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

/in , , , /by

April 20, 2021

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

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

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

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

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

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

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

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

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

###

About the Preterm Birth Prevention Alliance

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

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

Antimicrobial Resistance is a major looming threat to global health systems

/in , , , /by

By Sally Greenberg, NCL Executive Director

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

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

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

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

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

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

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

National Consumers League to host first-ever virtual National LifeSmarts Championship April 17-19

/in , , /by

April 16, 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—In celebration of Financial Literacy Month, the National Consumers League (NCL) has announced the nearly 60 champion teams who will gather this weekend to compete in the first-ever virtual National LifeSmarts Championship.

LifeSmarts (LifeSmarts.org), a consumer education competition that challenges teens in grades 9-12 about personal finance, health and safety, the environment, technology, and consumer rights and responsibilities, is a program of the National Consumers League (NCL). In LifeSmarts, students compete online and in-person at the local and state levels. Top-scorers progress to their state competitions, and then State Champion teams meet each April to compete in the National LifeSmarts Championship. In 2019, at the most recent National LifeSmarts Championship, Rhode Island’s Barrington High School took home the title.

A year ago, NCL was forced to cancel the 2020 national event due to the coronavirus pandemic, but 2020 State Champion and Wild Card teams are being welcomed back to compete in the rescheduled event, which will take place simultaneously online along with the 2021 program. In all, 33 teams will compete at the 2021 national event and 24 teams will compete for the 2020 title.

The 2020 and 2021 National LifeSmarts Champion teams will be crowned on Monday, April 19.

Complete roster of state champions teams listed below.

Consumer-savvy teens representing 30 states, the District of Columbia, and 11 Wild Card teams, will compete at this year’s event. Throughout the 2020-2021 program year, more than 100,000 teens competed online for a chance to represent their states at the 2021 National LifeSmarts Championship. Players answered more than 3.5 million consumer questions in the online competition.

“We are so proud of our 2020 and 2021 LifeSmarts champions, who have proven themselves to be the best and the brightest of the next generation of consumers,” said Lisa Hertzberg, National LifeSmarts Program Director. “For 27 years, LifeSmarts has been engaging and educating young consumers in a fun format and with a competitive approach. Our program goes in-depth on the issues kids—and young adults—are facing now as consumers and workers.”

The 2020 and 2021 National LifeSmarts Champions and other winning teams will walk away with prizes and $50,000 in scholarships. In addition to placing as a team, individual students have the opportunity to compete for scholarships by demonstrating knowledge in specific program topic areas. The top eight placing teams and top 10 individuals are recognized, as well as the recipients of specialized scholarships.

NCL thanks the sponsors who make the program possible including Amazon, Johnson & Johnson, Melaleuca, Toyota, American Express, Intuit, and the Washington State Employees Credit Union.

Event kickoff + competition and weekend activities
When: Saturday, April 17 at 1pm Eastern through Monday, April 19
Where: visit LifeSmarts.org for a link to the conference platform and more information about the program

2020 and 2021 National LifeSmarts Champions will be determined in matches taking place on Monday, April 19

Follow the competition online

Parents and supporters can follow the action at Facebook.com/LifeSmarts and via Twitter: #LifeSmartsNationals

2021 National LifeSmarts Championship Teams
Arizona—Altitude 6.0 – Flagstaff Home Educators
Arkansas—Bryant Hornets 4 – Bryant High School
California—Grizzlies2 – Los Osos High School
Connecticut—Crosby Bulldogs- Crosby High School
Florida—Leto Red – Leto High School
Georgia—Columbia County 4-H Senior Team
Hawaii—Waipahu High School
Idaho—Minidoka County 4-H Teen Association
Illinois—West Chicago Community High School
Kansas—Gardner Edgerton High School
Kentucky—Webster County 4-H
Louisiana—West Feliciana High School
Maryland—TWCA Club
Michigan—Fenton Accounting – Fenton High School
Minnesota—LCWM Blue, Lake Crystal Wellcome Memorial
Missouri—BHS Falcons – Blair Oaks High School
New Jersey—Montgomery MFJC – Montgomery High School
North Carolina—CATA Cougars, Central Academy of Technology and Arts
North Dakota—Bottineau High School
Oklahoma—Tiger 2021 – Pryor High School
Pennsylvania—Cumberland Valley High School
Rhode Island—East Greenwich High School Avengers
Tennessee—Putnam County 4-H
Texas—Bartlett FCCLA – Bartlett High School
Virginia—Econoponax – Massaponax High School
Washington—Selah FCCLA – Selah High School
West Virginia—JMHS Marketing – John Marshall High School
Wisconsin—Belleville High School
4-H Wild Card 1—Gordon County 4-H, Georgia
FCCLA Wild Card—Muleshoe Mules – Muleshoe High School, Texas
4-H Wild Card 2—Madison County 4-H, Georgia
Varsity Wild Card 1—North East High School, Pennsylvania
FBLA Wild Card—West Carteret High School FBLA, North Carolina

2020 National LifeSmarts Championship Teams
Arizona—Altitude 5.0 – Flagstaff Home Educators
DC—McKinley Technology High School
Florida—Duval 4-H Diplomats
Georgia—Oconee County 4-H
Illinois—West Chicago Community High School
Kansas—Iola High School
Louisiana—West Feliciana High School
Minnesota—Lake Crystal Wellcome Memorial
Missouri—Husker Varsity 1 – Lafayette County C-1 High School
North Carolina—North Carolina Leadership Academy
North Dakota—Jamestown High School
Oklahoma—Pryor High School
Pennsylvania—Dallas High School
Rhode Island—Barrington High School Blue
Texas—Biz-e-Teen – Midcities Montessori
Virginia—Econoponax – Massaponax High School
West Virginia—The Voluntolds – John Marshall High School
Wisconsin—Tomahawk High School
4-H Wild Card—Rockdale County 4-H, Georgia
FCCLA Wild Card—Niangua High School FCCLA, Missouri
Wild Card 1—Waipahu High School, Hawaii
Wild Card 2—Gwinnett County 4-H , Georgia
Wild Card 3—Sunrise Christian Academy, Kansas
Wild Card 4—4-H Y’all – WIT Home Educators, Virginia

###

About the National Consumers League and LifeSmarts

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.

LifeSmarts is a program of the National Consumers League. State coordinators run the programs on a volunteer basis. For more information, visit: www.LifeSmarts.org, email LifeSmarts@nclnet.org, or call the National Consumers League’s communications department at (202) 835-3323.

NCL statement on pause on J&J vaccine distribution

/in , , , /by

April 14, 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) commends the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) for their concerted efforts to promptly address recent adverse events observed by the Johnson & Johnson COVID-19 vaccine.

The decision for a momentary pause in distribution for the vaccine was enacted out of “an abundance of caution” on part of the CDC and FDA, following reports of 6 severe cases of a rare form of blood clots observed in young women, ranging from ages 18 to 48, roughly one to three weeks after receiving the shot.

Due to its ease of transport and one-shot delivery, the Johnson & Johnson COVID-19 vaccine is the most accessible and convenient vaccine presently on the market. The vaccine has been administered to more than 7 million Americans, with tremendous success. The measure to pause distribution to gather additional evidence is demonstrative of proper coordination between our most essential public health agencies.

The reports of adverse events experienced by patients who received the Johnson & Johnson COVID-19 vaccine are concerning, and NCL appreciates the efforts by public and industry partnerships to identify and resolve the situation. NCL has long advocated for vaccine safety and consumers need to feel confident that they are safe, especially in the midst of a mass vaccination campaign.

All three COVID-19 vaccines on the market have been shown to be effective against preventing severe symptoms and hospitalization from COVID-19. The incidence of adverse outcomes is very rare and should be put into context with the overwhelming benefits of the vaccine to prevent very serious effects of COVID transmission. Consumers should rest assured that vaccines are effective measures to protect public health and are vital to national efforts in ending the pandemic.

###

About the National Consumers League (NCL)

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.

Recognizing 2021 Black Maternal Health Week

/in , , , /by

April 12, 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) applauds the resolution introduced by Representative Alma Adams, (NC-12), Representative Lauren Underwood (IL- 14), and Senator Cory Booker (D-NJ) designating April 11-17, 2021 as national Black Maternal Health Week.

The dismal state of maternal and infant health disparities in the United States continues to disproportionately impact black women and babies. In 2020, the rate of pre-term births—the second largest contributor to infant death in the United States—increased to 10.2 percent of births. Black women experience premature delivery at a rate 50 percent higher than all other American women. To address this disparity, in June 2020 NCL led a coalition of organizations in advocating for the FDA to protect patient access to a critical therapy for pregnant mothers at risk of recurrent preterm birth—lack of access to this therapy could disproportionately and negatively impact women of color.

NCL has long advocated for policies to improve maternal health outcomes and sought to address the persistent racial and ethnic health disparities that lead to adverse birth outcomes for black women. NCL is proud to support the Black Maternal Health Momnibus, a package of 12 bills intended to comprehensively address the maternal health crisis that disproportionately impacts Black, Indigenous, and women of color in this country. NCL also applauded a provision within the American Rescue Plan that allows states to extend Medicaid coverage to women for up to one year after childbirth. This provision to expand postpartum care is vital to improving maternal health outcomes for our most vulnerable moms.

“In order to address the maternal mortality crisis in this country, we need to recognize the link between structural racism and the social determinants of health that contribute to the disproportionately high rate of maternal mortality among Black women. This resolution designating Black Maternal Health Week is an important step in supporting policies to improve maternal health outcomes for Black Mamas,” said NCL Health Policy Director Jeanette Contreras.

###

About the National Consumers League (NCL)

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.

Food insecurity among African and Hispanic American communities in America

/in , , , /by

By Nailah John, Program Associate

Millions of Americans struggle with food insecurity—defined as limited or uncertain access to sufficient, nutritious food. People experiencing severe food insecurity skip meals or go hungry because they lack financial resources to purchase food. Food insecurity is associated with harmful consequences to physical and mental health, along with adverse behavioral and academic outcomes.

With millions of Americans out of work since mid-March 2020 due to COVID-19, low-income families and communities of color, who were already at risk for food insecurity, face even greater hardship. In March and April 2020, 48 percent of African American households and 52 percent of Hispanic households experienced food insecurity, according to data published in the American Journal of Public Health. Over many decades, discriminatory policies and practices have caused African American communities to be more likely to live in poverty, face unemployment, and have fewer financial resources, like savings or property, than their white counterparts.

Food deserts, which are common in low-income areas, have contributed to the crisis of food insecurity. Food deserts are regions where people have limited access to healthy and affordable food. In these areas, people’s nutritional options are often limited to cheaper, high-calorie, and less nutritious food. In eight of the 10 counties in the U.S. with the highest food insecurity rates, more than 60 percent of the residents are African American. Associate Professor of Kinesiology and Nutrition at Northern Illinois University, Odoms-Young, said “it is really not surprising when you consider the drivers of food insecurity: income, employment. It is also an accumulation of disadvantages that happens. I don’t think people always recognize that accumulation—how disadvantages can accumulate over generations and cause those disparities in wealth.”

African American and Hispanic American populations are disproportionately enrolled in the government Supplemental Nutrition Assistance Program (SNAP). This benefits over 35 million Americans. The Biden Administration recently allocated $1 billion to the SNAP benefits distributed each month, which will increase the food stamp benefits of approximately 25 million people. Food insecurity, unfortunately, continues to be a major problem in America, exacerbated by the effects of the pandemic, from the lack of access to reduced-cost school meals to high rates of unemployment.

Access to nutritious food is essential to creating a more healthy, sustainable, and productive society. It is, therefore, crucial that we continue to advocate for African American and Hispanic communities, which are most at risk for food insecurity.

NCL statement on SCOTUS decision in Facebook Inc. v. Duguid

/in , /by

April 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) today urged Congress to act swiftly to address the loophole in federal consumer protection law that was created by the Supreme Court’s recent decision in Facebook v. Duguid. The following statement is attributable to NCL Public Policy Manager Sarah Robinson:

“We are disappointed to see the Supreme Court’s decision narrowing the federal robocall ban. It is clear that Congress must act to update our laws to reflect technological changes and protect consumers from these intrusive practices.”

###

About the National Consumers League (NCL)

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.

Jeanette Contreras portrait

PBMs profit while consumers foot the bill. Policymakers must act

/in , , , , , /by

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.