This episode contains sensitive topics, such as abortion and sexual violence, that may be difficult for some audiences. Listener discretion advised.
As listeners of our podcast know, the National Consumers League believes in equal health care access for all, and that includes a woman’s right to choose.
By NCL Health Policy Associate Milena Berhane
Technology has brought into the homes of millions of consumers many wonderful tools for accessing the drugs and medical products we need. We, as consumers — at the touch of a few buttons — have access to drugs and devices that would have required far more time and effort to acquire in the past. But with that ease of access, we also have millions of tainted or suspect products peddled to consumers, including counterfeit drugs.
At any one time, there are 35,000 active pharmacies online, according to ASOP Global. Ninety-five percent of them do not comply with applicable laws and pharmacy standards. Counterfeit products sold by this 95 percent are manufactured in often unsafe conditions and contain little or no active ingredients.
Those in charge of online registries could better control this. These registries control the websites that can be set up on the Internet, managing domain name extensions such as .com, .gov, and .org, and .pharmacy. It is critical that Internet registries and registrars monitor the activity on their domains and ensure that illegal activity is prevented.
Consumers look for drugs online for both cost and convenience reasons. It’s understandable that consumers are turning to the Internet for cheaper options when the cost of many prescription drug costs is so high. Those who do undoubtedly don’t understand the risk of illegal online pharmacies; research shows only an estimated 37 percent see little danger in ordering from such a pharmacy. In addition, 7 in 10 Americans incorrectly believe that appearing at or near the top of Internet search results legitimizes such a website.
The COVID-19 pandemic has also played a role in these risks, with an increased sale of online goods, including prescription drugs. About 31 percent of consumers who bought prescription medication online did so for the first time in 2020 because of the pandemic. As a result, now more than ever, we need to ensure that illegitimate online pharmacies are far better regulated, and frankly, put out of business.
The examples are stark. In 2021, the Drug Enforcement Administration (DEA) seized more than 9.5 million counterfeit pills, which is more than what was seized in 2020 and 2019 combined. Due to these high numbers, in late 2021, the DEA warned that “fake prescription pills are widely accessible and often sold on social media and e-commerce platforms — making them available to anyone with a smartphone, including minors.”
We believe that online platforms have the responsibility to enforce their terms and conditions. These registries and registrars are choosing profit over safety by allowing online pharmacies to sell fake drugs and products.
For this reason, the National Consumers League is supporting the DRUGS Act (H.R. 6352/S.3399) which aims to holds Internet registries and registrars responsible for any illegal and illegitimate drugs being sold through their online platforms. Modeled after a pilot “trusted notifier” program, this bill would require registries to suspend a website, conduct an investigation, and then shut the platform down if it is found to be selling illegal substances.
In the meantime, NCL will continue to educate consumers about the dangers of counterfeit drugs. NCL’s FakeRx Action Center provides consumers with the tools to protect themselves from fake drugs and illegal online pharmacies — as well as a place to report counterfeits. Consumers have a duty to do their homework, but we have to make it far harder for fakes and counterfeits to be peddled to unwitting consumers. The DRUGS Act will go a long way to make that a reality.
January 20, 2022
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242
Washington, DC—The Journal of Studies on Alcohol and Drugs today released new research that reveals the various tactics cannabidiol (CBD) companies use to thwart the Food and Drug Administration (FDA) review process and assert that their therapeutical claims are backed by science.
The study, The Use of Academic Research in Medical-Cannabis Marketing: A Qualitative and Quantitative Review, illuminates the need for FDA regulatory approval and stronger oversight to address the risks to consumers and patients alike when companies exploit that system. The findings reveal nearly 1,000 health claims touting CBD’s ability to mitigate symptoms or treat mental health, autism, pain, sexual health, AIDS, cancer, COVID-19, and more, providing just a snapshot of the current, unregulated marketing tactics being used to mislead the public.
The research was commissioned by Consumers for Safe CBD, a campaign spearheaded by the National Consumers League and conducted by Data Science Solutions. The research took place in the summer of 2020 and was published today in the Journal.
“It’s important that consumers understand what they’re up against when it comes to the current marketplace,” said Sally Greenberg, Executive Director of the National Consumers League. “Day in and day out we see CBD products promoted by celebrities and ‘health experts’ who have no clue what is truly in the products they push. This research helps give a snapshot of just how many misleading claims are out there and will help consumers better understand how to identify — and know to question — marketing red flags.”
“Unfortunately, many CBD manufacturers talk quite a bit about research, but have rarely engaged in the kind of large-scale randomized controlled trials necessary to establish that a drug is safe and effective,” said Theo Caputi, M.P.H, M.SC. author of the study. “CBD products are flooding the retail marketplace — readily available to consumers — and this review shows a serious need for adequate research and testing to ensure safety of these products and effectiveness for the claims companies are making.”
Most of the top medical marijuana companies analyzed:
“It is alarming to see so many companies purposefully evading the FDA process — the gold standard in consumer protection — and making therapeutic claims with little to no real, clinical evidence,” said Greenberg. “Many of these companies have received warning letters from the FDA, yet these harmful and misleading tactics continue. It’s time for Congress to empower FDA to use its full authority to protect consumers. Consumers for Safe CBD will continue to serve as a watchdog to ensure CBD products are safe and effective.”
The CBD market continues to grow despite the FDA stating that CBD cannot be generally regarded as safe (GRAS) for use in food and beverage products. According to a Statista report, CBD sales in the U.S. reached $4.6 billion in 2020. By 2026, the market is expected to grow to $16 billion. Consumers, through these “research as marketing” tactics, have been led to believe that CBD has both medical benefits and health maintenance effects. However, there is only thorough, scientific-backed proof of medical benefits in the one and only FDA-approved CBD prescription drug product available.
“It is arguably unethical and certainly misleading for commercial entities to use the legitimacy of early scientific research — and the announcement of such endeavors — as a marketing tool,” Caputi added, “In fact, this ‘research’ used — or even simply announced in press releases — is not nearly substantial enough to ensure safety and effectiveness of these products for therapeutic use. We must rely on the rigorous FDA approval process to be sure these products meet the gold standard for safety and efficacy.”
Click HERE to read the full study in the Journal of Studies on Alcohol and Drugs.
To learn more about the risks of unregulated CBD, visit 4safecbd.org.
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
By NCL Director of Health Policy Jeanette Contreras
Consumers have grown to expect surprise medical bills as a given in the fragmented U.S. healthcare system. Even people with large employer-sponsored health insurance coverage could expect to receive a surprise bill for an out-of-network medical service. A 2021 report from the U.S. Department of Health and Human Services outlined how more than half of U.S. consumers reported recently receiving an unexpected medical bill — many related to essential services like childbirth, elective surgeries, or emergency services. Thanks to the No Surprises Act, signed into law as part of the Consolidated Appropriations Act of 2021, surprise medical bills will be a thing of the past.
Beginning January 1, 2022, federal protections ban surprise medical bills any time a person receives emergency care, including some non-emergency services. For example, the new law bans out-of-network charges for out-of-network providers who work at an in-network facility. It also requires that cost-sharing for emergency services, like co-pays and co-insurance, be based on in-network rates.
Healthcare providers and facilities will be required to give patients easy-to-understand notice regarding out-of-network care, explaining that it could be more expensive. Providers will also need to tell patients whom to contact if they think the provider or facility has violated the surprise billing protections. Patients will be able to dispute a claim if they receive a medical bill that is higher than the estimated cost given in advance of care.
Whether or not a patient has insurance, they can submit a complaint about a medical billing issue if they have a question or are concerned that their provider may not be following the new rules. For more help, consumers can go to the CMS.gov webpage to submit a claim online or call the No Surprises Help Desk at 1-800-985-3059, 8am-8pm ET seven days a week; (TTY: 800-985-3059).
December 16, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242
Washington, DC—The National Consumers League (NCL) is pleased to support the Increasing Access to Biosimilars Act (S. 1427), as introduced by Senators Michael Bennet (D-CO) and John Cornyn (R-TX). This Act directs the U.S. Department of Health and Human Services (HHS) to launch a pilot program that increases Medicare payments for providers who use biosimilars. Representative Tony Cárdenas (D-CA) introduced a similar bill (H.R. 2869) in the House of Representatives.
Since 2014, the growth in pharmaceutical spending has been primarily driven by increased spending on biologic drugs. Biosimilars demonstrate no clinically meaningful differences in terms of safety, purity, and potency against their FDA-approved biologic counterpart, and are generally 15 percent to 35 percent lower in price. Therefore, biosimilars pose great potential to reduce health care costs.
The Increasing Access to Biosimilars Act would create a new pilot program administered by the Center for Medicare & Medicaid Innovation (CMMI) that aims to encourage physicians to prescribe less expensive biosimilars through shared savings. Shared savings is a payment strategy that offers providers a percentage of any net savings generated in order to reduce health care spending overall.
The following statement can be attributed to NCL’s Health Policy Director Jeanette Contreras:
“This legislation would not only broaden access to cost-saving biosimilars and reduce unnecessary spending on costly biologics, but it could also foster greater competition. In addition, it signals to future participants the viability of the biosimilars market, which is a win for consumers.
NCL believes that well-aligned payment incentives can steer providers toward cost-saving behavior with the overall objective of reducing Medicare expenditures. We strongly urge Congress to pass the Increasing Access to Biosimilars Act as the FDA continues to approve new biosimilars to market at increasing rates.”
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
By NCL Director of Health Policy Jeanette Contreras
Whether it be listening to your grandchildren share a story or having dinner with a friend, many consumers rely on devices to help them hear and understand speech every day. Hearing loss is something that we need to be mindful of at all ages, and as consumers, we look to our nation’s regulators to make sure these devices are safe to use.
Some people with hearing loss are able to work closely with hearing care professionals to finely adjust their hearing aids at sound levels that enable them to hear speech at comfortable levels without causing any harm. But, as more Americans struggle with their hearing, accessible hearing aids becomes increasingly important. Proposed regulations by the Food and Drug Administration will allow hearing aids to be sold over-the-counter to adults with mild-to-moderate hearing loss, a step forward in making them more affordable and accessible.
While these regulations are positive for access, the FDA’s proposed thresholds for volume or output for over-the-counter hearing devices are more in line with those for earbuds people use to listen to music for short periods than they are for hearing aids that are worn for several hours a day. These draft rules would allow a maximum sound output level of between 115 and 120 dBA, which is the equivalent to the volume of a chain saw. According to the CDC, exposure of sounds at 120 dB could become dangerous in as little as nine seconds. As you can imagine, being exposed to this level of sound for long periods of time is unsafe and could increase hearing loss and significantly damage the ear.
Hence, there is widespread concern among hearing care professionals that allowing an unnecessarily high level of amplification can lead to further hearing loss. Leading hearing care associations recommend a maximum output limit of 110 dBA for OTC hearing aids and establishing a gain limit of 25 dB.
As the leading consumer healthcare organization, we applaud the FDA’s efforts to increase access to hearing aids for those who need them. We do hope that the FDA will adjust its proposal, so it is in line with the recommendations of hearing care professionals before finalizing the regulations. Consumers shouldn’t be concerned that they may find their situation worsened by devices that are intended to help.
To learn more about gain and output and how to protect yourself from hearing loss, check out our new infographic.
Healthcare continues to be front and center in the national discourse, particularly in the midst of the pandemic. As Congress works on policy solutions to lower healthcare costs for consumers, we face an unfair disadvantage when it comes to what we’re paying at the pharmacy counter.
November 2, 2021
Media contact: National Consumers League – Carol McKay, carolm@nclnet.org or (412) 945-3242
Washington, DC—The National Consumers League (NCL) applauds the coordinated efforts of the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to approve the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11. Consumers should be reassured that an unbiased advisory committee composed of medical and scientific experts have reviewed the data and have held public meetings to provide Americans with a transparent approval process.
“NCL is committed to educating consumers about vaccine safety and efficacy in order to increase vaccine confidence. Every day, parents make tough decisions to keep their children safe. We want parents to feel informed and empowered in their decision to vaccinate their children. As a parent of two boys ages 8 and 10, I’m looking forward to being able to protect my children from COVID-19 and put this pandemic behind us,” said NCL Director of Health Policy Jeanette Contreras.
Parents and guardians are encouraged to use the CDC’s V-Safe mobile app to tell the CDC about any side effects experienced after getting vaccinated. Parents will be able to add dependents to their account and get reminders if you need an additional dose. Register here: https://vsafe.cdc.gov/
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About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
By NCL Director of Health Policy Jeanette Contreras with contributions by NCL Intern Grace Mills
The 2022 open enrollment period for the Health Insurance Marketplace is about to begin! Consumers can enroll in a health plan on Healthcare.gov beginning November 1.
As we commemorate Hispanic Heritage Month, the National Consumers League (NCL) wants Latino consumers to better understand their health coverage options through the Health Insurance Marketplace. Latinos make up approximately 18 percent of the U.S. population and represent the largest minority population (62.1 million). However, it is concerning that 22 percent of non-elderly Latinos are uninsured – the highest uninsured rate of any racial group in the United States.
Under the American Rescue Plan, more consumers are now eligible for increased tax credits that further reduce the cost of monthly premiums. An estimated 69 percent of uninsured Latino adults can access a zero-premium plan and 80 percent can access a plan that costs less than $50 a month. Additionally, consumers can use the Healthcare.gov platform to find out if they or their dependents can qualify for Medicaid or the Children’s Health Insurance Program. Here is what you need to know to make sure that you and your loved ones are insured during 2022.
This year, the Centers for Medicare and Medicaid Services (CMS) has issued $80 million in grants to fund Health Care Navigators across the country that are trained and certified to assist consumers with enrolling in a health plan. While agents and brokers are also available, Navigator Grantees are often a trusted source of information in their communities and can offer culturally competent enrollment assistance. Consumers can find local in-person assistance or an agent/broker in their area by clicking here.
¡La inscripción abierta para el Mercado de Seguros Médicos por el año 2022 empezará muy pronto! Los consumidores pueden inscribirse en un plan de salud por medio de CuidadoDeSalud.gov empezando el 1 de noviembre.
Para conmemorar el Mes de la Herencia Hispana, la Liga Nacional de Consumidores (“NCL” por sus siglas en inglés) desea que los consumidores latinos conozcan sus opciones de cobertura de salud a través de los Mercados de Seguros Médicos. Los latinos constituyen el 18% de la población de los Estados Unidos y representan la población de minorías más grande (de 62.1 millones). Sin embargo, nos preocupa que solamente el 22% de los Latinos adultos (que no son mayores) no tienen cobertura de salud y representan la tasa más alta sin seguro médico de todos los grupos raciales en EE. UU.
Bajo el Plan de Rescate Americano (conocido como “American Rescue Plan” en inglés), más consumidores están elegibles por los créditos fiscales que reducen el costo de sus pagos mensuales. Aproximadamente, el 69% de los Latinos (no asegurados} pueden acceder a un plan sin costo alguno y el 80% pueden acceder a un plan que cueste menos de $50 por mes. Además, los consumidores pueden usar la plataforma CuidadoDeSalud.gov para ver si ellos o sus dependientes califican para Medicaid o el Programa de Seguro de Salud Para Niños (conocido como “CHIP” por sus siglas en ingles). Aquí está lo que necesitan saber para que usted y sus seres queridos tengan cobertura médica durante el 2022.
Este año, Los Centros de Servicios de Medicare y Medicaid ha dado un subsidio de $80 millones para financiar los navegadores de salud a través del país que están calificados y certificados para ayudar con la inscripción en un plan de salud. Mientras que los agentes y corredores también están disponibles, los navegadores son una fuente de información en las comunidades latinas y ofrecen a sus comunidades asistencia confiada sobre la inscripción. Los consumidores pueden encontrar asistencia en persona o con un agente/corredor en donde viven, usando el enlace: https://ayudalocal.cuidadodesalud.gov/es/#/
CBD-infused foods and candies are often packaged and marketed to appeal to children, but buyer beware – there are a number of harmful ingredients that could be in a seemingly harmless gummy bear. Parents, teachers, guardians, and loved ones should know that none of the non-prescription CBD products on the market today – and the false medical claims often used to market these to consumers – have been tested or approved by the FDA.
The work of the National Consumers League is making a difference in people’s lives across the country. Meet some of the consumers touched by our programs.
Read about NCL’s impact
Paige, 55, a Nashville wife and mother of two, answered an employment ad for secret shoppers. Before sending payment to the scammers, she reached out to NCL.
Read about NCL’s impact
A grease fire flared up in Decklan’s kitchen. As his family scrambled and panicked, fearing that the whole house might erupt in flames, Decklan remained calm. He hurried over to the pantry, grabbed some baking soda, and dumped it on the fire quickly extinguishing the blaze.
Read about NCL’s impact
Cincinnati resident Charles, 45, lost his computer business — and health insurance— during a time of economic downturn. A diabetic, Charles was now unable to afford his medication. He stopped taking it which made him seriously ill and put his life at risk.
Read about NCL’s impact
Jeremy is a fast-food worker who has been employed at a number of Chipotle restaurants in New York City. When he was just 20 years old, he took part in an NCL research project that revealed that management practices within the fast food chain were putting workers—and food safety for customers—at risk.
Read about NCL’s impact
By Sally Greenberg, NCL Executive Director
While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.
The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.
Existing efforts to improve inclusion
Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.
Recognizing the potential for RWE in maternal health
The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.
Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.
Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.
The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.