Today the National Consumers League is celebrating the start of the 15th program year of LifeSmarts, the Ultimate Consumer Challenge! LifeSmarts is an exciting, hands-on educational competition program, run by […]
by Sally Greenberg, NCL Executive Director Some good news for consumers: we’ll soon be getting far better disclosures about potential safety hazards for food and drugs. In a blog about […]
According to a *fresh story in the Associated Press, the United States *Food and Drug Administration has announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the […]
This month, NCL’s featuring tips in its *2008 Consumer Calendar: Have We Got Tips for You! on protecting your phone records from “pretexting,” an *ID Theft technique used by criminals […]
It’s been three years since Hurricane Katrina devastated New Orleans, and as we commemorate the anniversary by remembering the victims and destruction it left behind, the region is once again […]
In Washington, DC, where the National Consumers League is headquartered, today is the first day of school for hundreds of thousands of kids. The DC Metro area is certainly not […]
By Catherine Bourque, NCL Health Intern This summer, Catherine has interned in the health policy department at the National Consumers League. She’s from Washington, DC and, this fall, will begin […]
Yesterday, we shared four sample LifeSmarts question to test your ‘smarts. How’d you do? Foods that bear the radura logo have been: c. Treated by irradiation You are a 16-year-old […]
The back-to-school sales prove it: Summer is coming to an end. During these warm days, NCL staff has been busy preparing for the 2008-2009 LifeSmarts program year, which will officially […]
Everybody’s talking about gas and fuel efficiency these days, but this month we’re celebrating Brake Safety Awareness. Keeping your car in good shape can prevent crashes and protect your investment, […]
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.
