October 19, 2011 Washington, DC– Voluntary industry guidelines designed to protect hundreds of millions of American consumers from cell phone “bill shock” will only work if the Federal Communications Commission […]
October 18, 2011 Contact: NCL Communications, (2020 835-3323, media@nclnet.org Washington, DC—With this year’s national LifeSmarts competition in full swing, the National Consumers League (NCL), the nation’s oldest consumer organization and […]
October 12, 2011 Contact: NCL Communications, (202) 835-3323, media@nclnet.org Washington, DC—The nation’s oldest consumer organization, the National Consumers League (NCL), today lauded California Governor Jerry Brown for signing into law Senate […]
October 12, 2011 Contact: NCL Communications, (202) 835-3323, media@nclnet.org Washington, DC—The National Consumers League (NCL) has issued the following statement regarding the voluntary guidelines issued by the Interagency Working Group on […]
October 5, 2011 Contact: NCL Communications, (202) 835-3323, media@nclnet.org Washington, DC—The nation’s oldest consumer organization, the National Consumers League (NCL), today lauded a U.S. Consumer Product Safety Commission (CPSC) vote on […]
October 4, 2011 Contact: NCL Communications, (202) 835-3323, media@nclnet.org Washington, D.C.—The National Consumers League will honor Federal Drug Administration (FDA) Commissioner, Dr. Margaret Hamburg, and American Federation of Teachers President, Randi […]
Last week, NCL’s Fraud Center was contacted by a woman we’ll call “Gloria.” Gloria has two young children who just returned to school, and with some extra time on her hands, Gloria began cruising online job boards for part time work.
September 30, 2011 Contact: NCL Communications, (202) 835-3323, media@nclnet.org Washington, DC- The National Consumers League is calling on the FDA to act swiftly to warn consumers about deadly cantaloupes and […]
Table saws cause tens of thousands of serious injuries every year, costing billions of dollars. Approximately 40,000 Americans go to hospital emergency rooms every year with injuries sustained while operating […]
September 14, 2011 Contact: NCL Communications, (202) 835-3323, media@nclnet.org WASHINGTON, D.C. – In a letter to the CEO of the Air Transport Association, a coalition of consumer interest groups today condemned […]
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.
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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.
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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.
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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.
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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.
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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.
