Join the National Consumers League for a panel discussion with experts from Health Capital Group, the Community Oncology Alliance, and Johns Hopkins on this new white paper, which analyzes 340B’s impact on hospital profit margins and charitable care spending and attempts to quantify the amount of program benefits accruing to covered entities, contract pharmacies and patients.
By NCL Health Policy Associate Milena Berhane
A lack of diversity in the health care workforce has been a persistent issue in the United States, posing significant implications to health equity, particularly for the Black or African American community.
An estimated five percent of physicians identify as Black, despite making up 13 percent of the U.S. population. A recent study utilizing U.S. Census Bureau information found that the proportion of Black physicians in the United States has only increased by four percent in more than a century — from 1900-2018. This study also reported that the percent of Black male physicians has remained relatively stagnant since 1940. Diversity issues also exist in other health care professions, with an estimated 7.8 percent of nurses, 3.8 percent of dentists, and 2.5 percent of physical therapists being Black.
The education, testing, application, and interviewing process required to pursue a career in health care is rigorous and costly. In addition to a four-year degree, candidates are also required to take standardized exams, pay expensive application fees, and pay for travel to interview. Most medical students expect to spend up to $10,000 for the application process. Once accepted to a health professional program, the tremendous monetary and time costs of schooling are immense obstacles for many. Medical school attendees accumulate an average $200,000 of student loans by the time they are finished with their programs.
Due to generations of systemic racism in our country, Black Americans are less resourced — financially and in terms of social capital — than their white counterparts. The rigorous process of applying to and remaining in health professional programs creates a pipeline that excludes disadvantaged students from the ability to pursue careers in clinical care.
The barriers to enter the workforce have further negative impact on communities and health equity. Black patients face a variety of issues that can influence their ability to access medical care, including medical mistrust caused by historical unethical medical mistreatment faced by Black Americans, dismissal of health concerns that Black patients express to health care providers, and others. Time and time again, Black patients have shared their experiences of medical providers ignoring their health concerns, and therefore being undertreated and going undiagnosed for their conditions. In addition, research indicates that Black patients report poorer patient-provider communication and shared decision-making. These issues lead to Black patients receiving lower quality care from medical providers, further worsening health conditions that could be treated.
Racial bias and a lack of culturally competent medical care in the healthcare system has led to poorer health outcomes for Black patients. Black Americans of all ages already face higher rates of hypertension, asthma, diabetes, and other health issues due to systemic racism and how it has affected the environments they live in, the food they have access to, their education prospects, income, etc. These inequities compiled with a culturally incompetent and bias medical system leaves Black Americans with little ability to receive proper medical treatment and improve their health and well-being. Although medical schools are attempting to teach the importance of culturally competent care, it is crucial that Black patients are also able to access healthcare providers that look like them and come from their communities.
Clearly, the current make up of racial diversity of the health care workforce has failed to keep up with the demographic shifts in the United States. Although public health efforts are important in addressing and improving health equity, inequities within the medical system must be addressed simultaneously. The COVID-19 pandemic has only highlighted and exacerbated health inequities. Increasing the amount of Black health professionals across the United States is a critical step in ensuring better health outcomes for Black patients and their overall well-being.
By NCL Health Policy Associate Milena Berhane
Technology has brought into the homes of millions of consumers many wonderful tools for accessing the drugs and medical products we need. We, as consumers — at the touch of a few buttons — have access to drugs and devices that would have required far more time and effort to acquire in the past. But with that ease of access, we also have millions of tainted or suspect products peddled to consumers, including counterfeit drugs.
At any one time, there are 35,000 active pharmacies online, according to ASOP Global. Ninety-five percent of them do not comply with applicable laws and pharmacy standards. Counterfeit products sold by this 95 percent are manufactured in often unsafe conditions and contain little or no active ingredients.
Those in charge of online registries could better control this. These registries control the websites that can be set up on the Internet, managing domain name extensions such as .com, .gov, and .org, and .pharmacy. It is critical that Internet registries and registrars monitor the activity on their domains and ensure that illegal activity is prevented.
Consumers look for drugs online for both cost and convenience reasons. It’s understandable that consumers are turning to the Internet for cheaper options when the cost of many prescription drug costs is so high. Those who do undoubtedly don’t understand the risk of illegal online pharmacies; research shows only an estimated 37 percent see little danger in ordering from such a pharmacy. In addition, 7 in 10 Americans incorrectly believe that appearing at or near the top of Internet search results legitimizes such a website.
The COVID-19 pandemic has also played a role in these risks, with an increased sale of online goods, including prescription drugs. About 31 percent of consumers who bought prescription medication online did so for the first time in 2020 because of the pandemic. As a result, now more than ever, we need to ensure that illegitimate online pharmacies are far better regulated, and frankly, put out of business.
The examples are stark. In 2021, the Drug Enforcement Administration (DEA) seized more than 9.5 million counterfeit pills, which is more than what was seized in 2020 and 2019 combined. Due to these high numbers, in late 2021, the DEA warned that “fake prescription pills are widely accessible and often sold on social media and e-commerce platforms — making them available to anyone with a smartphone, including minors.”
We believe that online platforms have the responsibility to enforce their terms and conditions. These registries and registrars are choosing profit over safety by allowing online pharmacies to sell fake drugs and products.
For this reason, the National Consumers League is supporting the DRUGS Act (H.R. 6352/S.3399) which aims to holds Internet registries and registrars responsible for any illegal and illegitimate drugs being sold through their online platforms. Modeled after a pilot “trusted notifier” program, this bill would require registries to suspend a website, conduct an investigation, and then shut the platform down if it is found to be selling illegal substances.
In the meantime, NCL will continue to educate consumers about the dangers of counterfeit drugs. NCL’s FakeRx Action Center provides consumers with the tools to protect themselves from fake drugs and illegal online pharmacies — as well as a place to report counterfeits. Consumers have a duty to do their homework, but we have to make it far harder for fakes and counterfeits to be peddled to unwitting consumers. The DRUGS Act will go a long way to make that a reality.
By NCL Director of Health Policy Jeanette Contreras
Consumers have grown to expect surprise medical bills as a given in the fragmented U.S. healthcare system. Even people with large employer-sponsored health insurance coverage could expect to receive a surprise bill for an out-of-network medical service. A 2021 report from the U.S. Department of Health and Human Services outlined how more than half of U.S. consumers reported recently receiving an unexpected medical bill — many related to essential services like childbirth, elective surgeries, or emergency services. Thanks to the No Surprises Act, signed into law as part of the Consolidated Appropriations Act of 2021, surprise medical bills will be a thing of the past.
Beginning January 1, 2022, federal protections ban surprise medical bills any time a person receives emergency care, including some non-emergency services. For example, the new law bans out-of-network charges for out-of-network providers who work at an in-network facility. It also requires that cost-sharing for emergency services, like co-pays and co-insurance, be based on in-network rates.
Healthcare providers and facilities will be required to give patients easy-to-understand notice regarding out-of-network care, explaining that it could be more expensive. Providers will also need to tell patients whom to contact if they think the provider or facility has violated the surprise billing protections. Patients will be able to dispute a claim if they receive a medical bill that is higher than the estimated cost given in advance of care.
Whether or not a patient has insurance, they can submit a complaint about a medical billing issue if they have a question or are concerned that their provider may not be following the new rules. For more help, consumers can go to the CMS.gov webpage to submit a claim online or call the No Surprises Help Desk at 1-800-985-3059, 8am-8pm ET seven days a week; (TTY: 800-985-3059).
By NCL Director of Health Policy Jeanette Contreras with contributions by NCL Intern Grace Mills
The 2022 open enrollment period for the Health Insurance Marketplace is about to begin! Consumers can enroll in a health plan on Healthcare.gov beginning November 1.
As we commemorate Hispanic Heritage Month, the National Consumers League (NCL) wants Latino consumers to better understand their health coverage options through the Health Insurance Marketplace. Latinos make up approximately 18 percent of the U.S. population and represent the largest minority population (62.1 million). However, it is concerning that 22 percent of non-elderly Latinos are uninsured – the highest uninsured rate of any racial group in the United States.
Under the American Rescue Plan, more consumers are now eligible for increased tax credits that further reduce the cost of monthly premiums. An estimated 69 percent of uninsured Latino adults can access a zero-premium plan and 80 percent can access a plan that costs less than $50 a month. Additionally, consumers can use the Healthcare.gov platform to find out if they or their dependents can qualify for Medicaid or the Children’s Health Insurance Program. Here is what you need to know to make sure that you and your loved ones are insured during 2022.
This year, the Centers for Medicare and Medicaid Services (CMS) has issued $80 million in grants to fund Health Care Navigators across the country that are trained and certified to assist consumers with enrolling in a health plan. While agents and brokers are also available, Navigator Grantees are often a trusted source of information in their communities and can offer culturally competent enrollment assistance. Consumers can find local in-person assistance or an agent/broker in their area by clicking here.
¡La inscripción abierta para el Mercado de Seguros Médicos por el año 2022 empezará muy pronto! Los consumidores pueden inscribirse en un plan de salud por medio de CuidadoDeSalud.gov empezando el 1 de noviembre.
Para conmemorar el Mes de la Herencia Hispana, la Liga Nacional de Consumidores (“NCL” por sus siglas en inglés) desea que los consumidores latinos conozcan sus opciones de cobertura de salud a través de los Mercados de Seguros Médicos. Los latinos constituyen el 18% de la población de los Estados Unidos y representan la población de minorías más grande (de 62.1 millones). Sin embargo, nos preocupa que solamente el 22% de los Latinos adultos (que no son mayores) no tienen cobertura de salud y representan la tasa más alta sin seguro médico de todos los grupos raciales en EE. UU.
Bajo el Plan de Rescate Americano (conocido como “American Rescue Plan” en inglés), más consumidores están elegibles por los créditos fiscales que reducen el costo de sus pagos mensuales. Aproximadamente, el 69% de los Latinos (no asegurados} pueden acceder a un plan sin costo alguno y el 80% pueden acceder a un plan que cueste menos de $50 por mes. Además, los consumidores pueden usar la plataforma CuidadoDeSalud.gov para ver si ellos o sus dependientes califican para Medicaid o el Programa de Seguro de Salud Para Niños (conocido como “CHIP” por sus siglas en ingles). Aquí está lo que necesitan saber para que usted y sus seres queridos tengan cobertura médica durante el 2022.
Este año, Los Centros de Servicios de Medicare y Medicaid ha dado un subsidio de $80 millones para financiar los navegadores de salud a través del país que están calificados y certificados para ayudar con la inscripción en un plan de salud. Mientras que los agentes y corredores también están disponibles, los navegadores son una fuente de información en las comunidades latinas y ofrecen a sus comunidades asistencia confiada sobre la inscripción. Los consumidores pueden encontrar asistencia en persona o con un agente/corredor en donde viven, usando el enlace: https://ayudalocal.cuidadodesalud.gov/es/#/
August 13, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242
Washington, DC—The National Consumers League (NCL) has long supported increased access to health coverage for all consumers, regardless of ability to pay. Among other provisions within the American Rescue Plan Act (ARPA) that aim to make health coverage more accessible, the law provides states that have not yet adopted Medicaid expansion with significant financial incentives to do so.
Beginning April 2022, ARPA would extend enhanced federal matching funds past the public health emergency for five years. This incentive is particularly critical to addressing maternal mortality in the United States, ensuring birthing people have access to health coverage in the most vulnerable stage of their lives. Currently, states can extend Medicaid coverage for up to 12 months postpartum following pregnancy for the duration of the pandemic. But once that period ends, states will have to file a section 1115 waiver to continue to extend those benefits through April 1, 2022 when the new law kicks in. To date, three states have approved 1115 waivers expanding Medicaid for up to one year postpartum.
NCL remains concerned that uninsured rates are still high in the states that have not expanded Medicaid. Even under the new law, 37 percent of nonelderly individuals living in the 12 states that have not expanded Medicaid are left uninsured. Ballot initiatives may be an avenue to enhance coverage for uninsured adults in states left to expand Medicaid. Of the states that have expanded Medicaid thus far, Idaho, Maine, Nebraska, Oklahoma, Utah, and Missouri have expanded it as a result of a ballot initiative, while the rest achieved Medicaid expansion either through their governors or state legislatures. Missouri and Oklahoma were able to secure Medicaid expansion by taking the decision straight to the polls, allowing state residents to decide. These victories at the ballot box show that Medicaid expansion is incredibly popular amongst voters in all states, despite the actions of some elected officials. In most cases, it’s largely within the power of the state governor to expand Medicaid to all residents.
Another way states are expanding Medicaid is through Section 1115 Demonstration Waivers, approved by the Centers for Medicare and Medicaid Services (CMS), which allow states to test new approaches to Medicaid in their states. Arizona, Arkansas, Indiana, Iowa, Michigan, Montana, Nebraska, New Hampshire, New Mexico, Ohio, and Utah all have approved Section 1115 waivers to operate their Medicaid expansion programs in ways not otherwise mandated under federal law. Other than New Mexico and Iowa, these Section 1115 waivers impose work requirements as a condition to qualify for Medicaid benefits. Tying health benefits to having a job is problematic in and of itself, but clearly inappropriate to enforce during a pandemic. NCL is encouraged that the Biden Administration has begun the process of withdrawing Section 1115 Demonstration Waivers that include work requirements.
Medicaid expansion is a critical element in achieving health equity, as BIPOC populations are more likely to fall in the Medicaid coverage gap. ARPA includes two years of full federal funding for Medicaid services provided by urban Indian and Native Hawaiian Health Centers. The new law also increases federal Medicaid funding for home- and community-based services (HCBS). Expanding Medicaid would yield economic benefits, as state economies are projected to increase by $350 billion in the span of three years, while also creating 1 million jobs nationwide. NCL supports all efforts leading to Medicaid expansion, which increases access to health care for more Americans.
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) 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 NCL Director of Health Policy Jeanette Contreras
As consumers, when we go to the pharmacy for our medications, we expect a fair price. However, there’s growing evidence that pharmacy benefit managers — or PBMs — have been impeding the savings that should be going to consumers. Consumers deserve to share in the cost savings, and we need policymakers to step in and help make that happen.
We previously wrote about our disappointment in how PBMs have evolved from once honest brokers to becoming profit driven and greedy, now taking savings away from consumers and patients.
One avenue PBMs use to pocket savings is through pharmaceutical rebates. PBMs negotiate with companies to lock in discounts for drugs in order to secure the drugs’ placement on a list (formulary). PBMs have notoriously leveraged formularies to give greatest access to the drugs that pay the PBMs the largest rebates, leaving less expensive drugs off-limits to consumers.
A recent Senate Finance Committee report found that rebates to PBMs have significantly increased since 2013 (some as high as 70 percent). But these discounts fail to lower the patients’ out-of-pocket costs for necessary treatments, such as insulin. For one product, the manufacturer offered the PBM a 56 percent rebate – which means more than half of the savings for insulin are going to a company that doesn’t even make the lifesaving medication.
Insulin is expensive. Forbes recently reported that newer versions cost patients between $175 and $300 a vial. The story points out diabetes patients need multiple vials, the cost of which add up quickly; the total annual value of rebates and discounts for PBMs is likely to be more than $5,000 per patient. As a result, consumers lose, paying more than many of them can afford for lifesaving drugs.
Another way PBMs profit is by avoiding competition, which would drive value and savings for consumers. Three main PBMs accounted for about 60 percent of all U.S. prescription claims in 2019. And when it comes to insulin, with so few industry players, it’s no surprise that consumers again find themselves on the losing end.
We’re pleased to see that some policymakers in the states are taking steps to address these issues. In New Jersey, the state is shaking things up by creating alternatives to how it contracts with PBMs — which is, in turn, increasing competition and benefitting consumers. New Jersey residents are saving a bundle (to the tune of $2.5 billion over five years).
In New Hampshire, a recent study shows that the state can expect to save an estimated $17.8-$22.2 million annually thanks to legislation that will utilize a similar competitive PBM contract process.
While this is encouraging news, there is still more work to be done to bring to light the role of PBMs. Policymakers need to step in to ensure PBMs deliver savings to patients as they were originally intended to do. We’re encouraging state and federal action to review the role PBMs play in driving up costs and to address the many loopholes they use to increase profits.
Consumers — not PBMs — should come first at the pharmacy counter. Reach out to your elected officials. Share this story on social media to help raise awareness. And stay tuned as we continue the conversation.
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.
By NCL Director of Health Policy Jeanette Contreras
As the United States prepares for the release of a third COVID-19 vaccine, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) meets to discuss further implementation considerations that will inform guidance for the vaccine rollout. At its March 1 meeting, ACIP dedicated a portion of the discussion to whether those who’ve recovered from the virus should still be vaccinated.
To date, there are more than 28 million confirmed cases of COVID-19, and experts estimate that the true number of individuals infected, yet not clinically confirmed, to be triple that amount, pushing the total prevalence to approximately 100 million. A recent study by the National Institutes of Health (NIH) indicates that those who’ve recovered will have a certain amount of natural immunity to the virus for up to eight months after infection, which is in line with the findings of a major British study published in early February, in which 88 percent of participants who previously tested positive for COVID-19 still had antibodies after six months.
Considering that the demand is greater than the supply, it is a difficult task to make recommendations for the equitable distribution of vaccines. For example, Spain issued recommendations that patients wait six months after diagnosis to get vaccinated if an individual is under age 55 with no major health complications. People over 55, or those with health risks that make them vulnerable to reinfection, are exempt from this delay and encouraged to be vaccinated.
Additionally, early studies are showing that immunity in individuals who had recovered and received one shot may be equal to or even exceed those not infected who had received two doses. According to the University of Maryland School of Medicine, a single dose of the Moderna or Pfizer mRNA vaccines would elicit an immune system response sufficient to provide comparable immunity to two doses in a non-infected person. On February 12, France became the first country to issue guidance recommending that people who have already recovered from COVID-19 only need to receive one dose of a vaccine, between 3 and 6 months after their infection.
Early research like this is informing public health policies in other countries. But the United States is known all over the world for its scientific rigor and reliance on randomized clinical trial data as a gold standard. In a recent blog, NIH Director Dr. Francis Collins reassures us that, should other studies support these early results, the experts at the Food and Drug Administration (FDA) and CDC will certainly consider whether one dose is enough.
The implementation of a one-dose vaccine would help to increase supply, however, the emergence of COVID-19 variants presents new challenges for curbing this pandemic. Current CDC guidance states that even if you’ve recovered from COVID-19, you should get vaccinated. Arming yourself with a vaccine will keep you and your family safe, and ultimately help to stave off new COVID-19 variants.
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
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.