS-CoV-2, or coronavirus, to get tested immediately.

Dr. Nasia Safdar, Medical Director for Infection Prevention at UW Health, states “we are seeing a decline in testing,” she said. “If we see the numbers continue to decline sharply, at some point then it may not be worthwhile to do widespread testing, but we’re certainly not there yet.” Without these measures, our healthcare system will be rendered unequipped to deal with dormant and emerging threats, like potential outbreaks and continuous mutations of the virus.

There are a couple of strategies that could help us get a hold on precipitous testing rates. It is estimated that a national program for universal mass testing for unvaccinated people would cost a few billion dollars a week—an amount that still presents a cost-benefit when considering potential shutdowns. The American Rescue Plan has appropriated $50 billion for expanded testing, which could help the situation significantly.

Another aspect of the problem is a lack of testing sites. With so many resources currently devoted to expanding vaccination sites at pharmacies and hospitals, people need places to get tested. Greater corporate involvement in the response could be a potential avenue for increasing capacity.

Finally, the Food and Drug Administration (FDA) is working to advance development and approval for over-the-counter (OTC) and point-of-care (POC) tests. Obtaining a greater number of FDA-approved OTC and POC COVID-19 tests could help address issues with logistics and access, and would give schools, workplaces, and communities more options for reliable and accurate screening.

The pandemic is far from over and experts predict that COVID-19 will likely be endemic, meaning it will be detected regularly, even if within small pockets of the population. We need all possible public health interventions at our disposal to ensure that we can effectively limit the spread of the virus and preserve ongoing plans to reopen the economy so that we can start the process to sustainably reintegrate back into society.

Dr. Safdar further emphasized, “the vaccines are great as they are, they’re not 100 percent. There will be a certain number of people that will…contract the illness despite having been vaccinated. It might be a milder condition which is very welcome news, but nonetheless, to make a diagnosis and figure out what treatment is required, you have to get a test.” Testing continues to be a simple, yet powerfully effective measure to prevent the massive spread of COVID-19 and we must persist in our efforts towards early detection.

NCL statement regarding efforts to ban menthol tobacco products

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Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—The National Consumers League (NCL) commends the Food and Drug Administration (FDA) for its efforts to ban menthol cigarettes and flavored cigars. The FDA states it will work to keep menthol flavored tobacco products off the market by enforcing a potential ban against manufacturers, distributors, wholesalers, importers, and retailers. The ban on menthol-flavored tobacco products is a historic measure to address health disparities present in vulnerable communities as a result of unfair marketing practices.

Menthol cigarettes continue to be heavily advertised, widely available, and priced cheaper in Black communities. Tobacco manufacturers have long deployed tactics that lure and entice young people with their menthol-flavored tobacco products, consequently contributing to a gateway for children to initiate cigarette smoking.

“For generations, tobacco companies have disproportionately targeted communities of color with advertisements of highly addictive menthol flavored tobacco products”, said NCL Executive Director, Sally Greenberg. The sales resulting from these predatory marketing practices have ravaged vulnerable communities, particularly African American youth. We applaud this Administration’s effort to protect consumers, particularly from the most marginalized areas of society, from the adverse effects of menthol-flavored tobacco products.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Giving a voice to women facing preterm birth

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By Sally Greenberg, NCL Executive Director

Born out of our historical focus on reducing health inequities in the United States, and a nearly year-long movement to preserve access to approved therapies that fight premature birth, NCL supported the launch of the Preterm Birth Prevention Alliance (PBPA), which brings together a coalition of 15 patient advocacy organizations who share concerns about the grave state of preterm birth in the United States and its disproportionate impact on Black, Indigenous, and women of color.

For the past decade, hydroxyprogesterone caproate, commonly called “17P,” has been the only available FDA-approved treatment option to reduce the risk of recurrent preterm birth. Patients and the healthcare providers who serve them currently have access to one branded and five generic versions of the prescription product. However, in 2020, the FDA proposed withdrawing all forms of 17P, based on conflicting efficacy data from two studies composed of vastly different populations — one inclusive of women in the U.S. most vulnerable to preterm birth and one not. Both studies showed that this class of treatment is safe for both mother and baby.

Despite multiple formal requests to consider additional data and alternate ways to study the efficacy of this class of drugs before effectively depriving women of access, FDA made its recommendation without engaging the most important stakeholders—patients who are at the highest risk and their providers. And even after a recently published meta-analysis showed that 17P injections reduced the risk of preterm birth before 34 weeks in high-risk women with singleton pregnancies, FDA persisted in its recommendation.

The Alliance was formed to stand up for the needs of moms and babies of every race and ethnicity and urge regulators to hear directly from women facing prematurity and their providers about their real-world experiences — in a public hearing — before making a decision on withdrawal.

We believe that evidence of efficacy for Black, Indigenous, and women of color in the United States — who are at highest risk of adverse outcomes — should be more determinative than a lack of demonstrated treatment efficacy on primarily white women from other countries. And we believe that more inclusive studies and data are needed, across more racially and ethnically diverse patient populations, to better understand the causes and impact of disparate outcomes in preterm birth.

Alliance partners currently include:

  • 1,000 Days
  • 2020 Mom
  • American Association of Birth Centers
  • Black Mamas Matter Alliance
  • Black Women’s Health Imperative
  • Expecting Health
  • Healthy Mothers, Healthy Babies Montana
  • HealthyWomen
  • Miracle Babies
  • National Birth Equity Collaborative
  • National Black Midwives Alliance
  • National Consumers League
  • National Partnership for Women & Families
  • Sidelines High-Risk Pregnancy Support
  • SisterReach

Organizations or advocates concerned about the needs of women facing prematurity — whether you are a healthcare professional, maternal and infant health advocate or a health equity champion — are invited to join us and add your voice to this effort.

Learn more and join the Alliance: https://nclnet.org/pbp/

Leading patient advocates launch preterm birth prevention alliance to protect critical access to the sole fda-approved class of therapies to reduce recurrent preterm birth

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April 20, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC—Today, the National Consumers League (NCL), along with a coalition of patient advocacy organizations dedicated to advancing the health of mothers and infants, announced the launch of the Preterm Birth Prevention Alliance.

Members of the Alliance are joining forces in an effort to preserve patient access to the only Food & Drug Administration-approved class of treatments for pregnant women who have previously had an unexpected, or spontaneous, preterm birth. Together, Alliance members seek to ensure that the Food & Drug Administration (FDA) hears concerns from the full range of stakeholders about the potential risks and impact of withdrawal for at-risk pregnant women and their providers.

For the fifth year in a row, the U.S. preterm birth rate has increased (to 10.2 percent of births), and preterm birth and its complications were the second largest contributor to infant death across the country. Preterm birth also represents a significant racial health disparity, with Black women in the U.S. experiencing premature delivery at a rate 50 percent higher than other racial groups throughout the country.

However, in 2020, the FDA proposed withdrawing hydroxyprogesterone caproate, commonly called “17P” or “17-OHPC”, the only FDA-approved class of branded and generic treatments to help prevent the risk of preterm birth in women with a history of spontaneous preterm birth. The FDA is currently determining whether to hold a hearing on the status of 17P, based on conflicting efficacy data from two studies composed of vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not.

“We’re fighting for a more inclusive healthcare system that gives everyone an equal chance to have the best outcomes possible,” said Sally Greenberg, executive director of the National Consumers League. “We don’t believe that removing 17P from the market without gaining a better understanding of who could benefit the most from its use is in the best interests of patients, nor their healthcare providers, particularly as there are no other approved treatment options available.”

To date, 14 organizations have joined NCL to advocate for the health interests of at-risk pregnant women and infants, including: 1,000 Days; 2020 Mom; American Association of Birth Centers; Black Mamas Matter Alliance; Black Women’s Health Imperative; Expecting Health; Healthy Mothers, Healthy Babies Montana; HealthyWomen; Miracle Babies; National Birth Equity Collaborative; National Black Midwives Alliance; National Partnership for Women & Families; Sidelines High-Risk National Support Network; and SisterReach.

“As a trained obstetrician and gynecologist, I know firsthand the impact of preterm birth on Black women and birthing people. I also know that racism – not race – is the driving factor leading the disproportionate impact of preterm birth on Black women and birthing people thereby exacerbating systemic inequities in maternal and infant health. To achieve birth equity, which is the assurance of the conditions of optimal births for all people with a willingness to address racial and social inequities in a sustained effort, we must work to protect and uphold a standard of care for spontaneous, recurrent preterm births and ensure it remains accessible and affordable for all who stand in need,” added Dr. Joia Crear Perry, founder and president of the National Birth Equity Collaborative.

The Preterm Birth Prevention Alliance is calling for the FDA to grant a public hearing to fully consider all of the data, additional research methods, and stakeholder perspectives before deciding whether to withdraw approval of this critical class of therapies. The health of America’s moms and babies warrants the utmost care and consideration.

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About the Preterm Birth Prevention Alliance

The Preterm Birth Prevention Alliance is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, we seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org.

Initial support for the Preterm Birth Prevention Alliance is provided by Covis Pharma.

Antimicrobial Resistance is a major looming threat to global health systems

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By Sally Greenberg, NCL Executive Director

If the pandemic has taught us anything, it’s that threats to our health care system can change lives, both in our communities and around the world. We have learned the value of preparedness and that the ability to respond to massive, impactful events is not easy or without compromise. Thankfully, as summer nears, we see that gradually, countries around the world are in a much better place, thanks to access to vaccines and greater knowledge of how to diagnose and care for patients.

Certainly, we can hope that lessons learned from our recent experience with the COVID-19 pandemic will put us in a better position to identify and address a health issue before it develops to pandemic proportions. But I would urge us to remain vigilant. There are other threats to our health care system that exist and deserve attention…now. One major threat to world health delivery systems is about to have its moment: Antimicrobial Resistance (AMR).

Antimicrobials, which include antibiotics, are critical to maintaining our health. Chances are, in the course of the year, someone in your family will take an antibiotic for an ear infection, an abscessed tooth, a hip replacement, organ transplant, or cancer treatment. In recent years, we have learned that taking too many antibiotics can lead to resistance and therefore a loss of effectiveness. This is true, but it’s important to note that the antimicrobials used to treat resistant infections are much more intense and used in more extreme circumstances than the antibiotics most of us are familiar with.

Antimicrobials fight bacteria and other causes of serious infection and are often the last line of defense against fatal infection. Antimicrobial resistance needs to be taken seriously. The Centers for Disease Control and Prevention (CDC) estimates that approximately three million Americans suffer from AMR infections each year with close to 50,000 deaths annually. Other estimates have placed annual deaths from AMR at 162,000, which makes AMR the third leading cause of death in the U.S. today. Surprised?

Here’s what surprised me: there has only been one new class of antibiotics approved in OVER 30 YEARS. Think about that. We have seen game-changing progress in medicine and treatments for countless diseases and conditions, but not AMR. And then think about how many causes of infection have become resistant to the tools we have to fight them.

AMR is a complex problem that’s not going to be easily solved. It takes years and years and billions of dollars to develop a molecule to fight AMR. Today we are faced with a slim menu of therapeutic options now and we find ourselves years away from expanding those options. I fear that AMR may be our next worldwide health emergency and I am not alone: The World Health Organization (WHO) lists AMR as one of the top ten health threats today. Sadly, it’s not a matter of “if”…but rather “when”.

Medicines don’t work forever. With the limited number of effective antimicrobials, we are looking straight down the barrel of the next health emergency. It’s difficult to even contemplate pivoting from all that we have been through with COVID to a new focus on something else equally frightening, but history tells us that being unprepared comes at a heavy cost. And being prepared is exactly what we need to do.

Jeanette Contreras portrait

Expanded Medicaid coverage for postpartum care

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By NCL Director of Health Policy Jeanette Contreras

The COVID-19 pandemic has enlightened us to how the social determinants of health adversely impact maternal outcomes in low-income, medically underserved communities. Year after year, the United States continues to have the highest maternal mortality ratio among wealthy countries. In efforts to address this disparity, the American Rescue Plan Act includes a provision that allows states to expand Medicaid coverage to women for up to one year after childbirth.

The dismal maternal and infant mortality rates are directly correlated with the health disparities that disproportionately afflict black, indigenous, and women of color. A 2019 report from the Centers for Disease Control and Prevention (CDC) found that Black women were 3.3 times more likely than white women to die from pregnancy-related complications and Native American and Alaska Native women were 2.5 times more likely than white women to die within a year after childbirth.

Medicaid has traditionally been seen as a safety net for low-income pregnant women and children, providing health coverage that funds more than four in ten births in the U.S. each year. Under federal law, Medicaid must cover pregnant women with incomes up to 138 percent of the Federal Poverty Level (FPL) through 60 days postpartum. Each year, over 1.6 million women across the U.S. are effectively placed at risk for becoming uninsured when that 60-day coverage period ends.

Women who live in states that expanded Medicaid under the Affordable Care Act (ACA) are eligible to continue their health coverage through Medicaid. Additionally, the Families First Coronavirus Response Act, which passed last year, provides states with a 6.2 percent increase to the Federal Medical Assistance Percentage (FMAP) rate to cover new enrollees eligible under the ACA Medicaid expansion as long as the Public Health Emergency is in place or at least throughout 2021. However, the women living in the 14 states that have yet to expand Medicaid would find themselves uninsured.

Under the American Rescue Plan, for the next five years, states have the option to extend Medicaid and the Children’s Health Insurance Program (CHIP) eligibility to pregnant individuals for 12 months postpartum. Though each state’s Medicaid program is different, the inclusion of this provision incentivizes states to extend health care to mothers during the most vulnerable time in their lives. This increased access to health care will pave the way towards improving health disparities for our most at-risk women and infants beyond the pandemic.

Consumers face an unfair disadvantage at the pharmacy counter

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By Sally Greenberg, NCL Executive Director

Everywhere we turn these days, we find ourselves wondering if we are getting a fair deal. Americans continue to suffer the economic consequences of a year-long global health pandemic, and many of us are trying to stick to the essentials and stretch our dollars where we can. As COVID-19 has reminded us, there aren’t many issues families face that are more significant than access to health care.

Families can’t go without essential prescriptions and often wonder why the price seems to go up each time they go for a refill. In fact, we are likely paying more than necessary at the pharmacy counter, but we don’t often know — or even think to ask — why.

A variety of factors drive drug costs, some of which are obvious: the cost of research and development, distributing the product, the pharmacies’ profits – but there is one far less known cause of price increases: PBMs, short for pharmacy benefit managers.

Most people have never heard of PBMs, and PBMs like it that way. They are billion-dollar companies that control more than 80 percent of the prescription drug formularies, (formularies are the lists of drugs that a health plan allows its members to access) — in the United States.

Because of their outsized role, too often PBMs determine how much consumers, businesses, government agencies, and others pay for medicines. As originally conceived, PBMs were meant to help ensure that patients get a fair deal by:

  • working with manufacturers to ensure rebates (or savings) for medications
  • working with insurance companies to determine which medications are covered
  • working with pharmacies to set the price points and help reimburse pharmacies for dispensing prescriptions.

In theory, PBMs should be lowering costs for everyone. However, as they have evolved and grown, they’ve become greedy and self-serving entities, scooping up discounts for themselves and throwing consumers under the bus. All the while, their profits continue to soar as they are all among the top Fortune 500 companies.

Sadly, PBMs have also found ways to manipulate the system and put their own profits first.

Insulin is a prime example. Diabetes patients who need their medication to survive are increasingly left with fewer options for treatment. When PBMs get involved, consumer costs increase.

One recent analysis found that the total value of rebates and discounts for insulin on an annual basis amounts to more than $5,000 per patient. Another report explained that the net price on one insulin product — what the company earns as revenue — declined by 53 percent since 2012, while the list price increased 141 percent. As the WSJ story explains, this is in part due to PBM middlemen meddling. In order to ensure formulary positions (which PBMs control), companies are paying more and more each year.

Consumers don’t know where high drug prices come from and they shouldn’t have to — the system needs to deliver affordable, accessible, safe and effective medications without any entities taking an unfair or hidden profit. The stakes are too high as we look ahead to the health challenges that millions face with the Covid pandemic.

NCL joins with many other groups, including America’s Agenda, United Food and Commercial Workers International Union, HMC Healthworks, Union of Bricklayers and Allied Craftworkers, National Community Pharmacists Association, National Alliance of State Pharmacy Associations, Diabetes Leadership Council, and Diabetes Patient Advocacy Coalition in helping to expose hidden, and frankly, indefensible profits being directed to the coffers of PBMs — money that should be redirected to bring drug prices down for patients and consumers.

Let’s all ask hard questions about PBMs’ role in our healthcare system and whether we can’t be using the profits they are taking to lower drug costs. Share this story with others. Talk with your friends and family. Ask your local pharmacist questions.

Consumers – not PBMs — should come first at the pharmacy counter. Stay tuned for more from us on this, and let’s continue the conversation.