The boom in e-commerce has been a boon for fraudsters
The COVID-19 pandemic has greatly accelerated the growth of e-commerce…
The COVID-19 pandemic has greatly accelerated the growth of e-commerce…
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.
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) is delighted to support the Protecting Seniors through Immunizations Act of 2021 (H.R. 1978/S. 912), introduced by Senators Mazie Hirono (D-HI), Tim Scott (R-SC), Sheldon Whitehouse (D-RI), and Shelley Moore Capito (R-WV), and Representatives Ann Kuster (D-NH) and Larry Bucshon (R-IN). The bill would expand access to immunizations for seniors by eliminating cost sharing for vaccines covered under Medicare Part D.
The legislation would eliminate out-of-pocket costs for all vaccines recommended by Centers for Disease Control and Prevention (CDC) and covered under Medicare Part D. This would apply to crucial immunizations such as the Shingles and tetanus, diphtheria, and pertussis, or Tdap, vaccines, along with future vaccinations. Currently all CDC recommended vaccines are covered with no out-of-pocket costs under private insurance, Medicaid, and Medicare Part B. Unfortunately, Medicare beneficiaries must often pay out-of-pocket costs of up to $160 for vaccines covered under Part D.
“As healthcare costs continue to skyrocket, policymakers should support legislation that eliminates financial barriers for Medicare beneficiaries to get their CDC recommended vaccines,” said NCL Director of Health Policy Jeanette Contreras. “Research shows that higher cost-sharing means fewer seniors will elect to receive their vaccines. By eliminating out-of-pocket costs for immunizations, older Americans will be better protected from vaccine preventable illnesses.”
More than 50,000 American adults die from vaccine-preventable diseases every year. Among other provisions, this bill would increase education about vaccines for Medicare beneficiaries and would authorize a study to find ways to boost adult vaccination rates. These steps are important at a time when misinformation regarding vaccine safety is spreading rampantly throughout society. Improving access to and utilization of vaccinations will enhance overall health outcomes and help to address existing racial and socioeconomic health disparities.
“Vaccines are amongst the most effective public health measures at our disposal. Routine immunizations can prevent diseases that have the potential to cause severe disease and wreak havoc on our most vulnerable communities,” said Contreras. “We urge Congress to pass the Protecting Seniors Through Immunization Act, to ensure greater equity in access to vaccines, in turn protecting the most vulnerable members in society from unnecessary and easily preventable illness and death.”
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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.
By Sarah Robinson, Public Policy Manager
Earlier this month, NCL joined other consumer advocates and industry stakeholders in an event to highlight our consensus that Congress must act to create strong federal consumer privacy rights urgently. We joined colleagues at the 21st Century Privacy Coalition, the Business Software Alliance, and Common Sense Media in calling on Congress to commit to passing comprehensive privacy legislation by the end of the 117th Congress. In a virtual press conference, the groups, along with Rep. Jan Schakowsky (D-IL), Rep. Gus Bilirakis (R-FL), and Sen. Richard Blumenthal (D-CT) agreed that Congressional action to strengthen consumers’ privacy rights is long overdue.
The Washington Post Editorial Board highlighted our event stating, “the surprising degree of consensus around not only the general necessity of nationwide data protections but also the particulars” makes taking action a “no-brainer.” A recent poll from Morning Consult revealed 80 percent of both Democrats and Republicans said Congress should make privacy a “top” or “important” priority in 2021.
There is bipartisan consensus and agreement from organizations across the spectrum that Congress must act. NCL’s message at the event is that it is now time to craft legislation that gives consumers back control over their personal data. At the event, Rep. Schakowsky, the chairwoman of the House Subcommittee on Consumer Protection and Commerce, announced her intention to hold a series of bipartisan roundtable discussions to examine ways to pass comprehensive privacy legislation. NCL is ready and eager to participate in those conversations to help ensure that a comprehensive bill gives all consumers strong, enforceable privacy rights.
While passing legislation this Congress is a priority, NCL made clear that we are not going to simply bargain away long held principles on data privacy. NCL believes that in order to protect the privacy and security of consumers’ personal data, the legislation must not preempt stronger state laws, must include strong enforcement provisions, including a private right of action and provide consumers with strong substantive privacy rights. The right legislation will include effective enforcement mechanisms that safeguard privacy rights for consumers and enshrine rules of the road for businesses.
We applaud Reps. Schakowsky and Bilirakis, and Sen. Blumenthal for their leadership and their commitment to continue fighting for comprehensive privacy legislation. We hope to continue to cooperate with this esteemed group as we work to achieve our shared goal.
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.
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.
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) applauds the Senate for voting to overturn the OCC’s “fake lender” rule, which allows predatory lenders to evade state interest rate laws by putting a bank’s name on the paperwork. In a 52 – 47 bipartisan vote this week, the U.S. Senate voted to approve S.J. Res. 15, a resolution under the Congressional Review Act (CRA), which was introduced by Senators Chris Van Hollen (D-MD) and Sherrod Brown (D-OH). Rep. “Chuy” García introduced a parallel resolution, H.J. Res. 35, in the U.S. House of Representatives. Now that the Senate has approved the resolution, the House needs to take swift action to stop the ongoing harm.
“We applaud this bipartisan rejection of rent-a-bank schemes,” said Sarah Robinson, NCL’s Public Policy Manager. “As consumers and small businesses look to rebuild from the devastation of the coronavirus pandemic, they must be protected from predatory lending. We now urge the House to move with urgency to prevent this rule from continuing to do harm.”
NCL was part of a broad coalition of more than 375 organizations representing all 50 states and the District of Columbia calling on Congress to overturn the “fake lender” rule, which threatens to harm consumers nationwide.
The rushed “fake lender” rule took effect in December and was issued by the Office of the Comptroller of the Currency (OCC). The rule protects “rent-a-bank” schemes whereby predatory lenders (the true lender) launder their loans through a few rogue banks (the fake lender), which are exempt from state interest rate caps. The rule overrides 200 years’ worth of case law allowing courts to see through usury law evasions to the truth and replaces it with a pro-evasion rule that looks only at the fine print on the loan agreement. Predatory lenders charging 100 percent to 200 percent APR are already starting to push high-cost installment loans across the country that exceed the rates permitted under states’ laws.
A broad, bipartisan cross-section of experts and officials have called on Congress to repeal the fake lender rule. They include a bipartisan group of 25 state attorneys general, concerned the rule would effectively gut their state usury laws. The Conference of State Bank Supervisors, National Association of Consumer Credit Administrators, National Association of Federally-Insured Credit Unions, and many other groups also support Congress overturning the rule.
According to national polling, two-thirds of voters (66 percent) are concerned about the ability of high-cost lenders to arrange loans through banks at rates higher than the state laws allowed.
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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.
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) supports Peloton Interactive Inc’s decision to recall its Tread+ treadmill.
“The company has finally come to its senses and agreed to recall its treadmill, which has been caused deadly injuries to children,” said NCL Executive Director Sally Greenberg. “Use of Peloton’s Tread+ exercise machines resulted in at least 72 reports of injuries, including the death of a 6-year-old boy.”
There were also 29 reports of children suffering broken bones, cuts, and abrasions. The agency that regulates these products, the Consumer Product Safety Commission (CPSC), took the unusual step of issuing an administrative subpoena in April when the company refused to provide information about the fatal injury to a child.
“It’s critically important that the company work with the CPSC to recall 125,000 treadmills, at no cost to customers, and safely replace or repair the treadmills so they no longer pose a threat to children or pets,” Greenberg said.
The recall agreement was accepted Wednesday morning in a vote by the Commission. The agreement requires Peloton to halt sales of the Tread+ machine and fully refund consumers who wish to return their equipment.
Greenberg also pointed out how problematic CPSC’s rules are for launching a recall like this one and called on Congress to amend its statute. “We agree with Acting Chair Robert Adler’s assessment that the CPSC faces nearly insurmountable hurdles in protecting the public because, under its statute, the Commission is required to negotiate at length with companies before it is allowed to issue any safety warnings. No other federal safety agency is under such restrictions. That needs to change for the safety of the public.”
To read our previous statement concerning the Peloton Tread+ recall controversy, click here.
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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.
May 6, 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—The National Consumers League (NCL), America’s pioneering consumer and worker advocacy organization, welcomes yesterday’s withdrawal of the Trump Administration’s “Independent Contractor Rule,” which would have too narrowly defined who is an “employee” under the Fair Labor Standards Act (FLSA).
“The Trump Administration’s ‘Independent Contractor Rule’ would have been bad for American workers, especially women and those who toil in low-wage industries. It would have made it easier to classify workers like construction workers, farmworkers, Uber- and Lyft- drivers, janitors, and care givers as ‘independent contractors,’ denying them the rights and benefits ’employees’ have. It would have left workers already vulnerable to wage theft and safety risks even more at risk,” said NCL Executive Director Sally Greenberg.
In its announcement about the impending rule’s withdrawal, the U.S. Department of Labor noted that the FLSA requires employees be paid “at least the federal minimum wage for every hour they work and overtime compensation at not less than one-and-one half times their regular rate of pay for every hour over 40 in a work week.” Withdrawing the new rule preserves these essential worker rights and other protections granted by the FLSA.
DOL rightfully noted that independent contractor designations are not necessary to provide workers with flexible hours—something proponents of the new rule had suggested. “Employment and flexibility are not mutually exclusive,” said DOL.
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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.
The work of the National Consumers League is making a difference in people’s lives across the country. Meet some of the consumers touched by our programs.
Read about NCL’s impact
Paige, 55, a Nashville wife and mother of two, answered an employment ad for secret shoppers. Before sending payment to the scammers, she reached out to NCL.
Read about NCL’s impact
A grease fire flared up in Decklan’s kitchen. As his family scrambled and panicked, fearing that the whole house might erupt in flames, Decklan remained calm. He hurried over to the pantry, grabbed some baking soda, and dumped it on the fire quickly extinguishing the blaze.
Read about NCL’s impact
Cincinnati resident Charles, 45, lost his computer business — and health insurance— during a time of economic downturn. A diabetic, Charles was now unable to afford his medication. He stopped taking it which made him seriously ill and put his life at risk.
Read about NCL’s impact
Jeremy is a fast-food worker who has been employed at a number of Chipotle restaurants in New York City. When he was just 20 years old, he took part in an NCL research project that revealed that management practices within the fast food chain were putting workers—and food safety for customers—at risk.
Read about NCL’s impact
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PBPA Commends HHS Funding to Support Maternal and Infant Health
The Preterm Birth Prevention Alliance (PBPA), a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, applauds the U.S. Department of Health and Human Services (HHS) for awarding nearly $350 million to states across the country to improve support for safe pregnancies and healthy babies.
“For far too long, U.S. maternal health care has lagged behind that of other developed countries, particularly for women of color,” noted Sally Greenberg, Executive Director of the National Consumers League. “This additional funding will enable local health departments and nonprofits to better address the health care needs of the most vulnerable mothers and their babies.”
The funding, awarded by HHS’ Health Resources and Services Administration (HRSA), will support home visiting services, increase access to doulas, address infant mortality and maternal illness, and improve data reporting on maternal mortality.
“Maternal health care in the U.S. has consistently failed women of color,” Greenberg continued. “We applaud HHS for this additional funding that will help to improve the maternal health for all mothers and babies, especially women of color and those most at-risk.”
The funding announcement follows the release of a report by the U.S. Commission on Civil Rights which found that Native American women are more than two times more likely to die from pregnancy-related complications than white women in the U.S. This disparity was further exacerbated for Black women in the U.S., who are three to four times more likely to die from pregnancy-related complications than white women.
“In addition to expanding programs to support maternal health, we must increase representation from racially and ethnically diverse groups in research and clinical trials, particularly those studying treatment options to prevent maternal morbidity and mortality,” said Greenberg. “The need for the additional HHS funding and the report from the Commission on Civil Rights clearly illustrate how critical representative research and real world evidence are to ensuring all mothers and their babies have the same opportunity for the best possible health outcomes.”
/in Blog, Health, Prevention Blog Post
By Sally Greenberg, NCL Executive Director
While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.
The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.
Existing efforts to improve inclusion
Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.
Recognizing the potential for RWE in maternal health
The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.
Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.
Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.
The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.
PRETERM BIRTH PREVENTION ALLIANCE APPLAUDS FDA’S GRANTING OF HEARING FOR THE ONLY FDA-APPROVED THERAPIES TO REDUCE RECURRENT PRETERM BIRTH
WASHINGTON, DC, August 26, 2021 –
Preterm Birth Prevention Alliance a coalition of maternal and women’s health advocates dedicated to improving preterm birth outcomes in the United States and addressing its disproportionate impact on women of color, commends the U.S. Food and Drug Administration (FDA) for granting a public hearing to discuss 17P, the only FDA-approved class of branded and generic treatments to reduce preterm birth in indicated patients.
We appreciate the FDA’s willingness to hear directly from individuals facing prematurity and the providers who treat them about their experiences with 17P,” said National Consumer League’s Executive Director Sally Greenberg. “It is an important step towards better understanding variations in efficacy across diverse populations and ensuring all women have an equal chance at the best possible outcomes.”
Last week, the FDA agreed to grant Covis Pharma, the manufacturer of the branded 17P product Makena its request for a public hearing to discuss 17P. Hydroxyprogesterone caproate—or “17P”—has been approved since 2011 and is the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth in the United States. In 2020, the FDA proposed withdrawing 17P in all its forms, including the branded product and its five generic versions, based on conflicting efficacy data from two studies composed of vastly different populations, one predominantly inclusive of women in the U.S. most vulnerable to preterm birth and one not.
“Mothers and birthing people deserve access to the best possible treatments to prevent preterm birth. We cannot achieve birth equity if we study pregnant women as a monolith,” said Blythe Thomas, Initiative Director of 1,000 Days. “It is only by systematically researching the real-world, post-market impact of 17P on individuals from a variety of racial and ethnic backgrounds, while maintaining access for all affected, that we can reduce disparities in maternal and infant health.”
While the hearing date has not yet been set, the Alliance looks forward to sharing the perspectives of affected individuals and their physicians with the agency once the hearing is scheduled and will continue to advocate for at-risk moms and babies of all races and ethnicities.
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ABOUT THE PRETERM BIRTH PREVENTION ALLIANCE
The Preterm Birth Prevention Alliance (PBPA) 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, the 15 partners in the PBPA 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
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
WASHINGTON, DC, April 20, 2021 – 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 America 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.
MEDIA CONTACT:
Carol McKay, carolm@nclnet.org
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