NCL on Upcoming Congressional Hearings with UnitedHealth Group CEO Andrew Witty

April 30, 2024

Media contact: National Consumers League – Melody Merin, melodym@nclnet.org, 202-207-2831

Washington, DC – Tomorrow, the Senate Finance Committee and House Energy and Commerce Committee will hear from UnitedHealth Group CEO on the insurance company’s cyberattack that put millions of medical records and patient privacy at risk.

The cyberattack is, of course, cause for concern, but there are also several other ways major insurance companies like UnitedHealth Group are hurting consumers. These companies have taken over the prescription drug marketplace – they are integrated with the pharmacy benefit managers (PBMs) who gatekeep our prescriptions, limiting access and increasing out-of-pocket costs.

Here are the top questions American consumers deserve answers to:

  • How will your company work to not only protect patient data going forward, but also protect patient choice and power in their healthcare decision-making?
  • Can you explain the relationships and makeup of UHG, Optum Rx, and Optum Health? How does this vertical integration give consumers a fair choice when it comes to their health when there is a clear incentive to keep patients – and thus profit – in the UHG family?
  • UnitedHealth Group’s PBM Optum Rx claims to benefit consumers by negotiating rebates with drug manufacturers – why, then, aren’t consumers experiencing lower costs at the pharmacy counter?
  • How much does Optum Rx collect each year in rebates from drug manufacturers? How much profit does the UHG corporation rake in from prescription drug purchases?
  • Is UHG aware of the significant health and financial challenges that prior authorization requirements impose on consumers and their families?

The insurance industry is riddled with poor incentives that ultimately hurt consumers. Lawmakers have an opportunity this week to shine a light on these problems. We need bipartisan reforms to give consumers more power when it comes to their prescriptions, and ultimately, their health.

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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 nclnet.org.

Consumer struggles with Native American healthcare

By Sam Sears, Health Policy Associate, National Consumers League

My name is Sam Sears, and I am the new Health Policy Associate working at the National Consumers League. I am excited to be working with Robin, Sally, and the rest of the staff at NCL. Consumer issues regarding health care, specifically access and confidence, are wide-reaching and I am thrilled to be able to lend my growing expertise and experience to support the cause and NCL.

I always thought I would end up in healthcare, but my younger self had always envisioned my work with a much more narrowed focus. Academically, my background is in policy and gender studies, where I focused on equal protections for women and queer, specifically related to intimate partner violence and protections and reproductive justice. After graduation, I worked as a barista while also taking placements through a temp agency here in DC, focusing on nonprofits and advocacy organizations. It was, in part, due to the temp placements that I found myself working on broader health policy issues such as the 340B Drug Pricing program and health care access for individuals.

Before joining NCL, I worked at the National Council of Urban Indian Health (NCUIH) for two years, where I was able to learn quite a bit about the healthcare delivery system for Native Americans and the barriers to access that they often face. While NCUIH’s focus is centered on ensuring that Native Americans living in urban settings have access to quality, accessible, and culturally competent health services, much of the work is done collaboratively with other advocates and organizations working within the space. Because of this, my work at NCUIH often was encompassing issues facing the larger community.

Upon joining NCL, I realized that a prominent problem for Native Americans is a much larger area of concern for all Americans and their healthcare – the pervasive and misleading Medicare Advantage plan advertisements seen on television. In fact, in a letter to Centers for Medicaid and Medicare Services (CMS) and Dr. Brooks-LaSure, the CMS Tribal Technical Advisory Group, a group of 17 representatives comprised of elected Tribal leaders or appointed representatives and representatives of national Indian organizations headquartered in DC, highlighted how Medicare Advantage (MA) plans have been “aggressive and invasive when marketing their plans”.

A Kaiser Family Foundation report on the 1,200 unique ads, mostly for MA plans, aired during the enrollment window found that 27% led beneficiaries into thinking they were being recruited for traditional Medicare plans. For Native Americans, this aggressive marketing has led people to enroll in plans that do not include local Indian Health Service providers, meaning they lose coverage and no longer able to go to the doctors they trust to care for them in a culturally competent manner. This confusion is not limited to just Native Americans, as Dr. Brooks-LaSure has stated previously.

It’s important to note that CMS has been addressing the misinformation and confusion from these ads. In April of 2023, the agency released a final rule regarding Medicare Advantage marketing and communications, amongst other Medicare part plans and related topics. Specifically, CMS must now pre-approve all television MA plan advertisements that will air during the open enrollment period, minimizing the opportunity for misinformation and predatory practices within the ads. CMS has also significantly increased its ability to investigate complaints about misleading agents and advertisements. This regulation, while large and with rolling applicability dates, will apply to the 2024 contract year for MA plan marketing and communication, meaning that the open and re-enrollment period at the tail end of the 2024 calendar year will be drastically different.

As I stated earlier, many of the issues that I had worked on while with NCUIH are also applicable to the broader population and community who struggle with access to healthcare. So, I am excited to be able to continue to work on these consumer issues with NCL. And I am eager to see how NCL could support and expand on the work I’ve been able to touch on through my other positions.

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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 nclnet.org.

Americans now have an Obesity Bill of Rights

January 31, 2024

Media contact: Nancy Glick, 202-320-5579, nancyg@nclnet.org; Simona Combi, 571-527-3982, simona.combi@ncoa.org

Washington, DC – Because obesity – the most prevalent and costly chronic disease in the United States –remains largely undiagnosed and untreated a decade after the American Medical Association (AMA) classified it as a serious disease requiring comprehensive care,[1] the National Consumers League (NCL) and National Council on Aging (NCOA) today introduced the nation’s first Obesity Bill of Rights and launched a grassroots movement – Right2ObesityCare – to advance changes in federal, state, and employer policies that will ensure these rights are incorporated into medical practice.

Developed in consultation with leading obesity specialists and endorsed by nearly 40 national obesity and chronic disease organizations, the Obesity Bill of Rights establishes eight essential rights, so people with obesity will be screened, diagnosed, counseled, and treated according to medical guidelines and no longer face widespread weight bias and ageism within the health care system or exclusionary coverage policies by insurers and government agencies.

“Our goal with the Obesity Bill of Rights is to define quality obesity care as the right of all adults and empower those with the disease to ask questions and demand treatment without discrimination or bias regardless of their size or weight” said Sally Greenberg, Chief Executive Officer of the National Consumers League. “For too long, adults with obesity have encountered a health care system that is working against them. They have been stigmatized, discriminated against, not treated with respect by their health providers, and have faced significant hurdles and burdensome requirements to receive obesity care.”

As described by Patricia Nece, J.D., Immediate Past Chair of the Obesity Action Coalition, “For my entire life, I’ve been a target of ridicule simply because of my weight. People rarely take time to look beyond my weight to see me.”

Currently, only 30 million[2] of the estimated 108 million adults living with obesity[3] have been diagnosed with the condition, and only about 2% of those eligible for anti-obesity medications have been prescribed these treatments.[4] The consequence of untreated obesity for the nation is worsening outcomes for over 230 obesity-related chronic diseases,[5] approximately 400,000 premature deaths a year,[6] and an estimated $1.72 trillion in direct and indirect costs to the U.S. economy.[7]

Defining Quality Obesity Care for All
The Obesity Bill of Rights establishes and promotes eight essential rights to drive transformational change and define the core requirements for people with obesity to receive person-centered, quality care:

  1. The Right to Accurate, Clear, Trusted, and Accessible Information on obesity as a treatable chronic disease
  2. The Right to Respect by all members of the integrated care team when screening, counseling, and providing treatment
  3. The Right to Make Treatment Decisions about one’s health goals and obesity care in consultation with the individual’s health providers
  4. The Right to Treatment from Qualified Health Providers including counseling and ongoing care from health providers with expertise in obesity care
  5. The Right to Person-Centered Care that is personalized, respects the individual’s cultural beliefs, meets their specific health goals, and considers the person’s whole health and not just their weight status
  6. The Right to Accessible Obesity Treatment from Health Systems, so those with severe obesity receive care in settings that allow for privacy, using size and weight-accessible equipment and diagnostic scans
  7. The Right for Older Adults to Receive Quality Obesity Care that comprises a respectful, comprehensive care approach consistent with their personalized medical needs
  8. The Right to Coverage for Treatment with access to the full range of treatment options for the person’s disease as prescribed by the individual’s health provider

“Collectively, these rights will ensure that adults with obesity have trusted, accurate information about their disease, respectful and nondiscriminatory care from medical professionals, and insurance that provides access to all treatments deemed appropriate by their health providers,” said Ramsey Alwin, NCOA President and CEO. “In town halls across the country, older adults told us they often feel invisible when seeking obesity care. The Obesity Bill of Rights recognizes and aims to address their unique challenges.”

Putting the Bill of Rights into practice

With the goal of reversing the trajectory of the nation’s obesity epidemic, NCL and NCOA will spearhead Right2ObesityCare, a new grassroots movement to engage people with obesity, their caregivers, health professionals, community leaders, employers, and a network of obesity and chronic disease organizations to drive adoption of the Obesity Bill of Rights in clinical settings.

Using the online hub www.right2obesitycare.org to mobilize stakeholders, Right2ObesityCare will focus on national and state policy efforts, including developing a set of national “obesity goals” for full implementation of the Obesity Bill of Rights by December 31, 2029. Plans include hosting regional town halls, workshops, and advocacy forums across the country; scheduling meetings with federal and state legislators and regulators; and arming interested citizens and advocacy leaders with materials and tools to advocate for implementation of the Obesity Bill of Rights in their communities and workplaces. NCL and NCOA also will pursue development of a model law that stakeholders can use to incorporate the Obesity Bill of Rights into state law.

“The Obesity Bill of Rights brings us a step closer to creating a society where all individuals are treated with respect and without discrimination or bias regardless of their size or weight. Establishing eight essential rights for people living with obesity strengthens efforts to end such blame, shame and discrimination and give individuals who want and need it, access to safe and effective options to improve their health,” added Joe Nadglowski, President and CEO of the Obesity Action Coalition.

Advocacy on implementing the Obesity Bill of Rights also gives policymakers new impetus to pass legislation that will remove the regulatory and insurance obstacles that keep many people with obesity from getting the care prescribed by their health providers.

According to Rep. Brad Wenstrup, DPM (R-OH), “By tackling obesity head on, we can better prevent numerous additional diseases like type 2 diabetes, high blood pressure, and heart disease. My bill, the Treat and Reduce Obesity Act (TROA), expands Medicare beneficiaries’ access to treatment options to include FDA-approved medications, clinical psychologists, registered dieticians, and nutrition professionals. Not only would this legislation help Americans live healthier and longer lives, but it can also save taxpayer dollars over the long run.”

Added Rep. Gwen Moore (D-WI), “Obesity is a chronic condition – not a personal or moral failing. We need to ensure our health care system treats it as a disease, so that Americans with obesity can access holistic, high-quality care that meets the full spectrum of their needs. I am proud to be a co-lead of the Treat and Reduce Obesity Act, which puts us on a path toward effectively treating obesity, helping create healthier outcomes for Americans and supporting enhanced quality of life for Medicare beneficiaries who need comprehensive care.”

Development of the Obesity Bill of Rights

A year in development, the Obesity Bill of Rights is the product of extensive research combined with four town hall meetings hosted in senior centers and churches in California, Delaware, Mississippi, and Oklahoma between June and August 2023. At these town halls, more than 250 older adults, community leaders, and local clinicians described a health care system that is inhospitable to delivering quality obesity care, and physicians described having limited time for counseling, not enough training in obesity management, and inadequate coverage and reimbursement for obesity care.

After turning this knowledge and the lived experiences of older adults into a first draft, NCL and NCOA hosted a roundtable at The Obesity Society annual meeting in October 2023 where leading obesity experts reviewed the preliminary document and made recommendations. NCL and NCOA then sought feedback from specialists in minority health, aging, and rural health, as well as health professionals and other stakeholders who provided additional guidance. The final step was to circulate the updated Obesity Bill of Rights to a wide group of stakeholder organizations, resulting in initial endorsements from 36 obesity, public health, and chronic disease organizations and medical societies.

Nearly 40 consumer, aging, and public health organizations endorse the Obesity Bill of Rights

To date, the following organizations have endorsed the first-ever Obesity Bill of Rights: 1) the Academy of Nutrition and Dietetics; 2) Alliance for Aging Research; 3) Alliance for Women’s Health & Prevention; 4) American College of Occupational and Environmental Medicine; 5) American Medical Women’s Association; 6) American Nurses Association; 7) American Society on Aging;  8) American Society for Nutrition; 9) Association of Black Cardiologists; 10) Association of Diabetes Care & Education Specialists; 11) Bias180; 12) Black Women’s Health Imperative; 13) Choose Healthy Life; 14) ConscienHealth; 15) Council on Black Health; 16) Defeat Malnutrition Today; 17)  Gerontological Society of America; 18) Global Liver Institute; 19) Health Equity Coalition for Chronic Disease; 20) HealthyWomen; 21) Lupus Foundation of America; 22) MANA; 23) National Asian Pacific Center on Aging; 24) National Black Nurses Association; 25) National Hispanic Council on Aging; 26) National Hispanic Health Foundation; 27) National Kidney Foundation; 28) Noom, Inc.; 29) Nurses Obesity Network; 30) Obesity Action Coalition; 31) Obesity Medicine Society;  32) Patients Rising;  33) Partnership to Advance Cardiovascular Health; 34) Preventive Cardiovascular Nurses Association; 35) The Obesity Society; and 36) WeightWatchers.

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About NCL

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. The organization’s 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.

About NCOA

The National Council on Aging is the national voice for every person’s right to age well. We believe that how we age should not be determined by gender, color, sexuality, income, or ZIP code. Working with thousands of national and local partners, we provide resources, tools, best practices, and advocacy to ensure every person can age with health and financial security. Founded in 1950, we are the oldest national organization focused on older adults. Learn more at www.ncoa.org.

 

[1] Obesity Medicine Association. June 19, 2013. “AMA House of Delegates Adopts Policy to Recognize Obesity as a Disease. Accessible at https://obesitymedicine.org/blog/ama-adopts-policy-recognize-obesity-disease/:

[2] PharMetrics-Ambulatory EMR database, 2018. Novo Nordisk Inc.

[3] Hales CM, et al. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. Centers for Disease Control and Prevention. NCHS Data Brief. No. 360. February 2020.

[4] PharMetrics-Ambulatory EMR database, 2018. Novo Nordisk Inc.

[5] Obesity Care Advocacy Network. Fact Sheet: Obesity Care Beyond Weight Loss

[6] Hurt Rt, et al. Obesity epidemic: overview, pathophysiology, and the intensive care unit conundrum. J Parenter Enteral Nutr. 2011 Sep;35(5 Suppl):45-135

[7] Milken Institute (October 2018), “America’s Obesity Crisis: The Health and Economic Costs of Excess Weight.”

NCL Health Policy Associate testifies on behalf of the Preterm Birth Alliance at the FDA hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena

October 17, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington D.C.— Today, NCL Health Policy Associate Milena Berhane representing the Preterm Birth Prevention Alliance testified at The Food and Drug Administration (FDA) hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena or 17P. Milena’s full testimony can be found below.

Hello and thank you for the opportunity to speak today. My name is Milena Berhane, and I am a Health Policy Associate at the National Consumers League. I am here representing The Preterm Birth Prevention Alliance, a coalition of 15 maternal and women’s health advocacy organizations that came together in 2021 with a shared concern about the state of preterm birth in the U.S. and what the proposed withdrawal of Makena and its generics could mean for women at risk.

Collectively, the Alliance seeks to improve preterm birth outcomes in the U.S. by maintaining access to safe, FDA-approved treatments and advocating for more diverse medical research that adequately represents the experiences of newborns and women of color.

Since convening as an Alliance, our members have included the following pre-existing organizations with their own missions, leadership and voices coming together to speak with one voice on this issue. These groups include:

  1. 1,000 Days
  2. 2020Mom
  3. The American Association of Birth Centers
  4. Black Women’s Health Imperative
  5. Black Mama’s Matter Alliance
  6. Expecting Health
  7. Healthy Mothers, Healthy Babies
  8. Healthy Women
  9. Miracle Babies
  10. The National Birth Equity Collaborative
  11. The National Black Midwives Alliance
  12. The National Consumers League
  13. The National Partnership for Women and Families
  14. Sidelines and
  15. SisterReach

Over the next few minutes, I will speak to why we believe it is unnecessary and potentially detrimental to cut off access to this entire class of drugs. And I will address how removing 17P and its generics will not affect all women equally.

For full transparency, the panel should be aware that COVIS Pharma – the sponsors of Makena – are one of more than 100 funders who support the work of the National Consumers League. The company has provided some initial funding to support the Alliance but is not involved in the strategic direction of the Alliance or its activities. And—like all of NCL’s funders—does not hold sway over our positions or efforts.

As I’m sure you know and will hear from many others, women of color have substantially higher rates of preterm birth than their white counterparts. According to the March of Dimes 2021 Report Card, while the U.S. preterm birth rate declined a fraction of a percent in recent years—from 10.2 percent in 2019 to 10.1 percent in 2020—rates of preterm birth increased for Black and American Indian/Alaska Native women, who continue to be up to 60 percent MORE likely to give birth preterm compared to White women.

We at the Alliance believe that the removal of Makena and its generics would exacerbate these inequities and contribute to the already stark divide in maternal and infant health outcomes between Black, Indigenous, and other women of color and their white counterparts.

For more than a decade, maternal-fetal medicine specialists have safely used 17P and its generics to help women with recurrent preterm birth carry their babies closer to term, improving the chances of a healthy birth and reducing the risk of long-term health issues for the infant. Taking it off of the market would mean cutting off access to the only safe and effective drug for this indication, which would leave pregnant women and their providers without an affordable approved alternative.

The Alliance believes the FDA should allow for additional studies to learn which populations 17P is MOST effective in treating. And we believe this can and should happen while maintaining access to 17P for women at high risk of adverse outcomes. Based on available evidence, maternal healthcare providers and their patients should have the opportunity to decide together whether 17P would be beneficial to them in their pregnancy. 

I want to pause on this point of available evidence. All of the clinical trial and real-world evidence to date points to Makena and its generics being safe for women who have had a previous preterm birth. This makes keeping 17P on the market a question of efficacy, not safety. So why aren’t we doing everything possible to understand which populations 17P is most effective in treating before taking it off the market entirely?

Given the discrepancy in efficacy data between the original and confirmatory trials, it seems a logical next step would be to conduct additional efficacy studies in the population known to be at highest risk for recurrent preterm birth, which in the U.S., is Black and indigenous women.

Yet, the proposal to withdraw approval was based not on the original trial – MEIS (“Mees”) – which included nearly 60% African American and other women of color in the United States and found that 17P substantially reduced the rate of recurrent preterm delivery among women at high risk for preterm birth. Instead, the proposal to withdraw seems to be based on the results of the confirmatory trial – PROLONG – which was conducted primarily outside of the U.S. among mostly white European women, and which found Makena to not have the same level of efficacy as in the MEIS trial.

These trials studied two vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not. So the fact that they had different outcomes is not surprising. What doesn’t make sense is why the outcomes among white European women should carry more weight in decision-making than the outcomes among women of color in the U.S.

The Preterm Birth Prevention Alliance believes that evidence of efficacy for women of color in the U.S should be more determinative than a lack of demonstrated efficacy on white women in Europe.

In 2021, a meta-analysis study called EPPPIC (“eh-pick”), published in the Lancet, pooled data from thirty-one randomized trials in asymptomatic women at risk of preterm birth.  It concluded that both 17P injections and vaginal progesterone reduced the risk of preterm birth before 34 weeks in high-risk women with singleton pregnancies. It also noted that shared decision making with women that have high-risk singleton pregnancies, should discuss an individual’s potential risks and benefits. However, despite this reinforcing conclusion about the efficacy of 17P, the agency made no change to its recommendation to remove.

To achieve birth equity and protect the physical, financial, and emotional wellbeing of mothers and infants, we cannot study pregnant women as a monolith.  Instead, we must gain a better understanding of who can benefit most from treatments like 17P, through more diverse studies that include adequate representation from the women in this country who we know are most affected and are at the highest risk.

We believe that this research must explore the causes of disparate outcomes and risk of eliminating approved treatment options before a decision is made. And we believe that while these additional studies are conducted, 17P should absolutely remain available to patients and providers.

This last point is truly critical from the Alliance’s perspective. Considering the proven, life-impacting outcomes from the first clinical trial, years of anecdotal clinical data, and follow-up studies like EPPPIC, we believe that maintaining patient access to 17P while additional studies are conducted is KEY. The Alliance is fighting for a more inclusive healthcare system that gives every pregnant person an equal chance at having the best birth outcomes possible.

We do not believe that removing 17P from the market without understanding who could benefit the most from its use is in the best interests of patients or healthcare providers, especially without any other approved treatment options available. 

Women of color need a seat at the table.

Thank you.

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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 https://nclnet.org.

NCL testifies at The Food and Drug Administration (FDA) hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena

October 17, 2022

Media contact: National Consumers League – Katie Brown, katie@nclnet.org, (202) 207-2832

Washington D.C.— Today, NCL Executive Director Sally Greenberg testified at The Food and Drug Administration (FDA) hearing on the Center for Drug Evaluation and Research’s (CDER’s) proposal to withdraw approval of Makena or 17P. Sally’s full testimony can be found below.

Hello and thank you for the opportunity to speak today. My name is Sally Greenberg, and I am the Executive Director of the National Consumers League, the nation’s oldest consumer advocacy organization. For 123 years, it has been our mission to protect and promote social and economic justice for consumers and to provide the consumer’s perspective on safe and effective medicines and patient-centered health care.

We are deeply concerned about CDER’s recommendation to withdraw all forms of 17P.

We have shared our concerns with the FDA many times over, dating back to our first letter in June of 2020, which urged the agency to protect patient access to this critical therapy for preterm birth. The sentiments outlined in that letter—which was co-signed by more than a dozen maternal and infant health advocates, many of whom you will hear from today—have been reiterated in a series of subsequent letters, statements, and requests for meetings.

And long before that, the National Consumers League spent years advocating for increased regulation and oversight of medication compounding – an issue central to the question of why pregnant women deserve to maintain access to approved 17P, the only class of FDA drugs indicated to prevent a recurrent spontaneous preterm birth.

I appreciate having the time today to share thoughts on behalf of the National Consumers League to share our ongoing concerns and want to start by addressing some of the distortions and half-truths that have been floating around in the public dialogue about 17P over the past few years. I am not a scientist or a doctor, but I take our organization’s mission and ethos, which is rooted in safe products for consumers, and my responsibility as a consumer advocate very seriously. I have talked with numerous scientific, medical, and regulatory experts about this to separate fact from fiction. It is unfortunate that there has to be misinformation about such a serious subject, but that does appear to be the case.

I think you will hear from certain stakeholders that:

Makena should never have been approved. But the truth is that we aren’t here to debate the past. This class of products has been on the market for 10 years, and there is both safety and efficacy data to support that. To state it very simply: We are here today because of new, conflicting efficacy data – but that doesn’t render the original evidence null and void.

You may hear that there is no confirmed clinical benefit to 17P. This is not supported by the existing body of literature or the experiences of hundreds of thousands of American women. The primary basis for FDA approval of Makena was a randomized controlled trial conducted through an NIH network, in the highest risk preterm birth centers in the United States.  The one-third reduction in recurrent preterm birth was described in the New England Journal of Medicine in YEAR. Makena is one of the most well-studied medications given in pregnancy, with data from more than 2,000 women who participated in placebo-controlled trials, and more than 300,000 women treated to date. Every day doctors prescribe 17P for their patients because they have seen evidence of its effectiveness.

You may hear that the benefits of Makena don’t outweigh the risks. This implies that there are safety issues with the therapy. But the published evidence from both clinical trials and ongoing safety surveillance data does not bear this out. We know the FDA can act when there are safety issues. If such issues existed, I find it hard to believe that the FDA – which is one of most stringent and respected regulatory bodies in the world – would have waited three years to act.

You may hear that there are other options that could replace 17P as the standard of care. This is simply not true. With very few medications specifically approved to be given in pregnancy – and no others beyond Makena for recurrent, spontaneous preterm birth – the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine continue to support their members’ expertise in determining if Makena is appropriate for their patients. Yet, the regulatory uncertainty relating to 17P has created what must be an unprecedented situation where some providers are putting their patients on vaginal progesterone, which was previously denied approval for this indication, and is often prescribed in compounded form and would therefore likely not be covered by insurance. I cannot imagine the FDA intended to put healthcare providers and pregnant people in this kind of position when there continues to be a safe, approved standard of care for pregnant women at risk of having preterm birth when the issue at hand is inconclusive data on the effectiveness of two trials. But that is the situation before us.

You may also hear about the precautionary principle of public health as a reason to remove all forms of 17P from the market. Again, this is a diversion that seeks to focus this hearing on implied, non-existent safety issues, rather than on the effectiveness and how it can best be determined for which women this therapy is most effective. I would think the precautionary principle of public health could be much more logically applied to the use of vaginal progesterone for recurrent spontaneous preterm birth, since it was denied approval for this indication but is increasingly being used off-label, in compounded form and therefore not covered by insurance, yet because of the uncertainty being created about 17P because of the current regulatory situation, it is essentially being treated as an approved, equivalent therapy.

 You may hear that the company that manufacturers Makena put those who speak in support of continued access to 17P up to defending the product. No one asked me to do this. After the National Consumers League was chartered in 1899 one of our founders, Florence Kelley, who was a champion for equal rights and consumer protections, led the campaign for enactment of of the first federal health care bill, more commonly known as the Sheppard-Towner Act of 1921, which allocated federal funds to combat elevated mortality rates among mothers and newborns. The money went to state programs for mothers and babies, particularly prenatal and newborn care facilities in rural states. For decades, NCL has worked on our own and in collaboration with other advocates to ensure access to safe therapies. I believe that removing access to 17P – a safe therapy, which has been shown to be effective in its first clinical trial and for hundreds of thousands of women since coming to market – while it is determined for whom the therapy is most effective, would be a dramatic step along a path that seeks to limit access to women’s health care. Every step along that path can lead to negative consequences for the women and families who are affected.

That is why I am here today.  As both a mother, and the leader of an organization that cares greatly about the safety and welfare of consumers and patients.

Personal and shared distress over a decision that could impact the long-term health of hundreds of thousands of women and babies led NCL to spearhead the Preterm Birth Prevention Alliance, a group of 15 advocacy organizations that share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P. My colleague Milena Berhane, who leads the Alliance, will talk on behalf of that coalition at another time during this hearing.

I want to state plainly and for the record that while this is an unprecedented situation, the National Consumers League believes the FDA can create a win-win path that leads to BOTH new data on 17P and protected access for pregnant people.

I also want to break down some specific concerns and thoughts that led to and guide the National Consumer’s League’s commitment to this issue:

Number 1: The risks of leaving women without a safe and affordable alternative. But there are real risks to removing the only approved, safe option for women for this indication and so talked with healthcare providers who care for at-risk pregnant women to understand the risks involved in removing access to 17P. If all versions of Makena were to be removed, all that would be available to pregnant women for recurrent spontaneous preterm birth would be unapproved therapy that is often provided in compounded form.

Compounding has a role in our healthcare system, but creating a situation where more pregnant women with a history of preterm birth are given compounding drugs is an unwise course of action. Even before this issue, NCL led an advocacy effort to promote passage of federal legislation to strengthen laws relating to compounding of medications. We know that if done improperly, the process of compounding can pose significant safety risks.

There has been progress since the 2012 series of medical errors that resulted in the contamination of compounded medicines, which in turn caused a deadly fungal meningitis outbreak in the U.S. — killing more than 70 people and causing more than 750 cases of infection in 20 states. And we know there have been recalls of compounded 17P since the Drug Quality and Security Act (DQSA) of 2013. However, the FDA does not interact with a vast majority of compounders and is often not aware of problems until after the report of an adverse event or contamination.

We strongly urge that all current options remain on the table while additional studies are conducted.

Number 2: The need for more diverse efficacy research on 17P At issue here is the fact that the original clinical trial and subsequent confirmatory trial – upon which the recommendation to remove was based – were essentially comparing apples to oranges. The majority of participants in the first clinical trial (Meis) were African American and other women of color in the United States. This trial demonstrated that 17P substantially reduced the rate of recurrent preterm delivery among women who were at particularly high risk for preterm birth.

The participants in a subsequent confirmatory trial (PROLONG), which was conducted primarily outside of the U.S. after 17P was approved, were predominantly white and Eastern European. While PROLONG reaffirmed the safety of 17P, it did not confirm the same benefit in white European women that it did for women of color in the U.S. But this is not the population at highest risk of preterm birth, either in the U.S. or abroad.

Even after a meta-analysis that pooled data from 31 trials concluded that both 17P injections and vaginal progesterone reduced the risk of preterm birth before 34 weeks in high-risk women with singleton pregnancies, CDER persisted in its recommendation to remove.

Given that there is conflicting efficacy data between the original approval trial and a second confirmatory trial, we are advocating to maintain patient access to a class of treatments while allowing for additional research that reflects the experiences of women in the U.S.

Women most affected by preterm birth are also historically underrepresented in clinical trials. We believe it is critical that more diverse efficacy research be gathered and combined with the extensive amount of real-world evidence on 17P that exists today.

Number 3: The state of preterm birth in the U.S. As other stakeholders have and undoubtedly will testify during this hearing, the state of maternal health and preterm birth in the U.S. is incredibly concerning and many unanswered questions remain relating to it, especially for women of color.

For far too long, U.S. maternal health care has lagged behind that of other developed countries, and maternal health care in the U.S. has consistently failed women of color.

Pregnancy should be one of the most special and exciting times in a woman’s life, with preparation and celebrations to welcome a new addition to the family. I know it was for me. Unfortunately, for about 1 in 10 women in America, their anticipation may be cut short because of an unexpected preterm delivery. Black families, as Black women have a 50% increased risk of delivery before 37 weeks of their pregnancy.

America’s preterm birth crisis led the NAACP to recently spearhead a letter to the FDA, that was also signed by the National Health Law Program, the Prevention Institute and the National Partnership for Women & Families, and stated, and I quote:

The undersigned organizations believe that the confirmed evidence of this treatment for Black women in this country is determinative, and that any disruption of access would be detrimental…As the FDA considers a path forward, we collectively urge the agency to carefully consider all available mechanisms to maintain equitable access to approved 17P while additional evidence can be developed that more accurately reflects underrepresented racial and ethnic patient populations in the U.S.

Preterm birth can have a lasting a physical, mental, emotional, and financial tolls on affected babies and families. Given the dire state of preterm birth in the U.S. and the often-devastating impact of preterm birth on pregnant people and their families, the National Consumers League believes that the decision to utilize 17P in all its forms, branded and generic, should be one left to women and their health care providers. The fact that leading medical societies continue to recognize the role of individual providers and their patients when making treatment decisions about 17P, despite the ongoing regulatory situation, is compelling.

In closing, the company that manufactures the branded version of 17P has publicly said they are willing to do more research – why would we leave that option off the table when clearly there is conflicting efficacy data that needs to be resolved? To remove the only approved and safe therapeutic option to help reduce the likelihood of another spontaneous preterm birth, with the knowledge that the population that most benefits from 17P are women of color –  is not in line with consumer interest.

There is a win-win path here that could lead to both new data and protected access. To the Committee, I urge you to keep this, and the consumer perspective, in mind when making your recommendation to the agency.

Thank you.

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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 https://nclnet.org.

NCL applauds federal funding for maternal health in 2022 appropriations

March 18, 2022

Media contact: National Consumers League –  Katie Brown, katie@nclnet.org, (202) 207-2832

Washington, DC— The National Consumers League applauds the passage of the 2022 omnibus appropriations act. The appropriations bill, signed into law, includes over $1 billion in federal funding to support critical maternal health provisions needed to address the nation’s alarming maternal mortality rates.

We are pleased that many provisions of the Black Maternal Health Momnibus Act of 2021 were included in the FY 2022 appropriations bill. The new law provides a significant increase in funding for the CDC’s safe motherhood & infant health programs. This additional support will help to identify drivers of maternal death rates in the states and expand evidence-based programs and interventions at hospitals and birthing facilities across the nation. The bill also includes a significant funding increase to the Maternal and Child Health Block Grant, which will assist state and local health entities in providing the essential health and social services that our most vulnerable birthing people and babies need.

Provisions from the Maternal Health Quality Improvement Act were also included in the fiscal year 2022 omnibus appropriations bill. These provisions provide funding that supports health professional schools to train future health care professionals about perceptions and biases in maternal health, which currently contribute to inequities in maternal health outcomes. In addition to racial bias, it is critical to invest in diversifying and expanding the perinatal workforce to include nurses, doulas, behavioral health professionals, and other practitioners. In a recent blog post, NCL Health Policy Associate Milena Berhane discusses the importance of diversifying the workforce and the negative impacts of racial bias on the quality of care for racial and ethnic minorities.

We recognize that perinatal suicides, which occur during pregnancy or up to one year postpartum, are a leading cause of maternal mortality in the United States. We are pleased that this appropriations act provides increased federal funding for maternal mental health programs. The additional funding will be critical in expanding access to community-based treatment and recovery services for pregnant people and new mothers who struggle with mental health or behavioral health conditions. The spending bill also funds additional necessary mental health resources, by increasing funding for the 24/7 maternal mental health hotline that is available to pregnant people and new mothers.

NCL applauds Congress for providing funding for critical maternal health provisions within the FY22 Omnibus bill. We will continue to advocate for the passage of additional maternal health provisions in future legislation and spending bills until we end the maternal mortality crisis in our nation.

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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.

Why we need more Black health professionals in the workforce

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.

Happy 8th anniversary to the Affordable Care Act – National Consumers League

Janay JohnsonOn March 23, 2010, in landmark legislation, President Barack Obama signed the Patient Protection and Affordable Care Act (ACA) into law. For the first time, Americans joined the rest of the developed world in hopes the law would bring us closer to realizing a health system where quality, affordable healthcare is available for all, and not a luxury for the privileged few. This sweeping overhaul of our healthcare system was met with mixed emotions: Democrats felt that the work of generations to see universal health care provided was finally fulfilled; the Republican party called it “Obamacare and railed about its many ills.

In the years since that historic day, those partisan sentiments persist. But despite a roller coaster of triumphs and setbacks, the ACA has been a huge success; millions had access to health care and in regions where pent-up demand was particularly acute – rural and urban areas alike.

The early leaders of the National Consumers League – from Florence Kelley to Frances Perkins – strongly supported health care for all Americans, so Obamacare was a fulfillment of our earliest agenda. And Obamacare, despite efforts to destroy its protections is the law of the land. The way health care is accessed and delivered in this country has been has been forever changed—most would say for the better. The ACA ushered in a new era in which comprehensive health coverage is finally within reach for millions of Americans who had been forgotten for way too long. And so today, this eighth anniversary of President Obama putting pen to paper, we acknowledge the ways the ACA has improved our health system. And we have no intention of going back.

Before the ACA was passed, the health insurance landscape looked significantly different. One in four Americans either lacked insurance or was underinsured, sick patients could be turned down for coverage because of pre-existing conditions, plans could charge women more than men for no reason other than their gender, and the cost of insurance was outpacing  Americans’ incomes. In short, our health system was about as lawless as the Wild  West. With the passage of the ACA, sweeping reforms not only outlawed many of the predatory and exclusionary practices that permeated our health care system, but expanded access to coverage and established a list of ten basic services that all health plans were mandated to meet.

Today, more consumers than ever before can get the care they need when they need it. Because of the ACA, nearly 20 million more Americans have gained health insurance. One of the primary ways the ACA achieved this was through the expansion of Medicaid, which extended coverage to millions of previously uninsured low-income individuals. The ACA also permitted young adults to stay on their parents’ insurance until age 26. Perhaps one of the most popular signature features of the ACA is the 10 Essential Health Benefits, including contraception, maternity care, mental health services, prescription drug coverage, and other services that all plans are mandated to provide. Other benefits and consumer protections we can thank the ACA for include a ban on lifetime coverage limits; the abolition of the “gender rating” practice, which allowed plans to charge women more than men; cost-sharing subsidies to help low-income Americans afford their coverage; the elimination of out-of-pocket costs for preventive care services such as immunizations, contraception, and cancer screenings; and a guarantee that an individual cannot be denied coverage or charged more because of a pre-existing condition.

Now of course it’s no secret that the Affordable Care Act has taken a beating. Despite a myriad of unsuccessful attempts by the Republicans to repeal and replace the ACA since its inception, the Trump Administration has made it a point to use whatever regulatory options are available to dismantle the ACA in any way it can. Though tribal loyalty within Congress has intensified exponentially in recent years, it’s time to put partisan politics aside and put the well-being of the American people first. Is the Affordable Care Act perfect? No. Is there room for improvement? Of course. But rather than tearing it apart, Republicans and Democrats should come together and strategize on how we can work together to strengthen and improve the ACA to better serve everyone.

At the White House signing ceremony in 2010, President Obama said in reference to the passage of the ACA, ” Our presence here today is remarkable and improbable. It’s been easy at times to doubt our ability to do such a big thing, such a complicated thing, to wonder if there are limits to what we as a people can still achieve.  But today we are affirming that essential truth…that we are not a nation that scales back its aspirations. We are a nation that does what is hard, what is necessary, what is right. Here in this country, we shape our own destiny.” And so even in these topsy-turvy political times, when it may seem that the protections we hold most dear are under attack and the progress we have made is at risk of being undone, we must remember that when we stand together, anything is possible – no matter how big, complicated, or improbable. The power of the people has always been stronger than the people in power and we have shown, particularly in the efforts to protect the Affordable Care Act, just how powerful we are. It is this spirit that vitalized advocates and everyday citizens to demand something better from our healthcare system, this spirit that saw the Affordable Care Act through to fruition, and the same spirit that will embolden us to defend it in the days ahead. And while we will continue to be steadfast in the fight to protect our care, today, we take a moment to celebrate how Obamacare revolutionized America’s health care system, provided access to health care for millions of underserved Americans in need, and has shown how fundamental it is for a nation with America’s riches to provide health care to all.

The path to mental health reform – National Consumers League

By Stephanie Sperry, NCL health policy intern

Mental illness in the United States is a public health crisis. On March 7, 2018, the Center for American Progress hosted a discussion between Sacramento Mayor Darrell Steinberg and New York City First Lady Chirlane McCray, covering the efforts of cities and states on the path to mental health reform.

Mental illness is not limited by age, gender, race, or geographic location, and proposed cuts to Medicaid and the Affordable Care Act will severely limit treatment options for those in need. Research done by the National Institute of Mental Health showed that annually, 1 in 6 adults in the United States experience mental illness. In the absence of national leadership efforts and support on the mental health front, First Lady McCray pioneered the ThriveNYC framework in 2015 to initiate an agenda for mental health reform, while Mayor Steinberg set about to change the delivery of mental health services by authoring the California Mental Health Services Act (Proposition 63) in 2004.

ThriveNYC aims to “reduce the toll of mental illness, promote mental health, and protect New Yorkers’ resiliency, self-esteem, family strength, and joy.”  It was built on 6 guiding principles: changing the culture of mental health; acting early with interventions; closing treatment gaps with wider access to care; partnering with communities to create solutions; using data better to provide accurate information and tools to City agencies, treatment providers, and others; and strengthening the government’s ability to lead through expectations of accountability and responsibility. First Lady McCray gave examples of current efforts, including the incorporation of screening for maternal depression during physician visits and training 250,000 people in mental health first aid. She explained that early detection is valuable, because 50% of the time, symptoms of mental illness emerge by age 14, and 75% of the time by age 24.  Early treatment can greatly reduce the long-term adverse consequences of mental illness, while saving both time and money.

Sacramento Mayor Steinberg called mental health the “under-attended issue in our time and in our society.” After both the Community Mental Health Act, signed by President John F. Kennedy in 1963, and the Lanterman–Petris–Short (LPS) Act, signed by Governor Ronald Reagan in 1967, failed to deliver on their promises to address mental health for over 50 years, Steinberg took action. He was instrumental in the creation and passage of the California Mental Health Services Act (Proposition 63, 2004). This Act imposed a 1% tax on personal income more than $1 million, with revenue going into the “Mental Health Services Fund”. This Fund aims to support county mental health programs and monitor progress toward statewide goals, with an emphasis on prevention, early intervention, and the expansion of programs serving affected or at-risk individuals.

In addition to dedicated funding, technology has a unique part to play in strengthening mental health reform. Mayor Steinberg noted the innovative work of Mindstrong Health, which uses digital phenotyping to collect biomarker measurements from smartphone use to provide information about an individual’s mood, cognition, and behavior. This can deliver insights to patients and providers, helping to diagnose and manage mental illness by establishing a baseline and spotting and analyzing deviations from it.

The discussion between Mayor Steinberg and First Lady McCray was a fascinating snapshot into state and local efforts to tackle the monumental challenge that mental illness presents in society. The National Consumers League applauds these two local leaders – and their counterparts across the country – for launching initiatives to improve prevention, detection, and treatment of mental illness, and laying the groundwork for better mental health outcomes.

President’s Day: A time to celebrate two great men and modern medicine – National Consumers League

Happy President’s Day! Given who is currently sitting in the White House, let’s change the subject and celebrate modern medicine as it affected the two American Presidents we are celebrating this holiday. Reading the news this week about the flu virus, I was reminded about how lucky we are in 2017 to avoid the scourge of infectious disease that afflicted both Presidents George Washington and Abraham Lincoln, two of my favorite presidents and the two this holiday is named for. 

As the flu season is in full tilt and a deadly one this year, if I had a nickel for every person who said, “I don’t get a flu shot because I think it gives you the flu,” I’d be a millionaire. No, flu shots don’t make you sick; and though they say the flu shot this year is only 36 percent effective, I’ll take those odds. According to reports, an estimated 4,000 people have died this year. The vast majority haven’t been vaccinated.

A headline in The Washington Post this week was overly grim. The article was great but the headline was misleading, focusing on the 36 percent statistic.

Read deeper and you find that administering the flu shot in children younger than 9 offers much greater protection to them, reducing by more than half the risk of becoming so sick that they need to see a doctor. That data comes against the backdrop of at least 63 kids dying from flu since October 1. As in past winter flu seasons, about three-quarters of children who have died were not fully vaccinated, officials said. That is critically important information for parents! My headline would have read:

Flu shot provides unusually high protection to children this year

This tracks with history. A new analysis of seasonal flu deaths in U.S. children in the six seasons since the 2009 pandemic found that children ages 2 and younger are most at risk. Of the children who died during those years, less than a third had been vaccinated. In other words, vaccination gives your kids a much better chance of fighting the virus.

But back to my favorite presidents—George Washington and Abraham Lincoln. Washington would have lived longer—and Lincoln and his wife Mary Todd Lincoln would not have been so terribly broken by the deaths of their young children from typhoid fever—had they been living today. Now, thanks to modern medicine, we get a shot that protects us from typhoid fever. NCL history tracks similar tragedy. Florence Kelley, NCL’s first general secretary, wrote often about the deaths of her siblings in the late 1800s, calling them the “dark days of diphtheria.” Today we get a shot to prevent diphtheria.

George Washington, it turns out, suffered from a host of infectious diseases in his lifetime. “There are many points before and after the Revolutionary War when he could have died,” said Dr. Howard Markel, director of University of Michigan’s Center for the History of Medicine. “He was really quite ill, even when he was president.” Today, Washington would have had a preventive shot for diphtheria and taken antibiotics for the tonsillitis that likely killed him at the ripe old age of 67; his body was weakened by fending off infectious disease after disease.

So consumers, don’t let anyone tell you NOT to get the flu shot—and don’t believe the urban myth: it will NOT give you the flu. There’s nothing the shot will do but increase your odds—and those of your children—from succumbing to the virulent virus. The Presidents we celebrate this week would have relished this chance to stave off disease. Let’s appreciate all that they did for America and at the same time thank modern medicine for the leaps and bounds we’ve made in fighting deadly infectious diseases.